NCT00916058 · ADVERSE EVENTS

Adverse events

Conditioning Regimen of Bendamustine and Melphalan Followed by Transplant in Patients With Multiple Myeloma · Source last updated 2019-06-04

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
Other-event reporting threshold: 5%

All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Dose Level 1 Dose Level 1; Bendamustine 30 mg/m\^2 total, Melphalan 200 mg/m\^2 total (140 mg/m\^2 total for patients with Creatinine Clearance \<70 ml/min) Bendamustine: 30 mg/m\^2 given on day 2 of melphalan Melphalan: 100 mg/m\^2 for 2 days (70 mg/m\^2 for patients with Creatinine Clearance \<70 ml/min)	0 / 3	3 / 3	2 / 3
Dose Level 2 Dose Level 2; Bendamustine 60 mg/m\^2 total, Melphalan 200 mg/m\^2 total (140 mg/m\^2 total for patients with Creatinine Clearance \<70 ml/min) Melphalan: 100 mg/m\^2 for 2 days (70 mg/m\^2 for patients with Creatinine Clearance \<70 ml/min) Bendamustine: 60 mg/m\^2 given on the 2nd day of melphalan	1 / 6	6 / 6	2 / 6
Dose Level 3 Dose Level 3; Bendamustine 90 mg/m\^2 total, Melphalan 200 mg/m\^2 total (140 mg/m\^2 total for patients with Creatinine Clearance \<70 ml/min) Melphalan: 100 mg/m\^2 for 2 days (70 mg/m\^2 for patients with Creatinine Clearance \<70 ml/min) Bendamustine: 90 mg/m\^2 given on the 2nd day of melphalan	0 / 3	3 / 3	0 / 3
Dose Level 4 Dose Level 4; Bendamustine 120 mg/m\^2 total, Melphalan 200 mg/m\^2 total (140 mg/m\^2 total for patients with Creatinine Clearance \<70 ml/min) Melphalan: 100 mg/m\^2 for 2 days (70 mg/m\^2 for patients with Creatinine Clearance \<70 ml/min) Bendamustine: 60 mg/m\^2 given on the 1st and 2nd day of melphalan	0 / 3	3 / 3	0 / 3
Dose Level 5 Dose Level 5; Bendamustine 150 mg/m\^2 total, Melphalan 200 mg/m\^2 total (140 mg/m\^2 total for patients with Creatinine Clearance \<70 ml/min) Melphalan: 100 mg/m\^2 for 2 days (70 mg/m\^2 for patients with Creatinine Clearance \<70 ml/min) Bendamustine: 90 mg/m\^2 given on the 1st day of melphalan and 60 mg/m\^2 given on the 2nd day of melphalan	0 / 3	3 / 3	1 / 3
Dose Level 6 Dose Level 6; Bendamustine 225 mg/m\^2 total, Melphalan 200 mg/m\^2 total (140 mg/m\^2 total for patients with Creatinine Clearance \<70 ml/min) Melphalan: 100 mg/m\^2 for 2 days (70 mg/m\^2 for patients with Creatinine Clearance \<70 ml/min) Bendamustine: 125 mg/m\^2 given on the 1st day of melphalan and 100mg/m\^2 given on the 2nd day of melphalan	0 / 7	7 / 7	1 / 7
Phase 2 Bendamustine 225 mg/m\^2 total, Melphalan 200 mg/m\^2 total (140 mg/m\^2 total for patients with Creatinine Clearance \<70 ml/min) Melphalan: 100 mg/m\^2 for 2 days (70 mg/m\^2 for patients with Creatinine Clearance \<70 ml/min) Bendamustine: 125 mg/m\^2 given on the 1st day of melphalan and 100mg/m\^2 given on the 2nd day of melphalan	8 / 28	28 / 28	6 / 28

Group identifiers: EG000: Dose Level 1 · EG001: Dose Level 2 · EG002: Dose Level 3 · EG003: Dose Level 4 · EG004: Dose Level 5 · EG005: Dose Level 6 · EG006: Phase 2

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
1
num At Risk
28
num Events
1
term
Febrile Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
28
num Events
0
term
Atrial Fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
28
num Events
0
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
1
num At Risk
28
num Events
1
term
Atrial Flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
1
num At Risk
28
num Events
1
term
Cholecystitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
1
num At Risk
28
num Events
1
term
Blood Bilirubin Increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
2
num At Risk
28
num Events
2
term
Fever
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
1
num At Risk
28
num Events
1
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
1
num At Risk
28
num Events
1
term
Infections and Infestations - Pneumonia

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
13
num At Risk
28
num Events
13
term
Febrile Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
2
num At Risk
28
num Events
2
term
Palpitations
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
group Id
EG002
num Affected
1
num At Risk
3
num Events
1
group Id
EG003
num Affected
2
num At Risk
3
num Events
2
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
2
num At Risk
7
num Events
2
group Id
EG006
num Affected
13
num At Risk
28
num Events
13
term
Peripheral Edema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
1
num At Risk
7
num Events
1
group Id
EG006
num Affected
8
num At Risk
28
num Events
8
term
Tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
15
num At Risk
28
num Events
15
term
Abdominal Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
4
num At Risk
6
num Events
4
group Id
EG002
num Affected
2
num At Risk
3
num Events
2
group Id
EG003
num Affected
2
num At Risk
3
num Events
2
group Id
EG004
num Affected
2
num At Risk
3
num Events
2
group Id
EG005
num Affected
5
num At Risk
7
num Events
5
group Id
EG006
num Affected
12
num At Risk
28
num Events
12
term
Anorexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
3
num At Risk
28
num Events
3
term
Bloating
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
group Id
EG002
num Affected
1
num At Risk
3
num Events
1
group Id
EG003
num Affected
1
num At Risk
3
num Events
1
group Id
EG004
num Affected
2
num At Risk
3
num Events
2
group Id
EG005
num Affected
1
num At Risk
7
num Events
1
group Id
EG006
num Affected
14
num At Risk
28
num Events
14
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
2
num At Risk
3
num Events
2
group Id
EG001
num Affected
6
num At Risk
6
num Events
6
group Id
EG002
num Affected
3
num At Risk
3
num Events
3
group Id
EG003
num Affected
3
num At Risk
3
num Events
3
group Id
EG004
num Affected
3
num At Risk
3
num Events
3
group Id
EG005
num Affected
5
num At Risk
7
num Events
5
group Id
EG006
num Affected
26
num At Risk
28
num Events
26
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
2
num At Risk
6
num Events
2
group Id
EG002
num Affected
2
num At Risk
3
num Events
2
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
1
num At Risk
7
num Events
1
group Id
EG006
num Affected
20
num At Risk
28
num Events
20
term
Dry Mouth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
4
num At Risk
6
num Events
4
group Id
EG002
num Affected
1
num At Risk
3
num Events
1
group Id
EG003
num Affected
1
num At Risk
3
num Events
1
group Id
EG004
num Affected
2
num At Risk
3
num Events
2
group Id
EG005
num Affected
3
num At Risk
7
num Events
3
group Id
EG006
num Affected
7
num At Risk
28
num Events
7
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
3
num At Risk
28
num Events
3
term
Dysphagia

Complete source fields

description

All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.

event Groups

deaths Num Affected
2
deaths Num At Risk
3
description
Dose Level 1; Bendamustine 30 mg/m\^2 total, Melphalan 200 mg/m\^2 total (140 mg/m\^2 total for patients with Creatinine Clearance \<70 ml/min) Bendamustine: 30 mg/m\^2 given on day 2 of melphalan Melphalan: 100 mg/m\^2 for 2 days (70 mg/m\^2 for patients with Creatinine Clearance \<70 ml/min)
id
EG000
other Num Affected
3
other Num At Risk
3
serious Num Affected
0
serious Num At Risk
3
title
Dose Level 1
deaths Num Affected
2
deaths Num At Risk
6
description
Dose Level 2; Bendamustine 60 mg/m\^2 total, Melphalan 200 mg/m\^2 total (140 mg/m\^2 total for patients with Creatinine Clearance \<70 ml/min) Melphalan: 100 mg/m\^2 for 2 days (70 mg/m\^2 for patients with Creatinine Clearance \<70 ml/min) Bendamustine: 60 mg/m\^2 given on the 2nd day of melphalan
id
EG001
other Num Affected
6
other Num At Risk
6
serious Num Affected
1
serious Num At Risk
6
title
Dose Level 2
deaths Num Affected
0
deaths Num At Risk
3
description
Dose Level 3; Bendamustine 90 mg/m\^2 total, Melphalan 200 mg/m\^2 total (140 mg/m\^2 total for patients with Creatinine Clearance \<70 ml/min) Melphalan: 100 mg/m\^2 for 2 days (70 mg/m\^2 for patients with Creatinine Clearance \<70 ml/min) Bendamustine: 90 mg/m\^2 given on the 2nd day of melphalan
id
EG002
other Num Affected
3
other Num At Risk
3
serious Num Affected
0
serious Num At Risk
3
title
Dose Level 3
deaths Num Affected
0
deaths Num At Risk
3
description
Dose Level 4; Bendamustine 120 mg/m\^2 total, Melphalan 200 mg/m\^2 total (140 mg/m\^2 total for patients with Creatinine Clearance \<70 ml/min) Melphalan: 100 mg/m\^2 for 2 days (70 mg/m\^2 for patients with Creatinine Clearance \<70 ml/min) Bendamustine: 60 mg/m\^2 given on the 1st and 2nd day of melphalan
id
EG003
other Num Affected
3
other Num At Risk
3
serious Num Affected
0
serious Num At Risk
3
title
Dose Level 4
deaths Num Affected
1
deaths Num At Risk
3
description
Dose Level 5; Bendamustine 150 mg/m\^2 total, Melphalan 200 mg/m\^2 total (140 mg/m\^2 total for patients with Creatinine Clearance \<70 ml/min) Melphalan: 100 mg/m\^2 for 2 days (70 mg/m\^2 for patients with Creatinine Clearance \<70 ml/min) Bendamustine: 90 mg/m\^2 given on the 1st day of melphalan and 60 mg/m\^2 given on the 2nd day of melphalan
id
EG004
other Num Affected
3
other Num At Risk
3
serious Num Affected
0
serious Num At Risk
3
title
Dose Level 5
deaths Num Affected
1
deaths Num At Risk
7
description
Dose Level 6; Bendamustine 225 mg/m\^2 total, Melphalan 200 mg/m\^2 total (140 mg/m\^2 total for patients with Creatinine Clearance \<70 ml/min) Melphalan: 100 mg/m\^2 for 2 days (70 mg/m\^2 for patients with Creatinine Clearance \<70 ml/min) Bendamustine: 125 mg/m\^2 given on the 1st day of melphalan and 100mg/m\^2 given on the 2nd day of melphalan
id
EG005
other Num Affected
7
other Num At Risk
7
serious Num Affected
0
serious Num At Risk
7
title
Dose Level 6
deaths Num Affected
6
deaths Num At Risk
28
description
Bendamustine 225 mg/m\^2 total, Melphalan 200 mg/m\^2 total (140 mg/m\^2 total for patients with Creatinine Clearance \<70 ml/min) Melphalan: 100 mg/m\^2 for 2 days (70 mg/m\^2 for patients with Creatinine Clearance \<70 ml/min) Bendamustine: 125 mg/m\^2 given on the 1st day of melphalan and 100mg/m\^2 given on the 2nd day of melphalan
id
EG006
other Num Affected
28
other Num At Risk
28
serious Num Affected
8
serious Num At Risk
28
title
Phase 2

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
13
num At Risk
28
num Events
13
term
Febrile Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
2
num At Risk
28
num Events
2
term
Palpitations
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
group Id
EG002
num Affected
1
num At Risk
3
num Events
1
group Id
EG003
num Affected
2
num At Risk
3
num Events
2
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
2
num At Risk
7
num Events
2
group Id
EG006
num Affected
13
num At Risk
28
num Events
13
term
Peripheral Edema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
1
num At Risk
7
num Events
1
group Id
EG006
num Affected
8
num At Risk
28
num Events
8
term
Tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
15
num At Risk
28
num Events
15
term
Abdominal Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
4
num At Risk
6
num Events
4
group Id
EG002
num Affected
2
num At Risk
3
num Events
2
group Id
EG003
num Affected
2
num At Risk
3
num Events
2
group Id
EG004
num Affected
2
num At Risk
3
num Events
2
group Id
EG005
num Affected
5
num At Risk
7
num Events
5
group Id
EG006
num Affected
12
num At Risk
28
num Events
12
term
Anorexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
3
num At Risk
28
num Events
3
term
Bloating
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
group Id
EG002
num Affected
1
num At Risk
3
num Events
1
group Id
EG003
num Affected
1
num At Risk
3
num Events
1
group Id
EG004
num Affected
2
num At Risk
3
num Events
2
group Id
EG005
num Affected
1
num At Risk
7
num Events
1
group Id
EG006
num Affected
14
num At Risk
28
num Events
14
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
2
num At Risk
3
num Events
2
group Id
EG001
num Affected
6
num At Risk
6
num Events
6
group Id
EG002
num Affected
3
num At Risk
3
num Events
3
group Id
EG003
num Affected
3
num At Risk
3
num Events
3
group Id
EG004
num Affected
3
num At Risk
3
num Events
3
group Id
EG005
num Affected
5
num At Risk
7
num Events
5
group Id
EG006
num Affected
26
num At Risk
28
num Events
26
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
2
num At Risk
6
num Events
2
group Id
EG002
num Affected
2
num At Risk
3
num Events
2
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
1
num At Risk
7
num Events
1
group Id
EG006
num Affected
20
num At Risk
28
num Events
20
term
Dry Mouth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
4
num At Risk
6
num Events
4
group Id
EG002
num Affected
1
num At Risk
3
num Events
1
group Id
EG003
num Affected
1
num At Risk
3
num Events
1
group Id
EG004
num Affected
2
num At Risk
3
num Events
2
group Id
EG005
num Affected
3
num At Risk
7
num Events
3
group Id
EG006
num Affected
7
num At Risk
28
num Events
7
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
3
num At Risk
28
num Events
3
term
Dysphagia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
1
num At Risk
28
num Events
1
term
Febrile Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
28
num Events
0
term
Atrial Fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
28
num Events
0
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
1
num At Risk
28
num Events
1
term
Atrial Flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
1
num At Risk
28
num Events
1
term
Cholecystitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
1
num At Risk
28
num Events
1
term
Blood Bilirubin Increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
2
num At Risk
28
num Events
2
term
Fever
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
1
num At Risk
28
num Events
1
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
1
num At Risk
28
num Events
1
term
Infections and Infestations - Pneumonia

time Frame

Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.

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Preserved source evidence · Not medical advice