NCT02541604 · ADVERSE EVENTS

Adverse events

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Preliminary Efficacy of Atezolizumab (Anti-Programmed Death-Ligand 1 [PD-L1] Antibody) in Pediatric and Young Adult Participants With Solid Tumors · Source last updated 2020-02-25

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: From baseline up to approximately 42 months
Other-event reporting threshold: 5%

Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
COHORT 1 EWING SARCOMA	4 / 11	11 / 11	6 / 11
COHORT 2 HODGKIN LYMPHOMA	3 / 9	8 / 9	5 / 9
COHORT 3 NEUROBLASTOMA	2 / 11	11 / 11	7 / 11
COHORT 4 NON HODGKIN LYMPHOMA	0 / 3	3 / 3	2 / 3
COHORT 5 NON-RHABDOMYOSARCOMA SOFT TISSUE SARCOMA;	3 / 10	10 / 10	9 / 10
COHORT 6 OSTEOSARCOMA	6 / 10	10 / 10	8 / 10
COHORT 7 RHABDOMYOSARCOMA	3 / 10	10 / 10	9 / 10
COHORT 8 WILMS TUMOR	5 / 10	10 / 10	9 / 10
COHORT 9 OTHER TUMOR TYPES WITH DOCUMENTED PD-L1 EXPRESSION	2 / 4	4 / 4	3 / 4
COHORT 10 OTHER TUMOR TYPES WITHOUT DOCUMENTED PD-L1 EXPRESSION	3 / 4	3 / 4	4 / 4
COHORT 11 RHABDOID TUMOR	1 / 2	2 / 2	2 / 2
COHORT 12 ATYPICAL TERATOID RHABDOID TUMOR	1 / 3	2 / 3	3 / 3

Group identifiers: EG000: COHORT 1 · EG001: COHORT 2 · EG002: COHORT 3 · EG003: COHORT 4 · EG004: COHORT 5 · EG005: COHORT 6 · EG006: COHORT 7 · EG007: COHORT 8 · EG008: COHORT 9 · EG009: COHORT 10 · EG010: COHORT 11 · EG011: COHORT 12

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 version 22.0
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
10
num Events
0
group Id
EG005
num Affected
0
num At Risk
10
num Events
0
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
1
num At Risk
10
num Events
1
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
2
num Events
0
group Id
EG011
num Affected
0
num At Risk
3
num Events
0
term
ANAEMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 22.0
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
10
num Events
0
group Id
EG005
num Affected
1
num At Risk
10
num Events
1
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
2
num Events
0
group Id
EG011
num Affected
0
num At Risk
3
num Events
0
term
FEBRILE NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA version 22.0
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
10
num Events
0
group Id
EG005
num Affected
0
num At Risk
10
num Events
0
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
1
num At Risk
4
num Events
1
group Id
EG010
num Affected
0
num At Risk
2
num Events
0
group Id
EG011
num Affected
0
num At Risk
3
num Events
0
term
PAPILLOEDEMA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 22.0
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
10
num Events
0
group Id
EG005
num Affected
0
num At Risk
10
num Events
0
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
1
num At Risk
10
num Events
1
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
2
num Events
0
group Id
EG011
num Affected
0
num At Risk
3
num Events
0
term
ABDOMINAL DISTENSION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 22.0
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
1
num At Risk
10
num Events
1
group Id
EG005
num Affected
0
num At Risk
10
num Events
0
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
2
num Events
0
group Id
EG011
num Affected
0
num At Risk
3
num Events
0
term
CONSTIPATION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 22.0
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
10
num Events
0
group Id
EG005
num Affected
0
num At Risk
10
num Events
0
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
1
num At Risk
10
num Events
1
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
2
num Events
0
group Id
EG011
num Affected
0
num At Risk
3
num Events
0
term
LARGE INTESTINAL OBSTRUCTION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 22.0
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
10
num Events
0
group Id
EG005
num Affected
0
num At Risk
10
num Events
0
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
2
num Events
0
group Id
EG011
num Affected
0
num At Risk
3
num Events
0
term
PANCREATITIS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 22.0
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
10
num Events
0
group Id
EG005
num Affected
0
num At Risk
10
num Events
0
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
1
num At Risk
4
num Events
1
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
2
num Events
0
group Id
EG011
num Affected
0
num At Risk
3
num Events
0
term
UPPER GASTROINTESTINAL HAEMORRHAGE
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA version 22.0
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
10
num Events
0
group Id
EG005
num Affected
2
num At Risk
10
num Events
2
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
2
num Events
0
group Id
EG011
num Affected
0
num At Risk
3
num Events
0
term
CHEST PAIN
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA version 22.0
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
10
num Events
0
group Id
EG005
num Affected
0
num At Risk
10
num Events
0
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
2
num Events
0
group Id
EG011
num Affected
0
num At Risk
3
num Events
0
term
FATIGUE
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA version 22.0
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
10
num Events
0
group Id
EG005
num Affected
1
num At Risk
10
num Events
1
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
1
num At Risk
10
num Events
1
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
2
num Events
0
group Id
EG011
num Affected
0
num At Risk
3
num Events
0
term
PAIN
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA version 22.0
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
group Id
EG002
num Affected
1
num At Risk
11
num Events
1
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
1
num At Risk
10
num Events
1
group Id
EG005
num Affected
0
num At Risk
10
num Events
0
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
2
num At Risk
10
num Events
3
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
2
num Events
0
group Id
EG011
num Affected
0
num At Risk
3
num Events
0
term
PYREXIA

Other reported adverse events

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

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 22.0
stats
group Id
EG000
num Affected
3
num At Risk
11
num Events
4
group Id
EG001
num Affected
1
num At Risk
9
num Events
1
group Id
EG002
num Affected
3
num At Risk
11
num Events
6
group Id
EG003
num Affected
1
num At Risk
3
num Events
1
group Id
EG004
num Affected
5
num At Risk
10
num Events
12
group Id
EG005
num Affected
2
num At Risk
10
num Events
2
group Id
EG006
num Affected
3
num At Risk
10
num Events
3
group Id
EG007
num Affected
2
num At Risk
10
num Events
2
group Id
EG008
num Affected
1
num At Risk
4
num Events
1
group Id
EG009
num Affected
1
num At Risk
4
num Events
1
group Id
EG010
num Affected
1
num At Risk
2
num Events
1
group Id
EG011
num Affected
1
num At Risk
3
num Events
1
term
ANAEMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 22.0
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
10
num Events
0
group Id
EG005
num Affected
0
num At Risk
10
num Events
0
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
2
num At Risk
10
num Events
2
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
2
num Events
0
group Id
EG011
num Affected
0
num At Risk
3
num Events
0
term
FEBRILE NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 22.0
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
10
num Events
0
group Id
EG005
num Affected
0
num At Risk
10
num Events
0
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
1
num At Risk
10
num Events
1
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
2
num Events
0
group Id
EG011
num Affected
0
num At Risk
3
num Events
0
term
LEUKOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 22.0
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
1
num At Risk
10
num Events
2
group Id
EG005
num Affected
0
num At Risk
10
num Events
0
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
2
num Events
0
group Id
EG011
num Affected
0
num At Risk
3
num Events
0
term
LYMPHADENOPATHY
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 22.0
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
1
num At Risk
10
num Events
2
group Id
EG005
num Affected
0
num At Risk
10
num Events
0
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
1
num At Risk
10
num Events
1
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
2
num Events
0
group Id
EG011
num Affected
0
num At Risk
3
num Events
0
term
LYMPHOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 22.0
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
1
num At Risk
10
num Events
1
group Id
EG005
num Affected
0
num At Risk
10
num Events
0
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
1
num At Risk
10
num Events
1
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
2
num Events
0
group Id
EG011
num Affected
0
num At Risk
3
num Events
0
term
NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 22.0
stats
group Id
EG000
num Affected
2
num At Risk
11
num Events
3
group Id
EG001
num Affected
2
num At Risk
9
num Events
2
group Id
EG002
num Affected
1
num At Risk
11
num Events
1
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
10
num Events
0
group Id
EG005
num Affected
0
num At Risk
10
num Events
0
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
2
num At Risk
10
num Events
2
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
1
num At Risk
4
num Events
1
group Id
EG010
num Affected
0
num At Risk
2
num Events
0
group Id
EG011
num Affected
0
num At Risk
3
num Events
0
term
THROMBOCYTOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 22.0
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
10
num Events
0
group Id
EG005
num Affected
0
num At Risk
10
num Events
0
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
1
num At Risk
4
num Events
1
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
2
num Events
0
group Id
EG011
num Affected
0
num At Risk
3
num Events
0
term
THROMBOCYTOSIS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 22.0
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
1
num At Risk
3
num Events
1
group Id
EG004
num Affected
0
num At Risk
10
num Events
0
group Id
EG005
num Affected
0
num At Risk
10
num Events
0
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
2
num Events
0
group Id
EG011
num Affected
0
num At Risk
3
num Events
0
term
PERICARDIAL EFFUSION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 22.0
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
10
num Events
0
group Id
EG005
num Affected
0
num At Risk
10
num Events
0
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
2
num At Risk
10
num Events
2
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
2
num Events
0
group Id
EG011
num Affected
0
num At Risk
3
num Events
0
term
SINUS TACHYCARDIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 22.0
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
group Id
EG001
num Affected
1
num At Risk
9
num Events
1
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
1
num At Risk
3
num Events
1
group Id
EG004
num Affected
1
num At Risk
10
num Events
1
group Id
EG005
num Affected
1
num At Risk
10
num Events
1
group Id
EG006
num Affected
2
num At Risk
10
num Events
2
group Id
EG007
num Affected
1
num At Risk
10
num Events
1
group Id
EG008
num Affected
1
num At Risk
4
num Events
1
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
2
num Events
0
group Id
EG011
num Affected
0
num At Risk
3
num Events
0
term
TACHYCARDIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Congenital, familial and genetic disorders
source Vocabulary
MedDRA version 22.0
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
10
num Events
0
group Id
EG005
num Affected
0
num At Risk
10
num Events
0
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
1
num At Risk
4
num Events
1
group Id
EG010
num Affected
0
num At Risk
2
num Events
0
group Id
EG011
num Affected
0
num At Risk
3
num Events
0
term
FANCONI SYNDROME

Complete source fields

description

Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.

event Groups

deaths Num Affected
6
deaths Num At Risk
11
description
EWING SARCOMA
id
EG000
other Num Affected
11
other Num At Risk
11
serious Num Affected
4
serious Num At Risk
11
title
COHORT 1
deaths Num Affected
5
deaths Num At Risk
9
description
HODGKIN LYMPHOMA
id
EG001
other Num Affected
8
other Num At Risk
9
serious Num Affected
3
serious Num At Risk
9
title
COHORT 2
deaths Num Affected
7
deaths Num At Risk
11
description
NEUROBLASTOMA
id
EG002
other Num Affected
11
other Num At Risk
11
serious Num Affected
2
serious Num At Risk
11
title
COHORT 3
deaths Num Affected
2
deaths Num At Risk
3
description
NON HODGKIN LYMPHOMA
id
EG003
other Num Affected
3
other Num At Risk
3
serious Num Affected
0
serious Num At Risk
3
title
COHORT 4
deaths Num Affected
9
deaths Num At Risk
10
description
NON-RHABDOMYOSARCOMA SOFT TISSUE SARCOMA;
id
EG004
other Num Affected
10
other Num At Risk
10
serious Num Affected
3
serious Num At Risk
10
title
COHORT 5
deaths Num Affected
8
deaths Num At Risk
10
description
OSTEOSARCOMA
id
EG005
other Num Affected
10
other Num At Risk
10
serious Num Affected
6
serious Num At Risk
10
title
COHORT 6
deaths Num Affected
9
deaths Num At Risk
10
description
RHABDOMYOSARCOMA
id
EG006
other Num Affected
10
other Num At Risk
10
serious Num Affected
3
serious Num At Risk
10
title
COHORT 7
deaths Num Affected
9
deaths Num At Risk
10
description
WILMS TUMOR
id
EG007
other Num Affected
10
other Num At Risk
10
serious Num Affected
5
serious Num At Risk
10
title
COHORT 8
deaths Num Affected
3
deaths Num At Risk
4
description
OTHER TUMOR TYPES WITH DOCUMENTED PD-L1 EXPRESSION
id
EG008
other Num Affected
4
other Num At Risk
4
serious Num Affected
2
serious Num At Risk
4
title
COHORT 9
deaths Num Affected
4
deaths Num At Risk
4
description
OTHER TUMOR TYPES WITHOUT DOCUMENTED PD-L1 EXPRESSION
id
EG009
other Num Affected
3
other Num At Risk
4
serious Num Affected
3
serious Num At Risk
4
title
COHORT 10
deaths Num Affected
2
deaths Num At Risk
2
description
RHABDOID TUMOR
id
EG010
other Num Affected
2
other Num At Risk
2
serious Num Affected
1
serious Num At Risk
2
title
COHORT 11
deaths Num Affected
3
deaths Num At Risk
3
description
ATYPICAL TERATOID RHABDOID TUMOR
id
EG011
other Num Affected
2
other Num At Risk
3
serious Num Affected
1
serious Num At Risk
3
title
COHORT 12

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 22.0
stats
group Id
EG000
num Affected
3
num At Risk
11
num Events
4
group Id
EG001
num Affected
1
num At Risk
9
num Events
1
group Id
EG002
num Affected
3
num At Risk
11
num Events
6
group Id
EG003
num Affected
1
num At Risk
3
num Events
1
group Id
EG004
num Affected
5
num At Risk
10
num Events
12
group Id
EG005
num Affected
2
num At Risk
10
num Events
2
group Id
EG006
num Affected
3
num At Risk
10
num Events
3
group Id
EG007
num Affected
2
num At Risk
10
num Events
2
group Id
EG008
num Affected
1
num At Risk
4
num Events
1
group Id
EG009
num Affected
1
num At Risk
4
num Events
1
group Id
EG010
num Affected
1
num At Risk
2
num Events
1
group Id
EG011
num Affected
1
num At Risk
3
num Events
1
term
ANAEMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 22.0
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
10
num Events
0
group Id
EG005
num Affected
0
num At Risk
10
num Events
0
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
2
num At Risk
10
num Events
2
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
2
num Events
0
group Id
EG011
num Affected
0
num At Risk
3
num Events
0
term
FEBRILE NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 22.0
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
10
num Events
0
group Id
EG005
num Affected
0
num At Risk
10
num Events
0
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
1
num At Risk
10
num Events
1
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
2
num Events
0
group Id
EG011
num Affected
0
num At Risk
3
num Events
0
term
LEUKOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 22.0
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
1
num At Risk
10
num Events
2
group Id
EG005
num Affected
0
num At Risk
10
num Events
0
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
2
num Events
0
group Id
EG011
num Affected
0
num At Risk
3
num Events
0
term
LYMPHADENOPATHY
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 22.0
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
1
num At Risk
10
num Events
2
group Id
EG005
num Affected
0
num At Risk
10
num Events
0
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
1
num At Risk
10
num Events
1
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
2
num Events
0
group Id
EG011
num Affected
0
num At Risk
3
num Events
0
term
LYMPHOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 22.0
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
1
num At Risk
10
num Events
1
group Id
EG005
num Affected
0
num At Risk
10
num Events
0
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
1
num At Risk
10
num Events
1
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
2
num Events
0
group Id
EG011
num Affected
0
num At Risk
3
num Events
0
term
NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 22.0
stats
group Id
EG000
num Affected
2
num At Risk
11
num Events
3
group Id
EG001
num Affected
2
num At Risk
9
num Events
2
group Id
EG002
num Affected
1
num At Risk
11
num Events
1
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
10
num Events
0
group Id
EG005
num Affected
0
num At Risk
10
num Events
0
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
2
num At Risk
10
num Events
2
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
1
num At Risk
4
num Events
1
group Id
EG010
num Affected
0
num At Risk
2
num Events
0
group Id
EG011
num Affected
0
num At Risk
3
num Events
0
term
THROMBOCYTOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 22.0
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
10
num Events
0
group Id
EG005
num Affected
0
num At Risk
10
num Events
0
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
1
num At Risk
4
num Events
1
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
2
num Events
0
group Id
EG011
num Affected
0
num At Risk
3
num Events
0
term
THROMBOCYTOSIS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 22.0
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
1
num At Risk
3
num Events
1
group Id
EG004
num Affected
0
num At Risk
10
num Events
0
group Id
EG005
num Affected
0
num At Risk
10
num Events
0
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
2
num Events
0
group Id
EG011
num Affected
0
num At Risk
3
num Events
0
term
PERICARDIAL EFFUSION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 22.0
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
10
num Events
0
group Id
EG005
num Affected
0
num At Risk
10
num Events
0
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
2
num At Risk
10
num Events
2
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
2
num Events
0
group Id
EG011
num Affected
0
num At Risk
3
num Events
0
term
SINUS TACHYCARDIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 22.0
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
group Id
EG001
num Affected
1
num At Risk
9
num Events
1
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
1
num At Risk
3
num Events
1
group Id
EG004
num Affected
1
num At Risk
10
num Events
1
group Id
EG005
num Affected
1
num At Risk
10
num Events
1
group Id
EG006
num Affected
2
num At Risk
10
num Events
2
group Id
EG007
num Affected
1
num At Risk
10
num Events
1
group Id
EG008
num Affected
1
num At Risk
4
num Events
1
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
2
num Events
0
group Id
EG011
num Affected
0
num At Risk
3
num Events
0
term
TACHYCARDIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Congenital, familial and genetic disorders
source Vocabulary
MedDRA version 22.0
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
10
num Events
0
group Id
EG005
num Affected
0
num At Risk
10
num Events
0
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
1
num At Risk
4
num Events
1
group Id
EG010
num Affected
0
num At Risk
2
num Events
0
group Id
EG011
num Affected
0
num At Risk
3
num Events
0
term
FANCONI SYNDROME

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 22.0
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
10
num Events
0
group Id
EG005
num Affected
0
num At Risk
10
num Events
0
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
1
num At Risk
10
num Events
1
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
2
num Events
0
group Id
EG011
num Affected
0
num At Risk
3
num Events
0
term
ANAEMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 22.0
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
10
num Events
0
group Id
EG005
num Affected
1
num At Risk
10
num Events
1
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
2
num Events
0
group Id
EG011
num Affected
0
num At Risk
3
num Events
0
term
FEBRILE NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA version 22.0
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
10
num Events
0
group Id
EG005
num Affected
0
num At Risk
10
num Events
0
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
1
num At Risk
4
num Events
1
group Id
EG010
num Affected
0
num At Risk
2
num Events
0
group Id
EG011
num Affected
0
num At Risk
3
num Events
0
term
PAPILLOEDEMA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 22.0
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
10
num Events
0
group Id
EG005
num Affected
0
num At Risk
10
num Events
0
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
1
num At Risk
10
num Events
1
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
2
num Events
0
group Id
EG011
num Affected
0
num At Risk
3
num Events
0
term
ABDOMINAL DISTENSION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 22.0
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
1
num At Risk
10
num Events
1
group Id
EG005
num Affected
0
num At Risk
10
num Events
0
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
2
num Events
0
group Id
EG011
num Affected
0
num At Risk
3
num Events
0
term
CONSTIPATION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 22.0
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
10
num Events
0
group Id
EG005
num Affected
0
num At Risk
10
num Events
0
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
1
num At Risk
10
num Events
1
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
2
num Events
0
group Id
EG011
num Affected
0
num At Risk
3
num Events
0
term
LARGE INTESTINAL OBSTRUCTION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 22.0
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
10
num Events
0
group Id
EG005
num Affected
0
num At Risk
10
num Events
0
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
2
num Events
0
group Id
EG011
num Affected
0
num At Risk
3
num Events
0
term
PANCREATITIS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 22.0
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
10
num Events
0
group Id
EG005
num Affected
0
num At Risk
10
num Events
0
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
1
num At Risk
4
num Events
1
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
2
num Events
0
group Id
EG011
num Affected
0
num At Risk
3
num Events
0
term
UPPER GASTROINTESTINAL HAEMORRHAGE
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA version 22.0
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
10
num Events
0
group Id
EG005
num Affected
2
num At Risk
10
num Events
2
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
2
num Events
0
group Id
EG011
num Affected
0
num At Risk
3
num Events
0
term
CHEST PAIN
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA version 22.0
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
10
num Events
0
group Id
EG005
num Affected
0
num At Risk
10
num Events
0
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
2
num Events
0
group Id
EG011
num Affected
0
num At Risk
3
num Events
0
term
FATIGUE
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA version 22.0
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
10
num Events
0
group Id
EG005
num Affected
1
num At Risk
10
num Events
1
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
1
num At Risk
10
num Events
1
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
2
num Events
0
group Id
EG011
num Affected
0
num At Risk
3
num Events
0
term
PAIN
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA version 22.0
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
group Id
EG002
num Affected
1
num At Risk
11
num Events
1
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
1
num At Risk
10
num Events
1
group Id
EG005
num Affected
0
num At Risk
10
num Events
0
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
2
num At Risk
10
num Events
3
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
2
num Events
0
group Id
EG011
num Affected
0
num At Risk
3
num Events
0
term
PYREXIA

time Frame

From baseline up to approximately 42 months

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

Preserved source evidence · Not medical advice