NCT04776018 · ADVERSE EVENTS

Adverse events

A Study Of TAK-981 Given With Monoclonal Antibodies (mAbs) In Adults With Relapsed or Refractory Multiple Myeloma (RRMM) · Source last updated 2024-10-02

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 the first dose of study drug through 30 days after the last dose of study drug (up to 13 months)
Other-event reporting threshold: 5%

The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Phase 1b, Part 1: TAK-981 60 mg BIW + Mezagitamab 600 mg Participants received TAK-981 60 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	0 / 3	3 / 3	0 / 3
Phase 1b, Part 1: TAK-981 90 mg BIW + Mezagitamab 600 mg Participants received TAK-981 90 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	1 / 3	3 / 3	1 / 3
Phase 1b, Part 1: TAK-981 90 mg QW + Mezagitamab 600 mg Participants received TAK-981 90 mg, infusion, intravenously, in combination with mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15, 22 during Cycles 1 and 2, then every 2 weeks during Cycles 3 through 6, further once every 4 weeks until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	4 / 10	10 / 10	4 / 10
Phase 1b, Part 1: TAK-981 120 mg BIW + Mezagitamab 600 mg Participants received TAK-981 120 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	1 / 3	3 / 3	1 / 3
Phase 1b, Part 1: TAK-981 120 mg QW + Mezagitamab 600 mg Participants received TAK-981 120 mg, infusion, intravenously, in combination with mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15, 22 during Cycles 1 and 2, then every 2 weeks during Cycles 3 through 6, further once every 4 weeks until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	3 / 8	8 / 8	4 / 8

Group identifiers: EG000: Phase 1b, Part 1: TAK-981 60 mg BIW + Mezagitamab 600 mg · EG001: Phase 1b, Part 1: TAK-981 90 mg BIW + Mezagitamab 600 mg · EG002: Phase 1b, Part 1: TAK-981 90 mg QW + Mezagitamab 600 mg · EG003: Phase 1b, Part 1: TAK-981 120 mg BIW + Mezagitamab 600 mg · EG004: Phase 1b, Part 1: TAK-981 120 mg QW + Mezagitamab 600 mg

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
Renal and urinary disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
10
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
1
num At Risk
8
term
Acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
10
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
8
term
Acute respiratory failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
10
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
8
term
Arthritis infective
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
10
group Id
EG003
num Affected
1
num At Risk
3
group Id
EG004
num Affected
1
num At Risk
8
term
Cytokine release syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
10
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
1
num At Risk
8
term
Death
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
10
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
8
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
10
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
1
num At Risk
8
term
Humerus fracture
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
10
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
1
num At Risk
8
term
Hypercalcaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
10
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
1
num At Risk
8
term
Infusion related reaction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
10
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
1
num At Risk
8
term
Lumbar vertebral fracture
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
10
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
1
num At Risk
8
term
Muscular weakness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
10
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
1
num At Risk
8
term
Osteomyelitis

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
Infections and infestations
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
10
group Id
EG003
num Affected
1
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
8
term
Abscess limb
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
10
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
8
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
2
num At Risk
3
group Id
EG002
num Affected
3
num At Risk
10
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
5
num At Risk
8
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
2
num At Risk
10
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
1
num At Risk
8
term
Anxiety
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
2
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
10
group Id
EG003
num Affected
2
num At Risk
3
group Id
EG004
num Affected
2
num At Risk
8
term
Arthralgia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
10
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
8
term
Aspartate aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
10
group Id
EG003
num Affected
1
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
8
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
2
num At Risk
3
group Id
EG001
num Affected
2
num At Risk
3
group Id
EG002
num Affected
2
num At Risk
10
group Id
EG003
num Affected
1
num At Risk
3
group Id
EG004
num Affected
1
num At Risk
8
term
Back pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Reproductive system and breast disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
10
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
8
term
Benign prostatic hyperplasia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
10
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
1
num At Risk
8
term
Blood creatinine increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
10
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
8
term
Blood lactate dehydrogenase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
10
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
2
num At Risk
8
term
CD4 lymphocytes decreased

