NCT03922100 · ADVERSE EVENTS

Adverse events

Study of NMS-03592088 in Patients With Relapsed or Refractory AML or CMML · Source last updated 2026-03-18

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 were collected from screening visit and assessed up to 18 months
Other-event reporting threshold: 0%

Adverse events (AEs) were assessed and documented at each scheduled clinic visit from signing Informed Consent until 42 days after last on-study treatment administration, or until all serious or study drug-related toxicities had resolved or determined to be "chronic" or "stable," whichever came first, or until alternative anticancer therapy was initiated. Reporting period ended at the time new treatment started.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Phase 1, Schedule A: 20 mg All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 20 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle.	0 / 3	3 / 3	3 / 3
Phase 1, Schedule A: 40 mg All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 40 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle	2 / 3	3 / 3	3 / 3
Phase 1, Schedule A: 80 mg All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 80 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle	2 / 3	3 / 3	3 / 3
Phase 1, Schedule A: 120 mg All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 120 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle	0 / 3	3 / 3	3 / 3
Phase 1, Schedule A: 180 mg All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 180 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle	2 / 3	3 / 3	3 / 3
Phase 1, Schedule A: 270 mg All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 270 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle	3 / 4	4 / 4	4 / 4
Phase 1, Schedule A: 300 mg All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 300 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle	8 / 10	10 / 10	9 / 10
Phase 1, Schedule A: 360 mg All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 360 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle	3 / 3	3 / 3	3 / 3
Phase 1, Schedule B: 120 mg All participants in Phase I, Schedule B, who received NMS-03592088 at the starting dose of 120 mg administered orally once daily for 28 consecutive days, in a 28-day cycle	4 / 4	4 / 4	4 / 4
Phase 1, Schedule B: 180 mg All participants in Phase I, Schedule B, who received NMS-03592088 at the starting dose of 180 mg administered orally once daily for 28 consecutive days, in a 28-day cycle	6 / 6	6 / 6	6 / 6
Phase 1, Schedule B: 250 mg All participants in Phase I, Schedule B, who received NMS-03592088 at the starting dose of 250 mg administered orally once daily for 28 consecutive days, in a 28-day cycle	4 / 4	3 / 4	4 / 4
Phase 2, Schedule B: 360-150 mg * Participants who have failed standard of care including Venetoclax and Gilteritining based therapies * Participants who have failed standard of care. NMS-03592088 will be administered, on Cycle 1, at 360 mg/day (loading dose) for 5 consecutive days, followed by 150 mg/day (maintenance dose) for 23 consecutive days. The same maintenance dose (150 mg/day) will be administered from Cycle 2 onwards.	14 / 15	14 / 15	9 / 15

Group identifiers: EG000: Phase 1, Schedule A: 20 mg · EG001: Phase 1, Schedule A: 40 mg · EG002: Phase 1, Schedule A: 80 mg · EG003: Phase 1, Schedule A: 120 mg · EG004: Phase 1, Schedule A: 180 mg · EG005: Phase 1, Schedule A: 270 mg · EG006: Phase 1, Schedule A: 300 mg · EG007: Phase 1, Schedule A: 360 mg · EG008: Phase 1, Schedule B: 120 mg · EG009: Phase 1, Schedule B: 180 mg · EG010: Phase 1, Schedule B: 250 mg · EG011: Phase 2, Schedule B: 360-150 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 21.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
4
num Events
0
group Id
EG006
num Affected
2
num At Risk
10
num Events
2
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
2
num At Risk
6
num Events
2
group Id
EG010
num Affected
1
num At Risk
4
num Events
1
group Id
EG011
num Affected
4
num At Risk
15
num Events
4
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
1
num At Risk
4
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
3
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
6
num Events
0
group Id
EG010
num Affected
0
num At Risk
4
num Events
0
group Id
EG011
num Affected
0
num At Risk
15
num Events
0
term
Haemorrhagic diathesis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
4
num Events
0
group Id
EG006
num Affected
1
num At Risk
10
num Events
1
group Id
EG007
num Affected
0
num At Risk
3
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
6
num Events
0
group Id
EG010
num Affected
0
num At Risk
4
num Events
0
group Id
EG011
num Affected
0
num At Risk
15
num Events
0
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
1
num At Risk
3
num Events
1
group Id
EG005
num Affected
0
num At Risk
4
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
3
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
6
num Events
0
group Id
EG010
num Affected
0
num At Risk
4
num Events
0
group Id
EG011
num Affected
0
num At Risk
15
num Events
0
term
Diplopia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
1
num At Risk
4
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
3
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
6
num Events
0
group Id
EG010
num Affected
0
num At Risk
4
num Events
0
group Id
EG011
num Affected
0
num At Risk
15
num Events
0
term
Gingival bleeding
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
2
num At Risk
4
num Events
3
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
2
num At Risk
3
num Events
3
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
1
num At Risk
6
num Events
1
group Id
EG010
num Affected
0
num At Risk
4
num Events
0
group Id
EG011
num Affected
2
num At Risk
15
num Events
2
term
Upper gastrointestinal haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
4
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
3
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
6
num Events
0
group Id
EG010
num Affected
0
num At Risk
4
num Events
0
group Id
EG011
num Affected
0
num At Risk
15
num Events
0
term
Decreased activity
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
1
num At Risk
3
num Events
1
group Id
EG005
num Affected
0
num At Risk
4
num Events
0
group Id
EG006
num Affected
1
num At Risk
10
num Events
2
group Id
EG007
num Affected
1
num At Risk
3
num Events
1
group Id
EG008
num Affected
2
num At Risk
4
num Events
2
group Id
EG009
num Affected
0
num At Risk
6
num Events
0
group Id
EG010
num Affected
1
num At Risk
4
num Events
1
group Id
EG011
num Affected
1
num At Risk
15
num Events
1
term
Disease progression
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
1
num At Risk
3
num Events
2
group Id
EG005
num Affected
0
num At Risk
4
num Events
0
group Id
EG006
num Affected
1
num At Risk
10
num Events
2
group Id
EG007
num Affected
0
num At Risk
3
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
6
num Events
0
group Id
EG010
num Affected
0
num At Risk
4
num Events
0
group Id
EG011
num Affected
0
num At Risk
15
num Events
0
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
1
num At Risk
3
num Events
1
group Id
EG005
num Affected
1
num At Risk
4
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
3
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
6
num Events
0
group Id
EG010
num Affected
0
num At Risk
4
num Events
0
group Id
EG011
num Affected
0
num At Risk
15
num Events
0
term
Bronchopulmonary aspergillosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
4
num Events
0
group Id
EG006
num Affected
1
num At Risk
10
num Events
2
group Id
EG007
num Affected
0
num At Risk
3
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
6
num Events
0
group Id
EG010
num Affected
0
num At Risk
4
num Events
0
group Id
EG011
num Affected
0
num At Risk
15
num Events
0
term
Cellulitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
4
num Events
0
group Id
EG006
num Affected
1
num At Risk
10
num Events
2
group Id
EG007
num Affected
0
num At Risk
3
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
6
num Events
0
group Id
EG010
num Affected
0
num At Risk
4
num Events
0
group Id
EG011
num Affected
0
num At Risk
15
num Events
0
term
Clostridium difficile colitis

