NCT03312530 · ADVERSE EVENTS

Adverse events

A Study of Cobimetinib Administered as Single Agent and in Combination With Venetoclax, With or Without Atezolizumab, in Participants With Relapsed and Refractory Multiple Myeloma · Source last updated 2023-02-28

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: Randomization up to end of study (up to approximately 3 years, 7 months)
Other-event reporting threshold: 5%

AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Safety Run-In: Cobimetinib + Venetoclax Participants received cobimetinib (on Day 1-21) plus venetoclax (on Day 1-28) at escalated doses, in 28-day cycles, to identify the dose level with acceptable safety.	2 / 6	6 / 6	5 / 6
Safety Run-In: Cobimetinib + Venetoclax + Atezolizumab Participants received cobimetinib (on Day 1-21) plus venetoclax (on Day 1-28) at escalated doses and atezolizumab (on Day 1 and Day 15) at a fixed dose of 840 mg IV, in 28-day cycles, to identify the dose level with acceptable safety.	3 / 6	6 / 6	5 / 6
A: Cobimetinib Participants received the standard single-agent cobimetinib dose of 60 milligrams (mg) (3 tablets of 20 mg each) orally (PO) daily on Days 1-21 of each 28-day cycle until disease progression. Upon progression, participants were allowed to receive treatment with cobimetinib and atezolizumab at the recommended Phase II dose of cobimetinib 60 mg PO on Days 1-21 plus atezolizumab intravenous (IV) infusion at a fixed dose of 840 mg on Day 1 and Day 15 of each 28-day cycle. Treatment continued until disease progression, unacceptable toxicity, death, participant or physician decision to withdraw, or pregnancy, whichever occurred first.	3 / 6	5 / 6	4 / 6
B: Cobimetinib + Venetoclax Participants received cobimetinib PO daily on Days 1-21 of each 28-day cycle plus venetoclax PO daily on Days 1-28 of each 28-day cycle, at the dose level identified in the safety run-in phase. Treatment continued until disease progression, unacceptable toxicity, death, participant or physician decision to withdraw, or pregnancy, whichever occurred first.	12 / 16	15 / 16	11 / 16
C: Cobimetinib + Venetoclax + Atezolizumab Participants received cobimetinib PO daily on Days 1-21 of each 28-day cycle plus venetoclax PO daily on Days 1-28 of each 28-day cycle, at the dose level identified in the safety run-in phase plus atezolizumab IV infusion at a fixed dose of 840 mg on Day 1 and Day 15 of each 28-day cycle. Treatment continued until disease progression, unacceptable toxicity, death, participant or physician decision to withdraw, or pregnancy, whichever occurred first.	11 / 15	15 / 15	8 / 15

Group identifiers: EG000: Safety Run-In: Cobimetinib + Venetoclax · EG001: Safety Run-In: Cobimetinib + Venetoclax + Atezolizumab · EG002: A: Cobimetinib · EG003: B: Cobimetinib + Venetoclax · EG004: C: Cobimetinib + Venetoclax + Atezolizumab

