NCT01803282 · ADVERSE EVENTS

Adverse events

Study to Evaluate the Safety and Tolerability of Andecaliximab as Monotherapy and in Combination With Chemotherapy in Participants With Advanced Solid Tumors · Source last updated 2020-06-02

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
Other-event reporting threshold: 5%

The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Part A: ADX 200 mg Participants with advanced solid tumors who had failed or were intolerant to standard therapy or for whom no standard therapy existed, received 200 mg ADX as monotherapy via IV infusion (approximately 30 minutes) every 2 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.	0 / 4	4 / 4	1 / 4
Part A: ADX 600 mg Participants with advanced solid tumors who had failed or were intolerant to standard therapy or for whom no standard therapy existed, received 600 mg ADX as monotherapy via IV infusion (approximately 30 minutes) every 2 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.	0 / 3	3 / 3	0 / 3
Part A: ADX 1800 mg Participants with advanced solid tumors who had failed or were intolerant to standard therapy or for whom no standard therapy existed, received 1800 mg ADX as monotherapy via IV infusion (approximately 30 minutes) every 2 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.	2 / 6	5 / 6	1 / 6
Part B: PAC, ADX 800 mg Participants with PAC received ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (gemcitabine and nab paclitaxel, on Days 1, 8, and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.	19 / 36	36 / 36	8 / 36
Part B: LAC, ADX 1200 mg Participants with LAC received ADX 1200 mg every 3 weeks via IV infusion in addition to the 21-day cycle chemotherapy (carboplatin and pemetrexed, on Day 1) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.	5 / 10	9 / 10	4 / 10
Part B: LSC, ADX 1200 mg Participants with LSC received ADX 1200 mg every 3 weeks via IV infusion in addition to the 21-day cycle chemotherapy (carboplatin and paclitaxel, on Day 1) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.	6 / 10	10 / 10	3 / 10
Part B: EGC, ADX 800 mg Participants with EGC received ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (mFOLFOX6, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.	19 / 40	40 / 40	13 / 40
Part B: FL CRC, ADX 800 mg+BEV 5 mg/kg Participants with CRC received FL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (mFOLFOX6 and bevacizumab 5 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.	17 / 45	45 / 45	22 / 45
Part B: FL CRC, ADX 800 mg+BEV 10 mg/kg Participants with CRC received FL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (mFOLFOX6 and bevacizumab 10 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.	3 / 11	11 / 11	5 / 11
Part B: SL CRC, ADX 800 mg+BEV 5 mg/kg Participants with CRC received SL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (FOLFIRI and bevacizumab 5 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.	13 / 44	44 / 44	25 / 44
Part B: SL CRC, ADX 800 mg+BEV 10 mg/kg Participants with CRC received SL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (FOLFIRI and bevacizumab 10 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.	4 / 8	8 / 8	5 / 8
Part B: BRCA, ADX 800 mg Participants with BRCA received ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (paclitaxel, on Days 1, 8, and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.	5 / 15	15 / 15	8 / 15

Group identifiers: EG000: Part A: ADX 200 mg · EG001: Part A: ADX 600 mg · EG002: Part A: ADX 1800 mg · EG003: Part B: PAC, ADX 800 mg · EG004: Part B: LAC, ADX 1200 mg · EG005: Part B: LSC, ADX 1200 mg · EG006: Part B: EGC, ADX 800 mg · EG007: Part B: FL CRC, ADX 800 mg+BEV 5 mg/kg · EG008: Part B: FL CRC, ADX 800 mg+BEV 10 mg/kg · EG009: Part B: SL CRC, ADX 800 mg+BEV 5 mg/kg · EG010: Part B: SL CRC, ADX 800 mg+BEV 10 mg/kg · EG011: Part B: BRCA, ADX 800 mg

