NCT01999335 · ADVERSE EVENTS

Adverse events

A Study of Oprozomib, Pomalidomide, and Dexamethasone in Adults With Primary Refractory or Relapsed and Refractory Multiple Myeloma · Source last updated 2021-04-27

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: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
Other-event reporting threshold: 5%

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

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Oprozomib 150 mg 5/14 + Pomalidomide 4 mg + Dexamethasone Participants received oprozomib 150 mg once daily on days 1 to 5 and days 15 to 19 (5/14 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg/day on days 1 to 21 and dexamethasone 20 mg on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.	0 / 3	3 / 3	1 / 3
Oprozomib 150 mg 5/14 + Pomalidomide 2 mg + Dexamethasone Participants received oprozomib 150 mg once daily on days 1 to 5 and days 15 to 19 (5/14 schedule) of each 28-day treatment cycle, in combination with pomalidomide 2 mg/day on days 1 to 21 and dexamethasone 20 mg on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.	1 / 1	1 / 1	0 / 1
Oprozomib 210 mg 2/7 + Pomalidomide 4 mg + Dexamethasone Participants received oprozomib 210 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.	3 / 7	7 / 7	4 / 7
Oprozomib 240 mg 2/7 + Pomalidomide 4 mg + Dexamethasone Participants received oprozomib 240 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.	6 / 10	10 / 10	3 / 10
Oprozomib 210 mg 2/7 + Pomalidomide 4 mg + Dexamethasone: Expansion Phase Participants received oprozomib 210 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.	6 / 10	10 / 10	4 / 12

Group identifiers: EG000: Oprozomib 150 mg 5/14 + Pomalidomide 4 mg + Dexamethasone · EG001: Oprozomib 150 mg 5/14 + Pomalidomide 2 mg + Dexamethasone · EG002: Oprozomib 210 mg 2/7 + Pomalidomide 4 mg + Dexamethasone · EG003: Oprozomib 240 mg 2/7 + Pomalidomide 4 mg + Dexamethasone · EG004: Oprozomib 210 mg 2/7 + Pomalidomide 4 mg + Dexamethasone: Expansion Phase

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
3
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
3
num At Risk
10
term
FEBRILE NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
1
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
10
term
CARDIAC FAILURE CONGESTIVE
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
1
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
10
term
SUPRAVENTRICULAR TACHYCARDIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
1
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
10
term
GASTRIC HAEMORRHAGE
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
1
num At Risk
10
term
PYREXIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
1
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
10
term
ABSCESS JAW
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
1
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
10
term
CELLULITIS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
1
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
10
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
3
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
1
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
10
term
ORAL 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
3
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
1
num At Risk
10
term
PARAINFLUENZAE VIRUS 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
3
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
1
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
10
term
PLEURAL 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
3
group Id
EG001
num Affected
1
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
2
num At Risk
10
group Id
EG004
num Affected
2
num At Risk
10
term
PNEUMONIA

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
1
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
1
group Id
EG002
num Affected
3
num At Risk
7
group Id
EG003
num Affected
4
num At Risk
10
group Id
EG004
num Affected
7
num At Risk
10
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
3
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
1
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
10
term
HYPERCOAGULATION
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
3
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
1
num At Risk
10
term
INCREASED TENDENCY TO BRUISE
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
3
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
1
num At Risk
10
term
LEUKOCYTOSIS
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
3
group Id
EG001
num Affected
1
num At Risk
1
group Id
EG002
num Affected
1
num At Risk
7
group Id
EG003
num Affected
1
num At Risk
10
group Id
EG004
num Affected
3
num At Risk
10
term
LEUKOPENIA
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
3
group Id
EG001
num Affected
1
num At Risk
1
group Id
EG002
num Affected
3
num At Risk
7
group Id
EG003
num Affected
2
num At Risk
10
group Id
EG004
num Affected
3
num At Risk
10
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
3
group Id
EG001
num Affected
1
num At Risk
1
group Id
EG002
num Affected
1
num At Risk
7
group Id
EG003
num Affected
1
num At Risk
10
group Id
EG004
num Affected
6
num At Risk
10
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
3
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
1
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
10
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
3
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
1
num At Risk
10
term
PALPITATIONS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
1
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
10
term
SUPRAVENTRICULAR TACHYCARDIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
1
num At Risk
10
term
TACHYCARDIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
1
num At Risk
10
term
TINNITUS

Complete source fields

description

event Groups

deaths Num Affected
1
deaths Num At Risk
3
description
Participants received oprozomib 150 mg once daily on days 1 to 5 and days 15 to 19 (5/14 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg/day on days 1 to 21 and dexamethasone 20 mg on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
id
EG000
other Num Affected
3
other Num At Risk
3
serious Num Affected
0
serious Num At Risk
3
title
Oprozomib 150 mg 5/14 + Pomalidomide 4 mg + Dexamethasone
deaths Num Affected
0
deaths Num At Risk
1
description
Participants received oprozomib 150 mg once daily on days 1 to 5 and days 15 to 19 (5/14 schedule) of each 28-day treatment cycle, in combination with pomalidomide 2 mg/day on days 1 to 21 and dexamethasone 20 mg on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
id
EG001
other Num Affected
1
other Num At Risk
1
serious Num Affected
1
serious Num At Risk
1
title
Oprozomib 150 mg 5/14 + Pomalidomide 2 mg + Dexamethasone
deaths Num Affected
4
deaths Num At Risk
7
description
Participants received oprozomib 210 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
id
EG002
other Num Affected
7
other Num At Risk
7
serious Num Affected
3
serious Num At Risk
7
title
Oprozomib 210 mg 2/7 + Pomalidomide 4 mg + Dexamethasone
deaths Num Affected
3
deaths Num At Risk
10
description
Participants received oprozomib 240 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
id
EG003
other Num Affected
10
other Num At Risk
10
serious Num Affected
6
serious Num At Risk
10
title
Oprozomib 240 mg 2/7 + Pomalidomide 4 mg + Dexamethasone
deaths Num Affected
4
deaths Num At Risk
12
description
Participants received oprozomib 210 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
id
EG004
other Num Affected
10
other Num At Risk
10
serious Num Affected
6
serious Num At Risk
10
title
Oprozomib 210 mg 2/7 + Pomalidomide 4 mg + Dexamethasone: Expansion Phase

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
1
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
1
group Id
EG002
num Affected
3
num At Risk
7
group Id
EG003
num Affected
4
num At Risk
10
group Id
EG004
num Affected
7
num At Risk
10
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
3
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
1
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
10
term
HYPERCOAGULATION
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
3
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
1
num At Risk
10
term
INCREASED TENDENCY TO BRUISE
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
3
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
1
num At Risk
10
term
LEUKOCYTOSIS
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
3
group Id
EG001
num Affected
1
num At Risk
1
group Id
EG002
num Affected
1
num At Risk
7
group Id
EG003
num Affected
1
num At Risk
10
group Id
EG004
num Affected
3
num At Risk
10
term
LEUKOPENIA
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
3
group Id
EG001
num Affected
1
num At Risk
1
group Id
EG002
num Affected
3
num At Risk
7
group Id
EG003
num Affected
2
num At Risk
10
group Id
EG004
num Affected
3
num At Risk
10
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
3
group Id
EG001
num Affected
1
num At Risk
1
group Id
EG002
num Affected
1
num At Risk
7
group Id
EG003
num Affected
1
num At Risk
10
group Id
EG004
num Affected
6
num At Risk
10
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
3
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
1
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
10
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
3
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
1
num At Risk
10
term
PALPITATIONS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
1
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
10
term
SUPRAVENTRICULAR TACHYCARDIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
1
num At Risk
10
term
TACHYCARDIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
1
num At Risk
10
term
TINNITUS

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
3
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
3
num At Risk
10
term
FEBRILE NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
1
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
10
term
CARDIAC FAILURE CONGESTIVE
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
1
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
10
term
SUPRAVENTRICULAR TACHYCARDIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
1
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
10
term
GASTRIC HAEMORRHAGE
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
1
num At Risk
10
term
PYREXIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
1
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
10
term
ABSCESS JAW
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
1
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
10
term
CELLULITIS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
1
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
10
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
3
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
1
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
10
term
ORAL 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
3
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
1
num At Risk
10
term
PARAINFLUENZAE VIRUS 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
3
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
1
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
10
term
PLEURAL 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
3
group Id
EG001
num Affected
1
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
2
num At Risk
10
group Id
EG004
num Affected
2
num At Risk
10
term
PNEUMONIA

time Frame

All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.

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Preserved source evidence · Not medical advice