NCT01832727 · ADVERSE EVENTS

Adverse events

Phase 1b/2, Multicenter, Open-label Study of Oprozomib and Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma · Source last updated 2020-07-13

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: All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
Other-event reporting threshold: 5%

All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Cohort 180 mg 5/14 Schedule (Phase 1b) Oprozomib 180 mg treatment once daily for 5 consecutive days bimonthly (days 1, 2, 3, 4, and 5 of a 14-day cycle) with 20 mg dexamethasone once daily on days 1, 2, 8, and 9 (referred to as the 5/14 schedule). Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.	4 / 9	9 / 9	0 / 9
Cohort 210 mg 5/14 Schedule (Phase 1b) Oprozomib 210 mg treatment once daily for 5 consecutive days bimonthly (days 1, 2, 3, 4, and 5 of a 14-day cycle) with 20 mg dexamethasone once daily on days 1, 2, 8, and 9 (referred to as the 5/14 schedule). Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason. This was the first cohort to enroll participants into the 5/14 schedule. The Cohort Safety Review Committee (CSRC) reviewed safety data and made dose adjustments for oprozomib in 30 mg increments for all cohorts.	2 / 7	7 / 7	1 / 7
Cohort 150/180 mg 5/14 Schedule (Phase 1b) Oprozomib 150 mg once daily treatment for 5 consecutive days (days 1, 2, 3, 4, and 5 of a 14-day cycle) followed by a step-up in oprozomib once daily dose to 180 mg starting in cycle 2 and moving forward. Dexamethasone 20 mg once daily was administered on days 1, 2, 8, and 9 of each 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.	2 / 3	3 / 3	0 / 3
Cohort 210 mg 2/7 Schedule (Phase 1b) Oprozomib 210 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason. This was the first cohort to enroll participants into the 2/7 schedule. The Cohort Safety Review Committee (CSRC) reviewed safety data and made dose adjustments for oprozomib in 30 mg increments for all cohorts.	2 / 4	4 / 4	0 / 4
Cohort 240 mg 2/7 Schedule (Phase 1b) Oprozomib 240 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.	1 / 4	4 / 4	1 / 4
Cohort 270 mg 2/7 Schedule (Phase 1b) Oprozomib 270 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.	1 / 6	6 / 6	0 / 6
Cohort 300 mg 2/7 Schedule (Phase 1b) Oprozomib 300 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.	3 / 8	8 / 8	0 / 8
Cohort 330 mg 2/7 Schedule (Phase 1b) Oprozomib 330 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.	0 / 6	6 / 6	0 / 6
Phase 2 300 mg 2/7 Schedule The Cohort Safety Review Committee (CSRC) determined this dose as the recommended phase 2 dose (RP2D). Oprozomib 300 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14- day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.	9 / 18	18 / 18	0 / 18

Group identifiers: EG000: Cohort 180 mg 5/14 Schedule (Phase 1b) · EG001: Cohort 210 mg 5/14 Schedule (Phase 1b) · EG002: Cohort 150/180 mg 5/14 Schedule (Phase 1b) · EG003: Cohort 210 mg 2/7 Schedule (Phase 1b) · EG004: Cohort 240 mg 2/7 Schedule (Phase 1b) · EG005: Cohort 270 mg 2/7 Schedule (Phase 1b) · EG006: Cohort 300 mg 2/7 Schedule (Phase 1b) · EG007: Cohort 330 mg 2/7 Schedule (Phase 1b) · EG008: Phase 2 300 mg 2/7 Schedule

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 20.1
stats
group Id
EG000
num Affected
0
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
1
num At Risk
8
group Id
EG007
num Affected
0
num At Risk
6
group Id
EG008
num Affected
0
num At Risk
18
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
0
num At Risk
9
group Id
EG001
num Affected
1
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
1
num At Risk
8
group Id
EG007
num Affected
0
num At Risk
6
group Id
EG008
num Affected
1
num At Risk
18
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
0
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
1
num At Risk
8
group Id
EG007
num Affected
0
num At Risk
6
group Id
EG008
num Affected
1
num At Risk
18
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
8
group Id
EG007
num Affected
0
num At Risk
6
group Id
EG008
num Affected
1
num At Risk
18
term
Gastrointestinal haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
8
group Id
EG007
num Affected
0
num At Risk
6
group Id
EG008
num Affected
0
num At Risk
18
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
0
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
8
group Id
EG007
num Affected
0
num At Risk
6
group Id
EG008
num Affected
0
num At Risk
18
term
Oesophagitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
8
group Id
EG007
num Affected
0
num At Risk
6
group Id
EG008
num Affected
0
num At Risk
18
term
Non-cardiac chest pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
8
group Id
EG007
num Affected
0
num At Risk
6
group Id
EG008
num Affected
0
num At Risk
18
term
Clostridium difficile infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
0
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
1
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
8
group Id
EG007
num Affected
0
num At Risk
6
group Id
EG008
num Affected
0
num At Risk
18
term
Influenza
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
0
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
1
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
8
group Id
EG007
num Affected
0
num At Risk
6
group Id
EG008
num Affected
0
num At Risk
18
term
Meningitis aseptic
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
1
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
1
num At Risk
8
group Id
EG007
num Affected
0
num At Risk
6
group Id
EG008
num Affected
3
num At Risk
18
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
0
num At Risk
9
group Id
EG001
num Affected
1
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
1
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
8
group Id
EG007
num Affected
0
num At Risk
6
group Id
EG008
num Affected
0
num At Risk
18
term
Sepsis

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 20.1
stats
group Id
EG000
num Affected
3
num At Risk
9
group Id
EG001
num Affected
2
num At Risk
7
group Id
EG002
num Affected
1
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
4
group Id
EG004
num Affected
1
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
5
num At Risk
8
group Id
EG007
num Affected
3
num At Risk
6
group Id
EG008
num Affected
8
num At Risk
18
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
0
num At Risk
9
group Id
EG001
num Affected
1
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
8
group Id
EG007
num Affected
1
num At Risk
6
group Id
EG008
num Affected
0
num At Risk
18
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
1
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
1
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
8
group Id
EG007
num Affected
1
num At Risk
6
group Id
EG008
num Affected
0
num At Risk
18
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
0
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
8
group Id
EG007
num Affected
1
num At Risk
6
group Id
EG008
num Affected
0
num At Risk
18
term
Microcytic anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
1
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
1
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
8
group Id
EG007
num Affected
1
num At Risk
6
group Id
EG008
num Affected
0
num At Risk
18
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
2
num At Risk
7
group Id
EG002
num Affected
1
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
4
group Id
EG004
num Affected
1
num At Risk
4
group Id
EG005
num Affected
2
num At Risk
6
group Id
EG006
num Affected
3
num At Risk
8
group Id
EG007
num Affected
2
num At Risk
6
group Id
EG008
num Affected
4
num At Risk
18
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
0
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
8
group Id
EG007
num Affected
1
num At Risk
6
group Id
EG008
num Affected
0
num At Risk
18
term
Angina unstable
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
8
group Id
EG007
num Affected
0
num At Risk
6
group Id
EG008
num Affected
0
num At Risk
18
term
Arrhythmia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
8
group Id
EG007
num Affected
0
num At Risk
6
group Id
EG008
num Affected
0
num At Risk
18
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
0
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
8
group Id
EG007
num Affected
0
num At Risk
6
group Id
EG008
num Affected
1
num At Risk
18
term
Bundle branch block right
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
0
num At Risk
9
group Id
EG001
num Affected
1
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
8
group Id
EG007
num Affected
0
num At Risk
6
group Id
EG008
num Affected
0
num At Risk
18
term
Diastolic dysfunction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
0
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
1
num At Risk
8
group Id
EG007
num Affected
0
num At Risk
6
group Id
EG008
num Affected
1
num At Risk
18
term
Palpitations

