NCT01080131 · ADVERSE EVENTS

Adverse events

Canakinumab in the Treatment of Acute Gout Flares and Prevention of New Flares in Patients Unable to Use Non-steroidal Anti-inflammatory Drugs (NSAIDs) and/or Colchicines Including a 12 Week Extension and a 1 Year Open-label Extension Study. · Source last updated 2014-01-30

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: Not reported
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
All Canakinumab Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study, participants completing the 12 week core study could continue to be treated on demand with the same study treatment for an additional 12 weeks for any new gout flare. In the second extension study participants were to receive open-label on demand treatment with canakinumab 150 mg sc upon new flare for 1 year, for a total duration of 18 months.	12 / 112	42 / 112	Not reported / Not reported
Canakinumab: Before Retreatment Participants who received canakinumab in the core study and were re-treated with canakinumab during the core study or extension study 1 or 2. Reported data include adverse events that occurred in this re-treated population before re-treatment with canakinumab.	1 / 62	15 / 62	Not reported / Not reported
Canakinumab: After Retreatment Participants who received canakinumab in the core study and were re-treated with canakinumab during the core study or extension study 1 or 2. Reported data include adverse events that occurred in this re-treated population after re-treatment with canakinumab.	5 / 62	19 / 62	Not reported / Not reported
All Triamcinolone Acetonide Participants received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same study treatment another 12 weeks for any new gout flare. Reported data include all adverse events that occurred during the core study and extension studies 1 and 2, before participants were switched to canakinumab.	4 / 114	36 / 114	Not reported / Not reported
Triam: Before Switch to Canakinumab Participants who were treated with triamcinolone acetonide (triam) during the core study and extension study 1 and who were switched to open-label on demand treatment with canakinumab 150 mg sc upon new flare in extension study 2. Data are reported for adverse events that occurred before the switch to canakinumab.	0 / 41	15 / 41	Not reported / Not reported
Triam: After Switch to Canakinumab Participants who were treated with triamcinolone acetonide during the core study and extension study 1 and who were switched to open-label on demand treatment with canakinumab 150 mg sc upon new flare in extension study 2. Data are reported for adverse events that occurred after the switch to canakinumab.	3 / 41	8 / 41	Not reported / Not reported

Group identifiers: EG000: All Canakinumab · EG001: Canakinumab: Before Retreatment · EG002: Canakinumab: After Retreatment · EG003: All Triamcinolone Acetonide · EG004: Triam: Before Switch to Canakinumab · EG005: Triam: After Switch to Canakinumab

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
stats
group Id
EG000
num Affected
0
num At Risk
112
group Id
EG001
num Affected
0
num At Risk
62
group Id
EG002
num Affected
0
num At Risk
62
group Id
EG003
num Affected
0
num At Risk
114
group Id
EG004
num Affected
0
num At Risk
41
group Id
EG005
num Affected
1
num At Risk
41
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
0
num At Risk
112
group Id
EG001
num Affected
0
num At Risk
62
group Id
EG002
num Affected
0
num At Risk
62
group Id
EG003
num Affected
0
num At Risk
114
group Id
EG004
num Affected
0
num At Risk
41
group Id
EG005
num Affected
1
num At Risk
41
term
Haemorrhagic anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
112
group Id
EG001
num Affected
0
num At Risk
62
group Id
EG002
num Affected
1
num At Risk
62
group Id
EG003
num Affected
0
num At Risk
114
group Id
EG004
num Affected
0
num At Risk
41
group Id
EG005
num Affected
1
num At Risk
41
term
Angina pectoris
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
0
num At Risk
112
group Id
EG001
num Affected
0
num At Risk
62
group Id
EG002
num Affected
0
num At Risk
62
group Id
EG003
num Affected
1
num At Risk
114
group Id
EG004
num Affected
0
num At Risk
41
group Id
EG005
num Affected
0
num At Risk
41
term
Aortic valve incompetence
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
112
group Id
EG001
num Affected
0
num At Risk
62
group Id
EG002
num Affected
0
num At Risk
62
group Id
EG003
num Affected
0
num At Risk
114
group Id
EG004
num Affected
0
num At Risk
41
group Id
EG005
num Affected
0
num At Risk
41
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
0
num At Risk
112
group Id
EG001
num Affected
0
num At Risk
62
group Id
EG002
num Affected
0
num At Risk
62
group Id
EG003
num Affected
1
num At Risk
114
group Id
EG004
num Affected
0
num At Risk
41
group Id
EG005
num Affected
0
num At Risk
41
term
Cardiomyopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Congenital, familial and genetic disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
0
num At Risk
112
group Id
EG001
num Affected
0
num At Risk
62
group Id
EG002
num Affected
0
num At Risk
62
group Id
EG003
num Affected
1
num At Risk
114
group Id
EG004
num Affected
0
num At Risk
41
group Id
EG005
num Affected
0
num At Risk
41
term
Bicuspid aortic valve
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
0
num At Risk
112
group Id
EG001
num Affected
0
num At Risk
62
group Id
EG002
num Affected
0
num At Risk
62
group Id
EG003
num Affected
1
num At Risk
114
group Id
EG004
num Affected
0
num At Risk
41
group Id
EG005
num Affected
0
num At Risk
41
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
0
num At Risk
112
group Id
EG001
num Affected
0
num At Risk
62
group Id
EG002
num Affected
0
num At Risk
62
group Id
EG003
num Affected
0
num At Risk
114
group Id
EG004
num Affected
0
num At Risk
41
group Id
EG005
num Affected
1
num At Risk
41
term
Lower gastrointestinal haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
0
num At Risk
112
group Id
EG001
num Affected
0
num At Risk
62
group Id
EG002
num Affected
0
num At Risk
62
group Id
EG003
num Affected
1
num At Risk
114
group Id
EG004
num Affected
0
num At Risk
41
group Id
EG005
num Affected
0
num At Risk
41
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
112
group Id
EG001
num Affected
0
num At Risk
62
group Id
EG002
num Affected
0
num At Risk
62
group Id
EG003
num Affected
0
num At Risk
114
group Id
EG004
num Affected
0
num At Risk
41
group Id
EG005
num Affected
0
num At Risk
41
term
Pancreatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
0
num At Risk
112
group Id
EG001
num Affected
0
num At Risk
62
group Id
EG002
num Affected
0
num At Risk
62
group Id
EG003
num Affected
1
num At Risk
114
group Id
EG004
num Affected
0
num At Risk
41
group Id
EG005
num Affected
0
num At Risk
41
term
Vomiting