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
MedDRA 24.0
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
2
num At Risk
6
num Events
5
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
1
num At Risk
16
num Events
2
group Id
EG004
num Affected
0
num At Risk
15
num Events
0
term
ANAEMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
0
num At Risk
6
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
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
16
num Events
0
group Id
EG004
num Affected
1
num At Risk
15
num Events
1
term
FEBRILE NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
1
num At Risk
6
num Events
3
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
1
num At Risk
16
num Events
2
group Id
EG004
num Affected
2
num At Risk
15
num Events
2
term
NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
0
num At Risk
6
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
6
num Events
0
group Id
EG003
num Affected
2
num At Risk
16
num Events
4
group Id
EG004
num Affected
1
num At Risk
15
num Events
1
term
THROMBOCYTOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
0
num At Risk
6
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
6
num Events
0
group Id
EG003
num Affected
1
num At Risk
16
num Events
1
group Id
EG004
num Affected
0
num At Risk
15
num Events
0
term
ABDOMINAL PAIN
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
0
num At Risk
6
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
6
num Events
0
group Id
EG003
num Affected
1
num At Risk
16
num Events
1
group Id
EG004
num Affected
1
num At Risk
15
num Events
1
term
DIARRHOEA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
0
num At Risk
6
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
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
16
num Events
0
group Id
EG004
num Affected
1
num At Risk
15
num Events
1
term
INTESTINAL ULCER
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
0
num At Risk
6
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
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
16
num Events
0
group Id
EG004
num Affected
1
num At Risk
15
num Events
2
term
VOMITING
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
0
num At Risk
6
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
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
16
num Events
0
group Id
EG004
num Affected
1
num At Risk
15
num Events
1
term
GENERAL PHYSICAL HEALTH DETERIORATION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
0
num At Risk
6
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
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
16
num Events
0
group Id
EG004
num Affected
1
num At Risk
15
num Events
1
term
PAIN
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
0
num At Risk
6
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
6
num Events
0
group Id
EG003
num Affected
1
num At Risk
16
num Events
1
group Id
EG004
num Affected
1
num At Risk
15
num Events
1
term
PYREXIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
0
num At Risk
6
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
6
num Events
0
group Id
EG003
num Affected
1
num At Risk
16
num Events
1
group Id
EG004
num Affected
0
num At Risk
15
num Events
0
term
CHOLECYSTITIS

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
MedDRA 24.0
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
2
group Id
EG001
num Affected
2
num At Risk
6
num Events
2
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
group Id
EG003
num Affected
9
num At Risk
16
num Events
11
group Id
EG004
num Affected
9
num At Risk
15
num Events
14
term
ANAEMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
0
num At Risk
6
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
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
16
num Events
0
group Id
EG004
num Affected
0
num At Risk
15
num Events
0
term
FEBRILE NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
group Id
EG003
num Affected
0
num At Risk
16
num Events
0
group Id
EG004
num Affected
0
num At Risk
15
num Events
0
term
HAEMORRHAGIC DIATHESIS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
2
num At Risk
6
num Events
4
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
16
num Events
0
group Id
EG004
num Affected
3
num At Risk
15
num Events
9
term
LEUKOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
0
num At Risk
6
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
6
num Events
0
group Id
EG003
num Affected
1
num At Risk
16
num Events
1
group Id
EG004
num Affected
4
num At Risk
15
num Events
4
term
LYMPHOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
3
num At Risk
6
num Events
4
group Id
EG001
num Affected
4
num At Risk
6
num Events
10
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
2
num At Risk
16
num Events
2
group Id
EG004
num Affected
7
num At Risk
15
num Events
17
term
NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
0
num At Risk
6
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
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
16
num Events
0
group Id
EG004
num Affected
1
num At Risk
15
num Events
1
term
PANCYTOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
group Id
EG001
num Affected
2
num At Risk
6
num Events
2
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
3
num At Risk
16
num Events
3
group Id
EG004
num Affected
5
num At Risk
15
num Events
5
term
THROMBOCYTOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
0
num At Risk
6
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
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
16
num Events
0
group Id
EG004
num Affected
1
num At Risk
15
num Events
1
term
ATRIOVENTRICULAR BLOCK
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
0
num At Risk
6
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
6
num Events
0
group Id
EG003
num Affected
1
num At Risk
16
num Events
1
group Id
EG004
num Affected
0
num At Risk
15
num Events
0
term
CARDIAC FAILURE
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
group Id
EG003
num Affected
0
num At Risk
16
num Events
0
group Id
EG004
num Affected
0
num At Risk
15
num Events
0
term
SUPRAVENTRICULAR TACHYCARDIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
0
num At Risk
6
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
6
num Events
0
group Id
EG003
num Affected
1
num At Risk
16
num Events
1
group Id
EG004
num Affected
0
num At Risk
15
num Events
0
term
TINNITUS

Complete source fields

description

AEs were recorded for the safety-evaluable population, which included all participants who received any amount of study drug and analyzed according to the treatment arm they received.

