## Protocol Section
### Identification Module
**NCT ID:** NCT01467479

**Brief Title:** A Study to Treat Subjects With Telaprevir, Ribavirin, and Peginterferon Who Are Coinfected With HIV and Hepatitis C Virus (HCV)

**Official Title:** An Open Label,Phase 3 Study of Telaprevir in Combination With Peginterferon Alfa 2a (Pegasys®) and Ribavirin (Copegus®) in Subjects Coinfected With Genotype 1 Hepatitis C Virus and Human Immunodeficiency Virus Type 1(HCV/HIV-1)

#### Organization Study ID Info
**ID:** VX11-950-115
#### Organization
**Class:** INDUSTRY
**Full Name:** Vertex Pharmaceuticals Incorporated
### Status Module
#### Completion Date
**Date:** 2014-02

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2015-03-17

**Type:** ESTIMATED

**Last Update Submit Date:** 2015-03-03

**Overall Status:** TERMINATED

#### Primary Completion Date
**Date:** 2014-02

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2015-03-17

**Type:** ESTIMATED

**Results First Submit Date:** 2015-03-03

**Results First Submit QC Date:** 2015-03-03

#### Start Date
**Date:** 2011-12

**Status Verified Date:** 2015-03

#### Study First Post Date
**Date:** 2011-11-08
**Type:** ESTIMATED
**Study First Submit Date:** 2011-11-03
**Study First Submit QC Date:** 2011-11-07
**Why Stopped:** It was decided by Sponsor on 13 January 2014 to terminate study early at primary efficacy endpoint as part of a decision to modify drug development plan.
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Vertex Pharmaceuticals Incorporated

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** The purpose of this study is to treat human immunodeficiency virus (HIV) and Hepatitis C Virus (HCV) co-infected subjects with telaprevir, pegylated interferon alfa-2a (Peg-IFN-alfa-2a), and ribavirin (RBV) to achieve undetectable hepatitis C virus ribonucleic acid (HCV RNA) 12 weeks after the last planned dose of study drug.

### Conditions Module

**Conditions:**

- Hepatitis C

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 185

**Type:** ACTUAL

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participants who were receiving atazanavir/ritonavir (ATV/r) based highly active antiretroviral therapy (HAART) at baseline, received Telaprevir (T)1125 milligram (mg) tablet twice daily for 12 weeks in combination with pegylated interferon alfa 2a (P) (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (R) (RBV) tablet orally twice daily at a dose of 800 milligram per day (mg/day) for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.

**Intervention Names:**

- Drug: Telaprevir

- Drug: Ribavirin

- Biological: Pegylated Interferon Alfa-2a

- Drug: Highly Active Antiretroviral Therapy (HAART)

**Label:** T/PR + HAART Regimen (ATV/r-Based)

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Participants who were receiving efavirenz (EFV) based highly active antiretroviral therapy (HAART) at baseline, received Telaprevir (T)1125 milligram (mg) tablet three times a day for 12 weeks in combination with pegylated interferon alfa 2a (P) (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (R) (RBV) tablet orally twice daily at a dose of 800 milligram per day (mg/day) for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.

**Intervention Names:**

- Drug: Telaprevir

- Drug: Ribavirin

- Biological: Pegylated Interferon Alfa-2a

- Drug: Highly Active Antiretroviral Therapy (HAART)

**Label:** T/PR + HAART Regimen (EFV-Based)

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** Participants who were receiving raltegravir (RAL) based highly active antiretroviral therapy (HAART) at baseline, received Telaprevir (T)1125 milligram (mg) tablet twice daily for 12 weeks in combination with pegylated interferon alfa 2a (P) (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (R) (RBV) tablet orally twice daily at a dose of 800 milligram per day (mg/day) for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.

**Intervention Names:**

- Drug: Telaprevir

- Drug: Ribavirin

- Biological: Pegylated Interferon Alfa-2a

- Drug: Highly Active Antiretroviral Therapy (HAART)

**Label:** T/PR + HAART Regimen (RAL-Based)

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- T/PR + HAART Regimen (ATV/r-Based)

- T/PR + HAART Regimen (EFV-Based)

- T/PR + HAART Regimen (RAL-Based)

**Description:** Tablet

**Name:** Telaprevir

**Other Names:**

- VX-950

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- T/PR + HAART Regimen (ATV/r-Based)

- T/PR + HAART Regimen (EFV-Based)

- T/PR + HAART Regimen (RAL-Based)

**Description:** Tablet

**Name:** Ribavirin

**Other Names:**

- Copegus®

- RBV

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- T/PR + HAART Regimen (ATV/r-Based)

- T/PR + HAART Regimen (EFV-Based)

- T/PR + HAART Regimen (RAL-Based)

**Description:** Subcutaneous Injection

**Name:** Pegylated Interferon Alfa-2a

**Other Names:**

- Pegasys®

- Peg-IFN-Alfa-2a

**Type:** BIOLOGICAL

#### Intervention 4

**Arm Group Labels:**

- T/PR + HAART Regimen (ATV/r-Based)

- T/PR + HAART Regimen (EFV-Based)

- T/PR + HAART Regimen (RAL-Based)

**Description:** Atazanavir/ritonavir (ATV/r) based HAART, Efavirenz (EFV) based HAART, or Raltegravir (RAL) based HAART, as per standard practice. HAART medications were not considered study drugs.

**Name:** Highly Active Antiretroviral Therapy (HAART)

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** SVR 12 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (\<lower limit of quantification) at 12 weeks after last planned dose of study drug. The plasma hepatitis C virus ribonucleic acid (HCV RNA) level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL).

**Measure:** Percentage of Participants With Sustained Viral Response 12 Weeks After Last Planned Dose of Study Drug (SVR12)

**Time Frame:** 12 weeks after last planned dose of study drug (up to Week 60)

#### Secondary Outcomes

**Description:** SVR 24 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (\<lower limit of quantification) at 24 weeks after last planned dose of study drug. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL).

**Measure:** Percentage of Participants With Sustained Viral Response 24 Weeks After Last Planned Dose of Study Drug (SVR 24)

**Time Frame:** 24 weeks after last planned dose of study drug (up to Week 72)

**Description:** The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL. RVR was defined as undetectable HCV RNA (\<lower limit of quantification) 4 weeks after the start of study treatment.

**Measure:** Percentage of Participants With Rapid Viral Response (RVR)

**Time Frame:** Week 4

**Description:** The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL. eRVR was defined as undetectable HCV RNA (\<lower limit of quantification) at both 4 weeks and 12 weeks after the start of study treatment.

**Measure:** Percentage of Participants With Extended Rapid Viral Response (eRVR)

**Time Frame:** Week 4 and Week 12

**Description:** The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL. Percentage of participants with undetectable HCV RNA (\<lower limit of quantification) at EOT (up to Week 48) are reported. Data for this outcome was not planned to be reported by prior response.

**Measure:** Percentage of Participants With Undetectable HCV RNA at End of Treatment (EOT)

**Time Frame:** EOT (up to Week 48)

**Description:** AE: any untoward medical occurrence in a participant during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after the informed consent form is signed. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event.

**Measure:** Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

**Time Frame:** Up to Week 52

**Description:** Cmax, Cmin, and Cavg were reported for atazanavir (ATV), efavirenz (EFV), raltegravir (RAL), and telaprevir.

