## Protocol Section
### Identification Module
**NCT ID:** NCT00862979

**Acronym:** MANDELA

**Brief Title:** A Study Investigating the Renal Tolerability, Efficacy, and Safety of a CNI-free Versus a Standard Regimen in de Novo Heart Transplant (HTx) Recipients

**Official Title:** A Multi-center, Randomized, Open-label, Parallel Group Study Investigating the Renal Tolerability, Efficacy and Safety of a CNI-free Regimen (Everolimus and MPA) Versus a CNI-regimen With Everolimus in Heart Transplant Recipients

#### Organization Study ID Info
**ID:** CRAD001ADE14
#### Organization
**Class:** INDUSTRY
**Full Name:** Novartis
#### Secondary ID Infos
**ID:** 2007-002671-14
### Status Module
#### Completion Date
**Date:** 2017-03-06

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2018-08-07

**Type:** ACTUAL

**Last Update Submit Date:** 2018-07-09

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2017-03-06

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2018-06-25

**Type:** ACTUAL

**Results First Submit Date:** 2018-03-05

**Results First Submit QC Date:** 2018-05-23

#### Start Date
**Date:** 2009-02-24

**Type:** ACTUAL

**Status Verified Date:** 2018-07

#### Study First Post Date
**Date:** 2009-03-17
**Type:** ESTIMATED
**Study First Submit Date:** 2009-03-16
**Study First Submit QC Date:** 2009-03-16
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Novartis Pharmaceuticals

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** This study will assess whether a calcineurin inhibitor (CNI)-free regimen with everolimus and mycophenolic acid is associated with a better renal outcome as compared to the standard regimen containing cyclosporine A (which belongs to the class of CNIs) and everolimus; while both treatments are expected to be comparable with respect to efficacy.

**Detailed Description:** This study will assess whether a calcineurin inhibitor (CNI)-free regimen with everolimus and mycophenolic acid is associated with a better renal outcome as compared to the standard regimen containing cyclosporine A (which belongs to the class of CNIs) and everolimus; while both treatments are expected to be comparable with respect to efficacy.

### Conditions Module

**Conditions:**

- Heart Transplantation

**Keywords:**

- Heart Transplantation

- Cardiac Transplantation

- CNI-sparing

- renal function

- CNI

- Cyclosporine A

- Everolimus

- mycophenolic acid

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 162

**Type:** ACTUAL

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** CNI-regimen: cyclosporine A (CyA) or tacrolimus (TAC) with everolimus (EVR) with corticosteroids

**Intervention Names:**

- Drug: Everolimus (EVR)

- Drug: cyclosporine A (CyA)

- Drug: tacrolimus (TAC)

- Drug: Corticosteroids

**Label:** CNI-regimen

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** CNI-free regimen: everolimus (EVR) with MPA (either MMF or enteric coated mycophenolate sodium (EC-MPS)) and corticosteroids

**Intervention Names:**

- Drug: Everolimus (EVR)

- Drug: cyclosporine A (CyA)

- Drug: tacrolimus (TAC)

- Drug: Enteric coated mycophenolate sodium (EC-MPS)

- Drug: mycophenolate mofetil (MMF)

- Drug: Corticosteroids

**Label:** CNI-free-regimen

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- CNI-free-regimen

- CNI-regimen

**Description:** Everolimus 0.25mg, 0.75mg or 1.0mg based on blood levels (5-10 ng/mL)

**Name:** Everolimus (EVR)

**Other Names:**

- Certican, RAD001

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- CNI-free-regimen

- CNI-regimen

**Description:** 10 mg, 25 mg, 50 mg or 100 mg capsule according to blood levels for CNI-regimen group. For CNI-free-regimen dispense on month 6 to 9 only

**Name:** cyclosporine A (CyA)

**Other Names:**

- Sandimmun Optoral

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- CNI-free-regimen

- CNI-regimen

**Description:** 0.5 mg, 1 mg, or 5 mg capsule given according to blood levels for CNI-regimen. For CNI-free-regimen give on month 6 to 9 only

**Name:** tacrolimus (TAC)

**Other Names:**

- Prograf

**Type:** DRUG

#### Intervention 4

**Arm Group Labels:**

- CNI-free-regimen

**Description:** 180 mg or 360 mg tablet dosed 1440-2280 mg per day

**Name:** Enteric coated mycophenolate sodium (EC-MPS)

**Other Names:**

- Myfortic

**Type:** DRUG

#### Intervention 5

**Arm Group Labels:**

- CNI-free-regimen

**Description:** 250 mg or 500 mg tablets with a dose of 1500-3000 mg per day

**Name:** mycophenolate mofetil (MMF)

**Other Names:**

- CellCept

**Type:** DRUG

#### Intervention 6

**Arm Group Labels:**

- CNI-free-regimen

- CNI-regimen

**Description:** according to local standard: 0.05-0.3 mg/kg of prednisolone or equivalent

**Name:** Corticosteroids

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Calculated Glomerular Filtration Rate (cGFR) Using Modification of Diet in Renal Disease (MDRD) Formula at Month 18 cGFR (in mL/min/1.73 m2) = 186.3\*(C-1.154)\*(A-0.203)\*G\*R where C = the serum concentration of creatinine (mg/dL), A = age (years), G = 0.742 when gender is female, otherwise G = 1, R = 1.21 when race is black, otherwise R = 1.