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 22.0
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
36
group Id
EG004
num Affected
1
num At Risk
10
group Id
EG005
num Affected
1
num At Risk
10
group Id
EG006
num Affected
1
num At Risk
40
group Id
EG007
num Affected
0
num At Risk
45
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
44
group Id
EG010
num Affected
0
num At Risk
8
group Id
EG011
num Affected
0
num At Risk
15
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
36
group Id
EG004
num Affected
0
num At Risk
10
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
1
num At Risk
40
group Id
EG007
num Affected
0
num At Risk
45
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
44
group Id
EG010
num Affected
1
num At Risk
8
group Id
EG011
num Affected
0
num At Risk
15
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
36
group Id
EG004
num Affected
0
num At Risk
10
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
0
num At Risk
40
group Id
EG007
num Affected
1
num At Risk
45
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
44
group Id
EG010
num Affected
0
num At Risk
8
group Id
EG011
num Affected
0
num At Risk
15
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
36
group Id
EG004
num Affected
1
num At Risk
10
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
0
num At Risk
40
group Id
EG007
num Affected
0
num At Risk
45
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
44
group Id
EG010
num Affected
0
num At Risk
8
group Id
EG011
num Affected
0
num At Risk
15
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
36
group Id
EG004
num Affected
1
num At Risk
10
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
0
num At Risk
40
group Id
EG007
num Affected
0
num At Risk
45
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
44
group Id
EG010
num Affected
0
num At Risk
8
group Id
EG011
num Affected
0
num At Risk
15
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
36
group Id
EG004
num Affected
0
num At Risk
10
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
0
num At Risk
40
group Id
EG007
num Affected
1
num At Risk
45
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
44
group Id
EG010
num Affected
0
num At Risk
8
group Id
EG011
num Affected
0
num At Risk
15
term
Acute coronary syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
36
group Id
EG004
num Affected
0
num At Risk
10
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
0
num At Risk
40
group Id
EG007
num Affected
1
num At Risk
45
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
44
group Id
EG010
num Affected
0
num At Risk
8
group Id
EG011
num Affected
0
num At Risk
15
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
1
num At Risk
36
group Id
EG004
num Affected
0
num At Risk
10
group Id
EG005
num Affected
1
num At Risk
10
group Id
EG006
num Affected
0
num At Risk
40
group Id
EG007
num Affected
0
num At Risk
45
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
44
group Id
EG010
num Affected
0
num At Risk
8
group Id
EG011
num Affected
1
num At Risk
15
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
36
group Id
EG004
num Affected
0
num At Risk
10
group Id
EG005
num Affected
1
num At Risk
10
group Id
EG006
num Affected
0
num At Risk
40
group Id
EG007
num Affected
0
num At Risk
45
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
44
group Id
EG010
num Affected
0
num At Risk
8
group Id
EG011
num Affected
0
num At Risk
15
term
Atrial flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
36
group Id
EG004
num Affected
0
num At Risk
10
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
0
num At Risk
40
group Id
EG007
num Affected
0
num At Risk
45
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
1
num At Risk
44
group Id
EG010
num Affected
0
num At Risk
8
group Id
EG011
num Affected
0
num At Risk
15
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
36
group Id
EG004
num Affected
1
num At Risk
10
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
0
num At Risk
40
group Id
EG007
num Affected
0
num At Risk
45
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
44
group Id
EG010
num Affected
0
num At Risk
8
group Id
EG011
num Affected
0
num At Risk
15
term
Pericardial effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
36
group Id
EG004
num Affected
0
num At Risk
10
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
1
num At Risk
40
group Id
EG007
num Affected
0
num At Risk
45
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
44
group Id
EG010
num Affected
0
num At Risk
8
group Id
EG011
num Affected
0
num At Risk
15
term
Adrenal haemorrhage

