## Protocol Section
### Identification Module
**NCT ID:** NCT00531479

**Brief Title:** Anidulafungin Plus Voriconazole Versus Voriconazole For The Treatment Of Invasive Aspergillosis

**Official Title:** A Prospective, Randomized Trial Comparing The Efficacy Of Anidulafungin And Voriconazole In Combination To That Of Voriconazole Alone When Used For Primary Therapy Of Proven Or Probable Invasive Aspergillosis

#### Organization Study ID Info
**ID:** A8851009
#### Organization
**Class:** INDUSTRY
**Full Name:** Pfizer
### Status Module
#### Completion Date
**Date:** 2011-05

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2012-04-30

**Type:** ESTIMATED

**Last Update Submit Date:** 2012-04-03

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2011-04

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2012-04-30

**Type:** ESTIMATED

**Results First Submit Date:** 2012-04-03

**Results First Submit QC Date:** 2012-04-03

#### Start Date
**Date:** 2008-07

**Status Verified Date:** 2012-04

#### Study First Post Date
**Date:** 2007-09-18
**Type:** ESTIMATED
**Study First Submit Date:** 2007-09-14
**Study First Submit QC Date:** 2007-09-14
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Pfizer

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** This study compares the effectiveness and safety of the combination of anidulafungin and voriconazole compared to that of voriconazole alone (which is generally considered the standard of care) for the treatment of Invasive Aspergillosis.

### Conditions Module

**Conditions:**

- Aspergillosis

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 459

**Type:** ACTUAL

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Voriconazole monotherapy

**Intervention Names:**

- Drug: voriconazole

**Label:** Voriconazole

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** Combination therapy with voriconazole and anidulafungin

**Intervention Names:**

- Drug: anidulafungin

- Drug: voriconazole

**Label:** Voriconazole and Anidulafungin

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Voriconazole

**Description:** First week: Voriconazole 6 mg/kg IV bid for the first 24 hours, followed by 4 mg/kg IV BID plus anidulafungin placebo IV qd.

Second week: Voriconazole 4 mg/kg IV bid or 300 mg PO bid plus anidulafungin placebo IV qd.

Third and fourth weeks: Voriconazole 4 mg/kg IV bid OR 300 mg PO bid plus anidulafungin placebo IV qd,

OR

Voriconazole 4 mg/kg IV bid or 300 mg PO bid monotherapy.

Fifth and sixth weeks: Voriconazole 4 mg/kg IV bid or 300 mg PO bid monotherapy.

**Name:** voriconazole

**Other Names:**

- Vfend

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Voriconazole and Anidulafungin

**Description:** First week: Voriconazole 6 mg/kg IV bid for the first 24 hours, followed by 4 mg/kg IV bid plus anidulafungin 200 mg IV on day 1, followed by 100 mg IV qd thereafter.

Second week: Voriconazole 4 mg/kg IV bid or 300 mg PO bid plus anidulafungin 100 mg IV qd.

Third and fourth weeks: Voriconazole 4 mg/kg IV bid OR 300 mg PO bid plus anidulafungin 100 mg IV qd,

OR

Voriconazole 4 mg/kg IV bid or 300 mg PO bid monotherapy.

Fifth and sixth weeks: Voriconazole 4 mg/kg IV bid or 300 mg PO bid monotherapy.

**Name:** anidulafungin

**Other Names:**

- Eraxis

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- Voriconazole and Anidulafungin

**Description:** First week: Voriconazole 6 mg/kg IV bid for the first 24 hours, followed by 4 mg/kg IV bid plus anidulafungin 200 mg IV on day 1, followed by 100 mg IV qd thereafter.

Second week: Voriconazole 4 mg/kg IV bid or 300 mg PO bid plus anidulafungin 100 mg IV qd.

Third and fourth weeks: Voriconazole 4 mg/kg IV bid OR 300 mg PO bid plus anidulafungin 100 mg IV qd,

OR

Voriconazole 4 mg/kg IV bid or 300 mg PO bid monotherapy.

Fifth and sixth weeks: Voriconazole 4 mg/kg IV bid or 300 mg PO bid monotherapy.

**Name:** voriconazole

**Other Names:**

- Vfend

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Number of deaths measured 6 weeks after start of treatment. Time to death defined as date of death minus first treatment date + 1.

**Measure:** All-cause Mortality at Week 6 in Participants With Proven or Probable Invasive Aspergillosis

**Time Frame:** Day 1 to Day 42 (Week 6)

#### Secondary Outcomes

**Description:** Number of participants with a successful response (complete or partial global response). Complete response = resolution of all clinical signs and symptoms and \>90% of lesions due to IA that were visible on radiologic studies at baseline (BL); partial response = clinical improvement and \>50% improvement in radiological findings present at BL.

**Measure:** Global Response at Week 6

**Time Frame:** Baseline, Day 42 (Week 6)

**Description:** Number of deaths due to any cause measured 6 weeks after start of treatment. Time to death defined as date of death minus first treatment date + 1.

**Measure:** All-cause Mortality at Week 6 in Participants With Possible, Probable, or Proven Invasive Aspergillosis (IA)

**Time Frame:** Day 1 to Day 42 (Week 6)

**Description:** Number of deaths due to any cause measured 12 weeks after start of treatment. Time to death defined as date of death minus first treatment date + 1.

**Measure:** All-cause Mortality at Week 12 in Participants With Probable or Proven Invasive Aspergillosis (IA)

**Time Frame:** Day 1 to Day 84 (Week 12)

**Description:** Number of deaths due to Invasive Aspergillosis measured 6 weeks after start of treatment. Time to death defined as date of death minus first treatment date + 1.

**Measure:** Mortality Due to Invasive Aspergillosis (IA) at Week 6 in Participants With Probable or Proven IA

**Time Frame:** Day 1 to Day 42 (Week 6)

**Description:** Survival time from start of treatment. Time to death defined as date of death due to any cause minus first treatment date + 1.

**Measure:** Time to Death: All-Cause Mortality

**Time Frame:** Day 1 to Day 84 (Week 12)

**Description:** Survival time from start of treatment. Time to death defined as date of death due to IA minus first treatment date + 1.