**Measure:** Calculated Glomerular Filtration Rate (cGFR) Using Modification of Diet in Renal Disease (MDRD) Formula at Month 18

**Time Frame:** Month 18

#### Secondary Outcomes

**Description:** Treatment failure was defined as composite endpoint of biopsy proven acute rejection of ISHLT 1990 grade ≥ 3A resp. ISHLT 2004 grade ≥ 2R, acute rejection episodes associated with hemodynamic compromise, graft loss / re-transplant, death, loss to follow up (at least one condition must be present). If participant had an occurrence in each period it was counted for each period.

**Measure:** Occurrence of Treatment Failures From Month 6 to 9 and Month 9 to 18

**Time Frame:** Month 6 to Month 9; Month 9 to Month 18

**Description:** Major cardiac events (MACE) was defined as one of the following: any death, myocardial infarction, coronary artery bypass grafting

**Measure:** Occurrence of Major Cardiac Events (MACE) From Month 6 to 18

**Time Frame:** Month 6 to Month 18

**Description:** Calculated Glomerular Filtration Rate (cGFR) according to Cockcroft-Gault at Month 12 and 18. For men: GFR=(140-Age) x Body weight (kg) / 72 x Serum Creatinine (mg/dl) For women: GFR=0.85 (140 -Age) x Body weight(kg)/ 72 x Serum Creatinine (mg/dl)

**Measure:** Calculated Glomerular Filtration Rate (cGFR) According to Cockcroft-Gault at Month 12 and 18

**Time Frame:** Month 12 and 18

**Description:** Serum Creatinine is an indicator of renal function measured in the blood

**Measure:** Serum Creatinine at Month 6, 8, 9, 10 12 and 18

**Time Frame:** Month 6, 8, 9, 10 12 and 18

**Description:** Reciprocal Creatinine Slope is an indication of renal function over time with a higher slope value indicating an improvement in renal function.

**Measure:** Reciprocal Creatinine Slope Between Month 6 and Month 18

**Time Frame:** Between Month 6 and Month 18

### Eligibility Module

**Eligibility Criteria:** Inclusion criteria:

* Heart transplantation, 3 months prior to enrollment
* Patients have to receive an immunosuppressive regimen with Sandimmun® Optoral, Certican® and corticosteroids
* Sufficient graft function
* Sufficient renal function
* Females capable of becoming pregnant must have a negative serum pregnancy test within 7 days prior to or at baseline, and are required to practice an approved method of birth control for the duration of the study and for a period of 6 weeks following discontinuation of study medication, even where there has been a history of infertility

Exclusion criteria:

* Multi-organ recipients, re-transplantation, or previous transplant with any other organ.
* Patients who are recipients of A-B-O incompatible transplants
* Cold ischemia time \>6 hours
* Historical or current peak PRA of \> 25% at time of transplantation
* Already existing antibodies against the HLA-type of the receiving transplant Other protocol-defined inclusion/exclusion criteria may apply

**Maximum Age:** 70 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Bad Oeynhausen

**Country:** Germany

**Facility:** Novartis Investigative Site

**Zip:** 32545

**Location 2:**

**City:** Berlin

**Country:** Germany

**Facility:** Novartis Investigative Site

**Zip:** 13353

**Location 3:**

**City:** Hamburg

**Country:** Germany

**Facility:** Novartis Investigative Site

**Zip:** 20246

**Location 4:**

**City:** Hannover

**Country:** Germany

**Facility:** Novartis Investigative Site

**Zip:** 30625

**Location 5:**

**City:** Heidelberg

**Country:** Germany

**Facility:** Novartis Investigative Site

**Zip:** 69120

**Location 6:**

**City:** Leipzig

**Country:** Germany

**Facility:** Novartis Investigative Site

**Zip:** 04289

**Location 7:**

**City:** Muenster

**Country:** Germany

**Facility:** Novartis Investigative Site

**Zip:** 48149

**Location 8:**

**City:** München

**Country:** Germany

**Facility:** Novartis Investigative Site

**Zip:** 81377

**Location 9:**

**City:** Regensburg

**Country:** Germany

**Facility:** Novartis Investigative Site

**Zip:** 93053

#### Overall Officials

**Official 1:**

**Affiliation:** Novartis Pharmaceuticals

**Name:** Novartis Pharmaceuticals

**Role:** STUDY_DIRECTOR

## Document Section

### Large Document Module

#### Large Docs

- Date: 2016-01-19

- Filename: Prot_000.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: False

