NCT01207440 · ADVERSE EVENTS

Adverse events

Ponatinib for Chronic Myeloid Leukemia (CML) Evaluation and Ph+ Acute Lymphoblastic Leukemia (ALL) · Source last updated 2021-02-02

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: SAEs and Other AEs: From first dose up to 30 days after last dose of the study drug (Up to approximately 49 months); All-Cause Mortality: Up to approximately 8 years
Other-event reporting threshold: 5%

At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Cohort A: CP-CML R-I CP-CML participants R-I to dasatinib or nilotinib were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).	132 / 203	203 / 203	41 / 203
Cohort B: CP-CML With T315I Mutation CP-CML participants who had T315I mutation of breakpoint cluster region-Abelson complex (BCR-ABL) were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).	39 / 64	64 / 64	18 / 64
Cohort C: AP-CML R-I AP-CML R-I to dasatinib or nilotinib were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).	44 / 65	65 / 65	30 / 65
Cohort D: AP-CML With T315I Mutation AP-CML participants who had T315I mutation of BCR-ABL were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).	13 / 18	18 / 18	9 / 18
Cohort E: BP-CML/Ph+ ALL R-I BP-CML or Ph+ ALL R-I to dasatinib or nilotinib or Ph+ ALL R-I to dasatinib or nilotinib were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).	41 / 48	48 / 48	40 / 48
Cohort F: BP-CML or Ph+ ALL With T315I Mutation BP-CML or Ph+ ALL participants who had T315I mutation of BCR-ABL were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).	37 / 46	46 / 46	39 / 46
Unassigned AP/CP-CML Participants who were not assigned to any of the cohorts and have no T315I mutation at study entry and were not R-I to dasatinib or nilotinib, administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).	3 / 5	5 / 5	2 / 5

Group identifiers: EG000: Cohort A: CP-CML R-I · EG001: Cohort B: CP-CML With T315I Mutation · EG002: Cohort C: AP-CML R-I · EG003: Cohort D: AP-CML With T315I Mutation · EG004: Cohort E: BP-CML/Ph+ ALL R-I · EG005: Cohort F: BP-CML or Ph+ ALL With T315I Mutation · EG006: Unassigned AP/CP-CML