Complete source fields

description

event Groups

deaths Num Affected
0
deaths Num At Risk
9
description
Oprozomib 180 mg treatment once daily for 5 consecutive days bimonthly (days 1, 2, 3, 4, and 5 of a 14-day cycle) with 20 mg dexamethasone once daily on days 1, 2, 8, and 9 (referred to as the 5/14 schedule). Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
id
EG000
other Num Affected
9
other Num At Risk
9
serious Num Affected
4
serious Num At Risk
9
title
Cohort 180 mg 5/14 Schedule (Phase 1b)
deaths Num Affected
1
deaths Num At Risk
7
description
Oprozomib 210 mg treatment once daily for 5 consecutive days bimonthly (days 1, 2, 3, 4, and 5 of a 14-day cycle) with 20 mg dexamethasone once daily on days 1, 2, 8, and 9 (referred to as the 5/14 schedule). Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason. This was the first cohort to enroll participants into the 5/14 schedule. The Cohort Safety Review Committee (CSRC) reviewed safety data and made dose adjustments for oprozomib in 30 mg increments for all cohorts.
id
EG001
other Num Affected
7
other Num At Risk
7
serious Num Affected
2
serious Num At Risk
7
title
Cohort 210 mg 5/14 Schedule (Phase 1b)
deaths Num Affected
0
deaths Num At Risk
3
description
Oprozomib 150 mg once daily treatment for 5 consecutive days (days 1, 2, 3, 4, and 5 of a 14-day cycle) followed by a step-up in oprozomib once daily dose to 180 mg starting in cycle 2 and moving forward. Dexamethasone 20 mg once daily was administered on days 1, 2, 8, and 9 of each 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
id
EG002
other Num Affected
3
other Num At Risk
3
serious Num Affected
2
serious Num At Risk
3
title
Cohort 150/180 mg 5/14 Schedule (Phase 1b)
deaths Num Affected
0
deaths Num At Risk
4
description
Oprozomib 210 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason. This was the first cohort to enroll participants into the 2/7 schedule. The Cohort Safety Review Committee (CSRC) reviewed safety data and made dose adjustments for oprozomib in 30 mg increments for all cohorts.
id
EG003
other Num Affected
4
other Num At Risk
4
serious Num Affected
2
serious Num At Risk
4
title
Cohort 210 mg 2/7 Schedule (Phase 1b)
deaths Num Affected
1
deaths Num At Risk
4
description
Oprozomib 240 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
id
EG004
other Num Affected
4
other Num At Risk
4
serious Num Affected
1
serious Num At Risk
4
title
Cohort 240 mg 2/7 Schedule (Phase 1b)
deaths Num Affected
0
deaths Num At Risk
6
description
Oprozomib 270 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
id
EG005
other Num Affected
6
other Num At Risk
6
serious Num Affected
1
serious Num At Risk
6
title
Cohort 270 mg 2/7 Schedule (Phase 1b)
deaths Num Affected
0
deaths Num At Risk
8
description
Oprozomib 300 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
id
EG006
other Num Affected
8
other Num At Risk
8
serious Num Affected
3
serious Num At Risk
8
title
Cohort 300 mg 2/7 Schedule (Phase 1b)
deaths Num Affected
0
deaths Num At Risk
6
description
Oprozomib 330 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
id
EG007
other Num Affected
6
other Num At Risk
6
serious Num Affected
0
serious Num At Risk
6
title
Cohort 330 mg 2/7 Schedule (Phase 1b)
deaths Num Affected
0
deaths Num At Risk
18
description
The Cohort Safety Review Committee (CSRC) determined this dose as the recommended phase 2 dose (RP2D). Oprozomib 300 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14- day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
id
EG008
other Num Affected
18
other Num At Risk
18
serious Num Affected
9
serious Num At Risk
18
title
Phase 2 300 mg 2/7 Schedule

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
3
num At Risk
9
group Id
EG001
num Affected
2
num At Risk
7
group Id
EG002
num Affected
1
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
4
group Id
EG004
num Affected
1
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
5
num At Risk
8
group Id
EG007
num Affected
3
num At Risk
6
group Id
EG008
num Affected
8
num At Risk
18
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
0
num At Risk
9
group Id
EG001
num Affected
1
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
8
group Id
EG007
num Affected
1
num At Risk
6
group Id
EG008
num Affected
0
num At Risk
18
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
1
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
1
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
8
group Id
EG007
num Affected
1
num At Risk
6
group Id
EG008
num Affected
0
num At Risk
18
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
0
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
8
group Id
EG007
num Affected
1
num At Risk
6
group Id
EG008
num Affected
0
num At Risk
18
term
Microcytic anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
1
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
1
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
8
group Id
EG007
num Affected
1
num At Risk
6
group Id
EG008
num Affected
0
num At Risk
18
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
2
num At Risk
7
group Id
EG002
num Affected
1
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
4
group Id
EG004
num Affected
1
num At Risk
4
group Id
EG005
num Affected
2
num At Risk
6
group Id
EG006
num Affected
3
num At Risk
8
group Id
EG007
num Affected
2
num At Risk
6
group Id
EG008
num Affected
4
num At Risk
18
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
0
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
8
group Id
EG007
num Affected
1
num At Risk
6
group Id
EG008
num Affected
0
num At Risk
18
term
Angina unstable
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
8
group Id
EG007
num Affected
0
num At Risk
6
group Id
EG008
num Affected
0
num At Risk
18
term
Arrhythmia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
8
group Id
EG007
num Affected
0
num At Risk
6
group Id
EG008
num Affected
0
num At Risk
18
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
0
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
8
group Id
EG007
num Affected
0
num At Risk
6
group Id
EG008
num Affected
1
num At Risk
18
term
Bundle branch block right
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
0
num At Risk
9
group Id
EG001
num Affected
1
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
8
group Id
EG007
num Affected
0
num At Risk
6
group Id
EG008
num Affected
0
num At Risk
18
term
Diastolic dysfunction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
0
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
1
num At Risk
8
group Id
EG007
num Affected
0
num At Risk
6
group Id
EG008
num Affected
1
num At Risk
18
term
Palpitations

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
0
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
1
num At Risk
8
group Id
EG007
num Affected
0
num At Risk
6
group Id
EG008
num Affected
0
num At Risk
18
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
0
num At Risk
9
group Id
EG001
num Affected
1
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
1
num At Risk
8
group Id
EG007
num Affected
0
num At Risk
6
group Id
EG008
num Affected
1
num At Risk
18
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
0
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
1
num At Risk
8
group Id
EG007
num Affected
0
num At Risk
6
group Id
EG008
num Affected
1
num At Risk
18
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
8
group Id
EG007
num Affected
0
num At Risk
6
group Id
EG008
num Affected
1
num At Risk
18
term
Gastrointestinal haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
8
group Id
EG007
num Affected
0
num At Risk
6
group Id
EG008
num Affected
0
num At Risk
18
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
0
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
8
group Id
EG007
num Affected
0
num At Risk
6
group Id
EG008
num Affected
0
num At Risk
18
term
Oesophagitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
8
group Id
EG007
num Affected
0
num At Risk
6
group Id
EG008
num Affected
0
num At Risk
18
term
Non-cardiac chest pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
8
group Id
EG007
num Affected
0
num At Risk
6
group Id
EG008
num Affected
0
num At Risk
18
term
Clostridium difficile infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
0
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
1
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
8
group Id
EG007
num Affected
0
num At Risk
6
group Id
EG008
num Affected
0
num At Risk
18
term
Influenza
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
0
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
1
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
8
group Id
EG007
num Affected
0
num At Risk
6
group Id
EG008
num Affected
0
num At Risk
18
term
Meningitis aseptic
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
1
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
1
num At Risk
8
group Id
EG007
num Affected
0
num At Risk
6
group Id
EG008
num Affected
3
num At Risk
18
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
0
num At Risk
9
group Id
EG001
num Affected
1
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
1
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
8
group Id
EG007
num Affected
0
num At Risk
6
group Id
EG008
num Affected
0
num At Risk
18
term
Sepsis

time Frame

All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282

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

Preserved source evidence · Not medical advice