NCT03000452 · ADVERSE EVENTS

Adverse events

A Study to Determine the Efficacy of the Combination of Daratumumab (DARA) Plus Durvalumab (DURVA) (D2) in Subjects With Relapsed and Refractory Multiple Myeloma (RRMM) · Source last updated 2018-10-16

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 drug to 90 days after the last dose of daratumumab and durvalumab, whichever was later, as well as SAEs made known to the investigator at any time thereafter that are suspected of being related to daratumumab or durvalumab. Maximum overall time on treatment was 16 weeks for daratumumab and durvalumab
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Daratumumab and Durvalumab Participants received intravenous daratumumab at 16 mg/kg on the same dosing schedule (weekly, every 2 weeks, or every 4 weeks of each 28-day treatment cycle) on their last prior therapy containing daratumumab regimen. The dosing schedule for daratumumab could be adjusted during the course of the study, provided the participant had a response of stable disease or better. Participants also received IV durvalumab at 1500 mg on Day 2 of Cycle 1 and then on Day 1 of Cycles ≥ 2 of each 28-day treatment cycle. Participants could continue on study treatment until progressive disease or unacceptable toxicity.	7 / 18	17 / 18	4 / 18

Group identifiers: EG000: Daratumumab and Durvalumab

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 V20.0
stats
group Id
EG000
num Affected
1
num At Risk
18
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MEDDRA V20.0
stats
group Id
EG000
num Affected
4
num At Risk
18
term
General physical health deterioration
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MEDDRA V20.0
stats
group Id
EG000
num Affected
1
num At Risk
18
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MEDDRA V20.0
stats
group Id
EG000
num Affected
1
num At Risk
18
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MEDDRA V20.0
stats
group Id
EG000
num Affected
1
num At Risk
18
term
Acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MEDDRA V20.0
stats
group Id
EG000
num Affected
1
num At Risk
18
term
Pleural effusion

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 V20.0
stats
group Id
EG000
num Affected
12
num At Risk
18
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MEDDRA V20.0
stats
group Id
EG000
num Affected
1
num At Risk
18
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MEDDRA V20.0
stats
group Id
EG000
num Affected
3
num At Risk
18
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MEDDRA V20.0
stats
group Id
EG000
num Affected
7
num At Risk
18
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MEDDRA V20.0
stats
group Id
EG000
num Affected
1
num At Risk
18
term
Tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MEDDRA V20.0
stats
group Id
EG000
num Affected
1
num At Risk
18
term
Cataract
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MEDDRA V20.0
stats
group Id
EG000
num Affected
1
num At Risk
18
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MEDDRA V20.0
stats
group Id
EG000
num Affected
1
num At Risk
18
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MEDDRA V20.0
stats
group Id
EG000
num Affected
2
num At Risk
18
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MEDDRA V20.0
stats
group Id
EG000
num Affected
1
num At Risk
18
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MEDDRA V20.0
stats
group Id
EG000
num Affected
1
num At Risk
18
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MEDDRA V20.0
stats
group Id
EG000
num Affected
1
num At Risk
18
term
Chest discomfort

Complete source fields

event Groups

deaths Num Affected
4
deaths Num At Risk
18
description
Participants received intravenous daratumumab at 16 mg/kg on the same dosing schedule (weekly, every 2 weeks, or every 4 weeks of each 28-day treatment cycle) on their last prior therapy containing daratumumab regimen. The dosing schedule for daratumumab could be adjusted during the course of the study, provided the participant had a response of stable disease or better. Participants also received IV durvalumab at 1500 mg on Day 2 of Cycle 1 and then on Day 1 of Cycles ≥ 2 of each 28-day treatment cycle. Participants could continue on study treatment until progressive disease or unacceptable toxicity.
id
EG000
other Num Affected
17
other Num At Risk
18
serious Num Affected
7
serious Num At Risk
18
title
Daratumumab and Durvalumab

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MEDDRA V20.0
stats
group Id
EG000
num Affected
12
num At Risk
18
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MEDDRA V20.0
stats
group Id
EG000
num Affected
1
num At Risk
18
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MEDDRA V20.0
stats
group Id
EG000
num Affected
3
num At Risk
18
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MEDDRA V20.0
stats
group Id
EG000
num Affected
7
num At Risk
18
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MEDDRA V20.0
stats
group Id
EG000
num Affected
1
num At Risk
18
term
Tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MEDDRA V20.0
stats
group Id
EG000
num Affected
1
num At Risk
18
term
Cataract
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MEDDRA V20.0
stats
group Id
EG000
num Affected
1
num At Risk
18
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MEDDRA V20.0
stats
group Id
EG000
num Affected
1
num At Risk
18
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MEDDRA V20.0
stats
group Id
EG000
num Affected
2
num At Risk
18
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MEDDRA V20.0
stats
group Id
EG000
num Affected
1
num At Risk
18
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MEDDRA V20.0
stats
group Id
EG000
num Affected
1
num At Risk
18
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MEDDRA V20.0
stats
group Id
EG000
num Affected
1
num At Risk
18
term
Chest discomfort

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MEDDRA V20.0
stats
group Id
EG000
num Affected
1
num At Risk
18
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MEDDRA V20.0
stats
group Id
EG000
num Affected
4
num At Risk
18
term
General physical health deterioration
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MEDDRA V20.0
stats
group Id
EG000
num Affected
1
num At Risk
18
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MEDDRA V20.0
stats
group Id
EG000
num Affected
1
num At Risk
18
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MEDDRA V20.0
stats
group Id
EG000
num Affected
1
num At Risk
18
term
Acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MEDDRA V20.0
stats
group Id
EG000
num Affected
1
num At Risk
18
term
Pleural effusion

time Frame

From first dose of study drug to 90 days after the last dose of daratumumab and durvalumab, whichever was later, as well as SAEs made known to the investigator at any time thereafter that are suspected of being related to daratumumab or durvalumab. Maximum overall time on treatment was 16 weeks for daratumumab and durvalumab

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

Preserved source evidence · Not medical advice