Complete source fields

description

event Groups

deaths Num Affected
0
deaths Num At Risk
3
description
Participants received TAK-981 60 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.
id
EG000
other Num Affected
3
other Num At Risk
3
serious Num Affected
0
serious Num At Risk
3
title
Phase 1b, Part 1: TAK-981 60 mg BIW + Mezagitamab 600 mg
deaths Num Affected
1
deaths Num At Risk
3
description
Participants received TAK-981 90 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.
id
EG001
other Num Affected
3
other Num At Risk
3
serious Num Affected
1
serious Num At Risk
3
title
Phase 1b, Part 1: TAK-981 90 mg BIW + Mezagitamab 600 mg
deaths Num Affected
4
deaths Num At Risk
10
description
Participants received TAK-981 90 mg, infusion, intravenously, in combination with mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15, 22 during Cycles 1 and 2, then every 2 weeks during Cycles 3 through 6, further once every 4 weeks until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.
id
EG002
other Num Affected
10
other Num At Risk
10
serious Num Affected
4
serious Num At Risk
10
title
Phase 1b, Part 1: TAK-981 90 mg QW + Mezagitamab 600 mg
deaths Num Affected
1
deaths Num At Risk
3
description
Participants received TAK-981 120 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.
id
EG003
other Num Affected
3
other Num At Risk
3
serious Num Affected
1
serious Num At Risk
3
title
Phase 1b, Part 1: TAK-981 120 mg BIW + Mezagitamab 600 mg
deaths Num Affected
4
deaths Num At Risk
8
description
Participants received TAK-981 120 mg, infusion, intravenously, in combination with mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15, 22 during Cycles 1 and 2, then every 2 weeks during Cycles 3 through 6, further once every 4 weeks until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.
id
EG004
other Num Affected
8
other Num At Risk
8
serious Num Affected
3
serious Num At Risk
8
title
Phase 1b, Part 1: TAK-981 120 mg QW + Mezagitamab 600 mg

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
10
group Id
EG003
num Affected
1
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
8
term
Abscess limb
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
10
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
8
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
2
num At Risk
3
group Id
EG002
num Affected
3
num At Risk
10
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
5
num At Risk
8
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
2
num At Risk
10
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
1
num At Risk
8
term
Anxiety
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
2
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
10
group Id
EG003
num Affected
2
num At Risk
3
group Id
EG004
num Affected
2
num At Risk
8
term
Arthralgia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
10
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
8
term
Aspartate aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
10
group Id
EG003
num Affected
1
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
8
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
2
num At Risk
3
group Id
EG001
num Affected
2
num At Risk
3
group Id
EG002
num Affected
2
num At Risk
10
group Id
EG003
num Affected
1
num At Risk
3
group Id
EG004
num Affected
1
num At Risk
8
term
Back pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Reproductive system and breast disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
10
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
8
term
Benign prostatic hyperplasia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
10
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
1
num At Risk
8
term
Blood creatinine increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
10
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
8
term
Blood lactate dehydrogenase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
10
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
2
num At Risk
8
term
CD4 lymphocytes decreased

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
10
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
1
num At Risk
8
term
Acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
10
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
8
term
Acute respiratory failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
10
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
8
term
Arthritis infective
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
10
group Id
EG003
num Affected
1
num At Risk
3
group Id
EG004
num Affected
1
num At Risk
8
term
Cytokine release syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
10
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
1
num At Risk
8
term
Death
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
10
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
8
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
10
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
1
num At Risk
8
term
Humerus fracture
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
10
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
1
num At Risk
8
term
Hypercalcaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
10
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
1
num At Risk
8
term
Infusion related reaction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
10
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
1
num At Risk
8
term
Lumbar vertebral fracture
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
10
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
1
num At Risk
8
term
Muscular weakness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
10
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
1
num At Risk
8
term
Osteomyelitis

time Frame

From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months)

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

Preserved source evidence · Not medical advice