NCT02014116 · ADVERSE EVENTS

Adverse events

A Study of LY3009120 in Participants With Advanced Cancer or Cancer That Has Spread to Other Parts of Their Body · Source last updated 2019-12-27

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: Baseline to Study Completion (Up to 33 months)
Other-event reporting threshold: 5%

All participants who received at least one dose of study drug.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Cohort 1 50 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.	0 / 3	3 / 3	2 / 3
Cohort 2 100 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.	2 / 4	4 / 4	2 / 4
Cohort 3 200 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.	1 / 3	3 / 3	1 / 3
Cohort 4 400 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.	5 / 7	7 / 7	5 / 7
Cohort 5 500 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.	1 / 2	2 / 2	0 / 2
Cohort 6 300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.	12 / 16	16 / 16	4 / 16
Cohort A 300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.	1 / 1	1 / 1	1 / 1
Cohort B 300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.	5 / 5	5 / 5	4 / 5
Cohort C 300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.	6 / 10	9 / 10	4 / 10

Group identifiers: EG000: Cohort 1 · EG001: Cohort 2 · EG002: Cohort 3 · EG003: Cohort 4 · EG004: Cohort 5 · EG005: Cohort 6 · EG006: Cohort A · EG007: Cohort B · EG008: Cohort C

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
Cardiac disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
0
num At Risk
16
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
1
num At Risk
5
num Events
1
group Id
EG008
num Affected
0
num At Risk
10
num Events
0
term
Angina pectoris
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
0
num At Risk
16
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
1
num At Risk
5
num Events
1
group Id
EG008
num Affected
0
num At Risk
10
num Events
0
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
1
num At Risk
16
num Events
1
group Id
EG006
num Affected
1
num At Risk
1
num Events
1
group Id
EG007
num Affected
0
num At Risk
5
num Events
0
group Id
EG008
num Affected
0
num At Risk
10
num Events
0
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
1
num At Risk
16
num Events
1
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
5
num Events
0
group Id
EG008
num Affected
0
num At Risk
10
num Events
0
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
1
num At Risk
7
num Events
1
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
0
num At Risk
16
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
5
num Events
0
group Id
EG008
num Affected
0
num At Risk
10
num Events
0
term
Intestinal perforation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
4
num Events
1
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
0
num At Risk
16
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
5
num Events
0
group Id
EG008
num Affected
0
num At Risk
10
num Events
0
term
Large intestine perforation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
1
num At Risk
16
num Events
1
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
1
num At Risk
5
num Events
1
group Id
EG008
num Affected
0
num At Risk
10
num Events
0
term
Small intestinal obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
1
num At Risk
2
num Events
1
group Id
EG005
num Affected
0
num At Risk
16
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
5
num Events
0
group Id
EG008
num Affected
0
num At Risk
10
num Events
0
term
Stomatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
1
num At Risk
16
num Events
1
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
5
num Events
0
group Id
EG008
num Affected
0
num At Risk
10
num Events
0
term
Upper gastrointestinal haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
1
num At Risk
16
num Events
1
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
5
num Events
0
group Id
EG008
num Affected
0
num At Risk
10
num Events
0
term
General physical health deterioration
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
1
num At Risk
16
num Events
1
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
5
num Events
0
group Id
EG008
num Affected
0
num At Risk
10
num Events
0
term
Hyperthermia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
1
num At Risk
16
num Events
1
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
5
num Events
0
group Id
EG008
num Affected
0
num At Risk
10
num Events
0
term
Oedema peripheral

