NCT00833833 · ADVERSE EVENTS

Adverse events

MTD, Safety, and Efficacy of Pomalidomide (CC-4047) Alone or With Low-dose Dexamethasone in Patients With Relapsed and Refractory Multiple Myeloma · Source last updated 2016-04-27

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: Data cut-off 01 April 2011 Phase 1: up to 126 weeks Phase 2: up to 70 weeks
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Phase 1: 2 mg Pomalidomide Pomalidomide 2 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.	3 / 6	6 / 6	Not reported / Not reported
Phase 1: 3 mg Pomalidomide Pomalidomide 3 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.	4 / 8	8 / 8	Not reported / Not reported
Phase 1: 4 mg Pomalidomide Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.	8 / 14	14 / 14	Not reported / Not reported
Phase 1: 5 mg Pomalidomide Pomalidomide 5 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.	4 / 10	10 / 10	Not reported / Not reported
Phase 2: Pomalidomide + Dexamethasone Combination therapy of 4 mg pomalidomide given once per day on Days 1-21 of each 28-day cycle and the starting dose of dexamethasone (either 40mg or 20 mg) on days 1, 8, 15, and 22 of each 28-day cycle.	69 / 112	112 / 112	Not reported / Not reported
Phase 2: Pomalidomide (Pom Only) Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing therapy or adding dexamethasone. Data are reported during the time when participants were on pomalidomide alone, before dexamethasone was added.	50 / 107	105 / 107	Not reported / Not reported
Phase 2: Pomalidomide (Pom + Dex Only) Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing therapy or adding dexamethasone. Data are reported during the time after PD when participants were on both pomalidomide and dexamethasone.	29 / 61	57 / 61	Not reported / Not reported
Phase 2: Pomalidomide (Overall) Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing therapy or adding dexamethasone. Data are reported during the entire study up to the data cut-off, thus including both the time participants were only on pomalidomide and the time after PD when participants were on pomalidomide and dexamethasone.	72 / 107	106 / 107	Not reported / Not reported

Group identifiers: EG000: Phase 1: 2 mg Pomalidomide · EG001: Phase 1: 3 mg Pomalidomide · EG002: Phase 1: 4 mg Pomalidomide · EG003: Phase 1: 5 mg Pomalidomide · EG004: Phase 2: Pomalidomide + Dexamethasone · EG005: Phase 2: Pomalidomide (Pom Only) · EG006: Phase 2: Pomalidomide (Pom + Dex Only) · EG007: Phase 2: Pomalidomide (Overall)