**Measure:** Time to Death Due to Invasive Aspergillosis (IA)

**Time Frame:** Day 1 to Day 84 (Week 12)

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Immunocompromised state due to either 1. receipt of hematopoeitic stem cell transplantation or 2. hematologic malignancy;
* Diagnosis of possible, probable, or proven invasive aspergillosis.

Exclusion Criteria:

* Patients with aspergilloma or chronic aspergillosis
* Receipt of 4 or more days of systemic antifungal treatment for the current episode of invasive aspergillosis
* Anticipated survival of less than 5 days or Karnofsky score \<=20

**Minimum Age:** 16 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

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**Location 103:**

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**Location 105:**

**City:** Ankara

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**Location 106:**

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**City:** Manchester

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#### Overall Officials

**Official 1:**

**Affiliation:** Pfizer

**Name:** Pfizer CT.gov Call Center

**Role:** STUDY_DIRECTOR

### References Module

#### References

**Citation:** Marr KA, Schlamm HT, Herbrecht R, Rottinghaus ST, Bow EJ, Cornely OA, Heinz WJ, Jagannatha S, Koh LP, Kontoyiannis DP, Lee DG, Nucci M, Pappas PG, Slavin MA, Queiroz-Telles F, Selleslag D, Walsh TJ, Wingard JR, Maertens JA. Combination antifungal therapy for invasive aspergillosis: a randomized trial. Ann Intern Med. 2015 Jan 20;162(2):81-9. doi: 10.7326/M13-2508. Erratum In: Ann Intern Med. 2015 Mar 17;162(6):463. Ann Intern Med. 2019 Feb 5;170(3):220.

**PMID:** 25599346

**Citation:** Liu P, Mould DR. Population pharmacokinetic-pharmacodynamic analysis of voriconazole and anidulafungin in adult patients with invasive aspergillosis. Antimicrob Agents Chemother. 2014 Aug;58(8):4727-36. doi: 10.1128/AAC.02809-13. Epub 2014 Jun 9.

**PMID:** 24914120

**Citation:** Liu P, Mould DR. Population pharmacokinetic analysis of voriconazole and anidulafungin in adult patients with invasive aspergillosis. Antimicrob Agents Chemother. 2014 Aug;58(8):4718-26. doi: 10.1128/AAC.02808-13. Epub 2014 Jun 9.

**PMID:** 24913161

#### See Also Links

**Label:** To obtain contact information for a study center near you, click here.

**URL:** https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A8851009&StudyName=Anidulafungin%20Plus%20Voriconazole%20versus%20Voriconazole%20For%20The%20Treatment%20Of%20Invasive%20Aspergillosis

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009181

- Term: Mycoses

- ID: D000001423

- Term: Bacterial Infections and Mycoses

- ID: D000007239

- Term: Infections

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M4535

- Name: Aspergillosis

- Relevance: HIGH

- As Found: Aspergillosis

- ID: M12136

- Name: Mycoses

- 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: M4722

- Name: Bacterial Infections

- Relevance: LOW

- As Found: Unknown

- ID: M4721

- Name: Bacterial Infections and Mycoses

- Relevance: LOW

- As Found: Unknown

- ID: T511

- Name: Aspergillosis

- Relevance: HIGH

- As Found: Aspergillosis

### Condition Browse Module - Meshes

- ID: D000001228

- Term: Aspergillosis

### Intervention Browse Module - Ancestors

- ID: D000000935

- Term: Antifungal Agents

- ID: D000000890

- Term: Anti-Infective Agents

- ID: D000058888

- Term: 14-alpha Demethylase Inhibitors

- ID: D000065607

- Term: Cytochrome P-450 Enzyme Inhibitors

- ID: D000004791

- Term: Enzyme Inhibitors

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000065088

- Term: Steroid Synthesis Inhibitors

- ID: D000006727

- Term: Hormone Antagonists

- ID: D000006730

- Term: Hormones, Hormone Substitutes, and Hormone Antagonists

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000065692

- Term: Cytochrome P-450 CYP3A Inhibitors

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M30607

- Name: Voriconazole

- Relevance: HIGH

- As Found: Diaphragmatic

- ID: M1868

- Name: Anidulafungin

- Relevance: HIGH

- As Found: JUVÉDERM

- ID: M6252

- Name: Clotrimazole

- Relevance: LOW

- As Found: Unknown

- ID: M11796

- Name: Miconazole

- Relevance: LOW

- As Found: Unknown

- ID: M4254

- Name: Antifungal Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4214

- Name: Anti-Infective Agents

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M30537

- Name: Cytochrome P-450 Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M9789

- Name: Hormones

- Relevance: LOW

- As Found: Unknown

- ID: M9788

- Name: Hormone Antagonists

- Relevance: LOW

- As Found: Unknown

- ID: M30564

- Name: Cytochrome P-450 CYP3A Inhibitors

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000065819

- Term: Voriconazole

- ID: D000077612

- Term: Anidulafungin

### Misc Info Module

#### Removed Countries

- Country: Austria

- Country: Saudi Arabia

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

**Description:** The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

#### Event Groups

**Group ID:** EG000

**Title:** Voriconazole/Anidulafungin

**Description:** Week 1: Voriconazole 6 mg/kg intravenously (IV) twice a day (bid) for 24 hours, followed by voriconazole 4 milligrams per kilogram (mg/kg) IV BID plus anidulafungin 200 mg IV on day 1, followed by 100 mg IV once a day (QD); Week 2: Voriconazole 4 mg/kg IV BID or 300 mg orally (PO) BID plus anidulafungin 100 mg IV QD; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin 100 mg IV QD or voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.

**ID:** EG000

**Other Num Affected:** 194

**Other Num at Risk:** 228

**Serious Number Affected:** 115

**Serious Number At Risk:** 228

**Title:** Voriconazole/Anidulafungin

**Group ID:** EG001

**Title:** Voriconazole / Placebo

**Description:** Week 1: Voriconazole 6 mg/kg IV BID for 24 hours, followed by voriconazole 4 mg/kg IV BID plus anidulafungin placebo IV QD; Week 2: voriconazole 4 mg/kg IV BID or voriconazole 300 mg PO BID plus anidulafungin placebo IV QD through Day 14; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin placebo; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.