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 22.0
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
11
num At Risk
36
group Id
EG004
num Affected
7
num At Risk
10
group Id
EG005
num Affected
2
num At Risk
10
group Id
EG006
num Affected
12
num At Risk
40
group Id
EG007
num Affected
9
num At Risk
45
group Id
EG008
num Affected
1
num At Risk
11
group Id
EG009
num Affected
11
num At Risk
44
group Id
EG010
num Affected
2
num At Risk
8
group Id
EG011
num Affected
3
num At Risk
15
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
36
group Id
EG004
num Affected
0
num At Risk
10
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
0
num At Risk
40
group Id
EG007
num Affected
0
num At Risk
45
group Id
EG008
num Affected
1
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
44
group Id
EG010
num Affected
0
num At Risk
8
group Id
EG011
num Affected
0
num At Risk
15
term
Hypercoagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
36
group Id
EG004
num Affected
0
num At Risk
10
group Id
EG005
num Affected
1
num At Risk
10
group Id
EG006
num Affected
0
num At Risk
40
group Id
EG007
num Affected
0
num At Risk
45
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
44
group Id
EG010
num Affected
0
num At Risk
8
group Id
EG011
num Affected
0
num At Risk
15
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
1
num At Risk
36
group Id
EG004
num Affected
0
num At Risk
10
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
0
num At Risk
40
group Id
EG007
num Affected
0
num At Risk
45
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
1
num At Risk
44
group Id
EG010
num Affected
0
num At Risk
8
group Id
EG011
num Affected
1
num At Risk
15
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
12
num At Risk
36
group Id
EG004
num Affected
4
num At Risk
10
group Id
EG005
num Affected
2
num At Risk
10
group Id
EG006
num Affected
16
num At Risk
40
group Id
EG007
num Affected
18
num At Risk
45
group Id
EG008
num Affected
5
num At Risk
11
group Id
EG009
num Affected
12
num At Risk
44
group Id
EG010
num Affected
5
num At Risk
8
group Id
EG011
num Affected
6
num At Risk
15
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
3
num At Risk
36
group Id
EG004
num Affected
2
num At Risk
10
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
1
num At Risk
40
group Id
EG007
num Affected
0
num At Risk
45
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
44
group Id
EG010
num Affected
0
num At Risk
8
group Id
EG011
num Affected
0
num At Risk
15
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
10
num At Risk
36
group Id
EG004
num Affected
3
num At Risk
10
group Id
EG005
num Affected
3
num At Risk
10
group Id
EG006
num Affected
8
num At Risk
40
group Id
EG007
num Affected
3
num At Risk
45
group Id
EG008
num Affected
1
num At Risk
11
group Id
EG009
num Affected
1
num At Risk
44
group Id
EG010
num Affected
0
num At Risk
8
group Id
EG011
num Affected
0
num At Risk
15
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
36
group Id
EG004
num Affected
0
num At Risk
10
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
2
num At Risk
40
group Id
EG007
num Affected
0
num At Risk
45
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
44
group Id
EG010
num Affected
0
num At Risk
8
group Id
EG011
num Affected
0
num At Risk
15
term
Angina pectoris
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
36
group Id
EG004
num Affected
0
num At Risk
10
group Id
EG005
num Affected
1
num At Risk
10
group Id
EG006
num Affected
1
num At Risk
40
group Id
EG007
num Affected
0
num At Risk
45
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
1
num At Risk
44
group Id
EG010
num Affected
0
num At Risk
8
group Id
EG011
num Affected
1
num At Risk
15
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
36
group Id
EG004
num Affected
0
num At Risk
10
group Id
EG005
num Affected
1
num At Risk
10
group Id
EG006
num Affected
0
num At Risk
40
group Id
EG007
num Affected
0
num At Risk
45
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
44
group Id
EG010
num Affected
0
num At Risk
8
group Id
EG011
num Affected
0
num At Risk
15
term
Bradycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
36
group Id
EG004
num Affected
0
num At Risk
10
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
0
num At Risk
40
group Id
EG007
num Affected
0
num At Risk
45
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
1
num At Risk
44
group Id
EG010
num Affected
0
num At Risk
8
group Id
EG011
num Affected
0
num At Risk
15
term
Palpitations
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
2
num At Risk
36
group Id
EG004
num Affected
0
num At Risk
10
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
2
num At Risk
40
group Id
EG007
num Affected
0
num At Risk
45
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
44
group Id
EG010
num Affected
0
num At Risk
8
group Id
EG011
num Affected
0
num At Risk
15
term
Sinus tachycardia

Complete source fields

description

The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).

event Groups

deaths Num Affected
1
deaths Num At Risk
4
description
Participants with advanced solid tumors who had failed or were intolerant to standard therapy or for whom no standard therapy existed, received 200 mg ADX as monotherapy via IV infusion (approximately 30 minutes) every 2 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
id
EG000
other Num Affected
4
other Num At Risk
4
serious Num Affected
0
serious Num At Risk
4
title
Part A: ADX 200 mg
deaths Num Affected
0
deaths Num At Risk
3
description
Participants with advanced solid tumors who had failed or were intolerant to standard therapy or for whom no standard therapy existed, received 600 mg ADX as monotherapy via IV infusion (approximately 30 minutes) every 2 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
id
EG001
other Num Affected
3
other Num At Risk
3
serious Num Affected
0
serious Num At Risk
3
title
Part A: ADX 600 mg
deaths Num Affected
1
deaths Num At Risk
6
description
Participants with advanced solid tumors who had failed or were intolerant to standard therapy or for whom no standard therapy existed, received 1800 mg ADX as monotherapy via IV infusion (approximately 30 minutes) every 2 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
id
EG002
other Num Affected
5
other Num At Risk
6
serious Num Affected
2
serious Num At Risk
6
title
Part A: ADX 1800 mg
deaths Num Affected
8
deaths Num At Risk
36
description
Participants with PAC received ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (gemcitabine and nab paclitaxel, on Days 1, 8, and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
id
EG003
other Num Affected
36
other Num At Risk
36
serious Num Affected
19
serious Num At Risk
36
title
Part B: PAC, ADX 800 mg
deaths Num Affected
4
deaths Num At Risk
10
description
Participants with LAC received ADX 1200 mg every 3 weeks via IV infusion in addition to the 21-day cycle chemotherapy (carboplatin and pemetrexed, on Day 1) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
id
EG004
other Num Affected
9
other Num At Risk
10
serious Num Affected
5
serious Num At Risk
10
title
Part B: LAC, ADX 1200 mg
deaths Num Affected
3
deaths Num At Risk
10
description
Participants with LSC received ADX 1200 mg every 3 weeks via IV infusion in addition to the 21-day cycle chemotherapy (carboplatin and paclitaxel, on Day 1) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
id
EG005
other Num Affected
10
other Num At Risk
10
serious Num Affected
6
serious Num At Risk
10
title
Part B: LSC, ADX 1200 mg
deaths Num Affected
13
deaths Num At Risk
40
description
Participants with EGC received ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (mFOLFOX6, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
id
EG006
other Num Affected
40
other Num At Risk
40
serious Num Affected
19
serious Num At Risk
40
title
Part B: EGC, ADX 800 mg
deaths Num Affected
22
deaths Num At Risk
45
description
Participants with CRC received FL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (mFOLFOX6 and bevacizumab 5 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
id
EG007
other Num Affected
45
other Num At Risk
45
serious Num Affected
17
serious Num At Risk
45
title
Part B: FL CRC, ADX 800 mg+BEV 5 mg/kg
deaths Num Affected
5
deaths Num At Risk
11
description
Participants with CRC received FL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (mFOLFOX6 and bevacizumab 10 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
id
EG008
other Num Affected
11
other Num At Risk
11
serious Num Affected
3
serious Num At Risk
11
title
Part B: FL CRC, ADX 800 mg+BEV 10 mg/kg
deaths Num Affected
25
deaths Num At Risk
44
description
Participants with CRC received SL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (FOLFIRI and bevacizumab 5 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
id
EG009
other Num Affected
44
other Num At Risk
44
serious Num Affected
13
serious Num At Risk
44
title
Part B: SL CRC, ADX 800 mg+BEV 5 mg/kg
deaths Num Affected
5
deaths Num At Risk
8
description
Participants with CRC received SL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (FOLFIRI and bevacizumab 10 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
id
EG010
other Num Affected
8
other Num At Risk
8
serious Num Affected
4
serious Num At Risk
8
title
Part B: SL CRC, ADX 800 mg+BEV 10 mg/kg
deaths Num Affected
8
deaths Num At Risk
15
description
Participants with BRCA received ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (paclitaxel, on Days 1, 8, and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
id
EG011
other Num Affected
15
other Num At Risk
15
serious Num Affected
5
serious Num At Risk
15
title
Part B: BRCA, ADX 800 mg

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
11
num At Risk
36
group Id
EG004
num Affected
7
num At Risk
10
group Id
EG005
num Affected
2
num At Risk
10
group Id
EG006
num Affected
12
num At Risk
40
group Id
EG007
num Affected
9
num At Risk
45
group Id
EG008
num Affected
1
num At Risk
11
group Id
EG009
num Affected
11
num At Risk
44
group Id
EG010
num Affected
2
num At Risk
8
group Id
EG011
num Affected
3
num At Risk
15
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
36
group Id
EG004
num Affected
0
num At Risk
10
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
0
num At Risk
40
group Id
EG007
num Affected
0
num At Risk
45
group Id
EG008
num Affected
1
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
44
group Id
EG010
num Affected
0
num At Risk
8
group Id
EG011
num Affected
0
num At Risk
15
term
Hypercoagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
36
group Id
EG004
num Affected
0
num At Risk
10
group Id
EG005
num Affected
1
num At Risk
10
group Id
EG006
num Affected
0
num At Risk
40
group Id
EG007
num Affected
0
num At Risk
45
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
44
group Id
EG010
num Affected
0
num At Risk
8
group Id
EG011
num Affected
0
num At Risk
15
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
1
num At Risk
36
group Id
EG004
num Affected
0
num At Risk
10
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
0
num At Risk
40
group Id
EG007
num Affected
0
num At Risk
45
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
1
num At Risk
44
group Id
EG010
num Affected
0
num At Risk
8
group Id
EG011
num Affected
1
num At Risk
15
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
12
num At Risk
36
group Id
EG004
num Affected
4
num At Risk
10
group Id
EG005
num Affected
2
num At Risk
10
group Id
EG006
num Affected
16
num At Risk
40
group Id
EG007
num Affected
18
num At Risk
45
group Id
EG008
num Affected
5
num At Risk
11
group Id
EG009
num Affected
12
num At Risk
44
group Id
EG010
num Affected
5
num At Risk
8
group Id
EG011
num Affected
6
num At Risk
15
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
3
num At Risk
36
group Id
EG004
num Affected
2
num At Risk
10
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
1
num At Risk
40
group Id
EG007
num Affected
0
num At Risk
45
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
44
group Id
EG010
num Affected
0
num At Risk
8
group Id
EG011
num Affected
0
num At Risk
15
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
10
num At Risk
36
group Id
EG004
num Affected
3
num At Risk
10
group Id
EG005
num Affected
3
num At Risk
10
group Id
EG006
num Affected
8
num At Risk
40
group Id
EG007
num Affected
3
num At Risk
45
group Id
EG008
num Affected
1
num At Risk
11
group Id
EG009
num Affected
1
num At Risk
44
group Id
EG010
num Affected
0
num At Risk
8
group Id
EG011
num Affected
0
num At Risk
15
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
36
group Id
EG004
num Affected
0
num At Risk
10
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
2
num At Risk
40
group Id
EG007
num Affected
0
num At Risk
45
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
44
group Id
EG010
num Affected
0
num At Risk
8
group Id
EG011
num Affected
0
num At Risk
15
term
Angina pectoris
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
36
group Id
EG004
num Affected
0
num At Risk
10
group Id
EG005
num Affected
1
num At Risk
10
group Id
EG006
num Affected
1
num At Risk
40
group Id
EG007
num Affected
0
num At Risk
45
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
1
num At Risk
44
group Id
EG010
num Affected
0
num At Risk
8
group Id
EG011
num Affected
1
num At Risk
15
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
36
group Id
EG004
num Affected
0
num At Risk
10
group Id
EG005
num Affected
1
num At Risk
10
group Id
EG006
num Affected
0
num At Risk
40
group Id
EG007
num Affected
0
num At Risk
45
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
44
group Id
EG010
num Affected
0
num At Risk
8
group Id
EG011
num Affected
0
num At Risk
15
term
Bradycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
36
group Id
EG004
num Affected
0
num At Risk
10
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
0
num At Risk
40
group Id
EG007
num Affected
0
num At Risk
45
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
1
num At Risk
44
group Id
EG010
num Affected
0
num At Risk
8
group Id
EG011
num Affected
0
num At Risk
15
term
Palpitations
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
2
num At Risk
36
group Id
EG004
num Affected
0
num At Risk
10
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
2
num At Risk
40
group Id
EG007
num Affected
0
num At Risk
45
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
44
group Id
EG010
num Affected
0
num At Risk
8
group Id
EG011
num Affected
0
num At Risk
15
term
Sinus tachycardia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
36
group Id
EG004
num Affected
1
num At Risk
10
group Id
EG005
num Affected
1
num At Risk
10
group Id
EG006
num Affected
1
num At Risk
40
group Id
EG007
num Affected
0
num At Risk
45
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
44
group Id
EG010
num Affected
0
num At Risk
8
group Id
EG011
num Affected
0
num At Risk
15
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
36
group Id
EG004
num Affected
0
num At Risk
10
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
1
num At Risk
40
group Id
EG007
num Affected
0
num At Risk
45
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
44
group Id
EG010
num Affected
1
num At Risk
8
group Id
EG011
num Affected
0
num At Risk
15
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
36
group Id
EG004
num Affected
0
num At Risk
10
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
0
num At Risk
40
group Id
EG007
num Affected
1
num At Risk
45
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
44
group Id
EG010
num Affected
0
num At Risk
8
group Id
EG011
num Affected
0
num At Risk
15
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
36
group Id
EG004
num Affected
1
num At Risk
10
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
0
num At Risk
40
group Id
EG007
num Affected
0
num At Risk
45
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
44
group Id
EG010
num Affected
0
num At Risk
8
group Id
EG011
num Affected
0
num At Risk
15
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
36
group Id
EG004
num Affected
1
num At Risk
10
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
0
num At Risk
40
group Id
EG007
num Affected
0
num At Risk
45
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
44
group Id
EG010
num Affected
0
num At Risk
8
group Id
EG011
num Affected
0
num At Risk
15
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
36
group Id
EG004
num Affected
0
num At Risk
10
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
0
num At Risk
40
group Id
EG007
num Affected
1
num At Risk
45
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
44
group Id
EG010
num Affected
0
num At Risk
8
group Id
EG011
num Affected
0
num At Risk
15
term
Acute coronary syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
36
group Id
EG004
num Affected
0
num At Risk
10
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
0
num At Risk
40
group Id
EG007
num Affected
1
num At Risk
45
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
44
group Id
EG010
num Affected
0
num At Risk
8
group Id
EG011
num Affected
0
num At Risk
15
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
1
num At Risk
36
group Id
EG004
num Affected
0
num At Risk
10
group Id
EG005
num Affected
1
num At Risk
10
group Id
EG006
num Affected
0
num At Risk
40
group Id
EG007
num Affected
0
num At Risk
45
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
44
group Id
EG010
num Affected
0
num At Risk
8
group Id
EG011
num Affected
1
num At Risk
15
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
36
group Id
EG004
num Affected
0
num At Risk
10
group Id
EG005
num Affected
1
num At Risk
10
group Id
EG006
num Affected
0
num At Risk
40
group Id
EG007
num Affected
0
num At Risk
45
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
44
group Id
EG010
num Affected
0
num At Risk
8
group Id
EG011
num Affected
0
num At Risk
15
term
Atrial flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
36
group Id
EG004
num Affected
0
num At Risk
10
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
0
num At Risk
40
group Id
EG007
num Affected
0
num At Risk
45
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
1
num At Risk
44
group Id
EG010
num Affected
0
num At Risk
8
group Id
EG011
num Affected
0
num At Risk
15
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
36
group Id
EG004
num Affected
1
num At Risk
10
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
0
num At Risk
40
group Id
EG007
num Affected
0
num At Risk
45
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
44
group Id
EG010
num Affected
0
num At Risk
8
group Id
EG011
num Affected
0
num At Risk
15
term
Pericardial effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
36
group Id
EG004
num Affected
0
num At Risk
10
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
1
num At Risk
40
group Id
EG007
num Affected
0
num At Risk
45
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
44
group Id
EG010
num Affected
0
num At Risk
8
group Id
EG011
num Affected
0
num At Risk
15
term
Adrenal haemorrhage

time Frame

Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)

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

Preserved source evidence · Not medical advice