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
Infections and infestations
source Vocabulary
MedDRA (14.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
2
num At Risk
14
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
21
num At Risk
112
group Id
EG005
num Affected
10
num At Risk
107
group Id
EG006
num Affected
6
num At Risk
61
group Id
EG007
num Affected
15
num At Risk
107
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (14.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
group Id
EG001
num Affected
2
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
14
group Id
EG003
num Affected
1
num At Risk
10
group Id
EG004
num Affected
3
num At Risk
112
group Id
EG005
num Affected
4
num At Risk
107
group Id
EG006
num Affected
2
num At Risk
61
group Id
EG007
num Affected
6
num At Risk
107
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (14.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
14
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
6
num At Risk
112
group Id
EG005
num Affected
0
num At Risk
107
group Id
EG006
num Affected
0
num At Risk
61
group Id
EG007
num Affected
0
num At Risk
107
term
Urinary tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (14.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
14
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
1
num At Risk
112
group Id
EG005
num Affected
0
num At Risk
107
group Id
EG006
num Affected
1
num At Risk
61
group Id
EG007
num Affected
1
num At Risk
107
term
Bronchopneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (14.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
1
num At Risk
14
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
1
num At Risk
112
group Id
EG005
num Affected
0
num At Risk
107
group Id
EG006
num Affected
1
num At Risk
61
group Id
EG007
num Affected
1
num At Risk
107
term
Cellulitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (14.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
14
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
112
group Id
EG005
num Affected
0
num At Risk
107
group Id
EG006
num Affected
2
num At Risk
61
group Id
EG007
num Affected
2
num At Risk
107
term
Lobar pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (14.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
14
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
2
num At Risk
112
group Id
EG005
num Affected
0
num At Risk
107
group Id
EG006
num Affected
0
num At Risk
61
group Id
EG007
num Affected
0
num At Risk
107
term
Pneumonia respiratory syncytial viral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (14.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
14
group Id
EG003
num Affected
1
num At Risk
10
group Id
EG004
num Affected
1
num At Risk
112
group Id
EG005
num Affected
1
num At Risk
107
group Id
EG006
num Affected
0
num At Risk
61
group Id
EG007
num Affected
1
num At Risk
107
term
Respiratory syncytial virus infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (14.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
14
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
2
num At Risk
112
group Id
EG005
num Affected
0
num At Risk
107
group Id
EG006
num Affected
0
num At Risk
61
group Id
EG007
num Affected
0
num At Risk
107
term
Urosepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (14.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
14
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
112
group Id
EG005
num Affected
1
num At Risk
107
group Id
EG006
num Affected
1
num At Risk
61
group Id
EG007
num Affected
2
num At Risk
107
term
Viral infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (14.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
14
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
1
num At Risk
112
group Id
EG005
num Affected
0
num At Risk
107
group Id
EG006
num Affected
0
num At Risk
61
group Id
EG007
num Affected
0
num At Risk
107
term
Arthritis baterial
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (14.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
14
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
1
num At Risk
112
group Id
EG005
num Affected
0
num At Risk
107
group Id
EG006
num Affected
0
num At Risk
61
group Id
EG007
num Affected
0
num At Risk
107
term
Bacteraemia

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
General disorders
source Vocabulary
MedDRA (14.0)
stats
group Id
EG000
num Affected
4
num At Risk
6
group Id
EG001
num Affected
5
num At Risk
8
group Id
EG002
num Affected
9
num At Risk
14
