NCT03465540 · ADVERSE EVENTS

Adverse events

Safety, Tolerability, Pharmacokinetics and Efficacy of AMG 397 in Subjects With Selected Relapsed or Refractory Hematological Malignancies · Source last updated 2023-04-12

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: Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b)
Other-event reporting threshold: 5%

All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Part 1a: 80 mg AMG 397 Participants with RR MM and/or NHL received 80 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	2 / 2	2 / 2	1 / 2
Part 1a: 160 mg AMG 397 Participants with RR MM and/or NHL received 160 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	4 / 6	6 / 6	1 / 6
Part 1a: 320 mg AMG 397 Participants with RR MM received 320 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	2 / 4	4 / 4	0 / 4
Part 1b: 80 mg AMG 397 Participants with RR AML received 80 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	4 / 4	4 / 4	2 / 4
Part 1b: 160 mg AMG 397 Participants with RR AML received 160 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	4 / 5	5 / 5	0 / 5
Part 1b: 320 mg AMG 397 Participants with RR AML received 320 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	3 / 3	3 / 3	2 / 3

Group identifiers: EG000: Part 1a: 80 mg AMG 397 · EG001: Part 1a: 160 mg AMG 397 · EG002: Part 1a: 320 mg AMG 397 · EG003: Part 1b: 80 mg AMG 397 · EG004: Part 1b: 160 mg AMG 397 · EG005: Part 1b: 320 mg AMG 397

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 23.1
stats
group Id
EG000
num Affected
0
num At Risk
2
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
1
num At Risk
4
group Id
EG004
num Affected
1
num At Risk
5
group Id
EG005
num Affected
0
num At Risk
3
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
0
num At Risk
2
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
1
num At Risk
5
group Id
EG005
num Affected
0
num At Risk
3
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
0
num At Risk
2
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
1
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
0
num At Risk
3
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
0
num At Risk
2
group Id
EG001
num Affected
1
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
0
num At Risk
3
term
Gastritis erosive
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
0
num At Risk
2
group Id
EG001
num Affected
1
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
0
num At Risk
3
term
Gastrointestinal toxicity
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
1
num At Risk
2
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
0
num At Risk
3
term
Haematemesis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
0
num At Risk
2
group Id
EG001
num Affected
1
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
0
num At Risk
3
term
Ileus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
1
num At Risk
2
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
0
num At Risk
3
term
Melaena
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
0
num At Risk
2
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
1
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
0
num At Risk
3
term
Mouth ulceration
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
0
num At Risk
2
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
1
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
0
num At Risk
3
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
0
num At Risk
2
group Id
EG001
num Affected
1
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
0
num At Risk
3
term
Small intestinal obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
0
num At Risk
2
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
1
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
1
num At Risk
5
group Id
EG005
num Affected
0
num At Risk
3
term
Asthenia

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 23.1
stats
group Id
EG000
num Affected
0
num At Risk
2
group Id
EG001
num Affected
2
num At Risk
6
group Id
EG002
num Affected
2
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
0
num At Risk
3
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
0
num At Risk
2
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
1
num At Risk
5
group Id
EG005
num Affected
0
num At Risk
3
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
0
num At Risk
2
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
1
num At Risk
4
group Id
EG004
num Affected
1
num At Risk
5
group Id
EG005
num Affected
0
num At Risk
3
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
0
num At Risk
2
group Id
EG001
num Affected
5
num At Risk
6
group Id
EG002
num Affected
3
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
0
num At Risk
3
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
1
num At Risk
2
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
0
num At Risk
3
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
0
num At Risk
2
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
1
num At Risk
3
term
Bundle branch block right
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
2
num At Risk
2
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
0
num At Risk
3
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
1
num At Risk
2
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
1
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
0
num At Risk
3
term
Supraventricular extrasystoles
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
0
num At Risk
2
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
1
num At Risk
5
group Id
EG005
num Affected
0
num At Risk
3
term
Tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
0
num At Risk
2
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
1
num At Risk
5
group Id
EG005
num Affected
0
num At Risk
3
term
Dry eye
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
0
num At Risk
2
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
1
num At Risk
4
group Id
EG004
num Affected
1
num At Risk
5
group Id
EG005
num Affected
0
num At Risk
3
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
0
num At Risk
2
group Id
EG001
num Affected
1
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
2
num At Risk
5
group Id
EG005
num Affected
0
num At Risk
3
term
Abdominal pain

Complete source fields

description

All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.

