NCT03679624 · ADVERSE EVENTS

Adverse events

Daratumumab Plus Ibrutinib in Patients With Waldenstrӧm's Macroglobulinemia · Source last updated 2023-10-23

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: 3 months
Other-event reporting threshold: 0%

0 subjects were enrolled in Cohort B

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Cohort A - Ibrutinib Naive Cohort A will consist of subjects who are ibrutinib naïve and appropriate for ibrutinib based treatment. Treatment naïve subjects will be eligible to enroll in this cohort. All subjects in this cohort will receive ibrutinib plus daratumumab Ibrutinib: Ibrutinib, 420mg orally, once daily Daratumumab: Daratumumab, 16 mg/kg intravenously, weekly for 8 weeks, bi weekly for 16 weeks, then monthly for up to 19 months.	1 / 1	1 / 1	0 / 1
Cohort B - Ibrutinib Response Plateau Cohort B will consist of subjects who have had at least 6 months of exposure to single agent ibrutinib and who have demonstrated an IgM response plateau defined by two IgM measurements, at least 8 weeks apart that have changed \<15% from the previous mark. All subjects in this cohort will receive ibrutinib plus daratumumab Ibrutinib: Ibrutinib, 420mg orally, once daily Daratumumab: Daratumumab, 16 mg/kg intravenously, weekly for 8 weeks, bi weekly for 16 weeks, then monthly for up to 19 months.	0 / 0	0 / 0	0 / 0

Group identifiers: EG000: Cohort A - Ibrutinib Naive · EG001: Cohort B - Ibrutinib Response Plateau

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
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
group Id
EG001
num Affected
0
num At Risk
0
term
Elevated ALT/AST

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
notes
grade 1
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
group Id
EG001
num Affected
0
num At Risk
0
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Infusion-related reaction
organ System
Injury, poisoning and procedural complications
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
term
Infusion related
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
term
Scratchy Throat
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
term
ALT increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
term
AST increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
term
Abdominal Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
term
Malaise- flu like symptoms

Complete source fields

description

0 subjects were enrolled in Cohort B

event Groups

deaths Num Affected
0
deaths Num At Risk
1
description
Cohort A will consist of subjects who are ibrutinib naïve and appropriate for ibrutinib based treatment. Treatment naïve subjects will be eligible to enroll in this cohort. All subjects in this cohort will receive ibrutinib plus daratumumab Ibrutinib: Ibrutinib, 420mg orally, once daily Daratumumab: Daratumumab, 16 mg/kg intravenously, weekly for 8 weeks, bi weekly for 16 weeks, then monthly for up to 19 months.
id
EG000
other Num Affected
1
other Num At Risk
1
serious Num Affected
1
serious Num At Risk
1
title
Cohort A - Ibrutinib Naive
deaths Num Affected
0
deaths Num At Risk
0
description
Cohort B will consist of subjects who have had at least 6 months of exposure to single agent ibrutinib and who have demonstrated an IgM response plateau defined by two IgM measurements, at least 8 weeks apart that have changed \<15% from the previous mark. All subjects in this cohort will receive ibrutinib plus daratumumab Ibrutinib: Ibrutinib, 420mg orally, once daily Daratumumab: Daratumumab, 16 mg/kg intravenously, weekly for 8 weeks, bi weekly for 16 weeks, then monthly for up to 19 months.
id
EG001
other Num Affected
0
other Num At Risk
0
serious Num Affected
0
serious Num At Risk
0
title
Cohort B - Ibrutinib Response Plateau

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
notes
grade 1
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
group Id
EG001
num Affected
0
num At Risk
0
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Infusion-related reaction
organ System
Injury, poisoning and procedural complications
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
term
Infusion related
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
term
Scratchy Throat
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
term
ALT increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
term
AST increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
term
Abdominal Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
term
Malaise- flu like symptoms

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
group Id
EG001
num Affected
0
num At Risk
0
term
Elevated ALT/AST

time Frame

3 months

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Preserved source evidence · Not medical advice