- Label: Study Protocol

- Size: 590341

- Type Abbrev: Prot

- Upload Date: 2018-03-05T10:27

- Date: 2017-06-02

- Filename: SAP_001.pdf

- Has ICF: False

- Has Protocol: False

- Has SAP: True

- Label: Statistical Analysis Plan

- Size: 380010

- Type Abbrev: SAP

- Upload Date: 2018-03-05T10:27

## Derived Section

### Intervention Browse Module - Ancestors

- ID: D000007166

- Term: Immunosuppressive Agents

- ID: D000007155

- Term: Immunologic Factors

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000065095

- Term: Calcineurin Inhibitors

- ID: D000004791

- Term: Enzyme Inhibitors

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000000935

- Term: Antifungal Agents

- ID: D000000890

- Term: Anti-Infective Agents

- ID: D000003879

- Term: Dermatologic Agents

- ID: D000018501

- Term: Antirheumatic Agents

- ID: D000091203

- Term: MTOR Inhibitors

- ID: D000047428

- Term: Protein Kinase Inhibitors

- ID: D000000970

- Term: Antineoplastic Agents

- ID: D000000903

- Term: Antibiotics, Antineoplastic

- ID: D000000904

- Term: Antibiotics, Antitubercular

- ID: D000000995

- Term: Antitubercular Agents

- ID: D000000900

- Term: Anti-Bacterial Agents

### Intervention Browse Module - Browse Branches

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: ARhu

- Name: Antirheumatic Agents

- Abbrev: Derm

- Name: Dermatologic Agents

- Abbrev: Infl

- Name: Anti-Inflammatory Agents

- Abbrev: AnEm

- Name: Antiemetics

- Abbrev: NeuroAg

- Name: Neuroprotective Agents

- Abbrev: Gast

- Name: Gastrointestinal Agents

### Intervention Browse Module - Browse Leaves

- ID: M255

- Name: Everolimus

- Relevance: HIGH

- As Found: Head

- ID: M18961

- Name: Cyclosporine

- Relevance: HIGH

- As Found: New

- ID: M6730

- Name: Cyclosporins

- Relevance: HIGH

- As Found: New

- ID: M14120

- Name: Prednisolone

- Relevance: LOW

- As Found: Unknown

- ID: M16975

- Name: Triamcinolone Acetonide

- Relevance: LOW

- As Found: Unknown

- ID: M16974

- Name: Triamcinolone

- Relevance: LOW

- As Found: Unknown

- ID: M237966

- Name: Triamcinolone hexacetonide

- Relevance: LOW

- As Found: Unknown

- ID: M209573

- Name: Triamcinolone diacetate

- Relevance: LOW

- As Found: Unknown

- ID: M12128

- Name: Mycophenolic Acid

- Relevance: HIGH

- As Found: Phase 2

- ID: M18950

- Name: Tacrolimus

- Relevance: HIGH

- As Found: 3 weeks

- ID: M11749

- Name: Methylprednisolone

- Relevance: LOW

- As Found: Unknown

- ID: M1833

- Name: Methylprednisolone Acetate

- Relevance: LOW

- As Found: Unknown

- ID: M11750

- Name: Methylprednisolone Hemisuccinate

- Relevance: LOW

- As Found: Unknown

- ID: M229449

- Name: Prednisolone acetate

- Relevance: LOW

- As Found: Unknown

- ID: M211887

- Name: Prednisolone hemisuccinate

- Relevance: LOW

- As Found: Unknown

- ID: M248881

- Name: Prednisolone phosphate

- Relevance: LOW

- As Found: Unknown

- ID: M10212

- Name: Immunosuppressive Agents

- Relevance: LOW

- As Found: Unknown

- ID: M10201

- Name: Immunologic Factors

- Relevance: LOW

- As Found: Unknown

- ID: M30452

- Name: Calcineurin Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

- 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: M7074

- Name: Dermatologic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M20604

- Name: Antirheumatic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M21960

- Name: Sirolimus

- Relevance: LOW

- As Found: Unknown

- ID: M353695

- Name: Temsirolimus

- Relevance: LOW

- As Found: Unknown

- ID: M2827

- Name: MTOR Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M25820

- Name: Protein Kinase Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M4222

- Name: Anti-Bacterial Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4224

- Name: Antibiotics, Antitubercular

- Relevance: LOW

- As Found: Unknown

- ID: M4311

- Name: Antitubercular Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000016572

- Term: Cyclosporine

- ID: D000009173

- Term: Mycophenolic Acid

- ID: D000068338

- Term: Everolimus

- ID: D000016559

- Term: Tacrolimus

- ID: D000003524

- Term: Cyclosporins

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** CNI-regimen

**Deaths Num At Risk:** 84

**Description:** CNI-regimen: cyclosporine A (CyA) or tacrolimus (TAC) with everolimus (EVR) with corticosteroids

**ID:** EG000

**Other Num Affected:** 74

**Other Num at Risk:** 84

**Serious Number Affected:** 40

**Serious Number At Risk:** 84

**Title:** CNI-regimen

**Group ID:** EG001

**Title:** CNI-free-regimen

**Deaths Num Affected:** 1

**Deaths Num At Risk:** 78

**Description:** CNI-free regimen: MPA (either MMF or enteric coated mycophenolate sodium (EC-MPS)) and everolimus and corticosteroids; On month 6 to 9 only: Cyclosporin A or tacrolimus

