NCT02414139 · ADVERSE EVENTS

Adverse events

Study of Oral cMET Inhibitor INC280 in Patients With EGFR Wild-type (wt), Advanced Non-small Cell Lung Cancer (NSCLC) (Geometry Mono-1) · Source last updated 2024-03-20

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: Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approximately 5.5 years. Deaths were collected in the post treatment efficacy/survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 6 years.
Other-event reporting threshold: 5%

Deaths in the post-treatment efficacy/survival follow-up are not counted as AEs. The total number at risk in the post-treatment efficacy/survival includes patients who entered the post-treatment efficacy and/or survival follow-up periods.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Cohort 1a: On-treatment AEs collected during the on-treatment period (up to 30 days post-treatment)	42 / 69	66 / 69	10 / 69
Cohort 1b: On-treatment AEs collected during the on-treatment period (up to 30 days post-treatment)	21 / 42	41 / 42	7 / 42
Cohort 2: On-treatment AEs collected during on-treatment period (up to 30 days post-treatment)	30 / 54	53 / 54	12 / 54
Cohort 3: On-treatment AEs collected during on-treatment period (up to 30 days post-treatment)	15 / 30	28 / 30	4 / 30
Cohort 4: On-treatment AEs collected during on-treatment period (up to 30 days post-treatment)	38 / 69	66 / 69	14 / 69
Cohort 5a: On-treatment AEs collected during on-treatment period (up to 30 days post-treatment)	9 / 15	15 / 15	0 / 15
Cohort 5b: On-treatment AEs collected during on-treatment period (up to 30 days post-treatment)	14 / 28	28 / 28	5 / 28
Cohort 6.1 (Expansion of Cohort 1a): On-treatment AEs collected during on-treatment period (up to 30 days post-treatment)	2 / 3	3 / 3	1 / 3
Cohort 6.2 (Expansion of Cohort 4): On-treatment AEs collected during on-treatment period (up to 30 days post-treatment)	14 / 31	29 / 31	5 / 31
Cohort 7 (Expansion of Cohort 5b): On-treatment AEs collected during on-treatment period (up to 30 days post-treatment)	17 / 32	31 / 32	5 / 32
Cohort 4 + Cohort 6.2: On-treatment AEs collected during on-treatment period (up to 30 days post-treatment)	52 / 100	95 / 100	19 / 100
Cohort 5b + Cohort 7: On-treatment AEs collected during on-treatment period (up to 30 days post-treatment)	31 / 60	59 / 60	10 / 60
All Patients: On-treatment AEs collected during the on-treatment period (up to 30 days post-treatment)	202 / 373	360 / 373	63 / 373
Cohort 1a: Post-treatment Efficacy/Survival Follow-up Deaths collected in the post- treatment efficacy/survival follow-up period (starting from day 31 post- treatment). No AEs were collected during this period	0 / 0	0 / 0	44 / 59
Cohort 1b: Post-treatment Efficacy/Survival Follow-up Period Deaths collected in the post- treatment efficacy/survival follow-up period (starting from day 31 post- treatment). No AEs were collected during this period	0 / 0	0 / 0	26 / 35
Cohort 2: Post-treatment Efficacy/Survival Follow-up Period Deaths collected in the post-treatment efficacy/survival follow-up period (starting from day 31 post- treatment). No AEs were collected during this period	0 / 0	0 / 0	34 / 42
Cohort 3: Post-treatment Efficacy/Survival Follow-up Period Deaths collected in the post-treatment efficacy/survival follow-up period (starting from day 31 post- treatment). No AEs were collected during this period	0 / 0	0 / 0	22 / 25
Cohort 4: Post-treatment Efficacy/Survival Follow-up Period Deaths collected in the post-treatment efficacy/survival follow-up period (starting from day 31 post- treatment). No AEs were collected during this period	0 / 0	0 / 0	44 / 55
Cohort 5a: Post-treatment Efficacy/Survival Follow-up Period Deaths collected in the post-treatment efficacy/survival follow-up period (starting from day 31 post- treatment). No AEs were collected during this period	0 / 0	0 / 0	13 / 15
Cohort 5b: Post-treatment Efficacy/Survival Follow-up Period Deaths collected in the post-treatment efficacy/survival follow-up period (starting from day 31 post- treatment). No AEs were collected during this period	0 / 0	0 / 0	13 / 20
Cohort 6.1 (Expansion of Cohort 1a): Post-treatment Efficacy/Survival Follow-up Period Deaths collected in the post-treatment efficacy/survival follow-up period (starting from day 31 post- treatment). No AEs were collected during this period	0 / 0	0 / 0	2 / 2
Cohort 6.2 (Expansion of Cohort 4): Post-treatment Efficacy/Survival Follow-up Period Deaths collected in the post-treatment efficacy/survival follow-up period (starting from day 31 post- treatment). No AEs were collected during this period	0 / 0	0 / 0	17 / 20
Cohort 7 (Expansion of Cohort 5b): Post-treatment Efficacy/Survival Follow-up Period Deaths collected in the post-treatment efficacy/survival follow-up period (starting from day 31 post- treatment). No AEs were collected during this period	0 / 0	0 / 0	16 / 23
Cohort 4 + Cohort 6.2: Post-treatment Efficacy/Survival Follow-up Period Deaths collected in the post-treatment efficacy/survival follow-up period (starting from day 31 post- treatment). No AEs were collected during this period	0 / 0	0 / 0	61 / 75
Cohort 5b + Cohort 7: Post-treatment Efficacy/Survival Follow-up Period Deaths collected in the post-treatment efficacy/survival follow-up period (starting from day 31 post- treatment). No AEs were collected during this period	0 / 0	0 / 0	29 / 43
All Patients: Post-treatment Efficacy/Survival Follow-up Deaths collected in the post- treatment efficacy/survival follow-up period (starting from day 31 post- treatment). No AEs were collected during this period	0 / 0	0 / 0	231 / 296

Group identifiers: EG000: Cohort 1a: On-treatment · EG001: Cohort 1b: On-treatment · EG002: Cohort 2: On-treatment · EG003: Cohort 3: On-treatment · EG004: Cohort 4: On-treatment · EG005: Cohort 5a: On-treatment · EG006: Cohort 5b: On-treatment · EG007: Cohort 6.1 (Expansion of Cohort 1a): On-treatment · EG008: Cohort 6.2 (Expansion of Cohort 4): On-treatment · EG009: Cohort 7 (Expansion of Cohort 5b): On-treatment · EG010: Cohort 4 + Cohort 6.2: On-treatment · EG011: Cohort 5b + Cohort 7: On-treatment · EG012: All Patients: On-treatment · EG013: Cohort 1a: Post-treatment Efficacy/Survival Follow-up · EG014: Cohort 1b: Post-treatment Efficacy/Survival Follow-up Period · EG015: Cohort 2: Post-treatment Efficacy/Survival Follow-up Period · EG016: Cohort 3: Post-treatment Efficacy/Survival Follow-up Period · EG017: Cohort 4: Post-treatment Efficacy/Survival Follow-up Period · EG018: Cohort 5a: Post-treatment Efficacy/Survival Follow-up Period · EG019: Cohort 5b: Post-treatment Efficacy/Survival Follow-up Period · EG020: Cohort 6.1 (Expansion of Cohort 1a): Post-treatment Efficacy/Survival Follow-up Period · EG021: Cohort 6.2 (Expansion of Cohort 4): Post-treatment Efficacy/Survival Follow-up Period · EG022: Cohort 7 (Expansion of Cohort 5b): Post-treatment Efficacy/Survival Follow-up Period · EG023: Cohort 4 + Cohort 6.2: Post-treatment Efficacy/Survival Follow-up Period · EG024: Cohort 5b + Cohort 7: Post-treatment Efficacy/Survival Follow-up Period · EG025: All Patients: Post-treatment Efficacy/Survival Follow-up

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 (26.0)
stats
group Id
EG000
num Affected
1
num At Risk
69
group Id
EG001
num Affected
0
num At Risk
42
group Id
EG002
num Affected
0
num At Risk
54
group Id
EG003
num Affected
0
num At Risk
30
group Id
EG004
num Affected
0
num At Risk
69
group Id
EG005
num Affected
0
num At Risk
15
group Id
EG006
num Affected
0
num At Risk
28
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
31
group Id
EG009
num Affected
0
num At Risk
32
group Id
EG010
num Affected
0
num At Risk
100
group Id
EG011
num Affected
0
num At Risk
60
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
0
num At Risk
69
group Id
EG001
num Affected
0
num At Risk
42
group Id
EG002
num Affected
1
num At Risk
54
group Id
EG003
num Affected
0
num At Risk
30
group Id
EG004
num Affected
0
num At Risk
69
group Id
EG005
num Affected
0
num At Risk
15
group Id
EG006
num Affected
0
num At Risk
28
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
31
group Id
EG009
num Affected
0
num At Risk
32
group Id
EG010
num Affected
0
num At Risk
100
group Id
EG011
num Affected
0
num At Risk
60
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
0
num At Risk
69
group Id
EG001
num Affected
0
num At Risk
42
group Id
EG002
num Affected
0
num At Risk
54
group Id
EG003
num Affected
0
num At Risk
30
group Id
EG004
num Affected
0
num At Risk
69
group Id
EG005
num Affected
0
num At Risk
15
group Id
EG006
num Affected
0
num At Risk
28
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
1
num At Risk
31
group Id
EG009
num Affected
1
num At Risk
32
group Id
EG010
num Affected
1
num At Risk
100
group Id
EG011
num Affected
1
num At Risk
60
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
0
num At Risk
69
group Id
EG001
num Affected
0
num At Risk
42
group Id
EG002
num Affected
1
num At Risk
54
group Id
EG003
num Affected
0
num At Risk
30
group Id
EG004
num Affected
0
num At Risk
69
group Id
EG005
num Affected
0
num At Risk
15
group Id
EG006
num Affected
1
num At Risk
28
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
31
group Id
EG009
num Affected
0
num At Risk
32
group Id
EG010
num Affected
0
num At Risk
100
group Id
EG011
num Affected
1
num At Risk
60
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
0
num At Risk
69
group Id
EG001
num Affected
0
num At Risk
42
group Id
EG002
num Affected
1
num At Risk
54
group Id
EG003
num Affected
1
num At Risk
30
group Id
EG004
num Affected
0
num At Risk
69
group Id
EG005
num Affected
0
num At Risk
15
group Id
EG006
num Affected
0
num At Risk
28
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
31
group Id
EG009
num Affected
0
num At Risk
32
group Id
EG010
num Affected
0
num At Risk
100
group Id
EG011
num Affected
0
num At Risk
60
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
2
num At Risk
69
group Id
EG001
num Affected
0
num At Risk
42
group Id
EG002
num Affected
1
num At Risk
54
group Id
EG003
num Affected
0
num At Risk
30
group Id
EG004
num Affected
0
num At Risk
69
group Id
EG005
num Affected
0
num At Risk
15
group Id
EG006
num Affected
1
num At Risk
28
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
31
group Id
EG009
num Affected
0
num At Risk
32
group Id
EG010
num Affected
0
num At Risk
100
group Id
EG011
num Affected
1
num At Risk
60
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
0
num At Risk
69
group Id
EG001
num Affected
0
num At Risk
42
group Id
EG002
num Affected
0
num At Risk
54
group Id
EG003
num Affected
0
num At Risk
30
group Id
EG004
num Affected
0
num At Risk
69
group Id
EG005
num Affected
0
num At Risk
15
group Id
EG006
num Affected
0
num At Risk
28
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
31
group Id
EG009
num Affected
1
num At Risk
32
group Id
EG010
num Affected
0
num At Risk
100
group Id
EG011
num Affected
1
num At Risk
60
term
Cardiopulmonary failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
0
num At Risk
69
group Id
EG001
num Affected
0
num At Risk
42
group Id
EG002
num Affected
1
num At Risk
54
group Id
EG003
num Affected
0
num At Risk
30
group Id
EG004
num Affected
0
num At Risk
69
group Id
EG005
num Affected
0
num At Risk
15
group Id
EG006
num Affected
0
num At Risk
28
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
31
group Id
EG009
num Affected
0
num At Risk
32
group Id
EG010
num Affected
0
num At Risk
100
group Id
EG011
num Affected
0
num At Risk
60
term
Coronary artery disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
0
num At Risk
69
group Id
EG001
num Affected
0
num At Risk
42
group Id
EG002
num Affected
0
num At Risk
54
group Id
EG003
num Affected
0
num At Risk
30
group Id
EG004
num Affected
0
num At Risk
69
group Id
EG005
num Affected
1
num At Risk
15
group Id
EG006
num Affected
0
num At Risk
28
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
31
group Id
EG009
num Affected
0
num At Risk
32
group Id
EG010
num Affected
0
num At Risk
100
group Id
EG011
num Affected
0
num At Risk
60
term
Myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
0
num At Risk
69
group Id
EG001
num Affected
0
num At Risk
42
group Id
EG002
num Affected
0
num At Risk
54
group Id
EG003
num Affected
0
num At Risk
30
group Id
EG004
num Affected
0
num At Risk
69
group Id
EG005
num Affected
0
num At Risk
15
group Id
EG006
num Affected
0
num At Risk
28
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
1
num At Risk
31
group Id
EG009
num Affected
0
num At Risk
32
group Id
EG010
num Affected
1
num At Risk
100
group Id
EG011
num Affected
0
num At Risk
60
term
Pericardial effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
0
num At Risk
69
group Id
EG001
num Affected
0
num At Risk
42
group Id
EG002
num Affected
0
num At Risk
54
group Id
EG003
num Affected
0
num At Risk
30
group Id
EG004
num Affected
1
num At Risk
69
group Id
EG005
num Affected
0
num At Risk
15
group Id
EG006
num Affected
0
num At Risk
28
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
31
group Id
EG009
num Affected
0
num At Risk
32
group Id
EG010
num Affected
1
num At Risk
100
group Id
EG011
num Affected
0
num At Risk
60
term
Supraventricular tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
0
num At Risk
69
group Id
EG001
num Affected
0
num At Risk
42
group Id
EG002
num Affected
0
num At Risk
54
group Id
EG003
num Affected
0
num At Risk
30
group Id
EG004
num Affected
1
num At Risk
69
group Id
EG005
num Affected
0
num At Risk
15
group Id
EG006
num Affected
0
num At Risk
28
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
31
group Id
EG009
num Affected
0
num At Risk
32
group Id
EG010
num Affected
1
num At Risk
100
group Id
EG011
num Affected
0
num At Risk
60
term
Tachycardia

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 (26.0)
stats
group Id
EG000
num Affected
5
num At Risk
69
group Id
EG001
num Affected
2
num At Risk
42
group Id
EG002
num Affected
5
num At Risk
54
group Id
EG003
num Affected
6
num At Risk
30
group Id
EG004
num Affected
8
num At Risk
69
group Id
EG005
num Affected
1
num At Risk
15
group Id
EG006
num Affected
2
num At Risk
28
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
4
num At Risk
31
group Id
EG009
num Affected
2
num At Risk
32
group Id
EG010
num Affected
12
num At Risk
100
group Id
EG011
num Affected
4
num At Risk
60
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
1
num At Risk
69
group Id
EG001
num Affected
0
num At Risk
42
group Id
EG002
num Affected
2
num At Risk
54
group Id
EG003
num Affected
1
num At Risk
30
group Id
EG004
num Affected
0
num At Risk
69
group Id
EG005
num Affected
1
num At Risk
15
group Id
EG006
num Affected
0
num At Risk
28
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
1
num At Risk
31
group Id
EG009
num Affected
0
num At Risk
32
group Id
EG010
num Affected
1
num At Risk
100
group Id
EG011
num Affected
0
num At Risk
60
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
0
num At Risk
69
group Id
EG001
num Affected
0
num At Risk
42
group Id
EG002
num Affected
1
num At Risk
54
group Id
EG003
num Affected
2
num At Risk
30
group Id
EG004
num Affected
1
num At Risk
69
group Id
EG005
num Affected
0
num At Risk
15
group Id
EG006
num Affected
0
num At Risk
28
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
1
num At Risk
31
group Id
EG009
num Affected
0
num At Risk
32
group Id
EG010
num Affected
2
num At Risk
100
group Id
EG011
num Affected
0
num At Risk
60
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
2
num At Risk
69
group Id
EG001
num Affected
0
num At Risk
42
group Id
EG002
num Affected
1
num At Risk
54
group Id
EG003
num Affected
1
num At Risk
30
group Id
EG004
num Affected
1
num At Risk
69
group Id
EG005
num Affected
1
num At Risk
15
group Id
EG006
num Affected
2
num At Risk
28
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
1
num At Risk
31
group Id
EG009
num Affected
0
num At Risk
32
group Id
EG010
num Affected
2
num At Risk
100
group Id
EG011
num Affected
2
num At Risk
60
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
1
num At Risk
69
group Id
EG001
num Affected
0
num At Risk
42
group Id
EG002
num Affected
0
num At Risk
54
group Id
EG003
num Affected
0
num At Risk
30
group Id
EG004
num Affected
2
num At Risk
69
group Id
EG005
num Affected
0
num At Risk
15
group Id
EG006
num Affected
0
num At Risk
28
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
3
num At Risk
31
group Id
EG009
num Affected
3
num At Risk
32
group Id
EG010
num Affected
5
num At Risk
100
group Id
EG011
num Affected
3
num At Risk
60
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
2
num At Risk
69
group Id
EG001
num Affected
0
num At Risk
42
group Id
EG002
num Affected
2
num At Risk
54
group Id
EG003
num Affected
0
num At Risk
30
group Id
EG004
num Affected
2
num At Risk
69
group Id
EG005
num Affected
1
num At Risk
15
group Id
EG006
num Affected
0
num At Risk
28
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
31
group Id
EG009
num Affected
1
num At Risk
32
group Id
EG010
num Affected
2
num At Risk
100
group Id
EG011
num Affected
1
num At Risk
60
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
0
num At Risk
69
group Id
EG001
num Affected
1
num At Risk
42
group Id
EG002
num Affected
0
num At Risk
54
group Id
EG003
num Affected
0
num At Risk
30
group Id
EG004
num Affected
0
num At Risk
69
group Id
EG005
num Affected
0
num At Risk
15
group Id
EG006
num Affected
0
num At Risk
28
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
31
group Id
EG009
num Affected
2
num At Risk
32
group Id
EG010
num Affected
0
num At Risk
100
group Id
EG011
num Affected
2
num At Risk
60
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
1
num At Risk
69
group Id
EG001
num Affected
1
num At Risk
42
group Id
EG002
num Affected
1
num At Risk
54
group Id
EG003
num Affected
0
num At Risk
30
group Id
EG004
num Affected
2
num At Risk
69
group Id
EG005
num Affected
1
num At Risk
15
group Id
EG006
num Affected
1
num At Risk
28
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
31
group Id
EG009
num Affected
2
num At Risk
32
group Id
EG010
num Affected
2
num At Risk
100
group Id
EG011
num Affected
3
num At Risk
60
term
Palpitations
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
0
num At Risk
69
group Id
EG001
num Affected
0
num At Risk
42
group Id
EG002
num Affected
0
num At Risk
54
group Id
EG003
num Affected
0
num At Risk
30
group Id
EG004
num Affected
4
num At Risk
69
group Id
EG005
num Affected
0
num At Risk
15
group Id
EG006
num Affected
1
num At Risk
28
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
31
group Id
EG009
num Affected
0
num At Risk
32
group Id
EG010
num Affected
4
num At Risk
100
group Id
EG011
num Affected
1
num At Risk
60
term
Sinus bradycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
0
num At Risk
69
group Id
EG001
num Affected
3
num At Risk
42
group Id
EG002
num Affected
0
num At Risk
54
group Id
EG003
num Affected
0
num At Risk
30
group Id
EG004
num Affected
2
num At Risk
69
group Id
EG005
num Affected
0
num At Risk
15
group Id
EG006
num Affected
0
num At Risk
28
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
31
group Id
EG009
num Affected
0
num At Risk
32
group Id
EG010
num Affected
2
num At Risk
100
group Id
EG011
num Affected
0
num At Risk
60
term
Tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
2
num At Risk
69
group Id
EG001
num Affected
1
num At Risk
42
group Id
EG002
num Affected
1
num At Risk
54
group Id
EG003
num Affected
0
num At Risk
30
group Id
EG004
num Affected
3
num At Risk
69
group Id
EG005
num Affected
0
num At Risk
15
group Id
EG006
num Affected
2
num At Risk
28
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
31
group Id
EG009
num Affected
5
num At Risk
32
group Id
EG010
num Affected
3
num At Risk
100
group Id
EG011
num Affected
7
num At Risk
60
term
Hypoacusis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
1
num At Risk
69
group Id
EG001
num Affected
0
num At Risk
42
group Id
EG002
num Affected
0
num At Risk
54
group Id
EG003
num Affected
0
num At Risk
30
group Id
EG004
num Affected
0
num At Risk
69
group Id
EG005
num Affected
0
num At Risk
15
group Id
EG006
num Affected
3
num At Risk
28
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
3
num At Risk
31
group Id
EG009
num Affected
1
num At Risk
32
group Id
EG010
num Affected
3
num At Risk
100
group Id
EG011
num Affected
4
num At Risk
60
term
Tinnitus