**ID:** EG001

**Other Num Affected:** 192

**Other Num at Risk:** 226

**Serious Number Affected:** 104

**Serious Number At Risk:** 226

**Title:** Voriconazole / Placebo

**Frequency Threshold:** 5

#### Other Events

**Term:** Anaemia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.1

**Term:** Tachycardia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 14.1

**Term:** Vision blurred

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA 14.1

**Term:** Abdominal pain

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 14.1

**Term:** Abdominal pain upper

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 14.1

**Term:** Constipation

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 14.1

**Term:** Diarrhoea

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 14.1

**Term:** Dyspepsia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 14.1

**Term:** Nausea

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 14.1

**Term:** Vomiting

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 14.1

**Term:** Chest pain

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 14.1

**Term:** Chills

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 14.1

**Term:** Fatigue

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 14.1

**Term:** Mucosal inflammation

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 14.1

**Term:** Oedema

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 14.1

**Term:** Oedema peripheral

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 14.1

**Term:** Pain

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 14.1

**Term:** Pyrexia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 14.1

**Term:** Fall

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.1

**Term:** Aspartate aminotransferase increased

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 14.1

**Term:** Blood alkaline phosphatase increased

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 14.1

**Term:** Decreased appetite

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 14.1

**Term:** Hypokalaemia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 14.1

**Term:** Hypomagnesaemia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 14.1

**Term:** Back pain

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.1

**Term:** Pain in extremity

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.1

**Term:** Headache

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 14.1

**Term:** Agitation

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA 14.1

**Term:** Anxiety

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA 14.1

**Term:** Confusional state

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA 14.1

**Term:** Hallucination, visual

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA 14.1

**Term:** Insomnia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA 14.1

**Term:** Cough

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.1

**Term:** Dyspnoea

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.1

**Term:** Epistaxis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.1

**Term:** Petechiae

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.1

**Term:** Rash

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.1

**Term:** Hypertension

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 14.1

**Term:** Hypotension

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 14.1

#### Serious Events

**Term:** Anaemia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 228

**Group ID:** EG001

**Num At Risk:** 226

**Term:** Blood disorder

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 228

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 226

**Term:** Disseminated intravascular coagulation

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 228

**Group ID:** EG001

**Num At Risk:** 226

**Term:** Febrile neutropenia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 228

**Group ID:** EG001

**Num Affected:** 6

**Num At Risk:** 226

**Term:** Neutropenia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 228

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 226

**Term:** Pancytopenia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 228

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 226

**Term:** Thrombotic microangiopathy

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 228

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 226

**Term:** Thrombotic thrombocytopenic purpura

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 228

**Group ID:** EG001

**Num At Risk:** 226

**Term:** Arrhythmia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 228

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 226

**Term:** Atrial fibrillation

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 4

**Num At Risk:** 228

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 226

**Term:** Bradycardia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 228

**Group ID:** EG001

**Num At Risk:** 226

**Term:** Cardiac arrest

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 228

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 226

**Term:** Cardio-respiratory arrest

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 228

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 226

**Term:** Cardiopulmonary failure

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 228

**Group ID:** EG001

**Num At Risk:** 226

**Term:** Extrasystoles

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 228

**Group ID:** EG001

**Num At Risk:** 226

**Term:** Myocardial ischaemia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 228

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 226

**Term:** Pericardial effusion

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 228

**Group ID:** EG001

**Num At Risk:** 226

**Term:** Pulseless electrical activity

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 228

**Group ID:** EG001

**Num At Risk:** 226

**Term:** Supraventricular tachycardia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 228

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 226

**Term:** Tachycardia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 228

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 226

**Term:** Ventricular fibrillation

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 228

**Group ID:** EG001

**Num At Risk:** 226

**Term:** Blindness

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 228

**Group ID:** EG001

**Num At Risk:** 226

**Term:** Blindness unilateral

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 228

**Group ID:** EG001

**Num At Risk:** 226

**Term:** Abdominal pain

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 228

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 226

**Term:** Ascites

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 228

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 226

**Term:** Diarrhoea

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 228

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 226

**Term:** Duodenal ulcer haemorrhage

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 228

**Group ID:** EG001

**Num At Risk:** 226

**Term:** Faecaloma

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 228

**Group ID:** EG001

**Num At Risk:** 226

**Term:** Gastric haemorrhage

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 228

**Group ID:** EG001

**Num At Risk:** 226

**Term:** Gastrointestinal haemorrhage

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 228

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 226

**Term:** Haematemesis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 228

**Group ID:** EG001

**Num At Risk:** 226

**Term:** Ileitis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 228

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 226

**Term:** Ileus paralytic

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 228

**Group ID:** EG001

**Num At Risk:** 226

**Term:** Lower gastrointestinal haemorrhage

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 228

**Group ID:** EG001

**Num At Risk:** 226

**Term:** Megacolon

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 228

**Group ID:** EG001

**Num At Risk:** 226

**Term:** Neutropenic colitis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 228

**Group ID:** EG001

**Num At Risk:** 226

**Term:** Small intestinal obstruction

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 228

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 226

**Term:** Upper gastrointestinal haemorrhage

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 228

**Group ID:** EG001

**Num At Risk:** 226

**Term:** Vomiting

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 228

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 226

**Term:** Asthenia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 228

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 226

**Term:** Chest pain

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 228

**Group ID:** EG001

**Num At Risk:** 226

**Term:** Death

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 228

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 226

**Term:** Disease progression

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 228

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 226

**Term:** Fatigue

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 228

**Group ID:** EG001

**Num At Risk:** 226

**Term:** General physical health deterioration

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 228

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 226

**Term:** Multi-organ failure

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 5

**Num At Risk:** 228

**Group ID:** EG001

**Num Affected:** 4

**Num At Risk:** 226

**Term:** Pyrexia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 228

**Group ID:** EG001

**Num Affected:** 4

**Num At Risk:** 226

**Term:** Sudden cardiac death

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 228