**ID:** EG001

**Other Num Affected:** 65

**Other Num at Risk:** 78

**Serious Number Affected:** 29

**Serious Number At Risk:** 78

**Title:** CNI-free-regimen

**Frequency Threshold:** 5

#### Other Events

**Term:** ANAEMIA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (20.0)

**Term:** LEUKOPENIA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (20.0)

**Term:** SINUS TACHYCARDIA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA (20.0)

**Term:** TACHYCARDIA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA (20.0)

**Term:** HYPERTHYROIDISM

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Endocrine disorders

**Source Vocabulary:** MedDRA (20.0)

**Term:** APHTHOUS ULCER

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (20.0)

**Term:** DIARRHOEA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (20.0)

**Term:** NAUSEA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (20.0)

**Term:** VOMITING

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (20.0)

**Term:** FATIGUE

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (20.0)

**Term:** OEDEMA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (20.0)

**Term:** OEDEMA PERIPHERAL

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (20.0)

**Term:** PYREXIA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (20.0)

**Term:** BRONCHITIS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (20.0)

**Term:** CYTOMEGALOVIRUS INFECTION

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (20.0)

**Term:** NASOPHARYNGITIS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (20.0)

**Term:** ORAL HERPES

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (20.0)

**Term:** RESPIRATORY TRACT INFECTION

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (20.0)

**Term:** BLOOD CREATININE INCREASED

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (20.0)

**Term:** C-REACTIVE PROTEIN INCREASED

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (20.0)

**Term:** HYPERCHOLESTEROLAEMIA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA (20.0)

**Term:** HYPERLIPIDAEMIA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA (20.0)

**Term:** HYPERTRIGLYCERIDAEMIA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA (20.0)

**Term:** HYPERURICAEMIA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA (20.0)

**Term:** HYPOKALAEMIA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA (20.0)

**Term:** MUSCLE SPASMS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (20.0)

**Term:** MYALGIA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (20.0)

**Term:** OSTEOPOROSIS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (20.0)

**Term:** PAIN IN EXTREMITY

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (20.0)

**Term:** HEADACHE

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (20.0)

**Term:** COUGH

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (20.0)

**Term:** DYSPNOEA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (20.0)

**Term:** ACNE

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (20.0)

**Term:** RASH

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (20.0)

**Term:** HYPERTENSION

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA (20.0)