Complete source fields

description

event Groups

deaths Num Affected
10
deaths Num At Risk
69
description
AEs collected during the on-treatment period (up to 30 days post-treatment)
id
EG000
other Num Affected
66
other Num At Risk
69
serious Num Affected
42
serious Num At Risk
69
title
Cohort 1a: On-treatment
deaths Num Affected
7
deaths Num At Risk
42
description
AEs collected during the on-treatment period (up to 30 days post-treatment)
id
EG001
other Num Affected
41
other Num At Risk
42
serious Num Affected
21
serious Num At Risk
42
title
Cohort 1b: On-treatment
deaths Num Affected
12
deaths Num At Risk
54
description
AEs collected during on-treatment period (up to 30 days post-treatment)
id
EG002
other Num Affected
53
other Num At Risk
54
serious Num Affected
30
serious Num At Risk
54
title
Cohort 2: On-treatment
deaths Num Affected
4
deaths Num At Risk
30
description
AEs collected during on-treatment period (up to 30 days post-treatment)
id
EG003
other Num Affected
28
other Num At Risk
30
serious Num Affected
15
serious Num At Risk
30
title
Cohort 3: On-treatment
deaths Num Affected
14
deaths Num At Risk
69
description
AEs collected during on-treatment period (up to 30 days post-treatment)
id
EG004
other Num Affected
66
other Num At Risk
69
serious Num Affected
38
serious Num At Risk
69
title
Cohort 4: On-treatment
deaths Num Affected
0
deaths Num At Risk
15
description
AEs collected during on-treatment period (up to 30 days post-treatment)
id
EG005
other Num Affected
15
other Num At Risk
15
serious Num Affected
9
serious Num At Risk
15
title
Cohort 5a: On-treatment
deaths Num Affected
5
deaths Num At Risk
28
description
AEs collected during on-treatment period (up to 30 days post-treatment)
id
EG006
other Num Affected
28
other Num At Risk
28
serious Num Affected
14
serious Num At Risk
28
title
Cohort 5b: On-treatment
deaths Num Affected
1
deaths Num At Risk
3
description
AEs collected during on-treatment period (up to 30 days post-treatment)
id
EG007
other Num Affected
3
other Num At Risk
3
serious Num Affected
2
serious Num At Risk
3
title
Cohort 6.1 (Expansion of Cohort 1a): On-treatment
deaths Num Affected
5
deaths Num At Risk
31
description
AEs collected during on-treatment period (up to 30 days post-treatment)
id
EG008
other Num Affected
29
other Num At Risk
31
serious Num Affected
14
serious Num At Risk
31
title
Cohort 6.2 (Expansion of Cohort 4): On-treatment
deaths Num Affected
5
deaths Num At Risk
32
description
AEs collected during on-treatment period (up to 30 days post-treatment)
id
EG009
other Num Affected
31
other Num At Risk
32
serious Num Affected
17
serious Num At Risk
32
title
Cohort 7 (Expansion of Cohort 5b): On-treatment
deaths Num Affected
19
deaths Num At Risk
100
description
AEs collected during on-treatment period (up to 30 days post-treatment)
id
EG010
other Num Affected
95
other Num At Risk
100
serious Num Affected
52
serious Num At Risk
100
title
Cohort 4 + Cohort 6.2: On-treatment
deaths Num Affected
10
deaths Num At Risk
60
description
AEs collected during on-treatment period (up to 30 days post-treatment)
id
EG011
other Num Affected
59
other Num At Risk
60
serious Num Affected
31
serious Num At Risk
60
title
Cohort 5b + Cohort 7: On-treatment