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 21.1
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
2
num At Risk
4
num Events
2
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
2
num At Risk
7
num Events
3
group Id
EG004
num Affected
1
num At Risk
2
num Events
1
group Id
EG005
num Affected
4
num At Risk
16
num Events
6
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
2
num At Risk
5
num Events
5
group Id
EG008
num Affected
3
num At Risk
10
num Events
6
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
1
num At Risk
16
num Events
1
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
5
num Events
0
group Id
EG008
num Affected
0
num At Risk
10
num Events
0
term
Iron deficiency anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
1
num At Risk
2
num Events
1
group Id
EG005
num Affected
1
num At Risk
16
num Events
1
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
5
num Events
0
group Id
EG008
num Affected
0
num At Risk
10
num Events
0
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
0
num At Risk
16
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
1
num At Risk
5
num Events
1
group Id
EG008
num Affected
0
num At Risk
10
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
0
num At Risk
16
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
2
num At Risk
5
num Events
2
group Id
EG008
num Affected
1
num At Risk
10
num Events
1
term
Pericardial effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
1
num At Risk
7
num Events
1
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
1
num At Risk
16
num Events
1
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
2
num At Risk
5
num Events
2
group Id
EG008
num Affected
0
num At Risk
10
num Events
0
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
0
num At Risk
16
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
5
num Events
0
group Id
EG008
num Affected
1
num At Risk
10
num Events
1
term
Ventricular tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Congenital, familial and genetic disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
1
num At Risk
7
num Events
1
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
0
num At Risk
16
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
5
num Events
0
group Id
EG008
num Affected
0
num At Risk
10
num Events
0
term
Hypertrophic cardiomyopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
0
num At Risk
16
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
5
num Events
0
group Id
EG008
num Affected
0
num At Risk
10
num Events
0
term
Deafness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
0
num At Risk
16
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
5
num Events
0
group Id
EG008
num Affected
1
num At Risk
10
num Events
1
term
Eye discharge
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
0
num At Risk
16
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
5
num Events
0
group Id
EG008
num Affected
1
num At Risk
10
num Events
1
term
Eye haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
0
num At Risk
16
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
5
num Events
0
group Id
EG008
num Affected
0
num At Risk
10
num Events
0
term
Eye irritation

Complete source fields

description

All participants who received at least one dose of study drug.

event Groups

deaths Num Affected
2
deaths Num At Risk
3
description
50 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
id
EG000
other Num Affected
3
other Num At Risk
3
serious Num Affected
0
serious Num At Risk
3
title
Cohort 1
deaths Num Affected
2
deaths Num At Risk
4
description
100 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
id
EG001
other Num Affected
4
other Num At Risk
4
serious Num Affected
2
serious Num At Risk
4
title
Cohort 2
deaths Num Affected
1
deaths Num At Risk
3
description
200 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
id
EG002
other Num Affected
3
other Num At Risk
3
serious Num Affected
1
serious Num At Risk
3
title
Cohort 3
deaths Num Affected
5
deaths Num At Risk
7
description
400 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
id
EG003
other Num Affected
7
other Num At Risk
7
serious Num Affected
5
serious Num At Risk
7
title
Cohort 4
deaths Num Affected
0
deaths Num At Risk
2
description
500 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
id
EG004
other Num Affected
2
other Num At Risk
2
serious Num Affected
1
serious Num At Risk
2
title
Cohort 5
deaths Num Affected
4
deaths Num At Risk
16
description
300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
id
EG005
other Num Affected
16
other Num At Risk
16
serious Num Affected
12
serious Num At Risk
16
title
Cohort 6
deaths Num Affected
1
deaths Num At Risk
1
description
300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
id
EG006
other Num Affected
1
other Num At Risk
1
serious Num Affected
1
serious Num At Risk
1
title
Cohort A
deaths Num Affected
4
deaths Num At Risk
5
description
300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
id
EG007
other Num Affected
5
other Num At Risk
5
serious Num Affected
5
serious Num At Risk
5
title
Cohort B
deaths Num Affected
4
deaths Num At Risk
10
description
300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
id
EG008
other Num Affected
9
other Num At Risk
10
serious Num Affected
6
serious Num At Risk
10
title
Cohort C

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
2
num At Risk
4
num Events
2
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
2
num At Risk
7
num Events
3
group Id
EG004
num Affected
1
num At Risk
2
num Events
1
group Id
EG005
num Affected
4
num At Risk
16
num Events
6
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
2
num At Risk
5
num Events
5
group Id
EG008
num Affected
3
num At Risk
10
num Events
6
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
1
num At Risk
16
num Events
1
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
5
num Events
0
group Id
EG008
num Affected
0
num At Risk
10
num Events
0
term
Iron deficiency anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
1
num At Risk
2
num Events
1
group Id
EG005
num Affected
1
num At Risk
16
num Events
1
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
5
num Events
0
group Id
EG008
num Affected
0
num At Risk
10
num Events
0
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
0
num At Risk
16
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
1
num At Risk
5
num Events
1
group Id
EG008
num Affected
0
num At Risk
10
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
0
num At Risk
16
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
2
num At Risk
5
num Events
2
group Id
EG008
num Affected
1
num At Risk
10
num Events
1
term
Pericardial effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
1
num At Risk
7
num Events
1
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
1
num At Risk
16
num Events
1
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
2
num At Risk
5
num Events
2
group Id
EG008
num Affected
0
num At Risk
10
num Events
0
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
0
num At Risk
16
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
5
num Events
0
group Id
EG008
num Affected
1
num At Risk
10
num Events
1
term
Ventricular tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Congenital, familial and genetic disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
1
num At Risk
7
num Events
1
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
0
num At Risk
16
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
5
num Events
0
group Id
EG008
num Affected
0
num At Risk
10
num Events
0
term
Hypertrophic cardiomyopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
0
num At Risk
16
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
5
num Events
0
group Id
EG008
num Affected
0
num At Risk
10
num Events
0
term
Deafness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
0
num At Risk
16
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
5
num Events
0
group Id
EG008
num Affected
1
num At Risk
10
num Events
1
term
Eye discharge
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
0
num At Risk
16
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
5
num Events
0
group Id
EG008
num Affected
1
num At Risk
10
num Events
1
term
Eye haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
0
num At Risk
16
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
5
num Events
0
group Id
EG008
num Affected
0
num At Risk
10
num Events
0
term
Eye irritation

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
0
num At Risk
16
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
1
num At Risk
5
num Events
1
group Id
EG008
num Affected
0
num At Risk
10
num Events
0
term
Angina pectoris
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
0
num At Risk
16
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
1
num At Risk
5
num Events
1
group Id
EG008
num Affected
0
num At Risk
10
num Events
0
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
1
num At Risk
16
num Events
1
group Id
EG006
num Affected
1
num At Risk
1
num Events
1
group Id
EG007
num Affected
0
num At Risk
5
num Events
0
group Id
EG008
num Affected
0
num At Risk
10
num Events
0
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
1
num At Risk
16
num Events
1
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
5
num Events
0
group Id
EG008
num Affected
0
num At Risk
10
num Events
0
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
1
num At Risk
7
num Events
1
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
0
num At Risk
16
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
5
num Events
0
group Id
EG008
num Affected
0
num At Risk
10
num Events
0
term
Intestinal perforation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
4
num Events
1
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
0
num At Risk
16
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
5
num Events
0
group Id
EG008
num Affected
0
num At Risk
10
num Events
0
term
Large intestine perforation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
1
num At Risk
16
num Events
1
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
1
num At Risk
5
num Events
1
group Id
EG008
num Affected
0
num At Risk
10
num Events
0
term
Small intestinal obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
1
num At Risk
2
num Events
1
group Id
EG005
num Affected
0
num At Risk
16
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
5
num Events
0
group Id
EG008
num Affected
0
num At Risk
10
num Events
0
term
Stomatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
1
num At Risk
16
num Events
1
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
5
num Events
0
group Id
EG008
num Affected
0
num At Risk
10
num Events
0
term
Upper gastrointestinal haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
1
num At Risk
16
num Events
1
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
5
num Events
0
group Id
EG008
num Affected
0
num At Risk
10
num Events
0
term
General physical health deterioration
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
1
num At Risk
16
num Events
1
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
5
num Events
0
group Id
EG008
num Affected
0
num At Risk
10
num Events
0
term
Hyperthermia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
1
num At Risk
16
num Events
1
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
5
num Events
0
group Id
EG008
num Affected
0
num At Risk
10
num Events
0
term
Oedema peripheral

time Frame

Baseline to Study Completion (Up to 33 months)

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

Preserved source evidence · Not medical advice