#### Serious Events

**Term:** ANAEMIA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 84

**Group ID:** EG001

**Num At Risk:** 78

**Term:** ATRIAL FIBRILLATION

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 84

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 78

**Term:** ATRIAL FLUTTER

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 84

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 78

**Term:** CORONARY ARTERY STENOSIS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 84

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 78

**Term:** LEFT VENTRICULAR DYSFUNCTION

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 84

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 78

**Term:** PERICARDIAL EFFUSION

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 84

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 78

**Term:** SINUS TACHYCARDIA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 84

**Group ID:** EG001

**Num At Risk:** 78

**Term:** TACHYCARDIA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 84

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 78

**Term:** HYPERTHYROIDISM

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Endocrine disorders

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 84

**Group ID:** EG001

**Num At Risk:** 78

**Term:** EYE PAIN

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 84

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 78

**Term:** GLAUCOMA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 84

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 78

**Term:** ABDOMINAL HERNIA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 84

**Group ID:** EG001

**Num At Risk:** 78

**Term:** APHTHOUS ULCER

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 84

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 78

**Term:** COLITIS ISCHAEMIC

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 84

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 78

**Term:** DIARRHOEA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 84

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 78

**Term:** INGUINAL HERNIA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 84

**Group ID:** EG001

**Num At Risk:** 78

**Term:** NAUSEA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 84

**Group ID:** EG001

**Num At Risk:** 78

**Term:** VOMITING

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 84

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 78

**Term:** CHEST PAIN

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 84

**Group ID:** EG001

**Num At Risk:** 78

**Term:** CHILLS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 84

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 78

**Term:** FATIGUE

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 84

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 78

**Term:** OEDEMA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 84

**Group ID:** EG001

**Num At Risk:** 78

**Term:** OEDEMA PERIPHERAL

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 84

**Group ID:** EG001

**Num At Risk:** 78

**Term:** PYREXIA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 84

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 78

**Term:** STENOSIS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 84

**Group ID:** EG001

**Num At Risk:** 78

**Term:** CHOLECYSTITIS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 84

**Group ID:** EG001

**Num At Risk:** 78

**Term:** CHOLECYSTITIS ACUTE

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 84

**Group ID:** EG001

**Num At Risk:** 78

**Term:** CHOLECYSTITIS CHRONIC

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 84

**Group ID:** EG001

**Num At Risk:** 78

**Term:** CHOLELITHIASIS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 84

**Group ID:** EG001

**Num At Risk:** 78

**Term:** HEART TRANSPLANT REJECTION

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Immune system disorders

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 84

**Group ID:** EG001

**Num Affected:** 7

**Num At Risk:** 78

**Term:** ANAL ABSCESS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 84

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 78

**Term:** ASPERGILLOMA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 84

**Group ID:** EG001

**Num At Risk:** 78

**Term:** ASPERGILLUS INFECTION

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 84

**Group ID:** EG001

**Num At Risk:** 78

**Term:** BACTERAEMIA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 84

**Group ID:** EG001

**Num At Risk:** 78

**Term:** BACTERIAL INFECTION

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 84

**Group ID:** EG001

**Num At Risk:** 78

**Term:** CAMPYLOBACTER GASTROENTERITIS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 84

**Group ID:** EG001

**Num At Risk:** 78

**Term:** CLOSTRIDIUM DIFFICILE COLITIS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 84

**Group ID:** EG001

**Num At Risk:** 78

**Term:** CYTOMEGALOVIRUS INFECTION

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 84

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 78

**Term:** DEVICE RELATED INFECTION

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 84

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 78

**Term:** DIABETIC GANGRENE

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 84

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 78

**Term:** DIVERTICULITIS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 84

**Group ID:** EG001

**Num At Risk:** 78

**Term:** ENDOCARDITIS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 84

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 78

**Term:** ESCHERICHIA INFECTION

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 84

**Group ID:** EG001

**Num At Risk:** 78

**Term:** FEBRILE INFECTION

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 84

**Group ID:** EG001

**Num At Risk:** 78

**Term:** GASTROENTERITIS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 84

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 78

**Term:** GASTROENTERITIS NOROVIRUS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 84

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 78

**Term:** GASTROENTERITIS SALMONELLA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 84

**Group ID:** EG001

**Num At Risk:** 78

**Term:** GROIN INFECTION

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 84

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 78

**Term:** H1N1 INFLUENZA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 84

**Group ID:** EG001

**Num At Risk:** 78

**Term:** HERPES SIMPLEX

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 84

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 78

**Term:** HERPES ZOSTER

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 84

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 78

**Term:** HERPES ZOSTER INFECTION NEUROLOGICAL

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 84

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 78

**Term:** INFECTED LYMPHOCELE

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 84

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 78

**Term:** INFECTION

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 84

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 78

**Term:** INFECTIOUS PLEURAL EFFUSION

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 84

**Group ID:** EG001

**Num At Risk:** 78

**Term:** INFLUENZA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 84

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 78