**Measure:** Maximum (Cmax), Minimum (Cmin), and Average Plasma Concentration (Cavg)

**Time Frame:** Day -14 to Day -1 and Week 1 for ATV, EFV, and RAL; Week 1 for telaprevir

**Description:** Sequence analysis of the HCV NS3-4A region was performed to monitor telaprevir-resistant variants. HCV RNA was isolated from the plasma, amplified by reverse transcription-polymerase chain reaction (RT-PCR), and sequenced (sequencing assay limit of detection HCV RNA \>=1000 IU/mL). Results of this outcome measure were to be reported for overall participants instead of by HAART treatment.

**Measure:** Number of Participants With Telaprevir Resistant HCV Variant at Non-Structural Viral Protein 3-4A (NS3-4A) Region

**Time Frame:** Baseline, follow-up (Week 96)

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Participants must have chronic, genotype 1a or 1b, hepatitis C with HCV RNA greater than (\>) 1000 international units per milliliter (IU/mL)
* Population A: HCV Pegylated interferon (Peg-IFN)/RBV treatment naive (received no prior HCV therapy)or Peg-IFN/RBV prior treatment with relapse
* Population B: Peg-IFN/RBV prior null or partial responder
* Participants must not have achieved undetectable HCV RNA 24 weeks after the last planned dose of study drug (SVR24) after at least 1 prior course of Peg IFN/RBV therapy of standard duration
* Participant must have positive HIV antibody at Screening
* Participant must have a diagnosis of HIV-1 infection \>6 months before Screening
* Participants should be taking 1 of the following permissible highly active antiretroviral therapy (HAART) regimens for HIV continuously for 12 weeks prior to screening:

  * Atripla® or equivalent components (efavirenz, tenofovir, emtricitabine)
  * Efavirenz plus Epzicom® (abacavir, lamivudine) or equivalent components
  * Boosted atazanavir (atazanavir with ritonavir) plus Truvada® (tenofovir, emtricitabine) or equivalent components
  * Boosted atazanavir plus Epzicom®, or equivalent components
  * Raltegravir plus Truvada®, or equivalent components
  * Raltegravir plus Epzicom®, or equivalent components
* Cluster of differentiation 4 (CD4) counts and human immunodeficiency virus Type 1 (HIV-1) ribonucleic acid (RNA) meeting acceptable criteria at Screening as specified in the protocol
* Laboratory values within acceptable ranges at Screening as specified in the protocol

Exclusion Criteria:

* Subjects anticipating a need to switch HAART regimens within 14 weeks after Day 1 or any switches occurring 12 weeks prior to Day 1
* Use of azidothymidine (AZT), didanosine (ddI) or stavudine (d4T) nucleosides
* Contraindications to any planned HAART component as per the respective drug labeling information
* Contraindications to Peg-IFN or RBV
* Evidence of hepatic decompensation
* Clinical suspicion of acute hepatitis
* Any other cause of liver disease in addition to hepatitis C
* History of organ transplantation (except cornea and skin)
* Autoimmune-mediated disease
* Participated in any investigational drug study within 90 days before Day 1
* Previous treatment with an HCV protease inhibitor