group Id
EG003
num Affected
7
num At Risk
10
group Id
EG004
num Affected
62
num At Risk
112
group Id
EG005
num Affected
46
num At Risk
107
group Id
EG006
num Affected
11
num At Risk
61
group Id
EG007
num Affected
53
num At Risk
107
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (14.0)
stats
group Id
EG000
num Affected
2
num At Risk
6
group Id
EG001
num Affected
2
num At Risk
8
group Id
EG002
num Affected
3
num At Risk
14
group Id
EG003
num Affected
3
num At Risk
10
group Id
EG004
num Affected
31
num At Risk
112
group Id
EG005
num Affected
15
num At Risk
107
group Id
EG006
num Affected
6
num At Risk
61
group Id
EG007
num Affected
19
num At Risk
107
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (14.0)
stats
group Id
EG000
num Affected
2
num At Risk
6
group Id
EG001
num Affected
1
num At Risk
8
group Id
EG002
num Affected
1
num At Risk
14
group Id
EG003
num Affected
2
num At Risk
10
group Id
EG004
num Affected
18
num At Risk
112
group Id
EG005
num Affected
18
num At Risk
107
group Id
EG006
num Affected
8
num At Risk
61
group Id
EG007
num Affected
25
num At Risk
107
term
Oedema peripheral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (14.0)
stats
group Id
EG000
num Affected
3
num At Risk
6
group Id
EG001
num Affected
2
num At Risk
8
group Id
EG002
num Affected
1
num At Risk
14
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
22
num At Risk
112
group Id
EG005
num Affected
11
num At Risk
107
group Id
EG006
num Affected
5
num At Risk
61
group Id
EG007
num Affected
15
num At Risk
107
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (14.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
1
num At Risk
14
group Id
EG003
num Affected
1
num At Risk
10
group Id
EG004
num Affected
12
num At Risk
112
group Id
EG005
num Affected
9
num At Risk
107
group Id
EG006
num Affected
2
num At Risk
61
group Id
EG007
num Affected
10
num At Risk
107
term
Chills
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (14.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
2
num At Risk
8
group Id
EG002
num Affected
2
num At Risk
14
group Id
EG003
num Affected
3
num At Risk
10
group Id
EG004
num Affected
4
num At Risk
112
group Id
EG005
num Affected
5
num At Risk
107
group Id
EG006
num Affected
1
num At Risk
61
group Id
EG007
num Affected
6
num At Risk
107
term
Malaise
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (14.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
1
num At Risk
14
group Id
EG003
num Affected
1
num At Risk
10
group Id
EG004
num Affected
4
num At Risk
112
group Id
EG005
num Affected
6
num At Risk
107
group Id
EG006
num Affected
3
num At Risk
61
group Id
EG007
num Affected
8
num At Risk
107
term
Gait disturbance
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (14.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
1
num At Risk
14
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
5
num At Risk
112
group Id
EG005
num Affected
5
num At Risk
107
group Id
EG006
num Affected
1
num At Risk
61
group Id
EG007
num Affected
6
num At Risk
107
term
Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (14.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
14
group Id
EG003
num Affected
1
num At Risk
10
group Id
EG004
num Affected
4
num At Risk
112
group Id
EG005
num Affected
0
num At Risk
107
group Id
EG006
num Affected
0
num At Risk
61
group Id
EG007
num Affected
0
num At Risk
107
term
Irritability
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (14.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
1
num At Risk
8
group Id
EG002
num Affected
1
num At Risk
14
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
3
num At Risk
112
group Id
EG005
num Affected
0
num At Risk
107
group Id
EG006
num Affected
0
num At Risk
61
group Id
EG007
num Affected
0
num At Risk
107
term
Mucosal inflammation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (14.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
14
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
3
num At Risk
112
group Id
EG005
num Affected
1
num At Risk
107
group Id
EG006
num Affected
0
num At Risk
61
group Id
EG007
num Affected
1
num At Risk
107
term
Non-cardiac chest pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (14.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
1
num At Risk
14
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
3
num At Risk
112
group Id
EG005
num Affected
0
num At Risk
107
group Id
EG006
num Affected
0
num At Risk
61
group Id
EG007
num Affected
0
num At Risk
107
term
Feeling jittery

Complete source fields

event Groups

description
Pomalidomide 2 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
id
EG000
other Num Affected
6
other Num At Risk
6
serious Num Affected
3
serious Num At Risk
6
title
Phase 1: 2 mg Pomalidomide
description
Pomalidomide 3 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
id
EG001
other Num Affected
8
other Num At Risk
8
serious Num Affected
4
serious Num At Risk
8
title
Phase 1: 3 mg Pomalidomide
description
Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
id
EG002
other Num Affected
14
other Num At Risk
14
serious Num Affected
8
serious Num At Risk
14
title
Phase 1: 4 mg Pomalidomide
description
Pomalidomide 5 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
id
EG003
other Num Affected
10
other Num At Risk
10
serious Num Affected
4
serious Num At Risk
10
title
Phase 1: 5 mg Pomalidomide
description
Combination therapy of 4 mg pomalidomide given once per day on Days 1-21 of each 28-day cycle and the starting dose of dexamethasone (either 40mg or 20 mg) on days 1, 8, 15, and 22 of each 28-day cycle.
id
EG004
other Num Affected
112
other Num At Risk
112
serious Num Affected
69
serious Num At Risk
112
title
Phase 2: Pomalidomide + Dexamethasone
description
Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing therapy or adding dexamethasone. Data are reported during the time when participants were on pomalidomide alone, before dexamethasone was added.
id
EG005
other Num Affected
105
other Num At Risk
107
serious Num Affected
50
serious Num At Risk
107
title
Phase 2: Pomalidomide (Pom Only)
description
Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing therapy or adding dexamethasone. Data are reported during the time after PD when participants were on both pomalidomide and dexamethasone.
id
EG006
other Num Affected
57
other Num At Risk
61
serious Num Affected
29
serious Num At Risk
61
title
Phase 2: Pomalidomide (Pom + Dex Only)
description
Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing therapy or adding dexamethasone. Data are reported during the entire study up to the data cut-off, thus including both the time participants were only on pomalidomide and the time after PD when participants were on pomalidomide and dexamethasone.
id
EG007
other Num Affected
106
other Num At Risk
107
serious Num Affected
72
serious Num At Risk
107
title
Phase 2: Pomalidomide (Overall)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (14.0)
stats
group Id
EG000
num Affected
4
num At Risk
6
group Id
EG001
num Affected
5
num At Risk
8
group Id
EG002
num Affected
9
num At Risk
14
group Id
EG003
num Affected
7
num At Risk
10
group Id
EG004
num Affected
62
num At Risk
112
group Id
EG005
num Affected
46
num At Risk
107
group Id
EG006
num Affected
11
num At Risk
61
group Id
EG007
num Affected
53
num At Risk
107
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (14.0)
stats
group Id
EG000
num Affected
2
num At Risk
6
group Id
EG001
num Affected
2
num At Risk
8
group Id
EG002
num Affected
3
num At Risk
14
group Id
EG003
num Affected
3
num At Risk
10
group Id
EG004
num Affected
31
num At Risk
112
group Id
EG005
num Affected
15
num At Risk
107
group Id
EG006
num Affected
6
num At Risk
61
group Id
EG007
num Affected
19
num At Risk
107
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (14.0)
stats
group Id
EG000
num Affected
2
num At Risk
6
group Id
EG001
num Affected
1
num At Risk
8
group Id
EG002
num Affected
1
num At Risk
14
group Id
EG003
num Affected
2
num At Risk
10
group Id
EG004
num Affected
18
num At Risk
112
group Id
EG005
num Affected
18
num At Risk
107
group Id
EG006
num Affected
8
num At Risk
61
group Id
EG007
num Affected
25
num At Risk
107
term
Oedema peripheral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (14.0)
stats
group Id
EG000
num Affected
3
num At Risk
6
group Id
EG001
num Affected
2
num At Risk
8
group Id
EG002
num Affected
1
num At Risk
14
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
22
num At Risk
112
group Id
EG005
num Affected
11
num At Risk
107
group Id
EG006
num Affected
5
num At Risk
61
group Id
EG007
num Affected
15
num At Risk
107
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (14.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
1
num At Risk
14
group Id
EG003
num Affected
1
num At Risk
10
group Id
EG004
num Affected
12
num At Risk
112
group Id
EG005
num Affected
9
num At Risk
107
group Id
EG006
num Affected
2
num At Risk
61
group Id
EG007
num Affected
10
num At Risk
107
term
Chills
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (14.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
2
num At Risk
8
group Id
EG002
num Affected
2
num At Risk
14
group Id
EG003
num Affected
3
num At Risk
10
group Id
EG004
num Affected
4
num At Risk
112
group Id
EG005
num Affected
5
num At Risk
107
group Id
EG006
num Affected
1
num At Risk
61
group Id
EG007
num Affected
6
num At Risk
107
term
Malaise
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (14.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
1
num At Risk
14
group Id
EG003
num Affected
1
num At Risk
10
group Id
EG004
num Affected
4
num At Risk
112
group Id
EG005
num Affected
6
num At Risk
107
group Id
EG006
num Affected
3
num At Risk
61
group Id
EG007
num Affected
8
num At Risk
107
term
Gait disturbance
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (14.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
1
num At Risk
14
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
5
num At Risk
112
group Id
EG005
num Affected
5
num At Risk
107
group Id
EG006
num Affected
1
num At Risk
61
group Id
EG007
num Affected
6
num At Risk
107
term
Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (14.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
14
group Id
EG003
num Affected
1
num At Risk
10
group Id
EG004
num Affected
4
num At Risk
112
group Id
EG005
num Affected
0
num At Risk
107
group Id
EG006
num Affected
0
num At Risk
61
group Id
EG007
num Affected
0
num At Risk
107
term
Irritability
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (14.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
1
num At Risk
8
group Id
EG002
num Affected
1
num At Risk
14
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
3
num At Risk
112
group Id
EG005
num Affected
0
num At Risk
107
group Id
EG006
num Affected
0
num At Risk
61
group Id
EG007
num Affected
0
num At Risk
107
term
Mucosal inflammation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (14.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
14
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
3
num At Risk
112
group Id
EG005
num Affected
1
num At Risk
107
group Id
EG006
num Affected
0
num At Risk
61
group Id
EG007
num Affected
1
num At Risk
107
term
Non-cardiac chest pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (14.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
1
num At Risk
14
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
3
num At Risk
112
group Id
EG005
num Affected
0
num At Risk
107
group Id
EG006
num Affected
0
num At Risk
61
group Id
EG007
num Affected
0
num At Risk
107
term
Feeling jittery