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
Gastrointestinal disorders
source Vocabulary
MedDRA version 19.0
stats
group Id
EG000
num Affected
10
num At Risk
203
group Id
EG001
num Affected
4
num At Risk
64
group Id
EG002
num Affected
3
num At Risk
65
group Id
EG003
num Affected
0
num At Risk
18
group Id
EG004
num Affected
0
num At Risk
48
group Id
EG005
num Affected
0
num At Risk
46
group Id
EG006
num Affected
0
num At Risk
5
term
Pancreatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 19.0
stats
group Id
EG000
num Affected
7
num At Risk
203
group Id
EG001
num Affected
1
num At Risk
64
group Id
EG002
num Affected
4
num At Risk
65
group Id
EG003
num Affected
1
num At Risk
18
group Id
EG004
num Affected
4
num At Risk
48
group Id
EG005
num Affected
1
num At Risk
46
group Id
EG006
num Affected
0
num At Risk
5
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 19.0
stats
group Id
EG000
num Affected
3
num At Risk
203
group Id
EG001
num Affected
1
num At Risk
64
group Id
EG002
num Affected
1
num At Risk
65
group Id
EG003
num Affected
0
num At Risk
18
group Id
EG004
num Affected
0
num At Risk
48
group Id
EG005
num Affected
0
num At Risk
46
group Id
EG006
num Affected
0
num At Risk
5
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 19.0
stats
group Id
EG000
num Affected
1
num At Risk
203
group Id
EG001
num Affected
1
num At Risk
64
group Id
EG002
num Affected
1
num At Risk
65
group Id
EG003
num Affected
1
num At Risk
18
group Id
EG004
num Affected
1
num At Risk
48
group Id
EG005
num Affected
1
num At Risk
46
group Id
EG006
num Affected
0
num At Risk
5
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 19.0
stats
group Id
EG000
num Affected
2
num At Risk
203
group Id
EG001
num Affected
0
num At Risk
64
group Id
EG002
num Affected
1
num At Risk
65
group Id
EG003
num Affected
0
num At Risk
18
group Id
EG004
num Affected
0
num At Risk
48
group Id
EG005
num Affected
0
num At Risk
46
group Id
EG006
num Affected
0
num At Risk
5
term
Gastritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 19.0
stats
group Id
EG000
num Affected
0
num At Risk
203
group Id
EG001
num Affected
1
num At Risk
64
group Id
EG002
num Affected
1
num At Risk
65
group Id
EG003
num Affected
0
num At Risk
18
group Id
EG004
num Affected
2
num At Risk
48
group Id
EG005
num Affected
0
num At Risk
46
group Id
EG006
num Affected
0
num At Risk
5
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 19.0
stats
group Id
EG000
num Affected
2
num At Risk
203
group Id
EG001
num Affected
0
num At Risk
64
group Id
EG002
num Affected
0
num At Risk
65
group Id
EG003
num Affected
0
num At Risk
18
group Id
EG004
num Affected
0
num At Risk
48
group Id
EG005
num Affected
1
num At Risk
46
group Id
EG006
num Affected
0
num At Risk
5
term
Colitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 19.0
stats
group Id
EG000
num Affected
1
num At Risk
203
group Id
EG001
num Affected
0
num At Risk
64
group Id
EG002
num Affected
0
num At Risk
65
group Id
EG003
num Affected
0
num At Risk
18
group Id
EG004
num Affected
0
num At Risk
48
group Id
EG005
num Affected
0
num At Risk
46
group Id
EG006
num Affected
0
num At Risk
5
term
Hiatus hernia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 19.0
stats
group Id
EG000
num Affected
1
num At Risk
203
group Id
EG001
num Affected
0
num At Risk
64
group Id
EG002
num Affected
0
num At Risk
65
group Id
EG003
num Affected
0
num At Risk
18
group Id
EG004
num Affected
0
num At Risk
48
group Id
EG005
num Affected
0
num At Risk
46
group Id
EG006
num Affected
0
num At Risk
5
term
Ileus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 19.0
stats
group Id
EG000
num Affected
1
num At Risk
203
group Id
EG001
num Affected
0
num At Risk
64
group Id
EG002
num Affected
0
num At Risk
65
group Id
EG003
num Affected
0
num At Risk
18
group Id
EG004
num Affected
1
num At Risk
48
group Id
EG005
num Affected
0
num At Risk
46
group Id
EG006
num Affected
0
num At Risk
5
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 19.0
stats
group Id
EG000
num Affected
1
num At Risk
203
group Id
EG001
num Affected
0
num At Risk
64
group Id
EG002
num Affected
0
num At Risk
65
group Id
EG003
num Affected
0
num At Risk
18
group Id
EG004
num Affected
0
num At Risk
48
group Id
EG005
num Affected
0
num At Risk
46
group Id
EG006
num Affected
0
num At Risk
5
term
Oesophagitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 19.0
stats
group Id
EG000
num Affected
11
num At Risk
203
group Id
EG001
num Affected
4
num At Risk
64
group Id
EG002
num Affected
0
num At Risk
65
group Id
EG003
num Affected
0
num At Risk
18
group Id
EG004
num Affected
3
num At Risk
48
group Id
EG005
num Affected
2
num At Risk
46
group Id
EG006
num Affected
0
num At Risk
5
term
Atrial fibrillation