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
5
num At Risk
69
group Id
EG001
num Affected
2
num At Risk
42
group Id
EG002
num Affected
5
num At Risk
54
group Id
EG003
num Affected
6
num At Risk
30
group Id
EG004
num Affected
8
num At Risk
69
group Id
EG005
num Affected
1
num At Risk
15
group Id
EG006
num Affected
2
num At Risk
28
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
4
num At Risk
31
group Id
EG009
num Affected
2
num At Risk
32
group Id
EG010
num Affected
12
num At Risk
100
group Id
EG011
num Affected
4
num At Risk
60
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
1
num At Risk
69
group Id
EG001
num Affected
0
num At Risk
42
group Id
EG002
num Affected
2
num At Risk
54
group Id
EG003
num Affected
1
num At Risk
30
group Id
EG004
num Affected
0
num At Risk
69
group Id
EG005
num Affected
1
num At Risk
15
group Id
EG006
num Affected
0
num At Risk
28
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
1
num At Risk
31
group Id
EG009
num Affected
0
num At Risk
32
group Id
EG010
num Affected
1
num At Risk
100
group Id
EG011
num Affected
0
num At Risk
60
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
0
num At Risk
69
group Id
EG001
num Affected
0
num At Risk
42
group Id
EG002
num Affected
1
num At Risk
54
group Id
EG003
num Affected
2
num At Risk
30
group Id
EG004
num Affected
1
num At Risk
69
group Id
EG005
num Affected
0
num At Risk
15
group Id
EG006
num Affected
0
num At Risk
28
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
1
num At Risk
31
group Id
EG009
num Affected
0
num At Risk
32
group Id
EG010
num Affected
2
num At Risk
100
group Id
EG011
num Affected
0
num At Risk
60
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
2
num At Risk
69
group Id
EG001
num Affected
0
num At Risk
42
group Id
EG002
num Affected
1
num At Risk
54
group Id
EG003
num Affected
1
num At Risk
30
group Id
EG004
num Affected
1
num At Risk
69
group Id
EG005
num Affected
1
num At Risk
15
group Id
EG006
num Affected
2
num At Risk
28
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
1
num At Risk
31
group Id
EG009
num Affected
0
num At Risk
32
group Id
EG010
num Affected
2
num At Risk
100
group Id
EG011
num Affected
2
num At Risk
60
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
1
num At Risk
69
group Id
EG001
num Affected
0
num At Risk
42
group Id
EG002
num Affected
0
num At Risk
54
group Id
EG003
num Affected
0
num At Risk
30
group Id
EG004
num Affected
2
num At Risk
69
group Id
EG005
num Affected
0
num At Risk
15
group Id
EG006
num Affected
0
num At Risk
28
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
3
num At Risk
31
group Id
EG009
num Affected
3
num At Risk
32
group Id
EG010
num Affected
5
num At Risk
100
group Id
EG011
num Affected
3
num At Risk
60
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
2
num At Risk
69
group Id
EG001
num Affected
0
num At Risk
42
group Id
EG002
num Affected
2
num At Risk
54
group Id
EG003
num Affected
0
num At Risk
30
group Id
EG004
num Affected
2
num At Risk
69
group Id
EG005
num Affected
1
num At Risk
15
group Id
EG006
num Affected
0
num At Risk
28
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
31
group Id
EG009
num Affected
1
num At Risk
32
group Id
EG010
num Affected
2
num At Risk
100
group Id
EG011
num Affected
1
num At Risk
60
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
0
num At Risk
69
group Id
EG001
num Affected
1
num At Risk
42
group Id
EG002
num Affected
0
num At Risk
54
group Id
EG003
num Affected
0
num At Risk
30
group Id
EG004
num Affected
0
num At Risk
69
group Id
EG005
num Affected
0
num At Risk
15
group Id
EG006
num Affected
0
num At Risk
28
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
31
group Id
EG009
num Affected
2
num At Risk
32
group Id
EG010
num Affected
0
num At Risk
100
group Id
EG011
num Affected
2
num At Risk
60
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
1
num At Risk
69
group Id
EG001
num Affected
1
num At Risk
42
group Id
EG002
num Affected
1
num At Risk
54
group Id
EG003
num Affected
0
num At Risk
30
group Id
EG004
num Affected
2
num At Risk
69
group Id
EG005
num Affected
1
num At Risk
15
group Id
EG006
num Affected
1
num At Risk
28
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
31
group Id
EG009
num Affected
2
num At Risk
32
group Id
EG010
num Affected
2
num At Risk
100
group Id
EG011
num Affected
3
num At Risk
60
term
Palpitations
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
0
num At Risk
69
group Id
EG001
num Affected
0
num At Risk
42
group Id
EG002
num Affected
0
num At Risk
54
group Id
EG003
num Affected
0
num At Risk
30
group Id
EG004
num Affected
4
num At Risk
69
group Id
EG005
num Affected
0
num At Risk
15
group Id
EG006
num Affected
1
num At Risk
28
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
31
group Id
EG009
num Affected
0
num At Risk
32
group Id
EG010
num Affected
4
num At Risk
100
group Id
EG011
num Affected
1
num At Risk
60
term
Sinus bradycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
0
num At Risk
69
group Id
EG001
num Affected
3
num At Risk
42
group Id
EG002
num Affected
0
num At Risk
54
group Id
EG003
num Affected
0
num At Risk
30
group Id
EG004
num Affected
2
num At Risk
69
group Id
EG005
num Affected
0
num At Risk
15
group Id
EG006
num Affected
0
num At Risk
28
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
31
group Id
EG009
num Affected
0
num At Risk
32
group Id
EG010
num Affected
2
num At Risk
100
group Id
EG011
num Affected
0
num At Risk
60
term
Tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
2
num At Risk
69
group Id
EG001
num Affected
1
num At Risk
42
group Id
EG002
num Affected
1
num At Risk
54
group Id
EG003
num Affected
0
num At Risk
30
group Id
EG004
num Affected
3
num At Risk
69
group Id
EG005
num Affected
0
num At Risk
15
group Id
EG006
num Affected
2
num At Risk
28
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
31
group Id
EG009
num Affected
5
num At Risk
32
group Id
EG010
num Affected
3
num At Risk
100
group Id
EG011
num Affected
7
num At Risk
60
term
Hypoacusis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
1
num At Risk
69
group Id
EG001
num Affected
0
num At Risk
42
group Id
EG002
num Affected
0
num At Risk
54
group Id
EG003
num Affected
0
num At Risk
30
group Id
EG004
num Affected
0
num At Risk
69
group Id
EG005
num Affected
0
num At Risk
15
group Id
EG006
num Affected
3
num At Risk
28
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
3
num At Risk
31
group Id
EG009
num Affected
1
num At Risk
32
group Id
EG010
num Affected
3
num At Risk
100
group Id
EG011
num Affected
4
num At Risk
60
term
Tinnitus

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
1
num At Risk
69
group Id
EG001
num Affected
0
num At Risk
42
group Id
EG002
num Affected
0
num At Risk
54
group Id
EG003
num Affected
0
num At Risk
30
group Id
EG004
num Affected
0
num At Risk
69
group Id
EG005
num Affected
0
num At Risk
15
group Id
EG006
num Affected
0
num At Risk
28
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
31
group Id
EG009
num Affected
0
num At Risk
32
group Id
EG010
num Affected
0
num At Risk
100
group Id
EG011
num Affected
0
num At Risk
60
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
0
num At Risk
69
group Id
EG001
num Affected
0
num At Risk
42
group Id
EG002
num Affected
1
num At Risk
54
group Id
EG003
num Affected
0
num At Risk
30
group Id
EG004
num Affected
0
num At Risk
69
group Id
EG005
num Affected
0
num At Risk
15
group Id
EG006
num Affected
0
num At Risk
28
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
31
group Id
EG009
num Affected
0
num At Risk
32
group Id
EG010
num Affected
0
num At Risk
100
group Id
EG011
num Affected
0
num At Risk
60
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
0
num At Risk
69
group Id
EG001
num Affected
0
num At Risk
42
group Id
EG002
num Affected
0
num At Risk
54
group Id
EG003
num Affected
0
num At Risk
30
group Id
EG004
num Affected
0
num At Risk
69
group Id
EG005
num Affected
0
num At Risk
15
group Id
EG006
num Affected
0
num At Risk
28
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
1
num At Risk
31
group Id
EG009
num Affected
1
num At Risk
32
group Id
EG010
num Affected
1
num At Risk
100
group Id
EG011
num Affected
1
num At Risk
60
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
0
num At Risk
69
group Id
EG001
num Affected
0
num At Risk
42
group Id
EG002
num Affected
1
num At Risk
54
group Id
EG003
num Affected
0
num At Risk
30
group Id
EG004
num Affected
0
num At Risk
69
group Id
EG005
num Affected
0
num At Risk
15
group Id
EG006
num Affected
1
num At Risk
28
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
31
group Id
EG009
num Affected
0
num At Risk
32
group Id
EG010
num Affected
0
num At Risk
100
group Id
EG011
num Affected
1
num At Risk
60
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
0
num At Risk
69
group Id
EG001
num Affected
0
num At Risk
42
group Id
EG002
num Affected
1
num At Risk
54
group Id
EG003
num Affected
1
num At Risk
30
group Id
EG004
num Affected
0
num At Risk
69
group Id
EG005
num Affected
0
num At Risk
15
group Id
EG006
num Affected
0
num At Risk
28
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
31
group Id
EG009
num Affected
0
num At Risk
32
group Id
EG010
num Affected
0
num At Risk
100
group Id
EG011
num Affected
0
num At Risk
60
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
2
num At Risk
69
group Id
EG001
num Affected
0
num At Risk
42
group Id
EG002
num Affected
1
num At Risk
54
group Id
EG003
num Affected
0
num At Risk
30
group Id
EG004
num Affected
0
num At Risk
69
group Id
EG005
num Affected
0
num At Risk
15
group Id
EG006
num Affected
1
num At Risk
28
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
31
group Id
EG009
num Affected
0
num At Risk
32
group Id
EG010
num Affected
0
num At Risk
100
group Id
EG011
num Affected
1
num At Risk
60
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
0
num At Risk
69
group Id
EG001
num Affected
0
num At Risk
42
group Id
EG002
num Affected
0
num At Risk
54
group Id
EG003
num Affected
0
num At Risk
30
group Id
EG004
num Affected
0
num At Risk
69
group Id
EG005
num Affected
0
num At Risk
15
group Id
EG006
num Affected
0
num At Risk
28
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
31
group Id
EG009
num Affected
1
num At Risk
32
group Id
EG010
num Affected
0
num At Risk
100
group Id
EG011
num Affected
1
num At Risk
60
term
Cardiopulmonary failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
0
num At Risk
69
group Id
EG001
num Affected
0
num At Risk
42
group Id
EG002
num Affected
1
num At Risk
54
group Id
EG003
num Affected
0
num At Risk
30
group Id
EG004
num Affected
0
num At Risk
69
group Id
EG005
num Affected
0
num At Risk
15
group Id
EG006
num Affected
0
num At Risk
28
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
31
group Id
EG009
num Affected
0
num At Risk
32
group Id
EG010
num Affected
0
num At Risk
100
group Id
EG011
num Affected
0
num At Risk
60
term
Coronary artery disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
0
num At Risk
69
group Id
EG001
num Affected
0
num At Risk
42
group Id
EG002
num Affected
0
num At Risk
54
group Id
EG003
num Affected
0
num At Risk
30
group Id
EG004
num Affected
0
num At Risk
69
group Id
EG005
num Affected
1
num At Risk
15
group Id
EG006
num Affected
0
num At Risk
28
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
31
group Id
EG009
num Affected
0
num At Risk
32
group Id
EG010
num Affected
0
num At Risk
100
group Id
EG011
num Affected
0
num At Risk
60
term
Myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
0
num At Risk
69
group Id
EG001
num Affected
0
num At Risk
42
group Id
EG002
num Affected
0
num At Risk
54
group Id
EG003
num Affected
0
num At Risk
30
group Id
EG004
num Affected
0
num At Risk
69
group Id
EG005
num Affected
0
num At Risk
15
group Id
EG006
num Affected
0
num At Risk
28
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
1
num At Risk
31
group Id
EG009
num Affected
0
num At Risk
32
group Id
EG010
num Affected
1
num At Risk
100
group Id
EG011
num Affected
0
num At Risk
60
term
Pericardial effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
0
num At Risk
69
group Id
EG001
num Affected
0
num At Risk
42
group Id
EG002
num Affected
0
num At Risk
54
group Id
EG003
num Affected
0
num At Risk
30
group Id
EG004
num Affected
1
num At Risk
69
group Id
EG005
num Affected
0
num At Risk
15
group Id
EG006
num Affected
0
num At Risk
28
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
31
group Id
EG009
num Affected
0
num At Risk
32
group Id
EG010
num Affected
1
num At Risk
100
group Id
EG011
num Affected
0
num At Risk
60
term
Supraventricular tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
0
num At Risk
69
group Id
EG001
num Affected
0
num At Risk
42
group Id
EG002
num Affected
0
num At Risk
54
group Id
EG003
num Affected
0
num At Risk
30
group Id
EG004
num Affected
1
num At Risk
69
group Id
EG005
num Affected
0
num At Risk
15
group Id
EG006
num Affected
0
num At Risk
28
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
31
group Id
EG009
num Affected
0
num At Risk
32
group Id
EG010
num Affected
1
num At Risk
100
group Id
EG011
num Affected
0
num At Risk
60
term
Tachycardia

time Frame

Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approximately 5.5 years. Deaths were collected in the post treatment efficacy/survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 6 years.

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

Preserved source evidence · Not medical advice