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (14.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
2
num At Risk
14
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
21
num At Risk
112
group Id
EG005
num Affected
10
num At Risk
107
group Id
EG006
num Affected
6
num At Risk
61
group Id
EG007
num Affected
15
num At Risk
107
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (14.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
group Id
EG001
num Affected
2
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
14
group Id
EG003
num Affected
1
num At Risk
10
group Id
EG004
num Affected
3
num At Risk
112
group Id
EG005
num Affected
4
num At Risk
107
group Id
EG006
num Affected
2
num At Risk
61
group Id
EG007
num Affected
6
num At Risk
107
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (14.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
14
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
6
num At Risk
112
group Id
EG005
num Affected
0
num At Risk
107
group Id
EG006
num Affected
0
num At Risk
61
group Id
EG007
num Affected
0
num At Risk
107
term
Urinary tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (14.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
14
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
1
num At Risk
112
group Id
EG005
num Affected
0
num At Risk
107
group Id
EG006
num Affected
1
num At Risk
61
group Id
EG007
num Affected
1
num At Risk
107
term
Bronchopneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (14.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
1
num At Risk
14
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
1
num At Risk
112
group Id
EG005
num Affected
0
num At Risk
107
group Id
EG006
num Affected
1
num At Risk
61
group Id
EG007
num Affected
1
num At Risk
107
term
Cellulitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (14.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
14
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
112
group Id
EG005
num Affected
0
num At Risk
107
group Id
EG006
num Affected
2
num At Risk
61
group Id
EG007
num Affected
2
num At Risk
107
term
Lobar pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (14.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
14
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
2
num At Risk
112
group Id
EG005
num Affected
0
num At Risk
107
group Id
EG006
num Affected
0
num At Risk
61
group Id
EG007
num Affected
0
num At Risk
107
term
Pneumonia respiratory syncytial viral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (14.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
14
group Id
EG003
num Affected
1
num At Risk
10
group Id
EG004
num Affected
1
num At Risk
112
group Id
EG005
num Affected
1
num At Risk
107
group Id
EG006
num Affected
0
num At Risk
61
group Id
EG007
num Affected
1
num At Risk
107
term
Respiratory syncytial virus infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (14.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
14
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
2
num At Risk
112
group Id
EG005
num Affected
0
num At Risk
107
group Id
EG006
num Affected
0
num At Risk
61
group Id
EG007
num Affected
0
num At Risk
107
term
Urosepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (14.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
14
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
112
group Id
EG005
num Affected
1
num At Risk
107
group Id
EG006
num Affected
1
num At Risk
61
group Id
EG007
num Affected
2
num At Risk
107
term
Viral infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (14.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
14
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
1
num At Risk
112
group Id
EG005
num Affected
0
num At Risk
107
group Id
EG006
num Affected
0
num At Risk
61
group Id
EG007
num Affected
0
num At Risk
107
term
Arthritis baterial
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (14.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
14
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
1
num At Risk
112
group Id
EG005
num Affected
0
num At Risk
107
group Id
EG006
num Affected
0
num At Risk
61
group Id
EG007
num Affected
0
num At Risk
107
term
Bacteraemia

time Frame

Data cut-off 01 April 2011 Phase 1: up to 126 weeks Phase 2: up to 70 weeks

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice