NCT01796470 · ADVERSE EVENTS

Adverse events

Entospletinib in Combination With Idelalisib in Adults With Relapsed or Refractory Hematologic Malignancies · Source last updated 2020-06-02

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: First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
Other-event reporting threshold: 5%

The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Entospletinib + Idelalisib CLL Participants with a documented diagnosis of chronic lymphocytic leukemia (CLL) were included in this arm. Participants were administered 4 dose combinations of entospletinib plus idelalisib tablets orally twice daily under fasted conditions (400 mg/100 mg for 2 weeks, if no dose limiting toxicity (DLT) occurred, increased dose to 600 mg/100 mg for 2 weeks, if no DLT occurred, increased dose to 800 mg/100 mg for 4 weeks, if no DLT occurred, increased dose to 800 mg/150 mg) for up to 6 months. After discontinuation of combination therapy and a washout period of 14-28 days, participants could continue to receive entospletinib 400 mg monotherapy for up to 18 months.	24 / 35	34 / 35	3 / 35
Entospletinib + Idelalisib iNHL: FL Participants with a documented diagnosis of indolent non-Hodgkin lymphoma (iNHL) with follicular lymphoma (FL) were included in this arm. Participants were administered 4 dose combinations of entospletinib plus idelalisib tablets orally twice daily under fasted conditions (400 mg/100 mg for 2 weeks, if no dose limiting toxicity (DLT) occurred, increased dose to 600 mg/100 mg for 2 weeks, if no DLT occurred, increased dose to 800 mg/100 mg for 4 weeks, if no DLT occurred increased dose to 800 mg/150 mg) for up to 6 months. After discontinuation of combination therapy and a washout period of 14-28 days, participants could continue to receive entospletinib 400 mg monotherapy for up to 18 months.	2 / 14	14 / 14	1 / 14
Entospletinib + Idelalisib DLBCL Participants with a documented diagnosis of diffuse large B-cell lymphoma (DLBCL) were included in this arm. Participants were administered 4 dose combinations of entospletinib plus idelalisib tablets orally twice daily under fasted conditions (400 mg/100 mg for 2 weeks, if no dose limiting toxicity (DLT) occurred ,increased dose to 600 mg/100 mg for 2 weeks, if no DLT occurred, increased dose to 800 mg/100 mg for 4 weeks, if no DLT occurred, increased dose to 800 mg/150 mg) for up to 6 months. After discontinuation of combination therapy and a washout period of 14-28 days, participants could continue to receive entospletinib 400 mg monotherapy for up to 18 months.	4 / 6	6 / 6	2 / 6
Entospletinib + Idelalisib MCL Participants with a documented diagnosis of mantle cell lymphoma (MCL) were included in this arm. Participants were administered 4 dose combinations of entospletinib plus idelalisib tablets orally twice daily under fasted conditions (400 mg/100 mg for 2 weeks, if no dose limiting toxicity (DLT) occurred, increased dose to 600 mg/100 mg for 2 weeks, if no DLT occurred, increased dose to 800 mg/100 mg for 4 weeks, if no DLT occurred, increased dose to 800 mg/150 mg) for up to 6 months. After discontinuation of combination therapy and a washout period of 14-28 days, participants could continue to receive entospletinib 400 mg monotherapy for up to 18 months.	2 / 3	3 / 3	2 / 3
Entospletinib + Idelalisib iNHL: Others Participants with a documented diagnosis of iNHL with other subtypes lymphoplasmacytic lymphoma (LPL)/Waldenstrom macroglobulinemia (WM), small lymphocytic lymphoma (SLL), and marginal zone lymphoma (MZL) were included in this arm. Participants were administered 4 dose combinations of entospletinib plus idelalisib tablets orally twice daily under fasted conditions (400 mg/100 mg for 2 weeks, if no dose limiting toxicity (DLT) increased to 600 mg/100 mg for 2 weeks, if no DLT increased to 800 mg/100 mg for 4 weeks, if no DLT increased to 800 mg/150 mg) for up to 6 months. After discontinuation of combination therapy and a washout period of 14-28 days, participants could continue to receive entospletinib 400 mg monotherapy for up to 18 months.	5 / 8	8 / 8	2 / 8

Group identifiers: EG000: Entospletinib + Idelalisib CLL · EG001: Entospletinib + Idelalisib iNHL: FL · EG002: Entospletinib + Idelalisib DLBCL · EG003: Entospletinib + Idelalisib MCL · EG004: Entospletinib + Idelalisib iNHL: Others

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 (17.1)
stats
group Id
EG000
num Affected
2
num At Risk
35
group Id
EG001
num Affected
0
num At Risk
14
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
2
num At Risk
8
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
0
num At Risk
35
group Id
EG001
num Affected
1
num At Risk
14
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
8
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
1
num At Risk
35
group Id
EG001
num Affected
0
num At Risk
14
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
8
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
1
num At Risk
35
group Id
EG001
num Affected
0
num At Risk
14
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
8
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
1
num At Risk
35
group Id
EG001
num Affected
0
num At Risk
14
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
8
term
Drug interaction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
1
num At Risk
35
group Id
EG001
num Affected
0
num At Risk
14
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
8
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
1
num At Risk
35
group Id
EG001
num Affected
0
num At Risk
14
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
8
term
Bacteraemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
1
num At Risk
35
group Id
EG001
num Affected
0
num At Risk
14
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
8
term
Bronchopulmonary aspergillosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
1
num At Risk
35
group Id
EG001
num Affected
0
num At Risk
14
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
8
term
Fungal infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
1
num At Risk
35
group Id
EG001
num Affected
1
num At Risk
14
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
1
num At Risk
3
group Id
EG004
num Affected
1
num At Risk
8
term
Lung infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
5
num At Risk
35
group Id
EG001
num Affected
0
num At Risk
14
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
8
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
1
num At Risk
35
group Id
EG001
num Affected
0
num At Risk
14
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
2
num At Risk
8
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 (17.1)
stats
group Id
EG000
num Affected
5
num At Risk
35
group Id
EG001
num Affected
0
num At Risk
14
group Id
EG002
num Affected
2
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
8
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
2
num At Risk
35
group Id
EG001
num Affected
0
num At Risk
14
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
8
term
Increased tendency to bruise
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
0
num At Risk
35
group Id
EG001
num Affected
0
num At Risk
14
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
1
num At Risk
8
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
1
num At Risk
35
group Id
EG001
num Affected
1
num At Risk
14
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
8
term
Lymphadenopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
0
num At Risk
35
group Id
EG001
num Affected
0
num At Risk
14
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
1
num At Risk
8
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
4
num At Risk
35
group Id
EG001
num Affected
0
num At Risk
14
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
1
num At Risk
8
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
0
num At Risk
35
group Id
EG001
num Affected
1
num At Risk
14
group Id
EG002
num Affected
1
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
1
num At Risk
8
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
3
num At Risk
35
group Id
EG001
num Affected
2
num At Risk
14
group Id
EG002
num Affected
1
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
1
num At Risk
8
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
0
num At Risk
35
group Id
EG001
num Affected
0
num At Risk
14
group Id
EG002
num Affected
1
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
8
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
3
num At Risk
35
group Id
EG001
num Affected
1
num At Risk
14
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
8
term
Palpitations
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
0
num At Risk
35
group Id
EG001
num Affected
0
num At Risk
14
group Id
EG002
num Affected
1
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
8
term
Supraventricular tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
0
num At Risk
35
group Id
EG001
num Affected
0
num At Risk
14
group Id
EG002
num Affected
1
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
8
term
Tachycardia

Complete source fields

description

The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).

event Groups

deaths Num Affected
3
deaths Num At Risk
35
description
Participants with a documented diagnosis of chronic lymphocytic leukemia (CLL) were included in this arm. Participants were administered 4 dose combinations of entospletinib plus idelalisib tablets orally twice daily under fasted conditions (400 mg/100 mg for 2 weeks, if no dose limiting toxicity (DLT) occurred, increased dose to 600 mg/100 mg for 2 weeks, if no DLT occurred, increased dose to 800 mg/100 mg for 4 weeks, if no DLT occurred, increased dose to 800 mg/150 mg) for up to 6 months. After discontinuation of combination therapy and a washout period of 14-28 days, participants could continue to receive entospletinib 400 mg monotherapy for up to 18 months.
id
EG000
other Num Affected
34
other Num At Risk
35
serious Num Affected
24
serious Num At Risk
35
title
Entospletinib + Idelalisib CLL
deaths Num Affected
1
deaths Num At Risk
14
description
Participants with a documented diagnosis of indolent non-Hodgkin lymphoma (iNHL) with follicular lymphoma (FL) were included in this arm. Participants were administered 4 dose combinations of entospletinib plus idelalisib tablets orally twice daily under fasted conditions (400 mg/100 mg for 2 weeks, if no dose limiting toxicity (DLT) occurred, increased dose to 600 mg/100 mg for 2 weeks, if no DLT occurred, increased dose to 800 mg/100 mg for 4 weeks, if no DLT occurred increased dose to 800 mg/150 mg) for up to 6 months. After discontinuation of combination therapy and a washout period of 14-28 days, participants could continue to receive entospletinib 400 mg monotherapy for up to 18 months.
id
EG001
other Num Affected
14
other Num At Risk
14
serious Num Affected
2
serious Num At Risk
14
title
Entospletinib + Idelalisib iNHL: FL
deaths Num Affected
2
deaths Num At Risk
6
description
Participants with a documented diagnosis of diffuse large B-cell lymphoma (DLBCL) were included in this arm. Participants were administered 4 dose combinations of entospletinib plus idelalisib tablets orally twice daily under fasted conditions (400 mg/100 mg for 2 weeks, if no dose limiting toxicity (DLT) occurred ,increased dose to 600 mg/100 mg for 2 weeks, if no DLT occurred, increased dose to 800 mg/100 mg for 4 weeks, if no DLT occurred, increased dose to 800 mg/150 mg) for up to 6 months. After discontinuation of combination therapy and a washout period of 14-28 days, participants could continue to receive entospletinib 400 mg monotherapy for up to 18 months.
id
EG002
other Num Affected
6
other Num At Risk
6
serious Num Affected
4
serious Num At Risk
6
title
Entospletinib + Idelalisib DLBCL
deaths Num Affected
2
deaths Num At Risk
3
description
Participants with a documented diagnosis of mantle cell lymphoma (MCL) were included in this arm. Participants were administered 4 dose combinations of entospletinib plus idelalisib tablets orally twice daily under fasted conditions (400 mg/100 mg for 2 weeks, if no dose limiting toxicity (DLT) occurred, increased dose to 600 mg/100 mg for 2 weeks, if no DLT occurred, increased dose to 800 mg/100 mg for 4 weeks, if no DLT occurred, increased dose to 800 mg/150 mg) for up to 6 months. After discontinuation of combination therapy and a washout period of 14-28 days, participants could continue to receive entospletinib 400 mg monotherapy for up to 18 months.
id
EG003
other Num Affected
3
other Num At Risk
3
serious Num Affected
2
serious Num At Risk
3
title
Entospletinib + Idelalisib MCL
deaths Num Affected
2
deaths Num At Risk
8
description
Participants with a documented diagnosis of iNHL with other subtypes lymphoplasmacytic lymphoma (LPL)/Waldenstrom macroglobulinemia (WM), small lymphocytic lymphoma (SLL), and marginal zone lymphoma (MZL) were included in this arm. Participants were administered 4 dose combinations of entospletinib plus idelalisib tablets orally twice daily under fasted conditions (400 mg/100 mg for 2 weeks, if no dose limiting toxicity (DLT) increased to 600 mg/100 mg for 2 weeks, if no DLT increased to 800 mg/100 mg for 4 weeks, if no DLT increased to 800 mg/150 mg) for up to 6 months. After discontinuation of combination therapy and a washout period of 14-28 days, participants could continue to receive entospletinib 400 mg monotherapy for up to 18 months.
id
EG004
other Num Affected
8
other Num At Risk
8
serious Num Affected
5
serious Num At Risk
8
title
Entospletinib + Idelalisib iNHL: Others

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
5
num At Risk
35
group Id
EG001
num Affected
0
num At Risk
14
group Id
EG002
num Affected
2
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
8
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
2
num At Risk
35
group Id
EG001
num Affected
0
num At Risk
14
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
8
term
Increased tendency to bruise
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
0
num At Risk
35
group Id
EG001
num Affected
0
num At Risk
14
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
1
num At Risk
8
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
1
num At Risk
35
group Id
EG001
num Affected
1
num At Risk
14
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
8
term
Lymphadenopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
0
num At Risk
35
group Id
EG001
num Affected
0
num At Risk
14
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
1
num At Risk
8
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
4
num At Risk
35
group Id
EG001
num Affected
0
num At Risk
14
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
1
num At Risk
8
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
0
num At Risk
35
group Id
EG001
num Affected
1
num At Risk
14
group Id
EG002
num Affected
1
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
1
num At Risk
8
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
3
num At Risk
35
group Id
EG001
num Affected
2
num At Risk
14
group Id
EG002
num Affected
1
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
1
num At Risk
8
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
0
num At Risk
35
group Id
EG001
num Affected
0
num At Risk
14
group Id
EG002
num Affected
1
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
8
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
3
num At Risk
35
group Id
EG001
num Affected
1
num At Risk
14
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
8
term
Palpitations
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
0
num At Risk
35
group Id
EG001
num Affected
0
num At Risk
14
group Id
EG002
num Affected
1
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
8
term
Supraventricular tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
0
num At Risk
35
group Id
EG001
num Affected
0
num At Risk
14
group Id
EG002
num Affected
1
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
8
term
Tachycardia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
2
num At Risk
35
group Id
EG001
num Affected
0
num At Risk
14
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
2
num At Risk
8
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
0
num At Risk
35
group Id
EG001
num Affected
1
num At Risk
14
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
8
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
1
num At Risk
35
group Id
EG001
num Affected
0
num At Risk
14
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
8
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
1
num At Risk
35
group Id
EG001
num Affected
0
num At Risk
14
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
8
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
1
num At Risk
35
group Id
EG001
num Affected
0
num At Risk
14
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
8
term
Drug interaction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
1
num At Risk
35
group Id
EG001
num Affected
0
num At Risk
14
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
8
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
1
num At Risk
35
group Id
EG001
num Affected
0
num At Risk
14
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
8
term
Bacteraemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
1
num At Risk
35
group Id
EG001
num Affected
0
num At Risk
14
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
8
term
Bronchopulmonary aspergillosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
1
num At Risk
35
group Id
EG001
num Affected
0
num At Risk
14
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
8
term
Fungal infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
1
num At Risk
35
group Id
EG001
num Affected
1
num At Risk
14
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
1
num At Risk
3
group Id
EG004
num Affected
1
num At Risk
8
term
Lung infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
5
num At Risk
35
group Id
EG001
num Affected
0
num At Risk
14
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
8
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
1
num At Risk
35
group Id
EG001
num Affected
0
num At Risk
14
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
2
num At Risk
8
term
Sepsis

time Frame

First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)

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

Preserved source evidence · Not medical advice