**Term:** OTITIS EXTERNA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 84

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 78

**Term:** PNEUMOCYSTIS JIROVECII PNEUMONIA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 84

**Group ID:** EG001

**Num At Risk:** 78

**Term:** PNEUMONIA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 6

**Num At Risk:** 84

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 78

**Term:** SEPTIC SHOCK

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 84

**Group ID:** EG001

**Num At Risk:** 78

**Term:** STAPHYLOCOCCAL INFECTION

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 84

**Group ID:** EG001

**Num At Risk:** 78

**Term:** TUBERCULOSIS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 84

**Group ID:** EG001

**Num At Risk:** 78

**Term:** UPPER RESPIRATORY TRACT INFECTION

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 84

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 78

**Term:** URETERITIS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 84

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 78

**Term:** URINARY TRACT INFECTION

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 84

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 78

**Term:** WOUND INFECTION

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 84

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 78

**Term:** ACETABULUM FRACTURE

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 84

**Group ID:** EG001

**Num At Risk:** 78

**Term:** LUMBAR VERTEBRAL FRACTURE

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 84

**Group ID:** EG001

**Num At Risk:** 78

**Term:** VASCULAR PSEUDOANEURYSM

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 84

**Group ID:** EG001

**Num At Risk:** 78

**Term:** BLOOD CREATININE INCREASED

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 84

**Group ID:** EG001

**Num At Risk:** 78

**Term:** C-REACTIVE PROTEIN INCREASED

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 84

**Group ID:** EG001

**Num At Risk:** 78

**Term:** HAEMOGLOBIN DECREASED

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 84

**Group ID:** EG001

**Num At Risk:** 78

**Term:** INFLAMMATORY MARKER INCREASED

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 84

**Group ID:** EG001

**Num At Risk:** 78

**Term:** WEIGHT INCREASED

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 84

**Group ID:** EG001

**Num At Risk:** 78

**Term:** DEHYDRATION

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 84

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 78

**Term:** BACK PAIN

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 84

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 78

**Term:** OSTEOARTHRITIS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 84

**Group ID:** EG001

**Num At Risk:** 78

**Term:** OSTEOPOROSIS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 84

**Group ID:** EG001

**Num At Risk:** 78

**Term:** B-CELL LYMPHOMA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 84

**Group ID:** EG001

**Num At Risk:** 78

**Term:** BLADDER CANCER

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 84

**Group ID:** EG001

**Num At Risk:** 78

**Term:** PLASMACYTOMA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 84

**Group ID:** EG001

**Num At Risk:** 78

**Term:** PROSTATE CANCER RECURRENT

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 84

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 78

**Term:** MYOCLONIC EPILEPSY

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 84

**Group ID:** EG001

**Num At Risk:** 78

**Term:** SCIATICA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 84

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 78

**Term:** SYNCOPE

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 84

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 78

**Term:** ACUTE KIDNEY INJURY

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 84

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 78

**Term:** CHRONIC KIDNEY DISEASE

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 84

**Group ID:** EG001

**Num At Risk:** 78

**Term:** HAEMATURIA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 84

**Group ID:** EG001

**Num At Risk:** 78

**Term:** RENAL ARTERY STENOSIS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 84

**Group ID:** EG001

**Num At Risk:** 78

**Term:** RENAL FAILURE

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 84

**Group ID:** EG001

**Num At Risk:** 78

**Term:** RENAL IMPAIRMENT

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 84

**Group ID:** EG001

**Num At Risk:** 78

**Term:** URINARY RETENTION

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 84

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 78

**Term:** BENIGN PROSTATIC HYPERPLASIA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 84

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 78

**Term:** DYSPNOEA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 84

**Group ID:** EG001

**Num At Risk:** 78

**Term:** PULMONARY EMBOLISM

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 84

**Group ID:** EG001

**Num At Risk:** 78

**Term:** PULMONARY MASS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 84

**Group ID:** EG001

**Num At Risk:** 78

**Term:** ANGIOEDEMA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 84

**Group ID:** EG001

**Num At Risk:** 78

**Term:** DIABETIC FOOT

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 84

**Group ID:** EG001

**Num At Risk:** 78

**Term:** SKIN HAEMORRHAGE

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 84

**Group ID:** EG001

**Num At Risk:** 78

**Term:** MEDICAL DEVICE REMOVAL

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Surgical and medical procedures

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 84

**Group ID:** EG001

**Num At Risk:** 78

**Term:** ANEURYSM

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 84

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 78

**Term:** ANGIOPATHY

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 84

**Group ID:** EG001

**Num At Risk:** 78

**Term:** DEEP VEIN THROMBOSIS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 84

**Group ID:** EG001

**Num At Risk:** 78

**Term:** HYPERTENSION

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 84

**Group ID:** EG001

**Num At Risk:** 78

**Time Frame:** Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 74

**Group ID:** BG001

**Value:** 71

**Group ID:** BG002

**Value:** 145

**Units:** Participants

### Group

**ID:** BG000

**Title:** CNI-regimen

**Description:** CNI-regimen: cyclosporine A (CyA) or tacrolimus (TAC) with everolimus (EVR) with corticosteroids

### Group

**ID:** BG001

**Title:** CNI-free-regimen

**Description:** CNI-free regimen: everolimus (EVR) with MPA (either MMF or enteric coated mycophenolate sodium (EC-MPS)) and corticosteroids

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 9.7

**Value:** 52.7

#### Measurement

**Group ID:** BG001

**Spread:** 9.8

**Value:** 50.3

#### Measurement

**Group ID:** BG002

**Spread:** 9.8

**Value:** 51.5

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 9

#### Measurement

**Group ID:** BG001

**Value:** 12

#### Measurement

**Group ID:** BG002

**Value:** 21

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 65

#### Measurement

**Group ID:** BG001

**Value:** 59

#### Measurement

**Group ID:** BG002

**Value:** 124

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** American Indian or Alaska Native

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Asian

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Native Hawaiian or Other Pacific Islander

