NCT03837509 · ADVERSE EVENTS

Adverse events

INCB001158 Combined With Subcutaneous (SC) Daratumumab, Compared to Daratumumab SC, in Relapsed or Refractory Multiple Myeloma · Source last updated 2025-11-04

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

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

Collection time frame: Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years).
Other-event reporting threshold: 5%

Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Phase 1: INCB001158 75 mg BID + Daratumumab In Phase 1, participants received oral INCB001158 75 milligrams (mg) twice daily (BID) in 28-day cycles starting at Cycle 1, and 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2, once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. Treatment continued until disease progression, unacceptable toxicity, or discontinuation from study treatment for any other reason.	3 / 6	6 / 6	5 / 6
Phase 1: INCB001158 100 mg BID + Daratumumab In Phase 1, participants received oral INCB001158 100 mg BID in 28-day cycles starting at Cycle 1, and 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2, once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. Treatment continued until disease progression, unacceptable toxicity, or discontinuation from study treatment for any other reason.	1 / 4	4 / 4	2 / 4
Phase 2: INCB001158 100 mg BID + Daratumumab In Phase 1, participants received oral INCB001158 100 mg BID in 28-day cycles starting at Cycle 1, and 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2, once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. Treatment continued until disease progression, unacceptable toxicity, or discontinuation from study treatment for any other reason.	0 / 2	1 / 2	0 / 2
Phase 2: Daratumumab Monotherapy; Cross Over to INCB001158 + Daratumumab In Part 1 of Phase 2, participants received daratumumb 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2 (28-day cycles), once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. At the time of confirmed disease progression, participants crossed over to Part 2 of Phase 2 to receive oral INCB001158 100 mg BID starting at Cycle 1, and 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2, once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. Treatment in Phase 2 continued for as long as participants were receiving clinical benefit and did not met any criteria for study withdrawal.	1 / 1	1 / 1	1 / 1
Phase 2: INCB001158 Monotherapy; Cross Over to INCB001158 + Daratumumab In Part 1 of Phase 2, participants received oral INCB001158 100 mg BID in 28-day cycles starting at Cycle 1. At the time of confirmed disease progression, participants crossed over to Part 2 of Part 2 to receive oral INCB001158 100 mg BID starting at Cycle 1, and 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2, once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. Treatment in Phase 2 continued for as long as participants were receiving clinical benefit and did not met any criteria for study withdrawal.	0 / 2	1 / 2	1 / 2
Total Total	5 / 15	13 / 15	9 / 15

Group identifiers: EG000: Phase 1: INCB001158 75 mg BID + Daratumumab · EG001: Phase 1: INCB001158 100 mg BID + Daratumumab · EG002: Phase 2: INCB001158 100 mg BID + Daratumumab · EG003: Phase 2: Daratumumab Monotherapy; Cross Over to INCB001158 + Daratumumab · EG004: Phase 2: INCB001158 Monotherapy; Cross Over to INCB001158 + Daratumumab · EG005: Total

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
Cardiac disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
2
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
0
num At Risk
1
num Events
0
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
1
num At Risk
15
num Events
2
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
0
num At Risk
1
num Events
0
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
1
num At Risk
15
num Events
1
term
Condition aggravated
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
0
num At Risk
1
num Events
0
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
1
num At Risk
15
num Events
1
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
0
num At Risk
1
num Events
0
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
1
num At Risk
15
num Events
1
term
Delirium
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
1
num At Risk
4
num Events
1
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
0
num At Risk
1
num Events
0
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
1
num At Risk
15
num Events
1
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
1
num At Risk
4
num Events
1
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
0
num At Risk
1
num Events
0
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
1
num At Risk
15
num Events
1
term
Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
1
num At Risk
1
num Events
1
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
1
num At Risk
15
num Events
1
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
0
num At Risk
1
num Events
0
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
1
num At Risk
15
num Events
1
term
Type 2 diabetes mellitus