event Groups

deaths Num Affected
1
deaths Num At Risk
2
description
Participants with RR MM and/or NHL received 80 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.
id
EG000
other Num Affected
2
other Num At Risk
2
serious Num Affected
2
serious Num At Risk
2
title
Part 1a: 80 mg AMG 397
deaths Num Affected
1
deaths Num At Risk
6
description
Participants with RR MM and/or NHL received 160 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.
id
EG001
other Num Affected
6
other Num At Risk
6
serious Num Affected
4
serious Num At Risk
6
title
Part 1a: 160 mg AMG 397
deaths Num Affected
0
deaths Num At Risk
4
description
Participants with RR MM received 320 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.
id
EG002
other Num Affected
4
other Num At Risk
4
serious Num Affected
2
serious Num At Risk
4
title
Part 1a: 320 mg AMG 397
deaths Num Affected
2
deaths Num At Risk
4
description
Participants with RR AML received 80 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.
id
EG003
other Num Affected
4
other Num At Risk
4
serious Num Affected
4
serious Num At Risk
4
title
Part 1b: 80 mg AMG 397
deaths Num Affected
0
deaths Num At Risk
5
description
Participants with RR AML received 160 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.
id
EG004
other Num Affected
5
other Num At Risk
5
serious Num Affected
4
serious Num At Risk
5
title
Part 1b: 160 mg AMG 397
deaths Num Affected
2
deaths Num At Risk
3
description
Participants with RR AML received 320 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.
id
EG005
other Num Affected
3
other Num At Risk
3
serious Num Affected
3
serious Num At Risk
3
title
Part 1b: 320 mg AMG 397

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
0
num At Risk
2
group Id
EG001
num Affected
2
num At Risk
6
group Id
EG002
num Affected
2
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
0
num At Risk
3
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
0
num At Risk
2
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
1
num At Risk
5
group Id
EG005
num Affected
0
num At Risk
3
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
0
num At Risk
2
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
1
num At Risk
4
group Id
EG004
num Affected
1
num At Risk
5
group Id
EG005
num Affected
0
num At Risk
3
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
0
num At Risk
2
group Id
EG001
num Affected
5
num At Risk
6
group Id
EG002
num Affected
3
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
0
num At Risk
3
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
1
num At Risk
2
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
0
num At Risk
3
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
0
num At Risk
2
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
1
num At Risk
3
term
Bundle branch block right
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
2
num At Risk
2
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
0
num At Risk
3
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
1
num At Risk
2
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
1
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
0
num At Risk
3
term
Supraventricular extrasystoles
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
0
num At Risk
2
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
1
num At Risk
5
group Id
EG005
num Affected
0
num At Risk
3
term
Tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
0
num At Risk
2
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
1
num At Risk
5
group Id
EG005
num Affected
0
num At Risk
3
term
Dry eye
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
0
num At Risk
2
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
1
num At Risk
4
group Id
EG004
num Affected
1
num At Risk
5
group Id
EG005
num Affected
0
num At Risk
3
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
0
num At Risk
2
group Id
EG001
num Affected
1
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
2
num At Risk
5
group Id
EG005
num Affected
0
num At Risk
3
term
Abdominal pain

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
0
num At Risk
2
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
1
num At Risk
4
group Id
EG004
num Affected
1
num At Risk
5
group Id
EG005
num Affected
0
num At Risk
3
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
0
num At Risk
2
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
1
num At Risk
5
group Id
EG005
num Affected
0
num At Risk
3
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
0
num At Risk
2
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
1
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
0
num At Risk
3
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
0
num At Risk
2
group Id
EG001
num Affected
1
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
0
num At Risk
3
term
Gastritis erosive
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
0
num At Risk
2
group Id
EG001
num Affected
1
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
0
num At Risk
3
term
Gastrointestinal toxicity
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
1
num At Risk
2
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
0
num At Risk
3
term
Haematemesis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
0
num At Risk
2
group Id
EG001
num Affected
1
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
0
num At Risk
3
term
Ileus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
1
num At Risk
2
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
0
num At Risk
3
term
Melaena
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
0
num At Risk
2
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
1
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
0
num At Risk
3
term
Mouth ulceration
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
0
num At Risk
2
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
1
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
0
num At Risk
3
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
0
num At Risk
2
group Id
EG001
num Affected
1
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
0
num At Risk
3
term
Small intestinal obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
0
num At Risk
2
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
1
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
1
num At Risk
5
group Id
EG005
num Affected
0
num At Risk
3
term
Asthenia

time Frame

Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b)

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Preserved source evidence · Not medical advice