NCT05090566 · ADVERSE EVENTS

Adverse events

MagnetisMM-4: Umbrella Study of Elranatamab (PF-06863135) in Combination With Anti-Cancer Treatments in Multiple Myeloma · Source last updated 2026-04-24

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: From first dose of study intervention and up to 90 days after last dose or start of new anticancer therapy (approximately up to 48 months)
Other-event reporting threshold: 5%

Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
SSA, Phase 1b: Elranatamab + Nirogacestat, Dose Level 1 Participants with RRMM received elranatamab 4 mg SC on Cycle 0 Day 1 (7 days prior to Cycle 1 Day 1) \[priming dose\] and thereafter 4 mg weekly during each cycle (1 cycle = 4 weeks) and Nirogacestat 100 mg orally BID.	1 / 2	2 / 2	1 / 2
SSA, Phase 1b: Elranatamab + Nirogacestat, Dose Level 2 Participants with RRMM received elranatamab 4 mg SC on Cycle 0 Day 1 (7 days prior to Cycle 1 Day 1) and 8 mg on Cycle 0 Day 4 (3 days prior to Cycle 1 Day 1) \[priming dose\] and thereafter 12 mg weekly during each cycle (1 cycle = 4 weeks) and Nirogacestat 100 mg orally BID.	5 / 6	6 / 6	3 / 6
SSA, Phase 1b: Elranatamab + Nirogacestat,Dose Level 3 Participants with RRMM received elranatamab 12 mg SC on Cycle 0 Day 1 (7 days prior to Cycle 1 Day 1) and 32 mg on Cycle 0 Day 4 (3 days prior to Cycle 1 Day 1) \[priming dose\] and thereafter 32 mg weekly during each cycle (1 cycle = 4 weeks) and Nirogacestat 100 mg orally BID.	6 / 10	10 / 10	3 / 10
SSA, Phase 1b: Elranatamab + Nirogacestat, Dose Level 3A Participants with RRMM received elranatamab 12 mg SC on Cycle 0 Day 1 (7 days prior to Cycle 1 Day 1) and 32 mg on Cycle 0 Day 4 (3 days prior to Cycle 1 Day 1) \[priming dose\] and thereafter 32 mg weekly during each cycle (1 cycle = 4 weeks) and Nirogacestat 100 mg orally QD.	6 / 10	10 / 10	2 / 10
SSA, Phase 1b: Elranatamab + Nirogacestat, Dose Level 4A Participants with RRMM received elranatamab 12 mg SC on Cycle 0 Day 1 (7 days prior to Cycle 1 Day 1) and 32 mg on Cycle 0 Day 4 (3 days prior to Cycle 1 Day 1) \[priming dose\] and thereafter 76 mg weekly during each cycle (1 cycle = 4 weeks) and Nirogacestat 100 mg orally QD.	4 / 6	6 / 6	1 / 6
SSB, Phase 1b: Elranatamab + Lenalidomide + Dexamethasone, Dose Level 1 Participants with RRMM received elranatamab 12 mg SC on Cycle 0 Day 1 (7 days prior to Cycle 1 Day 1) and 32 mg on Cycle 0 Day 4 (3 days prior to Cycle 1 Day 1) \[priming dose\] and 44 mg on C0D8 and thereafter 44 mg weekly during each cycle (1 cycle = 4 weeks) and Lenalidomide 15 mg QD for 21 days and Dexamethasone 20 mg weekly on Cycle 1 and 2.	7 / 12	11 / 12	5 / 12
All Participants All participants who received at least one dose of study drug.	29 / 46	45 / 46	15 / 46

Group identifiers: EG000: SSA, Phase 1b: Elranatamab + Nirogacestat, Dose Level 1 · EG001: SSA, Phase 1b: Elranatamab + Nirogacestat, Dose Level 2 · EG002: SSA, Phase 1b: Elranatamab + Nirogacestat,Dose Level 3 · EG003: SSA, Phase 1b: Elranatamab + Nirogacestat, Dose Level 3A · EG004: SSA, Phase 1b: Elranatamab + Nirogacestat, Dose Level 4A · EG005: SSB, Phase 1b: Elranatamab + Lenalidomide + Dexamethasone, Dose Level 1 · EG006: All Participants

Serious adverse events

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

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v28.0
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
10
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
1
num At Risk
12
group Id
EG006
num Affected
1
num At Risk
46
term
Blood loss anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v28.0
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
10
group Id
EG003
num Affected
1
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
12
group Id
EG006
num Affected
1
num At Risk
46
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA v28.0
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
10
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
1
num At Risk
12
group Id
EG006
num Affected
1
num At Risk
46
term
Vertigo
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v28.0
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
10
group Id
EG003
num Affected
1
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
12
group Id
EG006
num Affected
1
num At Risk
46
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v28.0
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
10
group Id
EG003
num Affected
1
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
12
group Id
EG006
num Affected
1
num At Risk
46
term
Colitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v28.0
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
10
group Id
EG003
num Affected
1
num At Risk
10
group Id
EG004
num Affected
1
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
12
group Id
EG006
num Affected
2
num At Risk
46
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v28.0
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
10
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
12
group Id
EG006
num Affected
1
num At Risk
46
term
Haemorrhoidal haemorrhage
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA v28.0
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
10
group Id
EG003
num Affected
1
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
12
group Id
EG006
num Affected
2
num At Risk
46
term
Chest pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA v28.0
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
10
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
12
group Id
EG006
num Affected
1
num At Risk
46
term
Death
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA v28.0
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
1
num At Risk
10
group Id
EG003
num Affected
2
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
1
num At Risk
12
group Id
EG006
num Affected
5
num At Risk
46
term
Disease progression
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA v28.0
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
10
group Id
EG003
num Affected
1
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
1
num At Risk
12
group Id
EG006
num Affected
2
num At Risk
46
term
Pyrexia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
MedDRA v28.0
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
2
num At Risk
10
group Id
EG003
num Affected
2
num At Risk
10
group Id
EG004
num Affected
1
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
12
group Id
EG006
num Affected
6
num At Risk
46
term
Cytokine release syndrome

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
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
0
num At Risk
2
group Id
EG001
num Affected
3
num At Risk
6
group Id
EG002
num Affected
5
num At Risk
10
group Id
EG003
num Affected
4
num At Risk
10
group Id
EG004
num Affected
4
num At Risk
6
group Id
EG005
num Affected
8
num At Risk
12
group Id
EG006
num Affected
24
num At Risk
46
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v28.0
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
1
num At Risk
10
group Id
EG003
num Affected
1
num At Risk
10
group Id
EG004
num Affected
3
num At Risk
6
group Id
EG005
num Affected
2
num At Risk
12
group Id
EG006
num Affected
8
num At Risk
46
term
Leukopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v28.0
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
2
num At Risk
10
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
3
num At Risk
12
group Id
EG006
num Affected
6
num At Risk
46
term
Lymphopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
2
num At Risk
2
group Id
EG001
num Affected
2
num At Risk
6
group Id
EG002
num Affected
7
num At Risk
10
group Id
EG003
num Affected
4
num At Risk
10
group Id
EG004
num Affected
5
num At Risk
6
group Id
EG005
num Affected
7
num At Risk
12
group Id
EG006
num Affected
27
num At Risk
46
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v28.0
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
10
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
1
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
12
group Id
EG006
num Affected
1
num At Risk
46
term
Pancytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
0
num At Risk
2
group Id
EG001
num Affected
4
num At Risk
6
group Id
EG002
num Affected
5
num At Risk
10
group Id
EG003
num Affected
1
num At Risk
10
group Id
EG004
num Affected
4
num At Risk
6
group Id
EG005
num Affected
4
num At Risk
12
group Id
EG006
num Affected
18
num At Risk
46
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v28.0
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
10
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
1
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
12
group Id
EG006
num Affected
1
num At Risk
46
term
Angina pectoris
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v28.0
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
10
group Id
EG003
num Affected
1
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
12
group Id
EG006
num Affected
1
num At Risk
46
term
Atrial fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v28.0
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
10
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
1
num At Risk
12
group Id
EG006
num Affected
1
num At Risk
46
term
Bundle branch block left
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v28.0
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
1
num At Risk
10
group Id
EG003
num Affected
1
num At Risk
10
group Id
EG004
num Affected
1
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
12
group Id
EG006
num Affected
4
num At Risk
46
term
Palpitations
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v28.0
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
10
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
1
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
12
group Id
EG006
num Affected
1
num At Risk
46
term
Pericardial effusion
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v28.0
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
10
group Id
EG003
num Affected
1
num At Risk
10
group Id
EG004
num Affected
1
num At Risk
6
group Id
EG005
num Affected
1
num At Risk
12
group Id
EG006
num Affected
3
num At Risk
46
term
Sinus tachycardia

Complete source fields

description

event Groups

deaths Num Affected
1
deaths Num At Risk
2
description
Participants with RRMM received elranatamab 4 mg SC on Cycle 0 Day 1 (7 days prior to Cycle 1 Day 1) \[priming dose\] and thereafter 4 mg weekly during each cycle (1 cycle = 4 weeks) and Nirogacestat 100 mg orally BID.
id
EG000
other Num Affected
2
other Num At Risk
2
serious Num Affected
1
serious Num At Risk
2
title
SSA, Phase 1b: Elranatamab + Nirogacestat, Dose Level 1
deaths Num Affected
3
deaths Num At Risk
6
description
Participants with RRMM received elranatamab 4 mg SC on Cycle 0 Day 1 (7 days prior to Cycle 1 Day 1) and 8 mg on Cycle 0 Day 4 (3 days prior to Cycle 1 Day 1) \[priming dose\] and thereafter 12 mg weekly during each cycle (1 cycle = 4 weeks) and Nirogacestat 100 mg orally BID.
id
EG001
other Num Affected
6
other Num At Risk
6
serious Num Affected
5
serious Num At Risk
6
title
SSA, Phase 1b: Elranatamab + Nirogacestat, Dose Level 2
deaths Num Affected
3
deaths Num At Risk
10
description
Participants with RRMM received elranatamab 12 mg SC on Cycle 0 Day 1 (7 days prior to Cycle 1 Day 1) and 32 mg on Cycle 0 Day 4 (3 days prior to Cycle 1 Day 1) \[priming dose\] and thereafter 32 mg weekly during each cycle (1 cycle = 4 weeks) and Nirogacestat 100 mg orally BID.
id
EG002
other Num Affected
10
other Num At Risk
10
serious Num Affected
6
serious Num At Risk
10
title
SSA, Phase 1b: Elranatamab + Nirogacestat,Dose Level 3
deaths Num Affected
2
deaths Num At Risk
10
description
Participants with RRMM received elranatamab 12 mg SC on Cycle 0 Day 1 (7 days prior to Cycle 1 Day 1) and 32 mg on Cycle 0 Day 4 (3 days prior to Cycle 1 Day 1) \[priming dose\] and thereafter 32 mg weekly during each cycle (1 cycle = 4 weeks) and Nirogacestat 100 mg orally QD.
id
EG003
other Num Affected
10
other Num At Risk
10
serious Num Affected
6
serious Num At Risk
10
title
SSA, Phase 1b: Elranatamab + Nirogacestat, Dose Level 3A
deaths Num Affected
1
deaths Num At Risk
6
description
Participants with RRMM received elranatamab 12 mg SC on Cycle 0 Day 1 (7 days prior to Cycle 1 Day 1) and 32 mg on Cycle 0 Day 4 (3 days prior to Cycle 1 Day 1) \[priming dose\] and thereafter 76 mg weekly during each cycle (1 cycle = 4 weeks) and Nirogacestat 100 mg orally QD.
id
EG004
other Num Affected
6
other Num At Risk
6
serious Num Affected
4
serious Num At Risk
6
title
SSA, Phase 1b: Elranatamab + Nirogacestat, Dose Level 4A
deaths Num Affected
5
deaths Num At Risk
12
description
Participants with RRMM received elranatamab 12 mg SC on Cycle 0 Day 1 (7 days prior to Cycle 1 Day 1) and 32 mg on Cycle 0 Day 4 (3 days prior to Cycle 1 Day 1) \[priming dose\] and 44 mg on C0D8 and thereafter 44 mg weekly during each cycle (1 cycle = 4 weeks) and Lenalidomide 15 mg QD for 21 days and Dexamethasone 20 mg weekly on Cycle 1 and 2.
id
EG005
other Num Affected
11
other Num At Risk
12
serious Num Affected
7
serious Num At Risk
12
title
SSB, Phase 1b: Elranatamab + Lenalidomide + Dexamethasone, Dose Level 1
deaths Num Affected
15
deaths Num At Risk
46
description
All participants who received at least one dose of study drug.
id
EG006
other Num Affected
45
other Num At Risk
46
serious Num Affected
29
serious Num At Risk
46
title
All Participants