event Groups

deaths Num Affected
5
deaths Num At Risk
6
description
Participants received cobimetinib (on Day 1-21) plus venetoclax (on Day 1-28) at escalated doses, in 28-day cycles, to identify the dose level with acceptable safety.
id
EG000
other Num Affected
6
other Num At Risk
6
serious Num Affected
2
serious Num At Risk
6
title
Safety Run-In: Cobimetinib + Venetoclax
deaths Num Affected
5
deaths Num At Risk
6
description
Participants received cobimetinib (on Day 1-21) plus venetoclax (on Day 1-28) at escalated doses and atezolizumab (on Day 1 and Day 15) at a fixed dose of 840 mg IV, in 28-day cycles, to identify the dose level with acceptable safety.
id
EG001
other Num Affected
6
other Num At Risk
6
serious Num Affected
3
serious Num At Risk
6
title
Safety Run-In: Cobimetinib + Venetoclax + Atezolizumab
deaths Num Affected
4
deaths Num At Risk
6
description
Participants received the standard single-agent cobimetinib dose of 60 milligrams (mg) (3 tablets of 20 mg each) orally (PO) daily on Days 1-21 of each 28-day cycle until disease progression. Upon progression, participants were allowed to receive treatment with cobimetinib and atezolizumab at the recommended Phase II dose of cobimetinib 60 mg PO on Days 1-21 plus atezolizumab intravenous (IV) infusion at a fixed dose of 840 mg on Day 1 and Day 15 of each 28-day cycle. Treatment continued until disease progression, unacceptable toxicity, death, participant or physician decision to withdraw, or pregnancy, whichever occurred first.
id
EG002
other Num Affected
5
other Num At Risk
6
serious Num Affected
3
serious Num At Risk
6
title
A: Cobimetinib
deaths Num Affected
11
deaths Num At Risk
16
description
Participants received cobimetinib PO daily on Days 1-21 of each 28-day cycle plus venetoclax PO daily on Days 1-28 of each 28-day cycle, at the dose level identified in the safety run-in phase. Treatment continued until disease progression, unacceptable toxicity, death, participant or physician decision to withdraw, or pregnancy, whichever occurred first.
id
EG003
other Num Affected
15
other Num At Risk
16
serious Num Affected
12
serious Num At Risk
16
title
B: Cobimetinib + Venetoclax
deaths Num Affected
8
deaths Num At Risk
15
description
Participants received cobimetinib PO daily on Days 1-21 of each 28-day cycle plus venetoclax PO daily on Days 1-28 of each 28-day cycle, at the dose level identified in the safety run-in phase plus atezolizumab IV infusion at a fixed dose of 840 mg on Day 1 and Day 15 of each 28-day cycle. Treatment continued until disease progression, unacceptable toxicity, death, participant or physician decision to withdraw, or pregnancy, whichever occurred first.
id
EG004
other Num Affected
15
other Num At Risk
15
serious Num Affected
11
serious Num At Risk
15
title
C: Cobimetinib + Venetoclax + Atezolizumab

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
2
group Id
EG001
num Affected
2
num At Risk
6
num Events
2
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
group Id
EG003
num Affected
9
num At Risk
16
num Events
11
group Id
EG004
num Affected
9
num At Risk
15
num Events
14
term
ANAEMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
0
num At Risk
6
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
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
16
num Events
0
group Id
EG004
num Affected
0
num At Risk
15
num Events
0
term
FEBRILE NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
group Id
EG003
num Affected
0
num At Risk
16
num Events
0
group Id
EG004
num Affected
0
num At Risk
15
num Events
0
term
HAEMORRHAGIC DIATHESIS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
2
num At Risk
6
num Events
4
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
16
num Events
0
group Id
EG004
num Affected
3
num At Risk
15
num Events
9
term
LEUKOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
0
num At Risk
6
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
6
num Events
0
group Id
EG003
num Affected
1
num At Risk
16
num Events
1
group Id
EG004
num Affected
4
num At Risk
15
num Events
4
term
LYMPHOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
3
num At Risk
6
num Events
4
group Id
EG001
num Affected
4
num At Risk
6
num Events
10
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
2
num At Risk
16
num Events
2
group Id
EG004
num Affected
7
num At Risk
15
num Events
17
term
NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
0
num At Risk
6
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
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
16
num Events
0
group Id
EG004
num Affected
1
num At Risk
15
num Events
1
term
PANCYTOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
group Id
EG001
num Affected
2
num At Risk
6
num Events
2
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
3
num At Risk
16
num Events
3
group Id
EG004
num Affected
5
num At Risk
15
num Events
5
term
THROMBOCYTOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
0
num At Risk
6
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
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
16
num Events
0
group Id
EG004
num Affected
1
num At Risk
15
num Events
1
term
ATRIOVENTRICULAR BLOCK
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
0
num At Risk
6
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
6
num Events
0
group Id
EG003
num Affected
1
num At Risk
16
num Events
1
group Id
EG004
num Affected
0
num At Risk
15
num Events
0
term
CARDIAC FAILURE
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
group Id
EG003
num Affected
0
num At Risk
16
num Events
0
group Id
EG004
num Affected
0
num At Risk
15
num Events
0
term
SUPRAVENTRICULAR TACHYCARDIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
0
num At Risk
6
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
6
num Events
0
group Id
EG003
num Affected
1
num At Risk
16
num Events
1
group Id
EG004
num Affected
0
num At Risk
15
num Events
0
term
TINNITUS

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
2
num At Risk
6
num Events
5
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
1
num At Risk
16
num Events
2
group Id
EG004
num Affected
0
num At Risk
15
num Events
0
term
ANAEMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
0
num At Risk
6
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
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
16
num Events
0
group Id
EG004
num Affected
1
num At Risk
15
num Events
1
term
FEBRILE NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
1
num At Risk
6
num Events
3
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
1
num At Risk
16
num Events
2
group Id
EG004
num Affected
2
num At Risk
15
num Events
2
term
NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
0
num At Risk
6
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
6
num Events
0
group Id
EG003
num Affected
2
num At Risk
16
num Events
4
group Id
EG004
num Affected
1
num At Risk
15
num Events
1
term
THROMBOCYTOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
0
num At Risk
6
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
6
num Events
0
group Id
EG003
num Affected
1
num At Risk
16
num Events
1
group Id
EG004
num Affected
0
num At Risk
15
num Events
0
term
ABDOMINAL PAIN
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
0
num At Risk
6
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
6
num Events
0
group Id
EG003
num Affected
1
num At Risk
16
num Events
1
group Id
EG004
num Affected
1
num At Risk
15
num Events
1
term
DIARRHOEA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
0
num At Risk
6
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
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
16
num Events
0
group Id
EG004
num Affected
1
num At Risk
15
num Events
1
term
INTESTINAL ULCER
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
0
num At Risk
6
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
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
16
num Events
0
group Id
EG004
num Affected
1
num At Risk
15
num Events
2
term
VOMITING
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
0
num At Risk
6
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
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
16
num Events
0
group Id
EG004
num Affected
1
num At Risk
15
num Events
1
term
GENERAL PHYSICAL HEALTH DETERIORATION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
0
num At Risk
6
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
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
16
num Events
0
group Id
EG004
num Affected
1
num At Risk
15
num Events
1
term
PAIN
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
0
num At Risk
6
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
6
num Events
0
group Id
EG003
num Affected
1
num At Risk
16
num Events
1
group Id
EG004
num Affected
1
num At Risk
15
num Events
1
term
PYREXIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
0
num At Risk
6
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
6
num Events
0
group Id
EG003
num Affected
1
num At Risk
16
num Events
1
group Id
EG004
num Affected
0
num At Risk
15
num Events
0
term
CHOLECYSTITIS

time Frame

Randomization up to end of study (up to approximately 3 years, 7 months)

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Preserved source evidence · Not medical advice