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 226

**Term:** Cholecystitis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 228

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 226

**Term:** Cholecystitis acute

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 228

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 226

**Term:** Hepatic failure

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 228

**Group ID:** EG001

**Num At Risk:** 226

**Term:** Hepatic function abnormal

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 228

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 226

**Term:** Hepatic vein occlusion

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 228

**Group ID:** EG001

**Num At Risk:** 226

**Term:** Hepatotoxicity

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 228

**Group ID:** EG001

**Num At Risk:** 226

**Term:** Hyperbilirubinaemia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 228

**Group ID:** EG001

**Num At Risk:** 226

**Term:** Liver disorder

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 228

**Group ID:** EG001

**Num At Risk:** 226

**Term:** Graft versus host disease

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Immune system disorders

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 228

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 226

**Term:** Aspergillosis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 6

**Num At Risk:** 228

**Group ID:** EG001

**Num Affected:** 5

**Num At Risk:** 226

**Term:** Bacteraemia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 228

**Group ID:** EG001

**Num At Risk:** 226

**Term:** Bacterial sepsis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 228

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 226

**Term:** Cytomegalovirus infection

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 228

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 226

**Term:** Device related infection

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 228

**Group ID:** EG001

**Num At Risk:** 226

**Term:** Disseminated tuberculosis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 228

**Group ID:** EG001

**Num At Risk:** 226

**Term:** Endocarditis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 228

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 226

**Term:** Enterococcal bacteraemia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 228

**Group ID:** EG001

**Num At Risk:** 226

**Term:** Enterococcal sepsis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 228

**Group ID:** EG001

**Num At Risk:** 226

**Term:** Escherichia sepsis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 228

**Group ID:** EG001

**Num At Risk:** 226

**Term:** Fungal infection

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 228

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 226

**Term:** Gastroenteritis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 228

**Group ID:** EG001

**Num At Risk:** 226

**Term:** Genital herpes

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 228

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 226

**Term:** H1N1 influenza

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 228

**Group ID:** EG001

**Num At Risk:** 226

**Term:** Hepatic infection fungal

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 228

**Group ID:** EG001

**Num At Risk:** 226

**Term:** Herpes zoster

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 228

**Group ID:** EG001

**Num At Risk:** 226

**Term:** Klebsiella bacteraemia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 228

**Group ID:** EG001

**Num At Risk:** 226

**Term:** Lung abscess

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 228

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 226

**Term:** Lung infection

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 228

**Group ID:** EG001

**Num At Risk:** 226

**Term:** Meningitis fungal

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 228

**Group ID:** EG001

**Num At Risk:** 226

**Term:** Neutropenic sepsis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 228

**Group ID:** EG001

**Num At Risk:** 226

**Term:** Nocardiosis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 228

**Group ID:** EG001

**Num At Risk:** 226

**Term:** Oral herpes

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 228

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 226

**Term:** Pneumocystis jiroveci pneumonia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 228

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 226

**Term:** Pneumonia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 5

**Num At Risk:** 228

**Group ID:** EG001

**Num Affected:** 5

**Num At Risk:** 226

**Term:** Pneumonia staphylococcal

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 228

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 226

**Term:** Sepsis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 9

**Num At Risk:** 228

**Group ID:** EG001

**Num Affected:** 7

**Num At Risk:** 226

**Term:** Septic shock

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 10

**Num At Risk:** 228

**Group ID:** EG001

**Num Affected:** 14

**Num At Risk:** 226

**Term:** Sinusitis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 228

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 226

**Term:** Sinusitis aspergillus

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 228

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 226

**Term:** Staphylococcal bacteraemia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 228

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 226

**Term:** Staphylococcal infection

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 228

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 226

**Term:** Staphylococcal sepsis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 228

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 226

**Term:** Streptococcal sepsis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 228

**Group ID:** EG001

**Num At Risk:** 226

**Term:** Systemic candida

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 228

**Group ID:** EG001

**Num At Risk:** 226

**Term:** Tuberculosis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 228

**Group ID:** EG001

**Num At Risk:** 226

**Term:** Zygomycosis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 228

**Group ID:** EG001

**Num At Risk:** 226

**Term:** Complications of transplant surgery

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 228

**Group ID:** EG001

**Num At Risk:** 226

**Term:** Fall

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 228

**Group ID:** EG001

**Num At Risk:** 226

**Term:** Injury

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 228

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 226

**Term:** Subdural haematoma

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 228

**Group ID:** EG001

**Num At Risk:** 226

**Term:** Wound

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 228

**Group ID:** EG001

**Num At Risk:** 226

**Term:** Blood creatine phosphokinase increased

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 228

**Group ID:** EG001

**Num At Risk:** 226

**Term:** C-reactive protein increased

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 228

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 226

**Term:** Cytomegalovirus test positive

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 228

**Group ID:** EG001

**Num At Risk:** 226

**Term:** Electrocardiogram QT prolonged

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 228

**Group ID:** EG001

**Num At Risk:** 226

**Term:** Hepatic enzyme increased

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 228

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 226

**Term:** Lipase increased

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 228

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 226

**Term:** Liver function test abnormal

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 228

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 226

**Term:** Oxygen saturation decreased

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 228

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 226

**Term:** Procalcitonin increased

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 228

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 226

**Term:** Transaminases increased

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 228

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 226

**Term:** Hypoglycaemia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 228

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 226

**Term:** Hypokalaemia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 228

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 226

**Term:** Hyponatraemia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 228

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 226

**Term:** Hypovolaemia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 228

**Group ID:** EG001

**Num At Risk:** 226

**Term:** Lactic acidosis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 228

**Group ID:** EG001

**Num At Risk:** 226

**Term:** Metabolic acidosis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 228

**Group ID:** EG001

**Num At Risk:** 226

**Term:** Arthralgia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 228

**Group ID:** EG001

**Num At Risk:** 226

**Term:** Muscular weakness

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 228

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 226

**Term:** Acute leukaemia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 228

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 226

**Term:** Acute lymphocytic leukaemia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 228

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 226

**Term:** Acute myeloid leukaemia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 6

**Num At Risk:** 228

**Group ID:** EG001

**Num Affected:** 4

**Num At Risk:** 226

**Term:** B-cell lymphoma refractory

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 228

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 226

**Term:** Blast cell crisis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 228

**Group ID:** EG001

**Num At Risk:** 226

**Term:** Central nervous system lymphoma

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 228

**Group ID:** EG001

**Num At Risk:** 226

**Term:** Chronic lymphocytic leukaemia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 228

**Group ID:** EG001

**Num At Risk:** 226

**Term:** Chronic lymphocytic leukaemia recurrent

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 228

**Group ID:** EG001

**Num At Risk:** 226

**Term:** Leukaemia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 228

**Group ID:** EG001

**Num At Risk:** 226

**Term:** Leukaemia plasmacytic

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 228

**Group ID:** EG001

**Num At Risk:** 226

**Term:** Lymphoma

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 228

**Group ID:** EG001

**Num At Risk:** 226

**Term:** Multiple myeloma

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 228

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 226

**Term:** Neoplasm malignant

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 228

**Group ID:** EG001

**Num At Risk:** 226

**Term:** Non-Hodgkin's lymphoma

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 228

**Group ID:** EG001

**Num At Risk:** 226

**Term:** Aphasia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 228

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 226

**Term:** Cerebellar infarction

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 228

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 226

**Term:** Cerebral artery embolism

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 228

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 226

**Term:** Cerebral haemorrhage

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 228

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 226

**Term:** Cerebral infarction

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 228

**Group ID:** EG001

**Num At Risk:** 226

**Term:** Convulsion

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 228

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 226

**Term:** Dizziness

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 228

**Group ID:** EG001

**Num At Risk:** 226

**Term:** Encephalopathy

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 228

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 226

**Term:** Epilepsy

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 228

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 226

**Term:** Grand mal convulsion

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 228

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 226

**Term:** Hepatic encephalopathy

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 228

**Group ID:** EG001

**Num At Risk:** 226

**Term:** Ischaemic stroke

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 228

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 226

**Term:** Loss of consciousness

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 228

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 226

**Term:** Petit mal epilepsy

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 228

**Group ID:** EG001

**Num At Risk:** 226

**Term:** Toxic neuropathy

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 228

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 226

**Term:** Confusional state

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 228

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 226

**Term:** Hallucination

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 228

**Group ID:** EG001

**Num At Risk:** 226

**Term:** Hallucination, visual

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 228

**Group ID:** EG001

**Num At Risk:** 226

**Term:** Acute prerenal failure

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 228

**Group ID:** EG001

**Num At Risk:** 226

**Term:** Cystitis haemorrhagic

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 228

**Group ID:** EG001

**Num At Risk:** 226

**Term:** Hydronephrosis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 228

**Group ID:** EG001

**Num At Risk:** 226

**Term:** Nephritic syndrome

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 228

**Group ID:** EG001

**Num At Risk:** 226

**Term:** Oliguria

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 228

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 226

**Term:** Renal failure

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 228

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 226

**Term:** Renal failure acute

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 5

**Num At Risk:** 228

**Group ID:** EG001

**Num At Risk:** 226

**Term:** Renal impairment

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 228

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 226

**Term:** Vaginal haemorrhage

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 228

**Group ID:** EG001

**Num At Risk:** 226

**Term:** Acute respiratory distress syndrome

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 228

**Group ID:** EG001

**Num Affected:** 4

**Num At Risk:** 226

**Term:** Acute respiratory failure

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 228

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 226

**Term:** Bronchospasm

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 228

**Group ID:** EG001

**Num At Risk:** 226

**Term:** Cough

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 228

**Group ID:** EG001

**Num At Risk:** 226

**Term:** Dyspnoea

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 228

**Group ID:** EG001

**Num Affected:** 4

**Num At Risk:** 226

**Term:** Haemoptysis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 228

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 226

**Term:** Hypercapnia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 228

**Group ID:** EG001

**Num At Risk:** 226

**Term:** Hypoxia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 228

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 226

**Term:** Lung infiltration

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 228

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 226

**Term:** Pleural effusion

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 228

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 226

**Term:** Pneumonitis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 228

**Group ID:** EG001

**Num At Risk:** 226

**Term:** Pulmonary alveolar haemorrhage

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 228

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 226

**Term:** Pulmonary embolism

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 228

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 226

**Term:** Pulmonary haemorrhage

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 228

**Group ID:** EG001

**Num At Risk:** 226

**Term:** Pulmonary infarction

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 228

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 226

**Term:** Pulmonary oedema

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 228

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 226

**Term:** Respiratory disorder

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 228

**Group ID:** EG001

**Num At Risk:** 226

**Term:** Respiratory distress

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 228

**Group ID:** EG001

**Num Affected:** 6

**Num At Risk:** 226

**Term:** Respiratory failure

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 11

**Num At Risk:** 228

**Group ID:** EG001

**Num Affected:** 14

**Num At Risk:** 226

**Term:** Tachypnoea

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 228

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 226

**Term:** Aortic occlusion

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 228

**Group ID:** EG001

**Num At Risk:** 226

**Term:** Haematoma

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 228

**Group ID:** EG001

**Num At Risk:** 226

**Term:** Hypotension

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 228

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 226

**Term:** Iliac artery thrombosis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 228

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 226

**Term:** Shock

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 228

**Group ID:** EG001

**Num At Risk:** 226

**Term:** Shock haemorrhagic

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 228

**Group ID:** EG001

**Num At Risk:** 226

**Term:** Subclavian vein thrombosis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 228

**Group ID:** EG001

**Num At Risk:** 226

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 228

**Group ID:** BG001

**Value:** 226

**Group ID:** BG002

**Value:** 454

**Units:** Participants

### Group

**ID:** BG000

**Title:** Voriconazole/Anidulafungin

**Description:** Week 1: Voriconazole 6 mg/kg intravenously (IV) twice a day (bid) for 24 hours, followed by voriconazole 4 milligrams per kilogram (mg/kg) IV BID plus anidulafungin 200 mg IV on day 1, followed by 100 mg IV once a day (QD); Week 2: Voriconazole 4 mg/kg IV BID or 300 mg orally (PO) BID plus anidulafungin 100 mg IV QD; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin 100 mg IV QD or voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.

### Group

**ID:** BG001

**Title:** Voriconazole / Placebo

**Description:** Week 1: Voriconazole 6 mg/kg IV BID for 24 hours, followed by voriconazole 4 mg/kg IV BID plus anidulafungin placebo IV QD; Week 2: voriconazole 4 mg/kg IV BID or voriconazole 300 mg PO BID plus anidulafungin placebo IV QD through Day 14; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin placebo; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 15.4

**Value:** 52.0

#### Measurement

**Group ID:** BG001

**Spread:** 15.9

**Value:** 51.0

#### Measurement

**Group ID:** BG002

**Spread:** 15.7

**Value:** 51.5

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 94

#### Measurement

**Group ID:** BG001

**Value:** 95

#### Measurement

**Group ID:** BG002

**Value:** 189

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 134

#### Measurement

**Group ID:** BG001

**Value:** 131

#### Measurement

**Group ID:** BG002

**Value:** 265

**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
## Results Section - More Information Module
### Certain Agreement
**Other Details:** Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
**Restriction Type:** OTHER
**Restrictive Agreement:** True
### Point of Contact
**Email:** ClinicalTrials.gov_Inquiries@pfizer.com
**Organization:** Pfizer, Inc.
**Phone:** 1-800-718-1021
**Title:** Pfizer ClinicalTrials.gov Call Center
## Results Section - Outcome Measures Module
### Outcome Measure 1
#### Analysis
**CI Lower Limit:** -18.99
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.51
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** The 95% CI was based on using Greenwood's formula for the variance of the KM estimator.
**Group Description:** All-cause mortality calculated using the Kaplan-Meier (KM) product limit estimator on Day 42 (Week 6) within each stratum and weighted by the harmonic mean of the sample sizes in the strata. Treatment difference (stratified) based on a weighted difference in proportions. Stratification variables were site of infection and host factors.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0434
**P-Value Comment:** P-value based on a 1-sided test and tested against a 1-sided alpha of 0.025 to determine statistical significance.
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -8.74
**Statistical Comment:** 
**Statistical Method:** Z test for difference in proportions
**Tested Non-Inferiority:** False
### Outcome Measure 2
#### Analysis
**CI Lower Limit:** -21.6
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.15
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 95% confidence interval based on the difference in success rates using the normal approximation to the binoial distribution.
**Group Description:** Treatment difference (stratified) based on a weighted difference in proportions. Stratification variables: site of infection and host factors.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** P-value for global response was to be reported only if Week 6 mortality was significant.
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -10.23
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** False
### Outcome Measure 3
#### Analysis
**CI Lower Limit:** -10.77
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 5.56
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 95% confidence interval based on using Greenwood's formula for the variance of the Kaplan Meier estimator.
**Group Description:** Treatment difference (stratified) based on a weighted difference in proportions. Stratification variables: site of infection and host factors.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.2611
**P-Value Comment:** P-Value based on a 1-sided test and tested against a 1-sided alpha of 0.025 to determine statistical significance.
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -2.6
**Statistical Comment:** 
**Statistical Method:** Z test for difference in proportions
**Tested Non-Inferiority:** False
### Outcome Measure 4
#### Analysis
**CI Lower Limit:** -21.44
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.09
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 95% confidence intervalbased on using Greenwood's formula for the variance of the Kaplan Meier estimator.
**Group Description:** Treatment difference (stratified) based on a weighted difference in proportions. Stratification variables: site of infection and host factors.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0383
**P-Value Comment:** P-Value based on a 1-sided test and tested against a 1-sided alpha of 0.025 to determine statistical significance.
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -10.18
**Statistical Comment:** 
**Statistical Method:** Z test for difference in proportions
**Tested Non-Inferiority:** False
### Outcome Measure 5
#### Analysis
**CI Lower Limit:** -15.9
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 3.42
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 95% confidence interval based on Greenwood's formula for the variance of the Kaplan Meier estimator.
**Group Description:** Treatment difference (stratified) based on a weighted difference in proportions. Stratification variables: site of infection and host factors.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.1029
**P-Value Comment:** P-Value based on a one-sided test and tested against a 1-sided alpha of 0.025 to determine statistical significance.
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -6.24
**Statistical Comment:** 
**Statistical Method:** Z test for difference in proportions
**Tested Non-Inferiority:** False
### Outcome Measure 6
#### Analysis
**CI Lower Limit:** 0.46
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.04
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Hazard Ratio: hazard of death in the Voriconazole/Anidulafungin arm relative to the Voriconazole/Placebo arm, adjusted for host factor status and site of infection. Participants who died beyond Day 84 were censored.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.083
**P-Value Comment:** 
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 0.696
**Statistical Comment:** 
**Statistical Method:** Cox proportional hazards model
**Tested Non-Inferiority:** False
### Outcome Measure 7
#### Analysis
**CI Lower Limit:** 0.40
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.16
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 95% confidence interval based on Greenwood's formula.
**Group Description:** Analysis based on Cox proportional hazards model. Participants who died beyond day 84 were censored.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.164
**P-Value Comment:** 
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 0.687
**Statistical Comment:** 
**Statistical Method:** Cox proportional hazards model
**Tested Non-Inferiority:** False
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 26
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 39
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 44
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 61
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 44
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 47
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 39
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 55
**Title:** 
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 23
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 33
**Title:** 
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 2
- **Spread:** 
- **Upper Limit:** 84
- **Value:** 30.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 3
- **Spread:** 
- **Upper Limit:** 79
- **Value:** 30.0
**Title:** 
#### Outcome Measure 7
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 2
- **Spread:** 
- **Upper Limit:** 40
- **Value:** 14.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 4
- **Spread:** 
- **Upper Limit:** 45
- **Value:** 18.5
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Number of deaths measured 6 weeks after start of treatment. Time to death defined as date of death minus first treatment date + 1.
**Parameter Type:** NUMBER
**Population Description:** Modified intent-to-treat (MITT) population: all randomized participants with proven or probable IA confirmed by Day 7 following enrollment who received at least 1 dose of study medication. N=number of participants in MITT population at Week 6. Participants not known to have died were censored at last study visit (Day 84).
**Reporting Status:** POSTED
**Time Frame:** Day 1 to Day 42 (Week 6)
**Title:** All-cause Mortality at Week 6 in Participants With Proven or Probable Invasive Aspergillosis
**Type:** PRIMARY
**Unit of Measure:** participants
##### Group
**Description:** Week 1: Voriconazole 6 mg/kg intravenously (IV) twice a day (bid) for 24 hours, followed by voriconazole 4 milligrams per kilogram (mg/kg) IV BID plus anidulafungin 200 mg IV on day 1, followed by 100 mg IV once a day (QD); Week 2: Voriconazole 4 mg/kg IV BID or 300 mg orally (PO) BID plus anidulafungin 100 mg IV QD; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin 100 mg IV QD or voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
**ID:** OG000
**Title:** Voriconazole/Anidulafungin
##### Group
**Description:** Week 1: Voriconazole 6 mg/kg IV BID for 24 hours, followed by voriconazole 4 mg/kg IV BID plus anidulafungin placebo IV QD; Week 2: voriconazole 4 mg/kg IV BID or voriconazole 300 mg PO BID plus anidulafungin placebo IV QD through Day 14; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin placebo; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
**ID:** OG001
**Title:** Voriconazole / Placebo
#### Outcome Measure 2
**Description:** Number of participants with a successful response (complete or partial global response). Complete response = resolution of all clinical signs and symptoms and \>90% of lesions due to IA that were visible on radiologic studies at baseline (BL); partial response = clinical improvement and \>50% improvement in radiological findings present at BL.
**Parameter Type:** NUMBER
**Population Description:** MITT; N = number of participants in MITT population at Week 6. Missing data and participants who died at Week 6 were treated as failure.
**Reporting Status:** POSTED
**Time Frame:** Baseline, Day 42 (Week 6)
**Title:** Global Response at Week 6
**Type:** SECONDARY
**Unit of Measure:** participants
##### Group
**Description:** Week 1: Voriconazole 6 mg/kg intravenously (IV) twice a day (bid) for 24 hours, followed by voriconazole 4 milligrams per kilogram (mg/kg) IV BID plus anidulafungin 200 mg IV on day 1, followed by 100 mg IV once a day (QD); Week 2: Voriconazole 4 mg/kg IV BID or 300 mg orally (PO) BID plus anidulafungin 100 mg IV QD; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin 100 mg IV QD or voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
**ID:** OG000
**Title:** Voriconazole/Anidulafungin
##### Group
**Description:** Week 1: Voriconazole 6 mg/kg IV BID for 24 hours, followed by voriconazole 4 mg/kg IV BID plus anidulafungin placebo IV QD; Week 2: voriconazole 4 mg/kg IV BID or voriconazole 300 mg PO BID plus anidulafungin placebo IV QD through Day 14; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin placebo; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
**ID:** OG001
**Title:** Voriconazole / Placebo
#### Outcome Measure 3
**Description:** Number of deaths due to any cause measured 6 weeks after start of treatment. Time to death defined as date of death minus first treatment date + 1.
**Parameter Type:** NUMBER
**Population Description:** Intent-to-treat (ITT) population: participants in MITT analysis set plus participants with possible IA who could not be upgraded to probable or proven IA within 7 days and had received at least 1 dose of study medication. N=number of participants in ITT population at Week 6.
**Reporting Status:** POSTED
**Time Frame:** Day 1 to Day 42 (Week 6)
**Title:** All-cause Mortality at Week 6 in Participants With Possible, Probable, or Proven Invasive Aspergillosis (IA)
**Type:** SECONDARY
**Unit of Measure:** participants
##### Group
**Description:** Week 1: Voriconazole 6 mg/kg intravenously (IV) twice a day (bid) for 24 hours, followed by voriconazole 4 milligrams per kilogram (mg/kg) IV BID plus anidulafungin 200 mg IV on day 1, followed by 100 mg IV once a day (QD); Week 2: Voriconazole 4 mg/kg IV BID or 300 mg orally (PO) BID plus anidulafungin 100 mg IV QD; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin 100 mg IV QD or voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
**ID:** OG000
**Title:** Voriconazole/Anidulafungin
##### Group
**Description:** Week 1: Voriconazole 6 mg/kg IV BID for 24 hours, followed by voriconazole 4 mg/kg IV BID plus anidulafungin placebo IV QD; Week 2: voriconazole 4 mg/kg IV BID or voriconazole 300 mg PO BID plus anidulafungin placebo IV QD through Day 14; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin placebo; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
**ID:** OG001
**Title:** Voriconazole / Placebo
#### Outcome Measure 4
**Description:** Number of deaths due to any cause measured 12 weeks after start of treatment. Time to death defined as date of death minus first treatment date + 1.
**Parameter Type:** NUMBER
**Population Description:** MITT; N=number of participants in MITT population at Week 12.
**Reporting Status:** POSTED
**Time Frame:** Day 1 to Day 84 (Week 12)
**Title:** All-cause Mortality at Week 12 in Participants With Probable or Proven Invasive Aspergillosis (IA)
**Type:** SECONDARY
**Unit of Measure:** participants
##### Group
**Description:** Week 1: Voriconazole 6 mg/kg intravenously (IV) twice a day (bid) for 24 hours, followed by voriconazole 4 milligrams per kilogram (mg/kg) IV BID plus anidulafungin 200 mg IV on day 1, followed by 100 mg IV once a day (QD); Week 2: Voriconazole 4 mg/kg IV BID or 300 mg orally (PO) BID plus anidulafungin 100 mg IV QD; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin 100 mg IV QD or voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
**ID:** OG000
**Title:** Voriconazole/Anidulafungin
##### Group
**Description:** Week 1: Voriconazole 6 mg/kg IV BID for 24 hours, followed by voriconazole 4 mg/kg IV BID plus anidulafungin placebo IV QD; Week 2: voriconazole 4 mg/kg IV BID or voriconazole 300 mg PO BID plus anidulafungin placebo IV QD through Day 14; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin placebo; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
**ID:** OG001
**Title:** Voriconazole / Placebo
#### Outcome Measure 5
**Description:** Number of deaths due to Invasive Aspergillosis measured 6 weeks after start of treatment. Time to death defined as date of death minus first treatment date + 1.
**Parameter Type:** NUMBER
**Population Description:** MITT; N = number of participants in MITT population at Week 6. Participants who died due to causes other than IA before Week 6 were censored at their time of death in this analysis.
**Reporting Status:** POSTED
**Time Frame:** Day 1 to Day 42 (Week 6)
**Title:** Mortality Due to Invasive Aspergillosis (IA) at Week 6 in Participants With Probable or Proven IA
**Type:** SECONDARY
**Unit of Measure:** participants
##### Group
**Description:** Week 1: Voriconazole 6 mg/kg intravenously (IV) twice a day (bid) for 24 hours, followed by voriconazole 4 milligrams per kilogram (mg/kg) IV BID plus anidulafungin 200 mg IV on day 1, followed by 100 mg IV once a day (QD); Week 2: Voriconazole 4 mg/kg IV BID or 300 mg orally (PO) BID plus anidulafungin 100 mg IV QD; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin 100 mg IV QD or voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
**ID:** OG000
**Title:** Voriconazole/Anidulafungin
##### Group
**Description:** Week 1: Voriconazole 6 mg/kg IV BID for 24 hours, followed by voriconazole 4 mg/kg IV BID plus anidulafungin placebo IV QD; Week 2: voriconazole 4 mg/kg IV BID or voriconazole 300 mg PO BID plus anidulafungin placebo IV QD through Day 14; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin placebo; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
**ID:** OG001
**Title:** Voriconazole / Placebo
#### Outcome Measure 6
**Description:** Survival time from start of treatment. Time to death defined as date of death due to any cause minus first treatment date + 1.
**Dispersion Type:** Full Range
**Parameter Type:** MEDIAN
**Population Description:** MITT; N = number of participants in MITT population at time of assessment.
**Reporting Status:** POSTED
**Time Frame:** Day 1 to Day 84 (Week 12)
**Title:** Time to Death: All-Cause Mortality
**Type:** SECONDARY
**Unit of Measure:** days
##### Group
**Description:** Week 1: Voriconazole 6 mg/kg intravenously (IV) twice a day (bid) for 24 hours, followed by voriconazole 4 milligrams per kilogram (mg/kg) IV BID plus anidulafungin 200 mg IV on day 1, followed by 100 mg IV once a day (QD); Week 2: Voriconazole 4 mg/kg IV BID or 300 mg orally (PO) BID plus anidulafungin 100 mg IV QD; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin 100 mg IV QD or voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
**ID:** OG000
**Title:** Voriconazole/Anidulafungin
##### Group
**Description:** Week 1: Voriconazole 6 mg/kg IV BID for 24 hours, followed by voriconazole 4 mg/kg IV BID plus anidulafungin placebo IV QD; Week 2: voriconazole 4 mg/kg IV BID or voriconazole 300 mg PO BID plus anidulafungin placebo IV QD through Day 14; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin placebo; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
**ID:** OG001
**Title:** Voriconazole / Placebo
#### Outcome Measure 7
**Description:** Survival time from start of treatment. Time to death defined as date of death due to IA minus first treatment date + 1.
**Dispersion Type:** Full Range
**Parameter Type:** MEDIAN
**Population Description:** MITT; N = number of participants in MITT population at time of assessment. Participants who died due to causes other than IA were defined as censored at time of death.
**Reporting Status:** POSTED
**Time Frame:** Day 1 to Day 84 (Week 12)
**Title:** Time to Death Due to Invasive Aspergillosis (IA)
**Type:** SECONDARY
**Unit of Measure:** days
##### Group
**Description:** Week 1: Voriconazole 6 mg/kg intravenously (IV) twice a day (bid) for 24 hours, followed by voriconazole 4 milligrams per kilogram (mg/kg) IV BID plus anidulafungin 200 mg IV on day 1, followed by 100 mg IV once a day (QD); Week 2: Voriconazole 4 mg/kg IV BID or 300 mg orally (PO) BID plus anidulafungin 100 mg IV QD; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin 100 mg IV QD or voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
**ID:** OG000
**Title:** Voriconazole/Anidulafungin
##### Group
**Description:** Week 1: Voriconazole 6 mg/kg IV BID for 24 hours, followed by voriconazole 4 mg/kg IV BID plus anidulafungin placebo IV QD; Week 2: voriconazole 4 mg/kg IV BID or voriconazole 300 mg PO BID plus anidulafungin placebo IV QD through Day 14; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin placebo; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
**ID:** OG001
**Title:** Voriconazole / Placebo
### Participant Flow Module
#### Group
**Description:** Week 1: Voriconazole 6 mg/kg intravenously (IV) twice a day (bid) for 24 hours, followed by voriconazole 4 milligrams per kilogram (mg/kg) IV BID plus anidulafungin 200 mg IV on day 1, followed by 100 mg IV once a day (QD); Week 2: Voriconazole 4 mg/kg IV BID or 300 mg orally (PO) BID plus anidulafungin 100 mg IV QD; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin 100 mg IV QD or voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
**ID:** FG000
**Title:** Voriconazole/Anidulafungin
#### Group
**Description:** Week 1: Voriconazole 6 mg/kg IV BID for 24 hours, followed by voriconazole 4 mg/kg IV BID plus anidulafungin placebo IV QD; Week 2: voriconazole 4 mg/kg IV BID or voriconazole 300 mg PO BID plus anidulafungin placebo IV QD through Day 14; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin placebo; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
**ID:** FG001
**Title:** Voriconazole / Placebo
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Death
###### Reason
**Group ID:** FG000
**Number of Subjects:** 68
###### Reason
**Group ID:** FG001
**Number of Subjects:** 71
##### Withdraw
**Type:** Lost to Follow-up
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 2
##### Withdraw
**Type:** Other
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 6
###### Reason
**Group ID:** FG001
**Number of Subjects:** 6
##### Withdraw
**Type:** Did not receive treatment
###### Reason
**Group ID:** FG000
**Number of Subjects:** 2
###### Reason
**Group ID:** FG001
**Number of Subjects:** 3
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 230
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 229
##### Milestone
**Type:** Treated
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 228
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 226
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 154
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 146
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 76
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 83
**Pre-Assignment Details:** Participants were stratified at study entry for host and transplant variables known to have an independent impact on the probablity of death due to invasive aspergillosis (IA) (allogenic hematopoietic stem cell transplant versus other, and pulmonary IA).
**Has Results:** True