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
0
num At Risk
2
group Id
EG001
num Affected
3
num At Risk
6
group Id
EG002
num Affected
5
num At Risk
10
group Id
EG003
num Affected
4
num At Risk
10
group Id
EG004
num Affected
4
num At Risk
6
group Id
EG005
num Affected
8
num At Risk
12
group Id
EG006
num Affected
24
num At Risk
46
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v28.0
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
1
num At Risk
10
group Id
EG003
num Affected
1
num At Risk
10
group Id
EG004
num Affected
3
num At Risk
6
group Id
EG005
num Affected
2
num At Risk
12
group Id
EG006
num Affected
8
num At Risk
46
term
Leukopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v28.0
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
2
num At Risk
10
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
3
num At Risk
12
group Id
EG006
num Affected
6
num At Risk
46
term
Lymphopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
2
num At Risk
2
group Id
EG001
num Affected
2
num At Risk
6
group Id
EG002
num Affected
7
num At Risk
10
group Id
EG003
num Affected
4
num At Risk
10
group Id
EG004
num Affected
5
num At Risk
6
group Id
EG005
num Affected
7
num At Risk
12
group Id
EG006
num Affected
27
num At Risk
46
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v28.0
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
10
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
1
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
12
group Id
EG006
num Affected
1
num At Risk
46
term
Pancytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
0
num At Risk
2
group Id
EG001
num Affected
4
num At Risk
6
group Id
EG002
num Affected
5
num At Risk
10
group Id
EG003
num Affected
1
num At Risk
10
group Id
EG004
num Affected
4
num At Risk
6
group Id
EG005
num Affected
4
num At Risk
12
group Id
EG006
num Affected
18
num At Risk
46
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v28.0
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
10
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
1
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
12
group Id
EG006
num Affected
1
num At Risk
46
term
Angina pectoris
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v28.0
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
10
group Id
EG003
num Affected
1
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
12
group Id
EG006
num Affected
1
num At Risk
46
term
Atrial fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v28.0
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
10
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
1
num At Risk
12
group Id
EG006
num Affected
1
num At Risk
46
term
Bundle branch block left
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v28.0
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
1
num At Risk
10
group Id
EG003
num Affected
1
num At Risk
10
group Id
EG004
num Affected
1
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
12
group Id
EG006
num Affected
4
num At Risk
46
term
Palpitations
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v28.0
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
10
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
1
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
12
group Id
EG006
num Affected
1
num At Risk
46
term
Pericardial effusion
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v28.0
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
10
group Id
EG003
num Affected
1
num At Risk
10
group Id
EG004
num Affected
1
num At Risk
6
group Id
EG005
num Affected
1
num At Risk
12
group Id
EG006
num Affected
3
num At Risk
46
term
Sinus tachycardia

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v28.0
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
10
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
1
num At Risk
12
group Id
EG006
num Affected
1
num At Risk
46
term
Blood loss anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v28.0
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
10
group Id
EG003
num Affected
1
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
12
group Id
EG006
num Affected
1
num At Risk
46
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA v28.0
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
10
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
1
num At Risk
12
group Id
EG006
num Affected
1
num At Risk
46
term
Vertigo
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v28.0
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
10
group Id
EG003
num Affected
1
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
12
group Id
EG006
num Affected
1
num At Risk
46
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v28.0
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
10
group Id
EG003
num Affected
1
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
12
group Id
EG006
num Affected
1
num At Risk
46
term
Colitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v28.0
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
10
group Id
EG003
num Affected
1
num At Risk
10
group Id
EG004
num Affected
1
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
12
group Id
EG006
num Affected
2
num At Risk
46
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v28.0
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
10
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
12
group Id
EG006
num Affected
1
num At Risk
46
term
Haemorrhoidal haemorrhage
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA v28.0
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
10
group Id
EG003
num Affected
1
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
12
group Id
EG006
num Affected
2
num At Risk
46
term
Chest pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA v28.0
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
10
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
12
group Id
EG006
num Affected
1
num At Risk
46
term
Death
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA v28.0
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
1
num At Risk
10
group Id
EG003
num Affected
2
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
1
num At Risk
12
group Id
EG006
num Affected
5
num At Risk
46
term
Disease progression
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA v28.0
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
10
group Id
EG003
num Affected
1
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
1
num At Risk
12
group Id
EG006
num Affected
2
num At Risk
46
term
Pyrexia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
MedDRA v28.0
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
2
num At Risk
10
group Id
EG003
num Affected
2
num At Risk
10
group Id
EG004
num Affected
1
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
12
group Id
EG006
num Affected
6
num At Risk
46
term
Cytokine release syndrome

time Frame

From first dose of study intervention and up to 90 days after last dose or start of new anticancer therapy (approximately up to 48 months)

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

Preserved source evidence · Not medical advice