NCT02902965 · ADVERSE EVENTS

Adverse events

Study of Ibrutinib in Combination With Bortezomib and Dexamethasone in Subjects With Relapsed/Relapsed and Refractory Multiple Myeloma · Source last updated 2020-03-16

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 Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Other-event reporting threshold: 4%

Number of participants who had experienced at least one treatment emergent AE.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Ibrutinib+ Bortezomib+ Dexamethasone Ibrutinib (I): I 840 mg orally, once daily continuously starting day 1 of Cycle (C) 1 until confirmed disease progression, unacceptable toxicity or other protocol specified reason for discontinuation Bortezomib (B): C 1-8: (21-day C): B 1.3 mg/m\^2 sub-cutaneously on days 1, 4, 8, and 11 of each C C 9-12: (42-day C): B 1.3 mg/m\^2 sub-cutaneously on days 1, 8, 22 and 29 of each C Dexamethasone (D): C 1-8: (21-day C): D 20 mg orally on days 1, 2, 4, 5, 8, 9, 11 and 12 of each C C 9-12: (42-day C): D 20 mg orally on days 1, 2, 8, 9, 22, 23, 29 and 30 of each C C 13+ (28-day C): D 40 mg orally once weekly Dose adjustment of D to 10 mg on days specified during C 1-12 and 20 mg weekly during C 13+ is recommended for subjects \>75 years of age. Following implementation of Protocol Amendment 4, D administration was reduced to Days 1, 4, 8 and 11 during each 21-day C (C 1-8) and on Days 1, 8, 22 and 29 on each 42-day C (C 9-12) and unchanged thereafter.	47 / 74	74 / 74	27 / 74

Group identifiers: EG000: Ibrutinib+ Bortezomib+ Dexamethasone

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
Vascular disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
1
num At Risk
74
num Events
1
term
Circulatory collapse
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
1
num At Risk
74
num Events
1
term
Cancer pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
1
num At Risk
74
num Events
1
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
1
num At Risk
74
num Events
1
term
Death
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
1
num At Risk
74
num Events
1
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
1
num At Risk
74
num Events
1
term
Sudden death
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
1
num At Risk
74
num Events
1
term
Delirium
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
1
num At Risk
74
num Events
1
term
Humerus fracture
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
1
num At Risk
74
num Events
1
term
Spinal compression fracture
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
1
num At Risk
74
num Events
1
term
Thoracic vertebral fracture
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
1
num At Risk
74
num Events
1
term
Weight decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
3
num At Risk
74
num Events
3
term
Atrial fibrillation

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
Vascular disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
10
num At Risk
74
num Events
14
term
Hypertension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
8
num At Risk
74
num Events
9
term
Hypotension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
22
num At Risk
74
num Events
60
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
21
num At Risk
74
num Events
40
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
21
num At Risk
74
num Events
29
term
Oedema peripheral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
3
num At Risk
74
num Events
3
term
Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
5
num At Risk
74
num Events
6
term
Peripheral swelling
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
13
num At Risk
74
num Events
18
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
3
num At Risk
74
num Events
3
term
Depression
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
6
num At Risk
74
num Events
6
term
Insomnia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
4
num At Risk
74
num Events
6
term
Blood creatinine increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
4
num At Risk
74
num Events
5
term
Weight decreased

Complete source fields

description

Number of participants who had experienced at least one treatment emergent AE.

event Groups

deaths Num Affected
27
deaths Num At Risk
74
description
Ibrutinib (I): I 840 mg orally, once daily continuously starting day 1 of Cycle (C) 1 until confirmed disease progression, unacceptable toxicity or other protocol specified reason for discontinuation Bortezomib (B): C 1-8: (21-day C): B 1.3 mg/m\^2 sub-cutaneously on days 1, 4, 8, and 11 of each C C 9-12: (42-day C): B 1.3 mg/m\^2 sub-cutaneously on days 1, 8, 22 and 29 of each C Dexamethasone (D): C 1-8: (21-day C): D 20 mg orally on days 1, 2, 4, 5, 8, 9, 11 and 12 of each C C 9-12: (42-day C): D 20 mg orally on days 1, 2, 8, 9, 22, 23, 29 and 30 of each C C 13+ (28-day C): D 40 mg orally once weekly Dose adjustment of D to 10 mg on days specified during C 1-12 and 20 mg weekly during C 13+ is recommended for subjects \>75 years of age. Following implementation of Protocol Amendment 4, D administration was reduced to Days 1, 4, 8 and 11 during each 21-day C (C 1-8) and on Days 1, 8, 22 and 29 on each 42-day C (C 9-12) and unchanged thereafter.
id
EG000
other Num Affected
74
other Num At Risk
74
serious Num Affected
47
serious Num At Risk
74
title
Ibrutinib+ Bortezomib+ Dexamethasone

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
10
num At Risk
74
num Events
14
term
Hypertension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
8
num At Risk
74
num Events
9
term
Hypotension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
22
num At Risk
74
num Events
60
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
21
num At Risk
74
num Events
40
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
21
num At Risk
74
num Events
29
term
Oedema peripheral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
3
num At Risk
74
num Events
3
term
Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
5
num At Risk
74
num Events
6
term
Peripheral swelling
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
13
num At Risk
74
num Events
18
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
3
num At Risk
74
num Events
3
term
Depression
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
6
num At Risk
74
num Events
6
term
Insomnia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
4
num At Risk
74
num Events
6
term
Blood creatinine increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
4
num At Risk
74
num Events
5
term
Weight decreased

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
1
num At Risk
74
num Events
1
term
Circulatory collapse
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
1
num At Risk
74
num Events
1
term
Cancer pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
1
num At Risk
74
num Events
1
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
1
num At Risk
74
num Events
1
term
Death
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
1
num At Risk
74
num Events
1
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
1
num At Risk
74
num Events
1
term
Sudden death
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
1
num At Risk
74
num Events
1
term
Delirium
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
1
num At Risk
74
num Events
1
term
Humerus fracture
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
1
num At Risk
74
num Events
1
term
Spinal compression fracture
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
1
num At Risk
74
num Events
1
term
Thoracic vertebral fracture
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
1
num At Risk
74
num Events
1
term
Weight decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
3
num At Risk
74
num Events
3
term
Atrial fibrillation

time Frame

From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).

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

Preserved source evidence · Not medical advice