Other reported adverse events

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

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
3
num At Risk
112
group Id
EG001
num Affected
2
num At Risk
62
group Id
EG002
num Affected
1
num At Risk
62
group Id
EG003
num Affected
3
num At Risk
114
group Id
EG004
num Affected
1
num At Risk
41
group Id
EG005
num Affected
3
num At Risk
41
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
0
num At Risk
112
group Id
EG001
num Affected
0
num At Risk
62
group Id
EG002
num Affected
0
num At Risk
62
group Id
EG003
num Affected
5
num At Risk
114
group Id
EG004
num Affected
4
num At Risk
41
group Id
EG005
num Affected
2
num At Risk
41
term
Nasopharyngitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
9
num At Risk
112
group Id
EG001
num Affected
4
num At Risk
62
group Id
EG002
num Affected
7
num At Risk
62
group Id
EG003
num Affected
3
num At Risk
114
group Id
EG004
num Affected
1
num At Risk
41
group Id
EG005
num Affected
1
num At Risk
41
term
Upper respiratory tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
112
group Id
EG001
num Affected
0
num At Risk
62
group Id
EG002
num Affected
0
num At Risk
62
group Id
EG003
num Affected
3
num At Risk
114
group Id
EG004
num Affected
3
num At Risk
41
group Id
EG005
num Affected
3
num At Risk
41
term
Muscle strain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
8
num At Risk
112
group Id
EG001
num Affected
1
num At Risk
62
group Id
EG002
num Affected
5
num At Risk
62
group Id
EG003
num Affected
10
num At Risk
114
group Id
EG004
num Affected
3
num At Risk
41
group Id
EG005
num Affected
2
num At Risk
41
term
Arthralgia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
12
num At Risk
112
group Id
EG001
num Affected
2
num At Risk
62
group Id
EG002
num Affected
6
num At Risk
62
group Id
EG003
num Affected
2
num At Risk
114
group Id
EG004
num Affected
1
num At Risk
41
group Id
EG005
num Affected
0
num At Risk
41
term
Back pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
4
num At Risk
112
group Id
EG001
num Affected
2
num At Risk
62
group Id
EG002
num Affected
1
num At Risk
62
group Id
EG003
num Affected
7
num At Risk
114
group Id
EG004
num Affected
4
num At Risk
41
group Id
EG005
num Affected
0
num At Risk
41
term
Muscle spasms
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
2
num At Risk
112
group Id
EG001
num Affected
1
num At Risk
62
group Id
EG002
num Affected
0
num At Risk
62
group Id
EG003
num Affected
6
num At Risk
114
group Id
EG004
num Affected
4
num At Risk
41
group Id
EG005
num Affected
1
num At Risk
41
term
Pain in extremity
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
5
num At Risk
112
group Id
EG001
num Affected
3
num At Risk
62
group Id
EG002
num Affected
2
num At Risk
62
group Id
EG003
num Affected
6
num At Risk
114
group Id
EG004
num Affected
2
num At Risk
41
group Id
EG005
num Affected
1
num At Risk
41
term
Headache
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
14
num At Risk
112
group Id
EG001
num Affected
3
num At Risk
62
group Id
EG002
num Affected
7
num At Risk
62
group Id
EG003
num Affected
7
num At Risk
114
group Id
EG004
num Affected
2
num At Risk
41
group Id
EG005
num Affected
1
num At Risk
41
term
Hypertension

Complete source fields

event Groups

description
Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study, participants completing the 12 week core study could continue to be treated on demand with the same study treatment for an additional 12 weeks for any new gout flare. In the second extension study participants were to receive open-label on demand treatment with canakinumab 150 mg sc upon new flare for 1 year, for a total duration of 18 months.
id
EG000
other Num Affected
42
other Num At Risk
112
serious Num Affected
12
serious Num At Risk
112
title
All Canakinumab
description
Participants who received canakinumab in the core study and were re-treated with canakinumab during the core study or extension study 1 or 2. Reported data include adverse events that occurred in this re-treated population before re-treatment with canakinumab.
id
EG001
other Num Affected
15
other Num At Risk
62
serious Num Affected
1
serious Num At Risk
62
title
Canakinumab: Before Retreatment
description
Participants who received canakinumab in the core study and were re-treated with canakinumab during the core study or extension study 1 or 2. Reported data include adverse events that occurred in this re-treated population after re-treatment with canakinumab.
id
EG002
other Num Affected
19
other Num At Risk
62
serious Num Affected
5
serious Num At Risk
62
title
Canakinumab: After Retreatment
description
Participants received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same study treatment another 12 weeks for any new gout flare. Reported data include all adverse events that occurred during the core study and extension studies 1 and 2, before participants were switched to canakinumab.
id
EG003
other Num Affected
36
other Num At Risk
114
serious Num Affected
4
serious Num At Risk
114
title
All Triamcinolone Acetonide
description
Participants who were treated with triamcinolone acetonide (triam) during the core study and extension study 1 and who were switched to open-label on demand treatment with canakinumab 150 mg sc upon new flare in extension study 2. Data are reported for adverse events that occurred before the switch to canakinumab.
id
EG004
other Num Affected
15
other Num At Risk
41
serious Num Affected
0
serious Num At Risk
41
title
Triam: Before Switch to Canakinumab
description
Participants who were treated with triamcinolone acetonide during the core study and extension study 1 and who were switched to open-label on demand treatment with canakinumab 150 mg sc upon new flare in extension study 2. Data are reported for adverse events that occurred after the switch to canakinumab.
id
EG005
other Num Affected
8
other Num At Risk
41
serious Num Affected
3
serious Num At Risk
41
title
Triam: After Switch to Canakinumab

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
3
num At Risk
112
group Id
EG001
num Affected
2
num At Risk
62
group Id
EG002
num Affected
1
num At Risk
62
group Id
EG003
num Affected
3
num At Risk
114
group Id
EG004
num Affected
1
num At Risk
41
group Id
EG005
num Affected
3
num At Risk
41
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
0
num At Risk
112
group Id
EG001
num Affected
0
num At Risk
62
group Id
EG002
num Affected
0
num At Risk
62
group Id
EG003
num Affected
5
num At Risk
114
group Id
EG004
num Affected
4
num At Risk
41
group Id
EG005
num Affected
2
num At Risk
41
term
Nasopharyngitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
9
num At Risk
112
group Id
EG001
num Affected
4
num At Risk
62
group Id
EG002
num Affected
7
num At Risk
62
group Id
EG003
num Affected
3
num At Risk
114
group Id
EG004
num Affected
1
num At Risk
41
group Id
EG005
num Affected
1
num At Risk
41
term
Upper respiratory tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
112
group Id
EG001
num Affected
0
num At Risk
62
group Id
EG002
num Affected
0
num At Risk
62
group Id
EG003
num Affected
3
num At Risk
114
group Id
EG004
num Affected
3
num At Risk
41
group Id
EG005
num Affected
3
num At Risk
41
term
Muscle strain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
8
num At Risk
112
group Id
EG001
num Affected
1
num At Risk
62
group Id
EG002
num Affected
5
num At Risk
62
group Id
EG003
num Affected
10
num At Risk
114
group Id
EG004
num Affected
3
num At Risk
41
group Id
EG005
num Affected
2
num At Risk
41
term
Arthralgia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
12
num At Risk
112
group Id
EG001
num Affected
2
num At Risk
62
group Id
EG002
num Affected
6
num At Risk
62
group Id
EG003
num Affected
2
num At Risk
114
group Id
EG004
num Affected
1
num At Risk
41
group Id
EG005
num Affected
0
num At Risk
41
term
Back pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
4
num At Risk
112
group Id
EG001
num Affected
2
num At Risk
62
group Id
EG002
num Affected
1
num At Risk
62
group Id
EG003
num Affected
7
num At Risk
114
group Id
EG004
num Affected
4
num At Risk
41
group Id
EG005
num Affected
0
num At Risk
41
term
Muscle spasms
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
2
num At Risk
112
group Id
EG001
num Affected
1
num At Risk
62
group Id
EG002
num Affected
0
num At Risk
62
group Id
EG003
num Affected
6
num At Risk
114
group Id
EG004
num Affected
4
num At Risk
41
group Id
EG005
num Affected
1
num At Risk
41
term
Pain in extremity
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
5
num At Risk
112
group Id
EG001
num Affected
3
num At Risk
62
group Id
EG002
num Affected
2
num At Risk
62
group Id
EG003
num Affected
6
num At Risk
114
group Id
EG004
num Affected
2
num At Risk
41
group Id
EG005
num Affected
1
num At Risk
41
term
Headache
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
14
num At Risk
112
group Id
EG001
num Affected
3
num At Risk
62
group Id
EG002
num Affected
7
num At Risk
62
group Id
EG003
num Affected
7
num At Risk
114
group Id
EG004
num Affected
2
num At Risk
41
group Id
EG005
num Affected
1
num At Risk
41
term
Hypertension

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
0
num At Risk
112
group Id
EG001
num Affected
0
num At Risk
62
group Id
EG002
num Affected
0
num At Risk
62
group Id
EG003
num Affected
0
num At Risk
114
group Id
EG004
num Affected
0
num At Risk
41
group Id
EG005
num Affected
1
num At Risk
41
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
0
num At Risk
112
group Id
EG001
num Affected
0
num At Risk
62
group Id
EG002
num Affected
0
num At Risk
62
group Id
EG003
num Affected
0
num At Risk
114
group Id
EG004
num Affected
0
num At Risk
41
group Id
EG005
num Affected
1
num At Risk
41
term
Haemorrhagic anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
112
group Id
EG001
num Affected
0
num At Risk
62
group Id
EG002
num Affected
1
num At Risk
62
group Id
EG003
num Affected
0
num At Risk
114
group Id
EG004
num Affected
0
num At Risk
41
group Id
EG005
num Affected
1
num At Risk
41
term
Angina pectoris
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
0
num At Risk
112
group Id
EG001
num Affected
0
num At Risk
62
group Id
EG002
num Affected
0
num At Risk
62
group Id
EG003
num Affected
1
num At Risk
114
group Id
EG004
num Affected
0
num At Risk
41
group Id
EG005
num Affected
0
num At Risk
41
term
Aortic valve incompetence
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
112
group Id
EG001
num Affected
0
num At Risk
62
group Id
EG002
num Affected
0
num At Risk
62
group Id
EG003
num Affected
0
num At Risk
114
group Id
EG004
num Affected
0
num At Risk
41
group Id
EG005
num Affected
0
num At Risk
41
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
0
num At Risk
112
group Id
EG001
num Affected
0
num At Risk
62
group Id
EG002
num Affected
0
num At Risk
62
group Id
EG003
num Affected
1
num At Risk
114
group Id
EG004
num Affected
0
num At Risk
41
group Id
EG005
num Affected
0
num At Risk
41
term
Cardiomyopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Congenital, familial and genetic disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
0
num At Risk
112
group Id
EG001
num Affected
0
num At Risk
62
group Id
EG002
num Affected
0
num At Risk
62
group Id
EG003
num Affected
1
num At Risk
114
group Id
EG004
num Affected
0
num At Risk
41
group Id
EG005
num Affected
0
num At Risk
41
term
Bicuspid aortic valve
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
0
num At Risk
112
group Id
EG001
num Affected
0
num At Risk
62
group Id
EG002
num Affected
0
num At Risk
62
group Id
EG003
num Affected
1
num At Risk
114
group Id
EG004
num Affected
0
num At Risk
41
group Id
EG005
num Affected
0
num At Risk
41
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
0
num At Risk
112
group Id
EG001
num Affected
0
num At Risk
62
group Id
EG002
num Affected
0
num At Risk
62
group Id
EG003
num Affected
0
num At Risk
114
group Id
EG004
num Affected
0
num At Risk
41
group Id
EG005
num Affected
1
num At Risk
41
term
Lower gastrointestinal haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
0
num At Risk
112
group Id
EG001
num Affected
0
num At Risk
62
group Id
EG002
num Affected
0
num At Risk
62
group Id
EG003
num Affected
1
num At Risk
114
group Id
EG004
num Affected
0
num At Risk
41
group Id
EG005
num Affected
0
num At Risk
41
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
112
group Id
EG001
num Affected
0
num At Risk
62
group Id
EG002
num Affected
0
num At Risk
62
group Id
EG003
num Affected
0
num At Risk
114
group Id
EG004
num Affected
0
num At Risk
41
group Id
EG005
num Affected
0
num At Risk
41
term
Pancreatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
0
num At Risk
112
group Id
EG001
num Affected
0
num At Risk
62
group Id
EG002
num Affected
0
num At Risk
62
group Id
EG003
num Affected
1
num At Risk
114
group Id
EG004
num Affected
0
num At Risk
41
group Id
EG005
num Affected
0
num At Risk
41
term
Vomiting

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

Preserved source evidence · Not medical advice