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 19.0
stats
group Id
EG000
num Affected
39
num At Risk
203
group Id
EG001
num Affected
7
num At Risk
64
group Id
EG002
num Affected
20
num At Risk
65
group Id
EG003
num Affected
7
num At Risk
18
group Id
EG004
num Affected
14
num At Risk
48
group Id
EG005
num Affected
11
num At Risk
46
group Id
EG006
num Affected
1
num At Risk
5
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 19.0
stats
group Id
EG000
num Affected
1
num At Risk
203
group Id
EG001
num Affected
1
num At Risk
64
group Id
EG002
num Affected
2
num At Risk
65
group Id
EG003
num Affected
0
num At Risk
18
group Id
EG004
num Affected
3
num At Risk
48
group Id
EG005
num Affected
3
num At Risk
46
group Id
EG006
num Affected
0
num At Risk
5
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 19.0
stats
group Id
EG000
num Affected
0
num At Risk
203
group Id
EG001
num Affected
0
num At Risk
64
group Id
EG002
num Affected
0
num At Risk
65
group Id
EG003
num Affected
1
num At Risk
18
group Id
EG004
num Affected
1
num At Risk
48
group Id
EG005
num Affected
0
num At Risk
46
group Id
EG006
num Affected
0
num At Risk
5
term
Hypochromasia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 19.0
stats
group Id
EG000
num Affected
7
num At Risk
203
group Id
EG001
num Affected
0
num At Risk
64
group Id
EG002
num Affected
5
num At Risk
65
group Id
EG003
num Affected
2
num At Risk
18
group Id
EG004
num Affected
0
num At Risk
48
group Id
EG005
num Affected
0
num At Risk
46
group Id
EG006
num Affected
0
num At Risk
5
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 19.0
stats
group Id
EG000
num Affected
6
num At Risk
203
group Id
EG001
num Affected
0
num At Risk
64
group Id
EG002
num Affected
2
num At Risk
65
group Id
EG003
num Affected
0
num At Risk
18
group Id
EG004
num Affected
0
num At Risk
48
group Id
EG005
num Affected
1
num At Risk
46
group Id
EG006
num Affected
1
num At Risk
5
term
Lymphadenopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 19.0
stats
group Id
EG000
num Affected
42
num At Risk
203
group Id
EG001
num Affected
6
num At Risk
64
group Id
EG002
num Affected
24
num At Risk
65
group Id
EG003
num Affected
4
num At Risk
18
group Id
EG004
num Affected
13
num At Risk
48
group Id
EG005
num Affected
7
num At Risk
46
group Id
EG006
num Affected
0
num At Risk
5
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 19.0
stats
group Id
EG000
num Affected
90
num At Risk
203
group Id
EG001
num Affected
18
num At Risk
64
group Id
EG002
num Affected
32
num At Risk
65
group Id
EG003
num Affected
4
num At Risk
18
group Id
EG004
num Affected
16
num At Risk
48
group Id
EG005
num Affected
7
num At Risk
46
group Id
EG006
num Affected
1
num At Risk
5
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 19.0
stats
group Id
EG000
num Affected
9
num At Risk
203
group Id
EG001
num Affected
4
num At Risk
64
group Id
EG002
num Affected
3
num At Risk
65
group Id
EG003
num Affected
0
num At Risk
18
group Id
EG004
num Affected
3
num At Risk
48
group Id
EG005
num Affected
0
num At Risk
46
group Id
EG006
num Affected
0
num At Risk
5
term
Angina pectoris
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 19.0
stats
group Id
EG000
num Affected
10
num At Risk
203
group Id
EG001
num Affected
3
num At Risk
64
group Id
EG002
num Affected
1
num At Risk
65
group Id
EG003
num Affected
0
num At Risk
18
group Id
EG004
num Affected
2
num At Risk
48
group Id
EG005
num Affected
4
num At Risk
46
group Id
EG006
num Affected
1
num At Risk
5
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 19.0
stats
group Id
EG000
num Affected
1
num At Risk
203
group Id
EG001
num Affected
1
num At Risk
64
group Id
EG002
num Affected
1
num At Risk
65
group Id
EG003
num Affected
0
num At Risk
18
group Id
EG004
num Affected
0
num At Risk
48
group Id
EG005
num Affected
0
num At Risk
46
group Id
EG006
num Affected
1
num At Risk
5
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 19.0
stats
group Id
EG000
num Affected
0
num At Risk
203
group Id
EG001
num Affected
0
num At Risk
64
group Id
EG002
num Affected
0
num At Risk
65
group Id
EG003
num Affected
0
num At Risk
18
group Id
EG004
num Affected
3
num At Risk
48
group Id
EG005
num Affected
0
num At Risk
46
group Id
EG006
num Affected
0
num At Risk
5
term
Cardiomyopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 19.0
stats
group Id
EG000
num Affected
6
num At Risk
203
group Id
EG001
num Affected
1
num At Risk
64
group Id
EG002
num Affected
2
num At Risk
65
group Id
EG003
num Affected
1
num At Risk
18
group Id
EG004
num Affected
1
num At Risk
48
group Id
EG005
num Affected
0
num At Risk
46
group Id
EG006
num Affected
0
num At Risk
5
term
Palpitations

Complete source fields

description

event Groups

deaths Num Affected
41
deaths Num At Risk
203
description
CP-CML participants R-I to dasatinib or nilotinib were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
id
EG000
other Num Affected
203
other Num At Risk
203
serious Num Affected
132
serious Num At Risk
203
title
Cohort A: CP-CML R-I
deaths Num Affected
18
deaths Num At Risk
64
description
CP-CML participants who had T315I mutation of breakpoint cluster region-Abelson complex (BCR-ABL) were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
id
EG001
other Num Affected
64
other Num At Risk
64
serious Num Affected
39
serious Num At Risk
64
title
Cohort B: CP-CML With T315I Mutation
deaths Num Affected
30
deaths Num At Risk
65
description
AP-CML R-I to dasatinib or nilotinib were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
id
EG002
other Num Affected
65
other Num At Risk
65
serious Num Affected
44
serious Num At Risk
65
title
Cohort C: AP-CML R-I
deaths Num Affected
9
deaths Num At Risk
18
description
AP-CML participants who had T315I mutation of BCR-ABL were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
id
EG003
other Num Affected
18
other Num At Risk
18
serious Num Affected
13
serious Num At Risk
18
title
Cohort D: AP-CML With T315I Mutation
deaths Num Affected
40
deaths Num At Risk
48
description
BP-CML or Ph+ ALL R-I to dasatinib or nilotinib or Ph+ ALL R-I to dasatinib or nilotinib were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
id
EG004
other Num Affected
48
other Num At Risk
48
serious Num Affected
41
serious Num At Risk
48
title
Cohort E: BP-CML/Ph+ ALL R-I
deaths Num Affected
39
deaths Num At Risk
46
description
BP-CML or Ph+ ALL participants who had T315I mutation of BCR-ABL were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
id
EG005
other Num Affected
46
other Num At Risk
46
serious Num Affected
37
serious Num At Risk
46
title
Cohort F: BP-CML or Ph+ ALL With T315I Mutation
deaths Num Affected
2
deaths Num At Risk
5
description
Participants who were not assigned to any of the cohorts and have no T315I mutation at study entry and were not R-I to dasatinib or nilotinib, administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
id
EG006
other Num Affected
5
other Num At Risk
5
serious Num Affected
3
serious Num At Risk
5
title
Unassigned AP/CP-CML

