NCT02939183 · ADVERSE EVENTS

Adverse events

Phase 1b Study Evaluating OPomD in Relapsed or Refractory Multiple Myeloma · Source last updated 2024-09-26

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: Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Other-event reporting threshold: 5%

Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Oprozomib IR 150 mg/Day + Dexamethsone In Part 1, participants received oprozomib IR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months.	2 / 5	4 / 5	0 / 5
Oprozomib GR 150 mg/Day + Dexamethasone In Part 1, participants received oprozomib GR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months.	2 / 8	8 / 8	0 / 8
Oprozomib IR 150 mg/Day + Pomalidomide + Dexamethasone In Part 2, participants received oprozomib IR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months. Participants also received pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.	2 / 4	4 / 4	1 / 3
Oprozomib GR 150 mg/Day + Pomalidomide + Dexamethasone In Part 2, participants received oprozomib GR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months. Participants also received pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.	4 / 4	4 / 4	0 / 5
Oprozomib IR 200 mg/Day + Pomalidomide + Dexamethasone In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 200 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.	6 / 8	8 / 8	0 / 9
Oprozomib GR 200 mg/Day + Pomalidomide + Dexamethasone In Part 2, participants received oprozomib GR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib GR 200 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.	5 / 5	5 / 5	2 / 5
Oprozomib IR 225 mg/Day + Pomalidomide + Dexamethasone In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 225 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.	3 / 10	10 / 10	1 / 11
Oprozomib IR 250 mg/Day + Pomalidomide + Dexamethasone In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 250 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle	4 / 8	8 / 8	0 / 8
Open-label Roll-over Eligible participants who had enrolled on separate Amgen oprozomib studies (2011-001 \[NCT01416428\], 2012-001 \[NCT01832727\], OPZ003 \[NCT01881789\], OPZ007 \[NCT01999335\], and OPZ009 \[NCT02244112\]) and were receiving oprozomib as monotherapy, or a combination of oprozomib with dexamethasone, continued treatment in research centers within the United States only. Participants continued receiving the previous dose/schedule of oprozomib GR formulation until disease progression, death, or unacceptable toxicity.	4 / 7	7 / 7	0 / 7

Group identifiers: EG000: Oprozomib IR 150 mg/Day + Dexamethsone · EG001: Oprozomib GR 150 mg/Day + Dexamethasone · EG002: Oprozomib IR 150 mg/Day + Pomalidomide + Dexamethasone · EG003: Oprozomib GR 150 mg/Day + Pomalidomide + Dexamethasone · EG004: Oprozomib IR 200 mg/Day + Pomalidomide + Dexamethasone · EG005: Oprozomib GR 200 mg/Day + Pomalidomide + Dexamethasone · EG006: Oprozomib IR 225 mg/Day + Pomalidomide + Dexamethasone · EG007: Oprozomib IR 250 mg/Day + Pomalidomide + Dexamethasone · EG008: Open-label Roll-over

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
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
5
group Id
EG006
num Affected
1
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
7
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
1
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
5
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
7
term
Splenic infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
1
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
5
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
7
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
1
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
5
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
7
term
Ventricular tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
1
num At Risk
5
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
7
term
Eustachian tube dysfunction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
1
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
5
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
7
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
1
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
5
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
2
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
7
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
1
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
5
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
7
term
Gastritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
1
num At Risk
5
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
7
term
Gastrointestinal haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
5
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
1
num At Risk
7
term
Pancreatitis acute
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
1
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
5
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
7
term
Small intestinal obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
5
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
1
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
7
term
Vomiting

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 25.1
stats
group Id
EG000
num Affected
1
num At Risk
5
group Id
EG001
num Affected
2
num At Risk
8
group Id
EG002
num Affected
3
num At Risk
4
group Id
EG003
num Affected
1
num At Risk
4
group Id
EG004
num Affected
2
num At Risk
8
group Id
EG005
num Affected
2
num At Risk
5
group Id
EG006
num Affected
3
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
2
num At Risk
7
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
1
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
5
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
7
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
1
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
5
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
7
term
Haemolysis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
5
group Id
EG006
num Affected
1
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
7
term
Iron deficiency anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
5
group Id
EG006
num Affected
1
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
7
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
1
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
2
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
2
num At Risk
8
group Id
EG005
num Affected
1
num At Risk
5
group Id
EG006
num Affected
3
num At Risk
10
group Id
EG007
num Affected
1
num At Risk
8
group Id
EG008
num Affected
1
num At Risk
7
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
1
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
1
num At Risk
5
group Id
EG006
num Affected
2
num At Risk
10
group Id
EG007
num Affected
1
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
7
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
1
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
1
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
5
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
7
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
1
num At Risk
5
group Id
EG001
num Affected
1
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
1
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
5
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
1
num At Risk
7
term
Palpitations
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
1
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
5
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
7
term
Sinus bradycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
1
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
5
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
7
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
5
group Id
EG006
num Affected
1
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
7
term
Tachycardia

Complete source fields

description

event Groups

deaths Num Affected
0
deaths Num At Risk
5
description
In Part 1, participants received oprozomib IR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months.
id
EG000
other Num Affected
4
other Num At Risk
5
serious Num Affected
2
serious Num At Risk
5
title
Oprozomib IR 150 mg/Day + Dexamethsone
deaths Num Affected
0
deaths Num At Risk
8
description
In Part 1, participants received oprozomib GR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months.
id
EG001
other Num Affected
8
other Num At Risk
8
serious Num Affected
2
serious Num At Risk
8
title
Oprozomib GR 150 mg/Day + Dexamethasone
deaths Num Affected
1
deaths Num At Risk
3
description
In Part 2, participants received oprozomib IR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months. Participants also received pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
id
EG002
other Num Affected
4
other Num At Risk
4
serious Num Affected
2
serious Num At Risk
4
title
Oprozomib IR 150 mg/Day + Pomalidomide + Dexamethasone
deaths Num Affected
0
deaths Num At Risk
5
description
In Part 2, participants received oprozomib GR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months. Participants also received pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
id
EG003
other Num Affected
4
other Num At Risk
4
serious Num Affected
4
serious Num At Risk
4
title
Oprozomib GR 150 mg/Day + Pomalidomide + Dexamethasone
deaths Num Affected
0
deaths Num At Risk
9
description
In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 200 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
id
EG004
other Num Affected
8
other Num At Risk
8
serious Num Affected
6
serious Num At Risk
8
title
Oprozomib IR 200 mg/Day + Pomalidomide + Dexamethasone
deaths Num Affected
2
deaths Num At Risk
5
description
In Part 2, participants received oprozomib GR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib GR 200 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
id
EG005
other Num Affected
5
other Num At Risk
5
serious Num Affected
5
serious Num At Risk
5
title
Oprozomib GR 200 mg/Day + Pomalidomide + Dexamethasone
deaths Num Affected
1
deaths Num At Risk
11
description
In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 225 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
id
EG006
other Num Affected
10
other Num At Risk
10
serious Num Affected
3
serious Num At Risk
10
title
Oprozomib IR 225 mg/Day + Pomalidomide + Dexamethasone
deaths Num Affected
0
deaths Num At Risk
8
description
In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 250 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle
id
EG007
other Num Affected
8
other Num At Risk
8
serious Num Affected
4
serious Num At Risk
8
title
Oprozomib IR 250 mg/Day + Pomalidomide + Dexamethasone
deaths Num Affected
0
deaths Num At Risk
7
description
Eligible participants who had enrolled on separate Amgen oprozomib studies (2011-001 \[NCT01416428\], 2012-001 \[NCT01832727\], OPZ003 \[NCT01881789\], OPZ007 \[NCT01999335\], and OPZ009 \[NCT02244112\]) and were receiving oprozomib as monotherapy, or a combination of oprozomib with dexamethasone, continued treatment in research centers within the United States only. Participants continued receiving the previous dose/schedule of oprozomib GR formulation until disease progression, death, or unacceptable toxicity.
id
EG008
other Num Affected
7
other Num At Risk
7
serious Num Affected
4
serious Num At Risk
7
title
Open-label Roll-over

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
1
num At Risk
5
group Id
EG001
num Affected
2
num At Risk
8
group Id
EG002
num Affected
3
num At Risk
4
group Id
EG003
num Affected
1
num At Risk
4
group Id
EG004
num Affected
2
num At Risk
8
group Id
EG005
num Affected
2
num At Risk
5
group Id
EG006
num Affected
3
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
2
num At Risk
7
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
1
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
5
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
7
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
1
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
5
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
7
term
Haemolysis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
5
group Id
EG006
num Affected
1
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
7
term
Iron deficiency anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
5
group Id
EG006
num Affected
1
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
7
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
1
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
2
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
2
num At Risk
8
group Id
EG005
num Affected
1
num At Risk
5
group Id
EG006
num Affected
3
num At Risk
10
group Id
EG007
num Affected
1
num At Risk
8
group Id
EG008
num Affected
1
num At Risk
7
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
1
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
1
num At Risk
5
group Id
EG006
num Affected
2
num At Risk
10
group Id
EG007
num Affected
1
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
7
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
1
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
1
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
5
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
7
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
1
num At Risk
5
group Id
EG001
num Affected
1
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
1
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
5
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
1
num At Risk
7
term
Palpitations
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
1
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
5
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
7
term
Sinus bradycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
1
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
5
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
7
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
5
group Id
EG006
num Affected
1
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
7
term
Tachycardia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
5
group Id
EG006
num Affected
1
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
7
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
1
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
5
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
7
term
Splenic infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
1
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
5
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
7
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
1
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
5
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
7
term
Ventricular tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
1
num At Risk
5
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
7
term
Eustachian tube dysfunction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
1
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
5
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
7
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
1
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
5
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
2
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
7
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
1
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
5
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
7
term
Gastritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
1
num At Risk
5
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
7
term
Gastrointestinal haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
5
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
1
num At Risk
7
term
Pancreatitis acute
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
1
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
5
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
7
term
Small intestinal obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
5
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
1
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
7
term
Vomiting

time Frame

Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.

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

Preserved source evidence · Not medical advice