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Black or African American

#### Measurement

**Group ID:** BG000

**Value:** 74

#### Measurement

**Group ID:** BG001

**Value:** 71

#### Measurement

**Group ID:** BG002

**Value:** 145

**Category Title:** White

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** More than one race

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Unknown or Not Reported

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Population Description:** Full Analysis Set FAS- 145 patients were treated with study medication and had at least 1 post-baseline assessment of the primary outcome variable
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Full Analysis Set FAS- 145 patients were treated with study medication and had at least 1 post-baseline assessment of the primary outcome variable
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Full Analysis Set FAS- 145 patients were treated with study medication and had at least 1 post-baseline assessment of the primary outcome variable
**Title:** Race (NIH/OMB)
**Unit of Measure:** Participants
**Population Description:** Full Analysis Set FAS- 145 patients were treated with study medication and had at least 1 post-baseline assessment of the primary outcome variable
## Results Section - More Information Module
### Certain Agreement
### Point of Contact
**Email:** Novartis.email@novartis.com
**Organization:** Novartis Pharmaceuticals
**Phone:** 8627788300
**Title:** Study Director
## Results Section - Outcome Measures Module
### Outcome Measure 1
#### Analysis
**CI Lower Limit:** -16.5
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** -6.1
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** <.0001
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Net)
**Parameter Value:** -11.3
**Statistical Comment:** 
**Statistical Method:** ANCOVA
**Tested Non-Inferiority:** 
### Outcome Measure 2
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Month 6 to Month 9
**Non-Inferiority Comment:** difference
**Non-Inferiority Type:** OTHER
**Other Analysis Description:** 
**P-Value:** 0.203
**P-Value Comment:** 
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Fisher Exact
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Month 9 to Month 18
**Non-Inferiority Comment:** difference
**Non-Inferiority Type:** OTHER
**Other Analysis Description:** 
**P-Value:** 0.002
**P-Value Comment:** 
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Fisher Exact
**Tested Non-Inferiority:** 
### Outcome Measure 3
### Outcome Measure 4
#### Analysis
**CI Lower Limit:** -19.6
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** -8.3
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Month 12
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** <.0001
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -14.0
**Statistical Comment:** 
**Statistical Method:** ANCOVA
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** -16.5
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** -6.1
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Month 18
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** <.0001
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -11.3
**Statistical Comment:** 
**Statistical Method:** ANCOVA
**Tested Non-Inferiority:** 
### Outcome Measure 5
### Outcome Measure 6
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.008
**P-Value Comment:** 
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Wilcoxon (Mann-Whitney)
**Tested Non-Inferiority:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 17.9
- **Upper Limit:** 
- **Value:** 54.2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 23.0
- **Upper Limit:** 
- **Value:** 66.9
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 4
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 15
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 19.7
- **Upper Limit:** 
- **Value:** 54.2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 23.4
- **Upper Limit:** 
- **Value:** 69.8
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 68
- **Group ID:** OG001
- **Value:** 62
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 17.9
- **Upper Limit:** 
- **Value:** 54.2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 23.00
- **Upper Limit:** 
- **Value:** 66.9
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 69
- **Group ID:** OG001
- **Value:** 65
**Units:** Participants
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.49
- **Upper Limit:** 
- **Value:** 1.53
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.51
- **Upper Limit:** 
- **Value:** 1.49
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 74
- **Group ID:** OG001
- **Value:** 71
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.41
- **Upper Limit:** 
- **Value:** 1.44
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.35
- **Upper Limit:** 
- **Value:** 1.27
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 73
- **Group ID:** OG001
- **Value:** 70
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.75
- **Upper Limit:** 
- **Value:** 1.58
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.32
- **Upper Limit:** 
- **Value:** 1.24
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 74
- **Group ID:** OG001
- **Value:** 70
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.53
- **Upper Limit:** 
- **Value:** 1.53
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.30
- **Upper Limit:** 
- **Value:** 1.20
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 74
- **Group ID:** OG001
- **Value:** 70
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.52
- **Upper Limit:** 
- **Value:** 1.53
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.33
- **Upper Limit:** 
- **Value:** 1.22
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 74
- **Group ID:** OG001
- **Value:** 70
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.50
- **Upper Limit:** 
- **Value:** 1.50
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.44
- **Upper Limit:** 
- **Value:** 1.27
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 74
- **Group ID:** OG001
- **Value:** 71
**Units:** Participants
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.364
- **Upper Limit:** 
- **Value:** 0.045
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.863
- **Upper Limit:** 
- **Value:** 0.403
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Calculated Glomerular Filtration Rate (cGFR) Using Modification of Diet in Renal Disease (MDRD) Formula at Month 18 cGFR (in mL/min/1.73 m2) = 186.3\*(C-1.154)\*(A-0.203)\*G\*R where C = the serum concentration of creatinine (mg/dL), A = age (years), G = 0.742 when gender is female, otherwise G = 1, R = 1.21 when race is black, otherwise R = 1.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Full Analysis Set-Last observation carried forward (FAS-LOCF)- 145 patients were treated with study medication and had at least 1 post-baseline assessment of the primary outcome variable but for this analysis only participants that had values at Month 18 were analyzed
**Reporting Status:** POSTED
**Time Frame:** Month 18
**Title:** Calculated Glomerular Filtration Rate (cGFR) Using Modification of Diet in Renal Disease (MDRD) Formula at Month 18
**Type:** PRIMARY
**Unit of Measure:** mL/min
##### Group
**Description:** CNI-regimen: cyclosporine A (CyA) or tacrolimus (TAC) with everolimus (EVR) with corticosteroids
**ID:** OG000
**Title:** CNI-regimen
##### Group
**Description:** CNI-free regimen: everolimus (EVR) with MPA (either MMF or enteric coated mycophenolate sodium (EC-MPS)) and corticosteroids
**ID:** OG001
**Title:** CNI-free-regimen
#### Outcome Measure 2
**Description:** Treatment failure was defined as composite endpoint of biopsy proven acute rejection of ISHLT 1990 grade ≥ 3A resp. ISHLT 2004 grade ≥ 2R, acute rejection episodes associated with hemodynamic compromise, graft loss / re-transplant, death, loss to follow up (at least one condition must be present). If participant had an occurrence in each period it was counted for each period.
**Parameter Type:** NUMBER
**Population Description:** Full Analysis Set FAS- 145 patients were treated with study medication and had at least 1 post-baseline assessment of the primary outcome variable
**Reporting Status:** POSTED
**Time Frame:** Month 6 to Month 9; Month 9 to Month 18
**Title:** Occurrence of Treatment Failures From Month 6 to 9 and Month 9 to 18
**Type:** SECONDARY
**Unit of Measure:** Occurences
##### Group
**Description:** CNI-regimen: cyclosporine A (CyA) or tacrolimus (TAC) with everolimus (EVR) with corticosteroids
**ID:** OG000
**Title:** CNI-regimen
##### Group
**Description:** CNI-free regimen: everolimus (EVR) with MPA (either MMF or enteric coated mycophenolate sodium (EC-MPS)) and corticosteroids
**ID:** OG001
**Title:** CNI-free-regimen
#### Outcome Measure 3
**Description:** Major cardiac events (MACE) was defined as one of the following: any death, myocardial infarction, coronary artery bypass grafting
**Parameter Type:** NUMBER
**Population Description:** Full Analysis Set FAS- 145 patients were treated with study medication and had at least 1 post-baseline assessment of the primary outcome variable
**Reporting Status:** POSTED
**Time Frame:** Month 6 to Month 18
**Title:** Occurrence of Major Cardiac Events (MACE) From Month 6 to 18
**Type:** SECONDARY
**Unit of Measure:** Occurences
##### Group
**Description:** CNI-regimen: cyclosporine A (CyA) or tacrolimus (TAC) with everolimus (EVR) with corticosteroids
**ID:** OG000
**Title:** CNI-regimen
##### Group
**Description:** CNI-free regimen: everolimus (EVR) with MPA (either MMF or enteric coated mycophenolate sodium (EC-MPS)) and corticosteroids
**ID:** OG001
**Title:** CNI-free-regimen
#### Outcome Measure 4
**Description:** Calculated Glomerular Filtration Rate (cGFR) according to Cockcroft-Gault at Month 12 and 18. For men: GFR=(140-Age) x Body weight (kg) / 72 x Serum Creatinine (mg/dl) For women: GFR=0.85 (140 -Age) x Body weight(kg)/ 72 x Serum Creatinine (mg/dl)
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Full Analysis Set-Last observation carried forward (FAS-LOCF)- 145 patients were treated with study medication and had at least 1 post-baseline assessment of the primary outcome variable but for this analysis only participants that had values at Month 12 \& 18 were analyzed
**Reporting Status:** POSTED
**Time Frame:** Month 12 and 18
**Title:** Calculated Glomerular Filtration Rate (cGFR) According to Cockcroft-Gault at Month 12 and 18
**Type:** SECONDARY
**Unit of Measure:** mL/min
##### Group
**Description:** CNI-regimen: cyclosporine A (CyA) or tacrolimus (TAC) with everolimus (EVR) with corticosteroids
**ID:** OG000
**Title:** CNI-regimen
##### Group
**Description:** CNI-free regimen: everolimus (EVR) with MPA (either MMF or enteric coated mycophenolate sodium (EC-MPS)) and corticosteroids
**ID:** OG001
**Title:** CNI-free-regimen
#### Outcome Measure 5
**Description:** Serum Creatinine is an indicator of renal function measured in the blood
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Full Analysis Set FAS- 145 patients were treated with study medication and had at least 1 post-baseline assessment of the primary outcome variable
**Reporting Status:** POSTED
**Time Frame:** Month 6, 8, 9, 10 12 and 18
**Title:** Serum Creatinine at Month 6, 8, 9, 10 12 and 18
**Type:** SECONDARY
**Unit of Measure:** μmol/L
##### Group
**Description:** CNI-regimen: cyclosporine A (CyA) or tacrolimus (TAC) with everolimus (EVR) with corticosteroids
**ID:** OG000
**Title:** CNI-regimen
##### Group
**Description:** CNI-free regimen: everolimus (EVR) with MPA (either MMF or enteric coated mycophenolate sodium (EC-MPS)) and corticosteroids
**ID:** OG001
**Title:** CNI-free-regimen
#### Outcome Measure 6
**Description:** Reciprocal Creatinine Slope is an indication of renal function over time with a higher slope value indicating an improvement in renal function.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Full Analysis Set FAS- 145 patients were treated with study medication and had at least 1 post-baseline assessment of the primary outcome variable
**Reporting Status:** POSTED
**Time Frame:** Between Month 6 and Month 18
**Title:** Reciprocal Creatinine Slope Between Month 6 and Month 18
**Type:** SECONDARY
**Unit of Measure:** 1/(μmol/L)/(hour)
##### Group
**Description:** CNI-regimen: cyclosporine A (CyA) or tacrolimus (TAC) with everolimus (EVR) with corticosteroids
**ID:** OG000
**Title:** CNI-regimen
##### Group
**Description:** CNI-free regimen: everolimus (EVR) with MPA (either MMF or enteric coated mycophenolate sodium (EC-MPS)) and corticosteroids
**ID:** OG001
**Title:** CNI-free-regimen
### Participant Flow Module
#### Group
**Description:** CNI-regimen: cyclosporine A (CyA) or tacrolimus (TAC) with everolimus (EVR) with corticosteroids
**ID:** FG000
**Title:** CNI-regimen
#### Group
**Description:** CNI-free regimen: everolimus (EVR) with MPA (either MMF or enteric coated mycophenolate sodium (EC-MPS)) and corticosteroids
**ID:** FG001
**Title:** CNI-free-regimen
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Adverse Event
###### Reason
**Group ID:** FG000
**Number of Subjects:** 6
###### Reason
**Group ID:** FG001
**Number of Subjects:** 3
##### Withdraw
**Type:** Protocol Violation
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
##### Withdraw
**Type:** Patient withdrew consent
###### Reason
**Group ID:** FG000
**Number of Subjects:** 2
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
##### Withdraw
**Type:** Administrative problems
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
##### Withdraw
**Type:** Death
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 84
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 78
##### Milestone
**Type:** Full Analysis Set (FAS)
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 74
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 71
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 76
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 71
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 8
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 7
**Recruitment Details:** 232 patients were screened, of these , 193 patients were included in safety set which included 31 non-randomized and 162 randomized. Of these, 145 patients were treated with study medication and had at least 1 post-baseline assessment of the primary outcome variable and included in the Full Analysis Set FAS.
**Has Results:** True