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
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
0
num At Risk
1
num Events
0
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
1
num At Risk
15
num Events
1
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
0
num At Risk
1
num Events
0
group Id
EG004
num Affected
1
num At Risk
2
num Events
1
group Id
EG005
num Affected
1
num At Risk
15
num Events
1
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
1
num At Risk
4
num Events
1
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
0
num At Risk
1
num Events
0
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
1
num At Risk
15
num Events
1
term
Alopecia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
1
num At Risk
2
num Events
4
group Id
EG003
num Affected
0
num At Risk
1
num Events
0
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
1
num At Risk
15
num Events
4
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
1
num At Risk
1
num Events
1
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
1
num At Risk
15
num Events
1
term
Arthralgia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
0
num At Risk
1
num Events
0
group Id
EG004
num Affected
1
num At Risk
2
num Events
1
group Id
EG005
num Affected
1
num At Risk
15
num Events
1
term
Aspartate aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
1
num At Risk
4
num Events
1
group Id
EG002
num Affected
1
num At Risk
2
num Events
1
group Id
EG003
num Affected
1
num At Risk
1
num Events
1
group Id
EG004
num Affected
1
num At Risk
2
num Events
1
group Id
EG005
num Affected
4
num At Risk
15
num Events
4
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
0
num At Risk
1
num Events
0
group Id
EG004
num Affected
1
num At Risk
2
num Events
1
group Id
EG005
num Affected
2
num At Risk
15
num Events
2
term
Bone pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
1
num At Risk
4
num Events
1
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
0
num At Risk
1
num Events
0
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
1
num At Risk
15
num Events
1
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
1
num At Risk
1
num Events
1
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
1
num At Risk
15
num Events
1
term
Cardiovascular insufficiency
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
1
num At Risk
4
num Events
1
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
0
num At Risk
1
num Events
0
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
1
num At Risk
15
num Events
1
term
Clavicle fracture
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
1
num At Risk
4
num Events
1
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
0
num At Risk
1
num Events
0
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
1
num At Risk
15
num Events
1
term
Constipation

Complete source fields

description

event Groups

deaths Num Affected
5
deaths Num At Risk
6
description
In Phase 1, participants received oral INCB001158 75 milligrams (mg) twice daily (BID) in 28-day cycles starting at Cycle 1, and 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2, once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. Treatment continued until disease progression, unacceptable toxicity, or discontinuation from study treatment for any other reason.
id
EG000
other Num Affected
6
other Num At Risk
6
serious Num Affected
3
serious Num At Risk
6
title
Phase 1: INCB001158 75 mg BID + Daratumumab
deaths Num Affected
2
deaths Num At Risk
4
description
In Phase 1, participants received oral INCB001158 100 mg BID in 28-day cycles starting at Cycle 1, and 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2, once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. Treatment continued until disease progression, unacceptable toxicity, or discontinuation from study treatment for any other reason.
id
EG001
other Num Affected
4
other Num At Risk
4
serious Num Affected
1
serious Num At Risk
4
title
Phase 1: INCB001158 100 mg BID + Daratumumab
deaths Num Affected
0
deaths Num At Risk
2
description
In Phase 1, participants received oral INCB001158 100 mg BID in 28-day cycles starting at Cycle 1, and 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2, once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. Treatment continued until disease progression, unacceptable toxicity, or discontinuation from study treatment for any other reason.
id
EG002
other Num Affected
1
other Num At Risk
2
serious Num Affected
0
serious Num At Risk
2
title
Phase 2: INCB001158 100 mg BID + Daratumumab
deaths Num Affected
1
deaths Num At Risk
1
description
In Part 1 of Phase 2, participants received daratumumb 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2 (28-day cycles), once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. At the time of confirmed disease progression, participants crossed over to Part 2 of Phase 2 to receive oral INCB001158 100 mg BID starting at Cycle 1, and 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2, once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. Treatment in Phase 2 continued for as long as participants were receiving clinical benefit and did not met any criteria for study withdrawal.
id
EG003
other Num Affected
1
other Num At Risk
1
serious Num Affected
1
serious Num At Risk
1
title
Phase 2: Daratumumab Monotherapy; Cross Over to INCB001158 + Daratumumab
deaths Num Affected
1
deaths Num At Risk
2
description
In Part 1 of Phase 2, participants received oral INCB001158 100 mg BID in 28-day cycles starting at Cycle 1. At the time of confirmed disease progression, participants crossed over to Part 2 of Part 2 to receive oral INCB001158 100 mg BID starting at Cycle 1, and 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2, once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. Treatment in Phase 2 continued for as long as participants were receiving clinical benefit and did not met any criteria for study withdrawal.
id
EG004
other Num Affected
1
other Num At Risk
2
serious Num Affected
0
serious Num At Risk
2
title
Phase 2: INCB001158 Monotherapy; Cross Over to INCB001158 + Daratumumab
deaths Num Affected
9
deaths Num At Risk
15
description
Total
id
EG005
other Num Affected
13
other Num At Risk
15
serious Num Affected
5
serious Num At Risk
15
title
Total

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
0
num At Risk
1
num Events
0
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
1
num At Risk
15
num Events
1
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
0
num At Risk
1
num Events
0
group Id
EG004
num Affected
1
num At Risk
2
num Events
1
group Id
EG005
num Affected
1
num At Risk
15
num Events
1
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
1
num At Risk
4
num Events
1
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
0
num At Risk
1
num Events
0
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
1
num At Risk
15
num Events
1
term
Alopecia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
1
num At Risk
2
num Events
4
group Id
EG003
num Affected
0
num At Risk
1
num Events
0
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
1
num At Risk
15
num Events
4
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
1
num At Risk
1
num Events
1
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
1
num At Risk
15
num Events
1
term
Arthralgia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
0
num At Risk
1
num Events
0
group Id
EG004
num Affected
1
num At Risk
2
num Events
1
group Id
EG005
num Affected
1
num At Risk
15
num Events
1
term
Aspartate aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
1
num At Risk
4
num Events
1
group Id
EG002
num Affected
1
num At Risk
2
num Events
1
group Id
EG003
num Affected
1
num At Risk
1
num Events
1
group Id
EG004
num Affected
1
num At Risk
2
num Events
1
group Id
EG005
num Affected
4
num At Risk
15
num Events
4
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
0
num At Risk
1
num Events
0
group Id
EG004
num Affected
1
num At Risk
2
num Events
1
group Id
EG005
num Affected
2
num At Risk
15
num Events
2
term
Bone pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
1
num At Risk
4
num Events
1
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
0
num At Risk
1
num Events
0
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
1
num At Risk
15
num Events
1
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
1
num At Risk
1
num Events
1
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
1
num At Risk
15
num Events
1
term
Cardiovascular insufficiency
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
1
num At Risk
4
num Events
1
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
0
num At Risk
1
num Events
0
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
1
num At Risk
15
num Events
1
term
Clavicle fracture
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
1
num At Risk
4
num Events
1
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
0
num At Risk
1
num Events
0
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
1
num At Risk
15
num Events
1
term
Constipation

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
2
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
0
num At Risk
1
num Events
0
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
1
num At Risk
15
num Events
2
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
0
num At Risk
1
num Events
0
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
1
num At Risk
15
num Events
1
term
Condition aggravated
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
0
num At Risk
1
num Events
0
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
1
num At Risk
15
num Events
1
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
0
num At Risk
1
num Events
0
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
1
num At Risk
15
num Events
1
term
Delirium
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
1
num At Risk
4
num Events
1
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
0
num At Risk
1
num Events
0
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
1
num At Risk
15
num Events
1
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
1
num At Risk
4
num Events
1
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
0
num At Risk
1
num Events
0
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
1
num At Risk
15
num Events
1
term
Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
1
num At Risk
1
num Events
1
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
1
num At Risk
15
num Events
1
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
0
num At Risk
1
num Events
0
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
1
num At Risk
15
num Events
1
term
Type 2 diabetes mellitus

time Frame

Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years).

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

Preserved source evidence · Not medical advice