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Birmingham

**Country:** United States

**Facility:** Alabama

**State:** Alabama

**Location 2:**

**City:** Bakersfield

**Country:** United States

**Facility:** California

**State:** California

**Location 3:**

**City:** Beverly Hills

**Country:** United States

**Facility:** California

**State:** California

**Location 4:**

**City:** Coronado

**Country:** United States

**Facility:** California

**State:** California

**Location 5:**

**City:** Los Angeles

**Country:** United States

**Facility:** California

**State:** California

**Location 6:**

**City:** Oakland

**Country:** United States

**Facility:** California

**State:** California

**Location 7:**

**City:** Palo Alto

**Country:** United States

**Facility:** California

**State:** California

**Location 8:**

**City:** Sacremento

**Country:** United States

**Facility:** California

**State:** California

**Location 9:**

**City:** San Diego

**Country:** United States

**Facility:** California

**State:** California

**Location 10:**

**City:** San Francisco

**Country:** United States

**Facility:** California

**State:** California

**Location 11:**

**City:** New Haven

**Country:** United States

**Facility:** Connecticut

**State:** Connecticut

**Location 12:**

**City:** Washington DC

**Country:** United States

**Facility:** DC

**State:** District of Columbia

**Location 13:**

**City:** Washington

**Country:** United States

**Facility:** Washington, DC

**State:** District of Columbia

**Location 14:**

**City:** Bay Pines

**Country:** United States

**Facility:** Florida

**State:** Florida

**Location 15:**

**City:** Jacksonville

**Country:** United States

**Facility:** Florida

**State:** Florida

**Location 16:**

**City:** Miami

**Country:** United States

**Facility:** Florida

**State:** Florida

**Location 17:**

**City:** Orlando

**Country:** United States

**Facility:** Florida

**State:** Florida

**Location 18:**

**City:** West Palm Beach

**Country:** United States

**Facility:** Florida

**State:** Florida

**Location 19:**

**City:** Atlanta

**Country:** United States

**Facility:** Georgia

**State:** Georgia

**Location 20:**

**City:** Decatur

**Country:** United States

**Facility:** Georgia

**State:** Georgia

**Location 21:**

**City:** Chicago

**Country:** United States

**Facility:** Illinois

**State:** Illinois

**Location 22:**

**City:** Portland

**Country:** United States

**Facility:** Maine

**State:** Maine

**Location 23:**

**City:** Baltimore

**Country:** United States

**Facility:** Maryland

**State:** Maryland

**Location 24:**

**City:** Lutherville

**Country:** United States

**Facility:** Maryland

**State:** Maryland

**Location 25:**

**City:** Springfield

**Country:** United States

**Facility:** Massachusetts

**State:** Massachusetts

**Location 26:**

**City:** Detroit

**Country:** United States

**Facility:** Michigan

**State:** Michigan

**Location 27:**

**City:** Minneapolis

**Country:** United States

**Facility:** Minnesota

**State:** Minnesota

**Location 28:**

**City:** Kansas City

**Country:** United States

**Facility:** Missouri

**State:** Missouri

**Location 29:**

**City:** Saint Louis

**Country:** United States

**Facility:** Missouri

**State:** Missouri

**Location 30:**

**City:** Newark

**Country:** United States

**Facility:** New Jersey

**State:** New Jersey

**Location 31:**

**City:** Santa Fe

**Country:** United States

**Facility:** New Mexico

**State:** New Mexico

**Location 32:**

**City:** Bronx

**Country:** United States

**Facility:** New York

**State:** New York

**Location 33:**

**City:** New York

**Country:** United States

**Facility:** New York

**State:** New York

**Location 34:**

**City:** Rochester

**Country:** United States

**Facility:** New York

**State:** New York

**Location 35:**

**City:** Durham

**Country:** United States

**Facility:** North Carolina

**State:** North Carolina

**Location 36:**

**City:** Cincinnati

**Country:** United States

**Facility:** Ohio

**State:** Ohio

**Location 37:**

**City:** Cleveland

**Country:** United States

**Facility:** Ohio

**State:** Ohio

**Location 38:**

**City:** Portland

**Country:** United States

**Facility:** Oregon

**State:** Oregon

**Location 39:**

**City:** Philadelphia

**Country:** United States

**Facility:** Pennsylvania

**State:** Pennsylvania

**Location 40:**

**City:** Providence

**Country:** United States

**Facility:** Rhode Island

**State:** Rhode Island

**Location 41:**

**City:** Columbia

**Country:** United States

**Facility:** South Carlonia

**State:** South Carolina

**Location 42:**

**City:** Dallas

**Country:** United States

**Facility:** Texas

**State:** Texas

**Location 43:**

**City:** Houston

**Country:** United States

**Facility:** Texas

**State:** Texas

**Location 44:**

**City:** Salt Lake City

**Country:** United States

**Facility:** Utah

**State:** Utah

**Location 45:**

**City:** Richmond

**Country:** United States

**Facility:** Virginia

**State:** Virginia

**Location 46:**

**City:** Seattle

**Country:** United States

**Facility:** Washington

**State:** Washington

**Location 47:**

**City:** Edmonton

**Country:** Canada

**Facility:** Edmonton

**State:** Alberta

**Location 48:**

**City:** Vancouver

**Country:** Canada

**Facility:** Vancouver

**State:** British Columbia

**Location 49:**

**City:** Hamilton

**Country:** Canada

**Facility:** Hamilton

**State:** Ontario

**Location 50:**

**City:** Toronto

**Country:** Canada

**Facility:** Toronto

**State:** Ontario

**Location 51:**

**City:** Montreal

**Country:** Canada

**Facility:** Montreal

**State:** Quebec

**Location 52:**

**City:** Bonn

**Country:** Germany

**Facility:** Bonn

**Location 53:**

**City:** Essen

**Country:** Germany

**Facility:** Essen

**Location 54:**

**City:** Hamburg

**Country:** Germany

**Facility:** Hamburg

**Location 55:**

**City:** Munchen

**Country:** Germany

**Facility:** Munchen

**Location 56:**

**City:** San Juan

**Country:** Puerto Rico

**Facility:** Puerto Rico

**Location 57:**

**City:** Badalona

**Country:** Spain

**Facility:** Spain

**Location 58:**

**City:** Barcelona

**Country:** Spain

**Facility:** Barcelona

**Location 59:**

**City:** Madrid

**Country:** Spain

**Facility:** Madrid

#### Overall Officials

**Official 1:**

**Affiliation:** Vertex Pharmaceuticals Incorporated

**Name:** Medical Monitor

**Role:** STUDY_DIRECTOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000008107

- Term: Liver Diseases

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000006525

- Term: Hepatitis, Viral, Human

- ID: D000014777

- Term: Virus Diseases

- ID: D000007239

- Term: Infections

- ID: D000004769

- Term: Enterovirus Infections

- ID: D000010850

- Term: Picornaviridae Infections

- ID: D000012327

- Term: RNA Virus Infections

- ID: D000086982

- Term: Blood-Borne Infections

- ID: D000003141

- Term: Communicable Diseases

- ID: D000018178

- Term: Flaviviridae Infections

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M9592

- Name: Hepatitis A

- Relevance: HIGH

- As Found: Hepatitis

- ID: M9591

- Name: Hepatitis

- Relevance: HIGH

- As Found: Hepatitis

- ID: M3522

- Name: Acquired Immunodeficiency Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M18250

- Name: HIV Infections

- Relevance: LOW

- As Found: Unknown

- ID: M17522

- Name: Virus Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M9611

- Name: Hepatitis C

- Relevance: HIGH

- As Found: Hepatitis C

- ID: M10199

- Name: Immunologic Deficiency Syndromes

- Relevance: LOW

- As Found: Unknown

- ID: M11107

- Name: Liver Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M9610

- Name: Hepatitis, Viral, Human

- Relevance: LOW

- As Found: Unknown

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7930

- Name: Enterovirus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M13745

- Name: Picornaviridae Infections

- Relevance: LOW

- As Found: Unknown

- ID: M15149

- Name: RNA Virus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M2593

- Name: Blood-Borne Infections

- Relevance: LOW

- As Found: Unknown

- ID: M20324

- Name: Flaviviridae Infections

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000006506

- Term: Hepatitis A

- ID: D000006526

- Term: Hepatitis C

- ID: D000006505

- Term: Hepatitis

### Intervention Browse Module - Ancestors

- ID: D000000970

- Term: Antineoplastic Agents

- ID: D000000998

- Term: Antiviral Agents

- ID: D000000890

- Term: Anti-Infective Agents

- ID: D000000963

- Term: Antimetabolites

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000007155

- Term: Immunologic Factors

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: ANeo

- Name: Antineoplastic Agents

### Intervention Browse Module - Browse Leaves

- ID: M21394

- Name: Ritonavir

- Relevance: LOW

- As Found: Unknown

- ID: M10407

- Name: Interferons

- Relevance: HIGH

- As Found: Recurrent

- ID: M340137

- Name: Efavirenz

- Relevance: LOW

- As Found: Unknown

- ID: M19243

- Name: Interferon-alpha

- Relevance: HIGH

- As Found: Status

- ID: M15083

- Name: Ribavirin

- Relevance: HIGH

- As Found: Bevacizumab

- ID: M247369

- Name: Peginterferon alfa-2a

- Relevance: HIGH

- As Found: Releasing

- ID: M1685

- Name: Interferon alpha-2

- Relevance: HIGH

- As Found: Observation

- ID: M25428

- Name: Anti-Retroviral Agents

- Relevance: HIGH

- As Found: Skeletal

- ID: M333

- Name: Raltegravir Potassium

- Relevance: LOW

- As Found: Unknown

- ID: M415

- Name: Atazanavir Sulfate

- Relevance: LOW

- As Found: Unknown

- ID: M4314

- Name: Antiviral Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4214

- Name: Anti-Infective Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4281

- Name: Antimetabolites

- Relevance: LOW

- As Found: Unknown

- ID: M10201

- Name: Immunologic Factors

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000007372

- Term: Interferons

- ID: D000012254

- Term: Ribavirin

- ID: D000016898

- Term: Interferon-alpha

- ID: D000077190

- Term: Interferon alpha-2

- ID: C000100416

- Term: Peginterferon alfa-2a

- ID: D000044966

- Term: Anti-Retroviral Agents

### Misc Info Module

#### Removed Countries

- Country: Mexico

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

**Description:** Adverse events were planned to be reported as per HAART treatment.

#### Event Groups

**Group ID:** EG000

**Title:** T/PR + HAART Regimen (ATV/r-Based)

**Description:** Participants who were receiving ATV/r based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.

**ID:** EG000

**Other Num Affected:** 54

**Other Num at Risk:** 54

**Serious Number Affected:** 7

**Serious Number At Risk:** 54

**Title:** T/PR + HAART Regimen (ATV/r-Based)

**Group ID:** EG001

**Title:** T/PR + HAART Regimen (EFV-Based)

**Description:** Participants who were receiving EFV based HAART at baseline, received Telaprevir 1125 mg tablet three times a day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.

**ID:** EG001

**Other Num Affected:** 66

**Other Num at Risk:** 69

**Serious Number Affected:** 8

**Serious Number At Risk:** 69

**Title:** T/PR + HAART Regimen (EFV-Based)

**Group ID:** EG002

**Title:** T/PR + HAART Regimen (RAL-Based)

**Description:** Participants who were receiving RAL based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.

**ID:** EG002

**Other Num Affected:** 56

**Other Num at Risk:** 59

**Serious Number Affected:** 9

**Serious Number At Risk:** 59

**Title:** T/PR + HAART Regimen (RAL-Based)

**Frequency Threshold:** 0

#### Other Events

**Term:** Nausea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Diarrhoea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Vomiting

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Anorectal discomfort

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Anal pruritus

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Haemorrhoids

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Dry mouth

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Constipation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Abdominal pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Cheilitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Gastrooesophageal reflux disease

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Aphthous stomatitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Dyspepsia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Abdominal pain upper

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Proctalgia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Rectal haemorrhage

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Flatulence

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Oral pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Abdominal discomfort

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Anal ulcer

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Gastritis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Gingival pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Glossodynia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Haematochezia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Loose tooth

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Toothache

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Abdominal distension

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Abnormal faeces

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Anal fissure

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Anorectal disorder

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Chapped lips

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Dental caries

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Dysphagia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Eructation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Faeces discoloured

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Faeces hard

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Frequent bowel movements

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Gastrointestinal tract irritation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Gingival bleeding

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Lip dry

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Mouth ulceration

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Odynophagia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Oesophageal pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Oral discomfort

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Oral mucosal erythema

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Palatal disorder

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Rectal fissure

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Retching

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Sensitivity of teeth

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Stomatitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Tongue disorder

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Tongue eruption

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Fatigue

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Influenza like illness

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Pyrexia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Chills

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Asthenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Injection site reaction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Irritability

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Injection site erythema

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Malaise

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Injection site bruising

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Injection site rash

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Crying

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Feeling hot

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Thirst

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Chest discomfort

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Chest pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Cyst

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Feeling abnormal

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Gait disturbance

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Injection site pruritus

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Local swelling

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Localised oedema

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Oedema peripheral

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Sluggishness

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Temperature intolerance

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Xerosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Pruritus

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Rash

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Alopecia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Dry skin

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Pruritus generalised

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Rash pruritic

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Eczema

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Rash papular

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Night sweats

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Rash erythematous

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Rash maculo-papular

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Erythema

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Acne

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Dermatitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Hyperhidrosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Macule

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Photosensitivity reaction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Rash morbilliform

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Skin fissures

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Angioedema

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Cold sweat

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Dermatitis acneiform

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Dermatitis contact

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Dermatosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Erythema multiforme

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Nail disorder

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Neurodermatitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Pigmentation disorder

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Psoriasis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Rash generalised

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Seborrhoea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Seborrhoeic dermatitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Skin disorder

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Skin exfoliation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Skin hypopigmentation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Skin lesion

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Skin mass

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Headache

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Dizziness

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Dysgeusia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Disturbance in attention

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Paraesthesia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Hypoaesthesia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Dizziness postural

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Syncope

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Hypersomnia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Memory impairment

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Migraine

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Neuropathy peripheral

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Somnolence

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Tremor

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Ageusia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Allodynia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Amnesia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Burning sensation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Head discomfort

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Hyperaesthesia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Lethargy

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Parosmia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Peripheral sensory neuropathy

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Presyncope

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Sciatica

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Sensory disturbance

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Anaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Neutropenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Thrombocytopenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Lymphadenopathy

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Pancytopenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Haemolytic anaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Lymph node pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Lymphoid tissue hyperplasia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Lymphopenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Insomnia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Depression

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Mood swings

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Anxiety

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Sleep disorder

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Abnormal dreams

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Affect lability

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Anger

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Restlessness

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Anxiety disorder

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Bipolar disorder

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Bruxism

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Depressed mood

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Hallucination

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Libido decreased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Mood altered

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Panic disorder

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Stress

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Suicidal ideation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Myalgia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Arthralgia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Back pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Pain in extremity

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Bone pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Muscle spasms

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Neck pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Flank pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Joint stiffness

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Joint swelling

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Muscle haemorrhage

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Musculoskeletal pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Musculoskeletal stiffness

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Osteopenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Osteoporosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Pain in jaw

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Rhabdomyolysis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Spinal osteoarthritis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Upper respiratory tract infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (16.1)

**Term:** Folliculitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (16.1)

**Term:** Influenza

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (16.1)

**Term:** Sinusitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (16.1)

**Term:** Bronchitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (16.1)

**Term:** Oral candidiasis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (16.1)

**Term:** Pharyngitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (16.1)

**Term:** Tooth infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (16.1)

**Term:** Urinary tract infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (16.1)

**Term:** Cellulitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (16.1)

**Term:** Hordeolum

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (16.1)

**Term:** Nasopharyngitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (16.1)

**Term:** Onychomycosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (16.1)

**Term:** Otitis media

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (16.1)

**Term:** Pneumonia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (16.1)

**Term:** Abscess jaw

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (16.1)

**Term:** Abscess limb

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (16.1)

**Term:** Abscess soft tissue

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (16.1)

**Term:** Body tinea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (16.1)

**Term:** Campylobacter gastroenteritis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (16.1)

**Term:** Candida infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (16.1)

**Term:** Cardiac valve vegetation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (16.1)

**Term:** Eye infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (16.1)

**Term:** Furuncle

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (16.1)

**Term:** Gastroenteritis viral

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (16.1)

**Term:** Gingivitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (16.1)

**Term:** Injection site pustule

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (16.1)

**Term:** Mycoplasma infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (16.1)

**Term:** Oral herpes

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (16.1)

**Term:** Otitis externa

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (16.1)

**Term:** Respiratory syncytial virus infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (16.1)

**Term:** Rhinitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (16.1)

**Term:** Sepsis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (16.1)

**Term:** Staphylococcal skin infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (16.1)

**Term:** Tinea cruris

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (16.1)

**Term:** Tooth abscess

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (16.1)

**Term:** Urethritis chlamydial

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (16.1)

**Term:** Urethritis gonococcal

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (16.1)

**Term:** Vulvovaginal candidiasis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (16.1)

**Term:** Decreased appetite

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Hypokalaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Dehydration

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Diabetes mellitus

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Hypophosphataemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Abnormal loss of weight

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Acidosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Gout

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Hyperamylasaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Hyperlipasaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Hypertriglyceridaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Hyperuricaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Hypoalbuminaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Hyponatraemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Dyspnoea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Cough

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Dyspnoea exertional

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Epistaxis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Oropharyngeal pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Wheezing

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Respiratory tract congestion

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Rhinorrhoea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Nasal congestion

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Sneezing

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Dry throat

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Hiccups

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Increased viscosity of nasal secretion

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Oropharyngeal plaque

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Pharyngeal oedema

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Productive cough

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Sinus congestion

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Throat irritation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Throat tightness

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Upper-airway cough syndrome

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Weight decreased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (16.1)

**Term:** Neutrophil count decreased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (16.1)

**Term:** Blood uric acid increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (16.1)

**Term:** CD4 lymphocytes decreased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (16.1)

**Term:** Gamma-glutamyltransferase increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (16.1)

**Term:** Blood bilirubin increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (16.1)

**Term:** Activated partial thromboplastin time prolonged

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (16.1)

**Term:** Alanine aminotransferase increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (16.1)

**Term:** Aspartate aminotransferase increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (16.1)

**Term:** Blood creatine increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (16.1)

**Term:** Blood creatine phosphokinase increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (16.1)

**Term:** Blood glucose increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (16.1)

**Term:** Blood lactate dehydrogenase increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (16.1)

**Term:** Blood triglycerides increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (16.1)

**Term:** Creatinine renal clearance decreased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (16.1)

**Term:** Electrocardiogram QT prolonged

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (16.1)

**Term:** Electrocardiogram abnormal

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (16.1)

**Term:** Eosinophil count increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (16.1)

**Term:** Glomerular filtration rate decreased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (16.1)

**Term:** Haematocrit decreased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (16.1)

**Term:** Haemoglobin decreased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (16.1)

**Term:** International normalised ratio increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (16.1)

**Term:** Lipase increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (16.1)

**Term:** Liver function test abnormal

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (16.1)

**Term:** Neutrophil count increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (16.1)

**Term:** Prothrombin time prolonged

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (16.1)

**Term:** Reticulocyte count decreased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (16.1)

**Term:** Weight increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (16.1)

**Term:** Photophobia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Vision blurred

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Dry eye

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Ocular hyperaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Visual impairment

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Abnormal sensation in eye

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Blepharitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Conjunctivitis allergic

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Eye discharge

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Eye inflammation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Eye pruritus

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Hypermetropia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Lacrimation increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Ocular icterus

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Palpitations

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Tachycardia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Atrioventricular block first degree

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Bundle branch block left

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Mitral valve incompetence

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Myocardial ischaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Sinus tachycardia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Tricuspid valve incompetence

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Ventricular extrasystoles

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Dysuria

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Pyuria

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Enuresis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Haematuria

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Nephropathy

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Nocturia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Pollakiuria

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Polyuria

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Renal failure acute

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Urinary incontinence

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Arthropod bite

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA (16.1)

**Term:** Contusion

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA (16.1)

**Term:** Excoriation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA (16.1)

**Term:** Fall

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA (16.1)

**Term:** Joint dislocation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA (16.1)

**Term:** Joint injury

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA (16.1)

**Term:** Laceration

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA (16.1)

**Term:** Ligament sprain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA (16.1)

**Term:** Transfusion reaction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA (16.1)

**Term:** Erectile dysfunction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Reproductive system and breast disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Benign prostatic hyperplasia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Reproductive system and breast disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Genital hypoaesthesia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Reproductive system and breast disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Haematospermia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Reproductive system and breast disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Menstruation irregular

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Reproductive system and breast disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Sexual dysfunction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Reproductive system and breast disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Testicular pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Reproductive system and breast disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Jaundice

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Cholelithiasis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Hot flush

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Flushing

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Peripheral coldness

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Thrombosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Hypothyroidism

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Endocrine disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Hypogonadism

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Endocrine disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Cerumen impaction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Ear and labyrinth disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Ear pruritus

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Ear and labyrinth disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Hyperacusis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Ear and labyrinth disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Colour blindness

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Congenital, familial and genetic disorders

**Source Vocabulary:** MedDRA (16.1)

**Term:** Seasonal allergy

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Immune system disorders

**Source Vocabulary:** MedDRA (16.1)

#### Serious Events

**Term:** Anaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA (16.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 54

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 69

**Group ID:** EG002

**Num Affected:** 4

**Num At Risk:** 59

**Term:** Neutropenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA (16.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 54

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 69

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 59

**Term:** Leukocytosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA (16.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 54

**Group ID:** EG001

**Num At Risk:** 69

**Group ID:** EG002

**Num At Risk:** 59

**Term:** Diarrhoea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (16.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 54

**Group ID:** EG001

**Num At Risk:** 69

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 59

**Term:** Mallory-Weiss syndrome

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (16.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 54

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 69

**Group ID:** EG002

**Num At Risk:** 59

**Term:** Rectal haemorrhage

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (16.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 54

**Group ID:** EG001

**Num At Risk:** 69

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 59

**Term:** Vomiting

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (16.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 54

**Group ID:** EG001

**Num At Risk:** 69

**Group ID:** EG002

**Num At Risk:** 59

**Term:** Escherichia urinary tract infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (16.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 54

**Group ID:** EG001

**Num At Risk:** 69

**Group ID:** EG002

**Num At Risk:** 59

**Term:** Pneumonia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (16.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 54

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 69

**Group ID:** EG002

**Num At Risk:** 59

**Term:** Psoas abscess

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (16.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 54

**Group ID:** EG001

**Num At Risk:** 69

**Group ID:** EG002

**Num At Risk:** 59

**Term:** Dyspnoea exertional

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA (16.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 54

**Group ID:** EG001

**Num At Risk:** 69

**Group ID:** EG002

**Num At Risk:** 59

**Term:** Pneumonitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA (16.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 54

**Group ID:** EG001

**Num At Risk:** 69

**Group ID:** EG002

**Num At Risk:** 59

**Term:** Pulmonary embolism

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA (16.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 54

**Group ID:** EG001

**Num At Risk:** 69

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 59

**Term:** Non-cardiac chest pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (16.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 54

**Group ID:** EG001

**Num At Risk:** 69

**Group ID:** EG002

**Num At Risk:** 59

**Term:** Pyrexia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (16.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 54

**Group ID:** EG001

**Num At Risk:** 69

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 59

**Term:** Flank pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA (16.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 54

**Group ID:** EG001

**Num At Risk:** 69

**Group ID:** EG002

**Num At Risk:** 59

**Term:** Rhabdomyolysis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA (16.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 54

**Group ID:** EG001

**Num At Risk:** 69

**Group ID:** EG002

**Num At Risk:** 59

**Term:** Syncope

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (16.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 54

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 69

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 59

**Term:** Renal cyst

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA (16.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 54

**Group ID:** EG001

**Num At Risk:** 69

**Group ID:** EG002

**Num At Risk:** 59

**Term:** Renal failure acute

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA (16.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 54

**Group ID:** EG001

**Num At Risk:** 69

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 59

**Term:** Vertigo

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Ear and labyrinth disorders

**Source Vocabulary:** MedDRA (16.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 54

**Group ID:** EG001

**Num At Risk:** 69

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 59

**Term:** Basedow's disease

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Endocrine disorders

**Source Vocabulary:** MedDRA (16.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 54

**Group ID:** EG001

**Num At Risk:** 69

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 59

**Term:** Retinopathy

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA (16.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 54

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 69

**Group ID:** EG002

**Num At Risk:** 59

**Term:** Clavicle fracture

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA (16.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 54

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 69

**Group ID:** EG002

**Num At Risk:** 59

**Term:** Hepatic enzyme increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (16.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 54

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 69

**Group ID:** EG002

**Num At Risk:** 59

**Term:** Hypokalaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA (16.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 54

**Group ID:** EG001

**Num At Risk:** 69

**Group ID:** EG002

**Num At Risk:** 59

**Term:** Adenocarcinoma

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA (16.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 54

**Group ID:** EG001

**Num At Risk:** 69

**Group ID:** EG002

**Num At Risk:** 59

**Term:** Anxiety

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA (16.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 54

**Group ID:** EG001

**Num At Risk:** 69

**Group ID:** EG002

**Num At Risk:** 59

**Term:** Rash

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA (16.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 54

**Group ID:** EG001

**Num At Risk:** 69

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 59

**Term:** Skin lesion

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA (16.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 54

**Group ID:** EG001

**Num At Risk:** 69

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 59

**Time Frame:** Baseline up to Week 52

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 54

**Group ID:** BG001

**Value:** 69

**Group ID:** BG002

**Value:** 59

**Group ID:** BG003

**Value:** 182

**Units:** Participants

### Group

**ID:** BG000

**Title:** T/PR + HAART Regimen (ATV/r-Based)

**Description:** Participants who were receiving ATV/r based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.

### Group

**ID:** BG001

**Title:** T/PR + HAART Regimen (EFV-Based)

**Description:** Participants who were receiving EFV based HAART at baseline, received Telaprevir 1125 mg tablet three times a day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.

### Group

**ID:** BG002

**Title:** T/PR + HAART Regimen (RAL-Based)

**Description:** Participants who were receiving RAL based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.

### Group

**ID:** BG003

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 8.81

**Value:** 50.4

#### Measurement

**Group ID:** BG001

**Spread:** 8.84

**Value:** 49.6

#### Measurement

**Group ID:** BG002

**Spread:** 9.58

**Value:** 48.4

#### Measurement

**Group ID:** BG003

**Spread:** 9.06

**Value:** 49.5

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 6

#### Measurement

**Group ID:** BG001

**Value:** 9

#### Measurement

**Group ID:** BG002

**Value:** 15

#### Measurement

**Group ID:** BG003

**Value:** 30

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 48

#### Measurement

**Group ID:** BG001

**Value:** 60

#### Measurement

**Group ID:** BG002

**Value:** 44

#### Measurement

**Group ID:** BG003

**Value:** 152

**Category Title:** Male

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
**Population Description:** The Full Analysis Set (FAS), included all randomized participants who received at least 1 dose of study drug.
## Results Section - More Information Module
### Certain Agreement
**Other Details:** PI is free to publish results of the study after (1) the first multi-center publication, (2) if the sponsor elects not to publish the results, or (3) 18 months after close of the study, whichever occurs first. Proposed publications are to be submitted to the sponsor for review and comment for a period of at least 45 days (which may be extended under certain circumstances related to protection of intellectual property); the sponsor cannot require changes to the proposed publications.
**Restriction Type:** OTHER
**Restrictive Agreement:** True
### Limitations and Caveats
**Description:** It was decided by Sponsor on 13 January 2014 to terminate the study early at the primary efficacy endpoint (SVR12) as part of a decision to modify the drug development plan. Eligible participants completed virologic follow-up after termination.
### Point of Contact
**Email:** medicalinfo@vrtx.com
**Organization:** Vertex Pharmaceuticals Incorporated
**Phone:** 617-341-6777
**Title:** Medical Monitor
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
### Outcome Measure 3
### Outcome Measure 4
### Outcome Measure 5
### Outcome Measure 6
### Outcome Measure 7
### Outcome Measure 8
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 66.7
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 59.0
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 61.3
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 75.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 54.5
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 100
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 40
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 36.4
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 40
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 14.3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 87.5
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 55.6
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 53.7
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 58.0
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 57.6
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 65.2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 57.9
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 51.7
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 75.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 54.5
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 100
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 33.3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 22.2
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 35.7
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 14.3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 75.0
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 55.6
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 50.9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 54.5
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 51.8
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 50.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 53.8
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 74.2
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 62.5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 72.7
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 100
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 26.7
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 54.5
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 53.3
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 42.9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 50.0
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 44.4
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 44.4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 56.5
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 66.1
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 50.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 53.8
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 61.3
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 62.5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 72.7
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 100
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 26.7
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 54.5
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 53.3
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 14.3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 50.0
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 44.4
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 40.7
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 56.5
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 59.3
**Title:** 
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 55.6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 63.8
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 61.0
**Title:** 
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 100
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 95.7
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 94.9
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 13.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 11.6
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 15.3
**Title:** 
#### Outcome Measure 7
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1580
- **Upper Limit:** 
- **Value:** 2870
- **Comment:** Data not reported as no participant was evaluable for this parameter from this reporting group
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** NA
- **Upper Limit:** 
- **Value:** NA
- **Comment:** Data not reported as no participant was evaluable for this parameter from this reporting group
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** NA
- **Upper Limit:** 
- **Value:** NA
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 635
- **Upper Limit:** 
- **Value:** 991
- **Comment:** Data not reported as no participant was evaluable for this parameter from this reporting group
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** NA
- **Upper Limit:** 
- **Value:** NA
- **Comment:** Data not reported as no participant was evaluable for this parameter from this reporting group
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** NA
- **Upper Limit:** 
- **Value:** NA
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 647
- **Upper Limit:** 
- **Value:** 1100
- **Comment:** Data not reported as no participant was evaluable for this parameter from this reporting group
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** NA
- **Upper Limit:** 
- **Value:** NA
- **Comment:** Data not reported as no participant was evaluable for this parameter from this reporting group
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** NA
- **Upper Limit:** 
- **Value:** NA
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1570
- **Upper Limit:** 
- **Value:** 2820
- **Comment:** Data not reported as no participant was evaluable for this parameter from this reporting group
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** NA
- **Upper Limit:** 
- **Value:** NA
- **Comment:** Data not reported as no participant was evaluable for this parameter from this reporting group
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** NA
- **Upper Limit:** 
- **Value:** NA
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 636
- **Upper Limit:** 
- **Value:** 1280
- **Comment:** Data not reported as no participant was evaluable for this parameter from this reporting group
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** NA
- **Upper Limit:** 
- **Value:** NA
- **Comment:** Data not reported as no participant was evaluable for this parameter from this reporting group
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** NA
- **Upper Limit:** 
- **Value:** NA
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 685
- **Upper Limit:** 
- **Value:** 1320
- **Comment:** Data not reported as no participant was evaluable for this parameter from this reporting group
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** NA
- **Upper Limit:** 
- **Value:** NA
- **Comment:** Data not reported as no participant was evaluable for this parameter from this reporting group
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** NA
- **Upper Limit:** 
- **Value:** NA
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** Data not reported as no participant was evaluable for this parameter from this reporting group
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** NA
- **Upper Limit:** 
- **Value:** NA
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2600
- **Upper Limit:** 
- **Value:** 3800
- **Comment:** Data not reported as no participant was evaluable for this parameter from this reporting group
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** NA
- **Upper Limit:** 
- **Value:** NA
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** Data not reported as no participant was evaluable for this parameter from this reporting group
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** NA
- **Upper Limit:** 
- **Value:** NA
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1900
- **Upper Limit:** 
- **Value:** 2560
- **Comment:** Data not reported as no participant was evaluable for this parameter from this reporting group
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** NA
- **Upper Limit:** 
- **Value:** NA
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** Data not reported as no participant was evaluable for this parameter from this reporting group
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** NA
- **Upper Limit:** 
- **Value:** NA
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1680
- **Upper Limit:** 
- **Value:** 2150
- **Comment:** Data not reported as no participant was evaluable for this parameter from this reporting group
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** NA
- **Upper Limit:** 
- **Value:** NA
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** Data not reported as no participant was evaluable for this parameter from this reporting group
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** NA
- **Upper Limit:** 
- **Value:** NA
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2450
- **Upper Limit:** 
- **Value:** 3340
- **Comment:** Data not reported as no participant was evaluable for this parameter from this reporting group
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** NA
- **Upper Limit:** 
- **Value:** NA
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** Data not reported as no participant was evaluable for this parameter from this reporting group
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** NA
- **Upper Limit:** 
- **Value:** NA
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1880
- **Upper Limit:** 
- **Value:** 2290
- **Comment:** Data not reported as no participant was evaluable for this parameter from this reporting group
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** NA
- **Upper Limit:** 
- **Value:** NA
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** Data not reported as no participant was evaluable for this parameter from this reporting group
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** NA
- **Upper Limit:** 
- **Value:** NA
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1400
- **Upper Limit:** 
- **Value:** 1920
- **Comment:** Data not reported as no participant was evaluable for this parameter from this reporting group
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** NA
- **Upper Limit:** 
- **Value:** NA
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** Data not reported as no participant was evaluable for this parameter from this reporting group
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** NA
- **Upper Limit:** 
- **Value:** NA
- **Comment:** Data not reported as no participant was evaluable for this parameter from this reporting group
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** NA
- **Upper Limit:** 
- **Value:** NA
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 1880
- **Upper Limit:** 
- **Value:** 1900
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** Data not reported as no participant was evaluable for this parameter from this reporting group
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** NA
- **Upper Limit:** 
- **Value:** NA
- **Comment:** Data not reported as no participant was evaluable for this parameter from this reporting group
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** NA
- **Upper Limit:** 
- **Value:** NA
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 198
- **Upper Limit:** 
- **Value:** 196
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** Data not reported as no participant was evaluable for this parameter from this reporting group
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** NA
- **Upper Limit:** 
- **Value:** NA
- **Comment:** Data not reported as no participant was evaluable for this parameter from this reporting group
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** NA
- **Upper Limit:** 
- **Value:** NA
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 429
- **Upper Limit:** 
- **Value:** 483
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** Data not reported as no participant was evaluable for this parameter from this reporting group
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** NA
- **Upper Limit:** 
- **Value:** NA
- **Comment:** Data not reported as no participant was evaluable for this parameter from this reporting group
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** NA
- **Upper Limit:** 
- **Value:** NA
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 1970
- **Upper Limit:** 
- **Value:** 2320
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** Data not reported as no participant was evaluable for this parameter from this reporting group
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** NA
- **Upper Limit:** 
- **Value:** NA
- **Comment:** Data not reported as no participant was evaluable for this parameter from this reporting group
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** NA
- **Upper Limit:** 
- **Value:** NA
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 435
- **Upper Limit:** 
- **Value:** 281
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** Data not reported as no participant was evaluable for this parameter from this reporting group
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** NA
- **Upper Limit:** 
- **Value:** NA
- **Comment:** Data not reported as no participant was evaluable for this parameter from this reporting group
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** NA
- **Upper Limit:** 
- **Value:** NA
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 539
- **Upper Limit:** 
- **Value:** 643
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1180
- **Upper Limit:** 
- **Value:** 3160
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1670
- **Upper Limit:** 
- **Value:** 3780
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 868
- **Upper Limit:** 
- **Value:** 3470
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 863
- **Upper Limit:** 
- **Value:** 1650
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 961
- **Upper Limit:** 
- **Value:** 1750
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 741
- **Upper Limit:** 
- **Value:** 1840
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 907
- **Upper Limit:** 
- **Value:** 2320
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1290
- **Upper Limit:** 
- **Value:** 2430
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 643
- **Upper Limit:** 
- **Value:** 2520
**Title:** 
#### Outcome Measure 8
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 11
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** SVR 12 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (\<lower limit of quantification) at 12 weeks after last planned dose of study drug. The plasma hepatitis C virus ribonucleic acid (HCV RNA) level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL).
**Parameter Type:** NUMBER
**Population Description:** Safety Set included all participants who received at least 1 dose of study drug. Here, n = participants evaluable for specified category for each arm, respectively.
**Reporting Status:** POSTED
**Time Frame:** 12 weeks after last planned dose of study drug (up to Week 60)
**Title:** Percentage of Participants With Sustained Viral Response 12 Weeks After Last Planned Dose of Study Drug (SVR12)
**Type:** PRIMARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Participants who were receiving ATV/r based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
**ID:** OG000
**Title:** T/PR + HAART Regimen (ATV/r-Based)
##### Group
**Description:** Participants who were receiving EFV based HAART at baseline, received Telaprevir 1125 mg tablet three times a day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
**ID:** OG001
**Title:** T/PR + HAART Regimen (EFV-Based)
##### Group
**Description:** Participants who were receiving RAL based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
**ID:** OG002
**Title:** T/PR + HAART Regimen (RAL-Based)
#### Outcome Measure 2
**Description:** SVR 24 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (\<lower limit of quantification) at 24 weeks after last planned dose of study drug. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL).
**Parameter Type:** NUMBER
**Population Description:** Safety set. Here number of participants analyzed = participants evaluable for this measure and n = participants evaluable for specified categories, for each arm, respectively.
**Reporting Status:** POSTED
**Time Frame:** 24 weeks after last planned dose of study drug (up to Week 72)
**Title:** Percentage of Participants With Sustained Viral Response 24 Weeks After Last Planned Dose of Study Drug (SVR 24)
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Participants who were receiving ATV/r based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
**ID:** OG000
**Title:** T/PR + HAART Regimen (ATV/r-Based)
##### Group
**Description:** Participants who were receiving EFV based HAART at baseline, received Telaprevir 1125 mg tablet three times a day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
**ID:** OG001
**Title:** T/PR + HAART Regimen (EFV-Based)
##### Group
**Description:** Participants who were receiving RAL based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
**ID:** OG002
**Title:** T/PR + HAART Regimen (RAL-Based)
#### Outcome Measure 3
**Description:** The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL. RVR was defined as undetectable HCV RNA (\<lower limit of quantification) 4 weeks after the start of study treatment.
**Parameter Type:** NUMBER
**Population Description:** Safety set. Here, n = participants evaluable for specified category for each arm, respectively.
**Reporting Status:** POSTED
**Time Frame:** Week 4
**Title:** Percentage of Participants With Rapid Viral Response (RVR)
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Participants who were receiving ATV/r based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
**ID:** OG000
**Title:** T/PR + HAART Regimen (ATV/r-Based)
##### Group
**Description:** Participants who were receiving EFV based HAART at baseline, received Telaprevir 1125 mg tablet three times a day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
**ID:** OG001
**Title:** T/PR + HAART Regimen (EFV-Based)
##### Group
**Description:** Participants who were receiving RAL based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
**ID:** OG002
**Title:** T/PR + HAART Regimen (RAL-Based)
#### Outcome Measure 4
**Description:** The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL. eRVR was defined as undetectable HCV RNA (\<lower limit of quantification) at both 4 weeks and 12 weeks after the start of study treatment.
**Parameter Type:** NUMBER
**Population Description:** Safety set. Here, n = participants evaluable for specified category for each arm, respectively.
**Reporting Status:** POSTED
**Time Frame:** Week 4 and Week 12
**Title:** Percentage of Participants With Extended Rapid Viral Response (eRVR)
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Participants who were receiving ATV/r based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
**ID:** OG000
**Title:** T/PR + HAART Regimen (ATV/r-Based)
##### Group
**Description:** Participants who were receiving EFV based HAART at baseline, received Telaprevir 1125 mg tablet three times a day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
**ID:** OG001
**Title:** T/PR + HAART Regimen (EFV-Based)
##### Group
**Description:** Participants who were receiving RAL based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
**ID:** OG002
**Title:** T/PR + HAART Regimen (RAL-Based)
#### Outcome Measure 5
**Description:** The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL. Percentage of participants with undetectable HCV RNA (\<lower limit of quantification) at EOT (up to Week 48) are reported. Data for this outcome was not planned to be reported by prior response.
**Parameter Type:** NUMBER
**Population Description:** Full analysis set included all participants who received at least 1 dose of study drug.
**Reporting Status:** POSTED
**Time Frame:** EOT (up to Week 48)
**Title:** Percentage of Participants With Undetectable HCV RNA at End of Treatment (EOT)
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Participants who were receiving ATV/r based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
**ID:** OG000
**Title:** T/PR + HAART Regimen (ATV/r-Based)
##### Group
**Description:** Participants who were receiving EFV based HAART at baseline, received Telaprevir 1125 mg tablet three times a day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
**ID:** OG001
**Title:** T/PR + HAART Regimen (EFV-Based)
##### Group
**Description:** Participants who were receiving RAL based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
**ID:** OG002
**Title:** T/PR + HAART Regimen (RAL-Based)
#### Outcome Measure 6
**Description:** AE: any untoward medical occurrence in a participant during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after the informed consent form is signed. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event.
**Parameter Type:** NUMBER
**Population Description:** Safety set.
**Reporting Status:** POSTED
**Time Frame:** Up to Week 52
**Title:** Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Participants who were receiving ATV/r based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
**ID:** OG000
**Title:** T/PR + HAART Regimen (ATV/r-Based)
##### Group
**Description:** Participants who were receiving EFV based HAART at baseline, received Telaprevir 1125 mg tablet three times a day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
**ID:** OG001
**Title:** T/PR + HAART Regimen (EFV-Based)
##### Group
**Description:** Participants who were receiving RAL based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
**ID:** OG002
**Title:** T/PR + HAART Regimen (RAL-Based)
#### Outcome Measure 7
**Description:** Cmax, Cmin, and Cavg were reported for atazanavir (ATV), efavirenz (EFV), raltegravir (RAL), and telaprevir.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Full Analysis set.Here, n = participants evaluable for specified category for each arm, respectively.
**Reporting Status:** POSTED
**Time Frame:** Day -14 to Day -1 and Week 1 for ATV, EFV, and RAL; Week 1 for telaprevir
**Title:** Maximum (Cmax), Minimum (Cmin), and Average Plasma Concentration (Cavg)
**Type:** SECONDARY
**Unit of Measure:** nanogram per milliliter (ng/mL)
##### Group
**Description:** Participants who were receiving ATV/r based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
**ID:** OG000
**Title:** T/PR + HAART Regimen (ATV/r-Based)
##### Group
**Description:** Participants who were receiving EFV based HAART at baseline, received Telaprevir 1125 mg tablet three times a day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
**ID:** OG001
**Title:** T/PR + HAART Regimen (EFV-Based)
##### Group
**Description:** Participants who were receiving RAL based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
**ID:** OG002
**Title:** T/PR + HAART Regimen (RAL-Based)
#### Outcome Measure 8
**Description:** Sequence analysis of the HCV NS3-4A region was performed to monitor telaprevir-resistant variants. HCV RNA was isolated from the plasma, amplified by reverse transcription-polymerase chain reaction (RT-PCR), and sequenced (sequencing assay limit of detection HCV RNA \>=1000 IU/mL). Results of this outcome measure were to be reported for overall participants instead of by HAART treatment.
**Parameter Type:** NUMBER
**Population Description:** Full analysis set. Here number of participants analyzed = participants who were evaluable for this measure and n = participants evaluable for specified categories.
**Reporting Status:** POSTED
**Time Frame:** Baseline, follow-up (Week 96)
**Title:** Number of Participants With Telaprevir Resistant HCV Variant at Non-Structural Viral Protein 3-4A (NS3-4A) Region
**Type:** SECONDARY
**Unit of Measure:** participants
##### Group
**Description:** Participants who were receiving either ATV/r based HAART or EFV based HAART or RAL based HAART at baseline, received Telaprevir 1125 mg tablet twice daily or 1125 mg three times a day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their respective HAART, as per standard practice and investigator discretion.
**ID:** OG000
**Title:** T/PR + HAART Regimen
### Participant Flow Module
#### Group
**Description:** Participants who were receiving atazanavir/ritonavir (ATV/r) based HAART at baseline, received Telaprevir (T)1125 milligram (mg) tablet twice daily for 12 weeks in combination with pegylated interferon alfa 2a (P) (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (R) (RBV) tablet orally twice daily at a dose of 800 milligram per day (mg/day) for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
**ID:** FG000
**Title:** T/PR + HAART Regimen (ATV/r-Based)
#### Group
**Description:** Participants who were receiving efavirenz (EFV) based HAART at baseline, received Telaprevir 1125 mg tablet three times a day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
**ID:** FG001
**Title:** T/PR + HAART Regimen (EFV-Based)
#### Group
**Description:** Participants who were receiving raltegravir (RAL) based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
**ID:** FG002
**Title:** T/PR + HAART Regimen (RAL-Based)
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** No Study Medication
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
###### Reason
**Group ID:** FG002
**Number of Subjects:** 2
##### Withdraw
**Type:** Adverse Event
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 2
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
##### Withdraw
**Type:** Death
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
###### Reason
**Group ID:** FG002
**Number of Subjects:** 1
##### Withdraw
**Type:** Lost to Follow-up
###### Reason
**Group ID:** FG000
**Number of Subjects:** 2
###### Reason
**Group ID:** FG001
**Number of Subjects:** 5
###### Reason
**Group ID:** FG002
**Number of Subjects:** 3
##### Withdraw
**Type:** Withdrawal of Consent
###### Reason
**Group ID:** FG000
**Number of Subjects:** 3
###### Reason
**Group ID:** FG001
**Number of Subjects:** 7
###### Reason
**Group ID:** FG002
**Number of Subjects:** 7
##### Withdraw
**Type:** Study Terminated by Sponsor
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 3
###### Reason
**Group ID:** FG002
**Number of Subjects:** 3
##### Withdraw
**Type:** Other
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 55
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 69
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 61
##### Milestone
**Type:** Treated
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 54
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 69
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 59
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 46
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 52
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 45
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 9
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 17
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 16
**Pre-Assignment Details:** Efficacy analyses were reported as per highly active antiretroviral therapy (HAART) treatment (reporting arms) and also separately as per prior response (in categories) (Treatment-Naive, Prior Relapser, Prior Null Responder, Prior Partial Responder as well as for Total Participants), unless otherwise specified.
**Recruitment Details:** Study included Treatment-Naïve (no prior hepatitis C virus \[HCV\] therapy); Prior Relapser (prior HCV treatment with pegylated interferon alfa/ribavirin \[Peg-IFN/RBV\] and experienced viral relapse); and Prior Null/Partial Responder (prior HCV treatment with Peg-IFN/RBV and had null/partial response) participants.
**Has Results:** True