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 19.0
stats
group Id
EG000
num Affected
39
num At Risk
203
group Id
EG001
num Affected
7
num At Risk
64
group Id
EG002
num Affected
20
num At Risk
65
group Id
EG003
num Affected
7
num At Risk
18
group Id
EG004
num Affected
14
num At Risk
48
group Id
EG005
num Affected
11
num At Risk
46
group Id
EG006
num Affected
1
num At Risk
5
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 19.0
stats
group Id
EG000
num Affected
1
num At Risk
203
group Id
EG001
num Affected
1
num At Risk
64
group Id
EG002
num Affected
2
num At Risk
65
group Id
EG003
num Affected
0
num At Risk
18
group Id
EG004
num Affected
3
num At Risk
48
group Id
EG005
num Affected
3
num At Risk
46
group Id
EG006
num Affected
0
num At Risk
5
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 19.0
stats
group Id
EG000
num Affected
0
num At Risk
203
group Id
EG001
num Affected
0
num At Risk
64
group Id
EG002
num Affected
0
num At Risk
65
group Id
EG003
num Affected
1
num At Risk
18
group Id
EG004
num Affected
1
num At Risk
48
group Id
EG005
num Affected
0
num At Risk
46
group Id
EG006
num Affected
0
num At Risk
5
term
Hypochromasia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 19.0
stats
group Id
EG000
num Affected
7
num At Risk
203
group Id
EG001
num Affected
0
num At Risk
64
group Id
EG002
num Affected
5
num At Risk
65
group Id
EG003
num Affected
2
num At Risk
18
group Id
EG004
num Affected
0
num At Risk
48
group Id
EG005
num Affected
0
num At Risk
46
group Id
EG006
num Affected
0
num At Risk
5
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 19.0
stats
group Id
EG000
num Affected
6
num At Risk
203
group Id
EG001
num Affected
0
num At Risk
64
group Id
EG002
num Affected
2
num At Risk
65
group Id
EG003
num Affected
0
num At Risk
18
group Id
EG004
num Affected
0
num At Risk
48
group Id
EG005
num Affected
1
num At Risk
46
group Id
EG006
num Affected
1
num At Risk
5
term
Lymphadenopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 19.0
stats
group Id
EG000
num Affected
42
num At Risk
203
group Id
EG001
num Affected
6
num At Risk
64
group Id
EG002
num Affected
24
num At Risk
65
group Id
EG003
num Affected
4
num At Risk
18
group Id
EG004
num Affected
13
num At Risk
48
group Id
EG005
num Affected
7
num At Risk
46
group Id
EG006
num Affected
0
num At Risk
5
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 19.0
stats
group Id
EG000
num Affected
90
num At Risk
203
group Id
EG001
num Affected
18
num At Risk
64
group Id
EG002
num Affected
32
num At Risk
65
group Id
EG003
num Affected
4
num At Risk
18
group Id
EG004
num Affected
16
num At Risk
48
group Id
EG005
num Affected
7
num At Risk
46
group Id
EG006
num Affected
1
num At Risk
5
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 19.0
stats
group Id
EG000
num Affected
9
num At Risk
203
group Id
EG001
num Affected
4
num At Risk
64
group Id
EG002
num Affected
3
num At Risk
65
group Id
EG003
num Affected
0
num At Risk
18
group Id
EG004
num Affected
3
num At Risk
48
group Id
EG005
num Affected
0
num At Risk
46
group Id
EG006
num Affected
0
num At Risk
5
term
Angina pectoris
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 19.0
stats
group Id
EG000
num Affected
10
num At Risk
203
group Id
EG001
num Affected
3
num At Risk
64
group Id
EG002
num Affected
1
num At Risk
65
group Id
EG003
num Affected
0
num At Risk
18
group Id
EG004
num Affected
2
num At Risk
48
group Id
EG005
num Affected
4
num At Risk
46
group Id
EG006
num Affected
1
num At Risk
5
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 19.0
stats
group Id
EG000
num Affected
1
num At Risk
203
group Id
EG001
num Affected
1
num At Risk
64
group Id
EG002
num Affected
1
num At Risk
65
group Id
EG003
num Affected
0
num At Risk
18
group Id
EG004
num Affected
0
num At Risk
48
group Id
EG005
num Affected
0
num At Risk
46
group Id
EG006
num Affected
1
num At Risk
5
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 19.0
stats
group Id
EG000
num Affected
0
num At Risk
203
group Id
EG001
num Affected
0
num At Risk
64
group Id
EG002
num Affected
0
num At Risk
65
group Id
EG003
num Affected
0
num At Risk
18
group Id
EG004
num Affected
3
num At Risk
48
group Id
EG005
num Affected
0
num At Risk
46
group Id
EG006
num Affected
0
num At Risk
5
term
Cardiomyopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 19.0
stats
group Id
EG000
num Affected
6
num At Risk
203
group Id
EG001
num Affected
1
num At Risk
64
group Id
EG002
num Affected
2
num At Risk
65
group Id
EG003
num Affected
1
num At Risk
18
group Id
EG004
num Affected
1
num At Risk
48
group Id
EG005
num Affected
0
num At Risk
46
group Id
EG006
num Affected
0
num At Risk
5
term
Palpitations

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 19.0
stats
group Id
EG000
num Affected
10
num At Risk
203
group Id
EG001
num Affected
4
num At Risk
64
group Id
EG002
num Affected
3
num At Risk
65
group Id
EG003
num Affected
0
num At Risk
18
group Id
EG004
num Affected
0
num At Risk
48
group Id
EG005
num Affected
0
num At Risk
46
group Id
EG006
num Affected
0
num At Risk
5
term
Pancreatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 19.0
stats
group Id
EG000
num Affected
7
num At Risk
203
group Id
EG001
num Affected
1
num At Risk
64
group Id
EG002
num Affected
4
num At Risk
65
group Id
EG003
num Affected
1
num At Risk
18
group Id
EG004
num Affected
4
num At Risk
48
group Id
EG005
num Affected
1
num At Risk
46
group Id
EG006
num Affected
0
num At Risk
5
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 19.0
stats
group Id
EG000
num Affected
3
num At Risk
203
group Id
EG001
num Affected
1
num At Risk
64
group Id
EG002
num Affected
1
num At Risk
65
group Id
EG003
num Affected
0
num At Risk
18
group Id
EG004
num Affected
0
num At Risk
48
group Id
EG005
num Affected
0
num At Risk
46
group Id
EG006
num Affected
0
num At Risk
5
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 19.0
stats
group Id
EG000
num Affected
1
num At Risk
203
group Id
EG001
num Affected
1
num At Risk
64
group Id
EG002
num Affected
1
num At Risk
65
group Id
EG003
num Affected
1
num At Risk
18
group Id
EG004
num Affected
1
num At Risk
48
group Id
EG005
num Affected
1
num At Risk
46
group Id
EG006
num Affected
0
num At Risk
5
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 19.0
stats
group Id
EG000
num Affected
2
num At Risk
203
group Id
EG001
num Affected
0
num At Risk
64
group Id
EG002
num Affected
1
num At Risk
65
group Id
EG003
num Affected
0
num At Risk
18
group Id
EG004
num Affected
0
num At Risk
48
group Id
EG005
num Affected
0
num At Risk
46
group Id
EG006
num Affected
0
num At Risk
5
term
Gastritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 19.0
stats
group Id
EG000
num Affected
0
num At Risk
203
group Id
EG001
num Affected
1
num At Risk
64
group Id
EG002
num Affected
1
num At Risk
65
group Id
EG003
num Affected
0
num At Risk
18
group Id
EG004
num Affected
2
num At Risk
48
group Id
EG005
num Affected
0
num At Risk
46
group Id
EG006
num Affected
0
num At Risk
5
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 19.0
stats
group Id
EG000
num Affected
2
num At Risk
203
group Id
EG001
num Affected
0
num At Risk
64
group Id
EG002
num Affected
0
num At Risk
65
group Id
EG003
num Affected
0
num At Risk
18
group Id
EG004
num Affected
0
num At Risk
48
group Id
EG005
num Affected
1
num At Risk
46
group Id
EG006
num Affected
0
num At Risk
5
term
Colitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 19.0
stats
group Id
EG000
num Affected
1
num At Risk
203
group Id
EG001
num Affected
0
num At Risk
64
group Id
EG002
num Affected
0
num At Risk
65
group Id
EG003
num Affected
0
num At Risk
18
group Id
EG004
num Affected
0
num At Risk
48
group Id
EG005
num Affected
0
num At Risk
46
group Id
EG006
num Affected
0
num At Risk
5
term
Hiatus hernia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 19.0
stats
group Id
EG000
num Affected
1
num At Risk
203
group Id
EG001
num Affected
0
num At Risk
64
group Id
EG002
num Affected
0
num At Risk
65
group Id
EG003
num Affected
0
num At Risk
18
group Id
EG004
num Affected
0
num At Risk
48
group Id
EG005
num Affected
0
num At Risk
46
group Id
EG006
num Affected
0
num At Risk
5
term
Ileus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 19.0
stats
group Id
EG000
num Affected
1
num At Risk
203
group Id
EG001
num Affected
0
num At Risk
64
group Id
EG002
num Affected
0
num At Risk
65
group Id
EG003
num Affected
0
num At Risk
18
group Id
EG004
num Affected
1
num At Risk
48
group Id
EG005
num Affected
0
num At Risk
46
group Id
EG006
num Affected
0
num At Risk
5
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 19.0
stats
group Id
EG000
num Affected
1
num At Risk
203
group Id
EG001
num Affected
0
num At Risk
64
group Id
EG002
num Affected
0
num At Risk
65
group Id
EG003
num Affected
0
num At Risk
18
group Id
EG004
num Affected
0
num At Risk
48
group Id
EG005
num Affected
0
num At Risk
46
group Id
EG006
num Affected
0
num At Risk
5
term
Oesophagitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 19.0
stats
group Id
EG000
num Affected
11
num At Risk
203
group Id
EG001
num Affected
4
num At Risk
64
group Id
EG002
num Affected
0
num At Risk
65
group Id
EG003
num Affected
0
num At Risk
18
group Id
EG004
num Affected
3
num At Risk
48
group Id
EG005
num Affected
2
num At Risk
46
group Id
EG006
num Affected
0
num At Risk
5
term
Atrial fibrillation

time Frame

SAEs and Other AEs: From first dose up to 30 days after last dose of the study drug (Up to approximately 49 months); All-Cause Mortality: Up to approximately 8 years

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice