NCT02587598 · ADVERSE EVENTS

Adverse events

Study of INCB053914 in Subjects With Advanced Malignancies · Source last updated 2021-12-08

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: up to approximately 6 months
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Part 1 and 2 - INCB053914: 100 mg QD Part 1 and 2 - INCB053914: 100 mg QD	3 / 4	4 / 4	4 / 4
Part 1 and 2 - INCB053914: 50 mg BID Part 1 and 2 - INCB053914: 50 mg BID	6 / 11	11 / 11	8 / 11
Part 1 and 2 - INCB053914: 65 mg BID Part 1 and 2 - INCB053914: 65 mg BID	3 / 4	4 / 4	4 / 4
Part 1 and 2 - INCB053914: 80 mg BID Part 1 and 2 - INCB053914: 80 mg BID	6 / 21	20 / 21	19 / 21
Part 1 and 2 - INCB053914: 100 mg BID Part 1 and 2 - INCB053914: 100 mg BID	8 / 12	12 / 12	9 / 12
Part 1 and 2 - INCB053914: 115 mg BID Part 1 and 2 - INCB053914: 115 mg BID	5 / 6	6 / 6	4 / 6
Part 3 and 4 - INCB053914: 50 mg BID + Cytarabine Part 3 and 4 - INCB053914: 50 mg BID + Cytarabine	5 / 6	6 / 6	6 / 6
Part 3 and 4 - INCB053914: 50 mg BID + Azacitidine Part 3 and 4 - INCB053914: 50 mg BID + Azacitidine	5 / 7	7 / 7	7 / 7
Part 3 and 4 - INCB053914: 80 mg BID + Azacitidine Part 3 and 4 - INCB053914: 80 mg BID + Azacitidine	6 / 9	8 / 9	9 / 9
Part 3 and 4 - INCB053914: 50 mg BID + Ruxolitinib Part 3 and 4 - INCB053914: 50 mg BID + Ruxolitinib	0 / 3	3 / 3	1 / 3
Part 3 and 4 - INCB053914: 80 mg BID + Ruxolitinib Part 3 and 4 - INCB053914: 80 mg BID + Ruxolitinib	5 / 14	14 / 14	3 / 14

Group identifiers: EG000: Part 1 and 2 - INCB053914: 100 mg QD · EG001: Part 1 and 2 - INCB053914: 50 mg BID · EG002: Part 1 and 2 - INCB053914: 65 mg BID · EG003: Part 1 and 2 - INCB053914: 80 mg BID · EG004: Part 1 and 2 - INCB053914: 100 mg BID · EG005: Part 1 and 2 - INCB053914: 115 mg BID · EG006: Part 3 and 4 - INCB053914: 50 mg BID + Cytarabine · EG007: Part 3 and 4 - INCB053914: 50 mg BID + Azacitidine · EG008: Part 3 and 4 - INCB053914: 80 mg BID + Azacitidine · EG009: Part 3 and 4 - INCB053914: 50 mg BID + Ruxolitinib · EG010: Part 3 and 4 - INCB053914: 80 mg BID + Ruxolitinib

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
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
1
num At Risk
11
num Events
1
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
21
num Events
0
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
0
num At Risk
6
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
0
num At Risk
9
num Events
0
group Id
EG009
num Affected
0
num At Risk
3
num Events
0
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
term
Acute febrile neutrophilic dermatosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
11
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
21
num Events
0
group Id
EG004
num Affected
1
num At Risk
12
num Events
1
group Id
EG005
num Affected
1
num At Risk
6
num Events
1
group Id
EG006
num Affected
0
num At Risk
6
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
1
num At Risk
9
num Events
1
group Id
EG009
num Affected
0
num At Risk
3
num Events
0
group Id
EG010
num Affected
1
num At Risk
14
num Events
1
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
11
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
21
num Events
0
group Id
EG004
num Affected
1
num At Risk
12
num Events
1
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
1
num At Risk
6
num Events
3
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
1
num At Risk
9
num Events
1
group Id
EG009
num Affected
0
num At Risk
3
num Events
0
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
11
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
21
num Events
0
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
1
num At Risk
6
num Events
1
group Id
EG006
num Affected
0
num At Risk
6
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
0
num At Risk
9
num Events
0
group Id
EG009
num Affected
0
num At Risk
3
num Events
0
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
term
Arthralgia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
11
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
21
num Events
0
group Id
EG004
num Affected
1
num At Risk
12
num Events
1
group Id
EG005
num Affected
1
num At Risk
6
num Events
1
group Id
EG006
num Affected
0
num At Risk
6
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
1
num At Risk
9
num Events
1
group Id
EG009
num Affected
0
num At Risk
3
num Events
0
group Id
EG010
num Affected
1
num At Risk
14
num Events
2
term
Aspartate aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
11
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
21
num Events
0
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
1
num At Risk
6
num Events
1
group Id
EG006
num Affected
0
num At Risk
6
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
0
num At Risk
9
num Events
0
group Id
EG009
num Affected
0
num At Risk
3
num Events
0
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
term
Bacteraemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
11
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
1
num At Risk
21
num Events
1
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
0
num At Risk
6
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
0
num At Risk
9
num Events
0
group Id
EG009
num Affected
0
num At Risk
3
num Events
0
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
term
Carotid artery occlusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
11
num Events
0
group Id
EG002
num Affected
1
num At Risk
4
num Events
1
group Id
EG003
num Affected
0
num At Risk
21
num Events
0
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
0
num At Risk
6
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
0
num At Risk
9
num Events
0
group Id
EG009
num Affected
0
num At Risk
3
num Events
0
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
term
Colitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
2
group Id
EG001
num Affected
0
num At Risk
11
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
21
num Events
0
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
0
num At Risk
6
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
0
num At Risk
9
num Events
0
group Id
EG009
num Affected
0
num At Risk
3
num Events
0
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
term
Device related infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
11
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
2
num At Risk
21
num Events
2
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
1
num At Risk
6
num Events
1
group Id
EG006
num Affected
0
num At Risk
6
num Events
0
group Id
EG007
num Affected
3
num At Risk
7
num Events
3
group Id
EG008
num Affected
0
num At Risk
9
num Events
0
group Id
EG009
num Affected
0
num At Risk
3
num Events
0
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
term
Disease progression
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
11
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
21
num Events
0
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
1
num At Risk
6
num Events
1
group Id
EG006
num Affected
0
num At Risk
6
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
0
num At Risk
9
num Events
0
group Id
EG009
num Affected
0
num At Risk
3
num Events
0
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
term
Fall
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
2
group Id
EG001
num Affected
3
num At Risk
11
num Events
4
group Id
EG002
num Affected
1
num At Risk
4
num Events
1
group Id
EG003
num Affected
1
num At Risk
21
num Events
1
group Id
EG004
num Affected
2
num At Risk
12
num Events
3
group Id
EG005
num Affected
2
num At Risk
6
num Events
3
group Id
EG006
num Affected
1
num At Risk
6
num Events
1
group Id
EG007
num Affected
3
num At Risk
7
num Events
4
group Id
EG008
num Affected
3
num At Risk
9
num Events
3
group Id
EG009
num Affected
0
num At Risk
3
num Events
0
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
term
Febrile neutropenia

Other reported adverse events

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

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
11
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
21
num Events
0
group Id
EG004
num Affected
1
num At Risk
12
num Events
1
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
2
num At Risk
6
num Events
2
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
0
num At Risk
9
num Events
0
group Id
EG009
num Affected
0
num At Risk
3
num Events
0
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
11
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
4
num At Risk
21
num Events
4
group Id
EG004
num Affected
3
num At Risk
12
num Events
3
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
0
num At Risk
6
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
3
num At Risk
9
num Events
4
group Id
EG009
num Affected
1
num At Risk
3
num Events
1
group Id
EG010
num Affected
1
num At Risk
14
num Events
1
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
11
num Events
0
group Id
EG002
num Affected
1
num At Risk
4
num Events
1
group Id
EG003
num Affected
0
num At Risk
21
num Events
0
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
0
num At Risk
6
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
0
num At Risk
9
num Events
0
group Id
EG009
num Affected
0
num At Risk
3
num Events
0
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
term
Abdominal pain lower
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
11
num Events
0
group Id
EG002
num Affected
1
num At Risk
4
num Events
1
group Id
EG003
num Affected
0
num At Risk
21
num Events
0
group Id
EG004
num Affected
2
num At Risk
12
num Events
2
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
0
num At Risk
6
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
1
num At Risk
9
num Events
1
group Id
EG009
num Affected
0
num At Risk
3
num Events
0
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
11
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
21
num Events
0
group Id
EG004
num Affected
1
num At Risk
12
num Events
1
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
0
num At Risk
6
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
0
num At Risk
9
num Events
0
group Id
EG009
num Affected
0
num At Risk
3
num Events
0
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
term
Acute febrile neutrophilic dermatosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
11
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
2
num At Risk
21
num Events
2
group Id
EG004
num Affected
1
num At Risk
12
num Events
1
group Id
EG005
num Affected
1
num At Risk
6
num Events
1
group Id
EG006
num Affected
0
num At Risk
6
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
2
num At Risk
9
num Events
2
group Id
EG009
num Affected
0
num At Risk
3
num Events
0
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
term
Acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
11
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
21
num Events
0
group Id
EG004
num Affected
1
num At Risk
12
num Events
1
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
0
num At Risk
6
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
0
num At Risk
9
num Events
0
group Id
EG009
num Affected
0
num At Risk
3
num Events
0
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
term
Agitation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
2
num At Risk
4
num Events
2
group Id
EG001
num Affected
2
num At Risk
11
num Events
2
group Id
EG002
num Affected
1
num At Risk
4
num Events
2
group Id
EG003
num Affected
8
num At Risk
21
num Events
10
group Id
EG004
num Affected
4
num At Risk
12
num Events
5
group Id
EG005
num Affected
2
num At Risk
6
num Events
2
group Id
EG006
num Affected
4
num At Risk
6
num Events
4
group Id
EG007
num Affected
1
num At Risk
7
num Events
1
group Id
EG008
num Affected
4
num At Risk
9
num Events
8
group Id
EG009
num Affected
0
num At Risk
3
num Events
0
group Id
EG010
num Affected
6
num At Risk
14
num Events
7
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
2
num At Risk
4
num Events
3
group Id
EG001
num Affected
2
num At Risk
11
num Events
2
group Id
EG002
num Affected
3
num At Risk
4
num Events
4
group Id
EG003
num Affected
5
num At Risk
21
num Events
10
group Id
EG004
num Affected
5
num At Risk
12
num Events
22
group Id
EG005
num Affected
2
num At Risk
6
num Events
2
group Id
EG006
num Affected
3
num At Risk
6
num Events
9
group Id
EG007
num Affected
3
num At Risk
7
num Events
4
group Id
EG008
num Affected
3
num At Risk
9
num Events
3
group Id
EG009
num Affected
1
num At Risk
3
num Events
4
group Id
EG010
num Affected
5
num At Risk
14
num Events
9
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
11
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
21
num Events
0
group Id
EG004
num Affected
1
num At Risk
12
num Events
1
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
0
num At Risk
6
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
0
num At Risk
9
num Events
0
group Id
EG009
num Affected
0
num At Risk
3
num Events
0
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
term
Animal scratch
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
11
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
21
num Events
0
group Id
EG004
num Affected
1
num At Risk
12
num Events
1
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
0
num At Risk
6
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
1
num At Risk
9
num Events
1
group Id
EG009
num Affected
0
num At Risk
3
num Events
0
group Id
EG010
num Affected
1
num At Risk
14
num Events
1
term
Anxiety
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
1
num At Risk
11
num Events
1
group Id
EG002
num Affected
2
num At Risk
4
num Events
2
group Id
EG003
num Affected
2
num At Risk
21
num Events
2
group Id
EG004
num Affected
1
num At Risk
12
num Events
1
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
1
num At Risk
6
num Events
1
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
2
num At Risk
9
num Events
3
group Id
EG009
num Affected
0
num At Risk
3
num Events
0
group Id
EG010
num Affected
2
num At Risk
14
num Events
3
term
Arthralgia

Complete source fields

event Groups

deaths Num Affected
4
deaths Num At Risk
4
description
Part 1 and 2 - INCB053914: 100 mg QD
id
EG000
other Num Affected
4
other Num At Risk
4
serious Num Affected
3
serious Num At Risk
4
title
Part 1 and 2 - INCB053914: 100 mg QD
deaths Num Affected
8
deaths Num At Risk
11
description
Part 1 and 2 - INCB053914: 50 mg BID
id
EG001
other Num Affected
11
other Num At Risk
11
serious Num Affected
6
serious Num At Risk
11
title
Part 1 and 2 - INCB053914: 50 mg BID
deaths Num Affected
4
deaths Num At Risk
4
description
Part 1 and 2 - INCB053914: 65 mg BID
id
EG002
other Num Affected
4
other Num At Risk
4
serious Num Affected
3
serious Num At Risk
4
title
Part 1 and 2 - INCB053914: 65 mg BID
deaths Num Affected
19
deaths Num At Risk
21
description
Part 1 and 2 - INCB053914: 80 mg BID
id
EG003
other Num Affected
20
other Num At Risk
21
serious Num Affected
6
serious Num At Risk
21
title
Part 1 and 2 - INCB053914: 80 mg BID
deaths Num Affected
9
deaths Num At Risk
12
description
Part 1 and 2 - INCB053914: 100 mg BID
id
EG004
other Num Affected
12
other Num At Risk
12
serious Num Affected
8
serious Num At Risk
12
title
Part 1 and 2 - INCB053914: 100 mg BID
deaths Num Affected
4
deaths Num At Risk
6
description
Part 1 and 2 - INCB053914: 115 mg BID
id
EG005
other Num Affected
6
other Num At Risk
6
serious Num Affected
5
serious Num At Risk
6
title
Part 1 and 2 - INCB053914: 115 mg BID
deaths Num Affected
6
deaths Num At Risk
6
description
Part 3 and 4 - INCB053914: 50 mg BID + Cytarabine
id
EG006
other Num Affected
6
other Num At Risk
6
serious Num Affected
5
serious Num At Risk
6
title
Part 3 and 4 - INCB053914: 50 mg BID + Cytarabine
deaths Num Affected
7
deaths Num At Risk
7
description
Part 3 and 4 - INCB053914: 50 mg BID + Azacitidine
id
EG007
other Num Affected
7
other Num At Risk
7
serious Num Affected
5
serious Num At Risk
7
title
Part 3 and 4 - INCB053914: 50 mg BID + Azacitidine
deaths Num Affected
9
deaths Num At Risk
9
description
Part 3 and 4 - INCB053914: 80 mg BID + Azacitidine
id
EG008
other Num Affected
8
other Num At Risk
9
serious Num Affected
6
serious Num At Risk
9
title
Part 3 and 4 - INCB053914: 80 mg BID + Azacitidine
deaths Num Affected
1
deaths Num At Risk
3
description
Part 3 and 4 - INCB053914: 50 mg BID + Ruxolitinib
id
EG009
other Num Affected
3
other Num At Risk
3
serious Num Affected
0
serious Num At Risk
3
title
Part 3 and 4 - INCB053914: 50 mg BID + Ruxolitinib
deaths Num Affected
3
deaths Num At Risk
14
description
Part 3 and 4 - INCB053914: 80 mg BID + Ruxolitinib
id
EG010
other Num Affected
14
other Num At Risk
14
serious Num Affected
5
serious Num At Risk
14
title
Part 3 and 4 - INCB053914: 80 mg BID + Ruxolitinib

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
11
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
21
num Events
0
group Id
EG004
num Affected
1
num At Risk
12
num Events
1
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
2
num At Risk
6
num Events
2
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
0
num At Risk
9
num Events
0
group Id
EG009
num Affected
0
num At Risk
3
num Events
0
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
11
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
4
num At Risk
21
num Events
4
group Id
EG004
num Affected
3
num At Risk
12
num Events
3
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
0
num At Risk
6
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
3
num At Risk
9
num Events
4
group Id
EG009
num Affected
1
num At Risk
3
num Events
1
group Id
EG010
num Affected
1
num At Risk
14
num Events
1
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
11
num Events
0
group Id
EG002
num Affected
1
num At Risk
4
num Events
1
group Id
EG003
num Affected
0
num At Risk
21
num Events
0
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
0
num At Risk
6
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
0
num At Risk
9
num Events
0
group Id
EG009
num Affected
0
num At Risk
3
num Events
0
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
term
Abdominal pain lower
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
11
num Events
0
group Id
EG002
num Affected
1
num At Risk
4
num Events
1
group Id
EG003
num Affected
0
num At Risk
21
num Events
0
group Id
EG004
num Affected
2
num At Risk
12
num Events
2
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
0
num At Risk
6
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
1
num At Risk
9
num Events
1
group Id
EG009
num Affected
0
num At Risk
3
num Events
0
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
11
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
21
num Events
0
group Id
EG004
num Affected
1
num At Risk
12
num Events
1
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
0
num At Risk
6
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
0
num At Risk
9
num Events
0
group Id
EG009
num Affected
0
num At Risk
3
num Events
0
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
term
Acute febrile neutrophilic dermatosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
11
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
2
num At Risk
21
num Events
2
group Id
EG004
num Affected
1
num At Risk
12
num Events
1
group Id
EG005
num Affected
1
num At Risk
6
num Events
1
group Id
EG006
num Affected
0
num At Risk
6
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
2
num At Risk
9
num Events
2
group Id
EG009
num Affected
0
num At Risk
3
num Events
0
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
term
Acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
11
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
21
num Events
0
group Id
EG004
num Affected
1
num At Risk
12
num Events
1
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
0
num At Risk
6
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
0
num At Risk
9
num Events
0
group Id
EG009
num Affected
0
num At Risk
3
num Events
0
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
term
Agitation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
2
num At Risk
4
num Events
2
group Id
EG001
num Affected
2
num At Risk
11
num Events
2
group Id
EG002
num Affected
1
num At Risk
4
num Events
2
group Id
EG003
num Affected
8
num At Risk
21
num Events
10
group Id
EG004
num Affected
4
num At Risk
12
num Events
5
group Id
EG005
num Affected
2
num At Risk
6
num Events
2
group Id
EG006
num Affected
4
num At Risk
6
num Events
4
group Id
EG007
num Affected
1
num At Risk
7
num Events
1
group Id
EG008
num Affected
4
num At Risk
9
num Events
8
group Id
EG009
num Affected
0
num At Risk
3
num Events
0
group Id
EG010
num Affected
6
num At Risk
14
num Events
7
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
2
num At Risk
4
num Events
3
group Id
EG001
num Affected
2
num At Risk
11
num Events
2
group Id
EG002
num Affected
3
num At Risk
4
num Events
4
group Id
EG003
num Affected
5
num At Risk
21
num Events
10
group Id
EG004
num Affected
5
num At Risk
12
num Events
22
group Id
EG005
num Affected
2
num At Risk
6
num Events
2
group Id
EG006
num Affected
3
num At Risk
6
num Events
9
group Id
EG007
num Affected
3
num At Risk
7
num Events
4
group Id
EG008
num Affected
3
num At Risk
9
num Events
3
group Id
EG009
num Affected
1
num At Risk
3
num Events
4
group Id
EG010
num Affected
5
num At Risk
14
num Events
9
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
11
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
21
num Events
0
group Id
EG004
num Affected
1
num At Risk
12
num Events
1
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
0
num At Risk
6
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
0
num At Risk
9
num Events
0
group Id
EG009
num Affected
0
num At Risk
3
num Events
0
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
term
Animal scratch
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
11
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
21
num Events
0
group Id
EG004
num Affected
1
num At Risk
12
num Events
1
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
0
num At Risk
6
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
1
num At Risk
9
num Events
1
group Id
EG009
num Affected
0
num At Risk
3
num Events
0
group Id
EG010
num Affected
1
num At Risk
14
num Events
1
term
Anxiety
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
1
num At Risk
11
num Events
1
group Id
EG002
num Affected
2
num At Risk
4
num Events
2
group Id
EG003
num Affected
2
num At Risk
21
num Events
2
group Id
EG004
num Affected
1
num At Risk
12
num Events
1
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
1
num At Risk
6
num Events
1
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
2
num At Risk
9
num Events
3
group Id
EG009
num Affected
0
num At Risk
3
num Events
0
group Id
EG010
num Affected
2
num At Risk
14
num Events
3
term
Arthralgia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
1
num At Risk
11
num Events
1
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
21
num Events
0
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
0
num At Risk
6
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
0
num At Risk
9
num Events
0
group Id
EG009
num Affected
0
num At Risk
3
num Events
0
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
term
Acute febrile neutrophilic dermatosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
11
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
21
num Events
0
group Id
EG004
num Affected
1
num At Risk
12
num Events
1
group Id
EG005
num Affected
1
num At Risk
6
num Events
1
group Id
EG006
num Affected
0
num At Risk
6
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
1
num At Risk
9
num Events
1
group Id
EG009
num Affected
0
num At Risk
3
num Events
0
group Id
EG010
num Affected
1
num At Risk
14
num Events
1
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
11
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
21
num Events
0
group Id
EG004
num Affected
1
num At Risk
12
num Events
1
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
1
num At Risk
6
num Events
3
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
1
num At Risk
9
num Events
1
group Id
EG009
num Affected
0
num At Risk
3
num Events
0
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
11
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
21
num Events
0
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
1
num At Risk
6
num Events
1
group Id
EG006
num Affected
0
num At Risk
6
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
0
num At Risk
9
num Events
0
group Id
EG009
num Affected
0
num At Risk
3
num Events
0
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
term
Arthralgia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
11
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
21
num Events
0
group Id
EG004
num Affected
1
num At Risk
12
num Events
1
group Id
EG005
num Affected
1
num At Risk
6
num Events
1
group Id
EG006
num Affected
0
num At Risk
6
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
1
num At Risk
9
num Events
1
group Id
EG009
num Affected
0
num At Risk
3
num Events
0
group Id
EG010
num Affected
1
num At Risk
14
num Events
2
term
Aspartate aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
11
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
21
num Events
0
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
1
num At Risk
6
num Events
1
group Id
EG006
num Affected
0
num At Risk
6
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
0
num At Risk
9
num Events
0
group Id
EG009
num Affected
0
num At Risk
3
num Events
0
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
term
Bacteraemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
11
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
1
num At Risk
21
num Events
1
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
0
num At Risk
6
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
0
num At Risk
9
num Events
0
group Id
EG009
num Affected
0
num At Risk
3
num Events
0
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
term
Carotid artery occlusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
11
num Events
0
group Id
EG002
num Affected
1
num At Risk
4
num Events
1
group Id
EG003
num Affected
0
num At Risk
21
num Events
0
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
0
num At Risk
6
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
0
num At Risk
9
num Events
0
group Id
EG009
num Affected
0
num At Risk
3
num Events
0
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
term
Colitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
2
group Id
EG001
num Affected
0
num At Risk
11
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
21
num Events
0
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
0
num At Risk
6
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
0
num At Risk
9
num Events
0
group Id
EG009
num Affected
0
num At Risk
3
num Events
0
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
term
Device related infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
11
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
2
num At Risk
21
num Events
2
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
1
num At Risk
6
num Events
1
group Id
EG006
num Affected
0
num At Risk
6
num Events
0
group Id
EG007
num Affected
3
num At Risk
7
num Events
3
group Id
EG008
num Affected
0
num At Risk
9
num Events
0
group Id
EG009
num Affected
0
num At Risk
3
num Events
0
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
term
Disease progression
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
11
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
21
num Events
0
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
1
num At Risk
6
num Events
1
group Id
EG006
num Affected
0
num At Risk
6
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
0
num At Risk
9
num Events
0
group Id
EG009
num Affected
0
num At Risk
3
num Events
0
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
term
Fall
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
2
group Id
EG001
num Affected
3
num At Risk
11
num Events
4
group Id
EG002
num Affected
1
num At Risk
4
num Events
1
group Id
EG003
num Affected
1
num At Risk
21
num Events
1
group Id
EG004
num Affected
2
num At Risk
12
num Events
3
group Id
EG005
num Affected
2
num At Risk
6
num Events
3
group Id
EG006
num Affected
1
num At Risk
6
num Events
1
group Id
EG007
num Affected
3
num At Risk
7
num Events
4
group Id
EG008
num Affected
3
num At Risk
9
num Events
3
group Id
EG009
num Affected
0
num At Risk
3
num Events
0
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
term
Febrile neutropenia

time Frame

up to approximately 6 months

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

Preserved source evidence · Not medical advice