Other reported adverse events

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

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
2
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
3
num At Risk
3
num Events
14
group Id
EG003
num Affected
1
num At Risk
3
num Events
4
group Id
EG004
num Affected
1
num At Risk
3
num Events
4
group Id
EG005
num Affected
2
num At Risk
4
num Events
9
group Id
EG006
num Affected
2
num At Risk
10
num Events
2
group Id
EG007
num Affected
1
num At Risk
3
num Events
2
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
2
num At Risk
6
num Events
2
group Id
EG010
num Affected
0
num At Risk
4
num Events
0
group Id
EG011
num Affected
0
num At Risk
15
num Events
0
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
1
num At Risk
3
num Events
1
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
1
num At Risk
4
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
3
num Events
0
group Id
EG008
num Affected
1
num At Risk
4
num Events
1
group Id
EG009
num Affected
1
num At Risk
6
num Events
1
group Id
EG010
num Affected
0
num At Risk
4
num Events
0
group Id
EG011
num Affected
1
num At Risk
15
num Events
1
term
Haemorrhagic diathesis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
2
num At Risk
3
num Events
3
group Id
EG001
num Affected
1
num At Risk
3
num Events
1
group Id
EG002
num Affected
1
num At Risk
3
num Events
2
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
1
num At Risk
4
num Events
1
group Id
EG006
num Affected
1
num At Risk
10
num Events
1
group Id
EG007
num Affected
0
num At Risk
3
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
6
num Events
1
group Id
EG010
num Affected
0
num At Risk
4
num Events
0
group Id
EG011
num Affected
0
num At Risk
15
num Events
0
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
2
num At Risk
3
num Events
6
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
2
num At Risk
3
num Events
2
group Id
EG005
num Affected
0
num At Risk
4
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
3
num Events
2
group Id
EG008
num Affected
2
num At Risk
4
num Events
2
group Id
EG009
num Affected
1
num At Risk
6
num Events
1
group Id
EG010
num Affected
0
num At Risk
4
num Events
0
group Id
EG011
num Affected
1
num At Risk
15
num Events
1
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
1
num At Risk
3
num Events
1
group Id
EG005
num Affected
1
num At Risk
4
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
3
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
6
num Events
0
group Id
EG010
num Affected
0
num At Risk
4
num Events
0
group Id
EG011
num Affected
1
num At Risk
15
num Events
1
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
3
num Events
1
group Id
EG002
num Affected
2
num At Risk
3
num Events
3
group Id
EG003
num Affected
1
num At Risk
3
num Events
3
group Id
EG004
num Affected
1
num At Risk
3
num Events
2
group Id
EG005
num Affected
2
num At Risk
4
num Events
2
group Id
EG006
num Affected
1
num At Risk
10
num Events
1
group Id
EG007
num Affected
2
num At Risk
3
num Events
3
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
2
num At Risk
6
num Events
3
group Id
EG010
num Affected
1
num At Risk
4
num Events
1
group Id
EG011
num Affected
2
num At Risk
15
num Events
2
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
1
num At Risk
3
num Events
1
group Id
EG005
num Affected
0
num At Risk
4
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
3
num Events
1
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
1
num At Risk
6
num Events
2
group Id
EG010
num Affected
0
num At Risk
4
num Events
0
group Id
EG011
num Affected
0
num At Risk
15
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
2
num At Risk
3
num Events
2
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
4
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
3
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
6
num Events
0
group Id
EG010
num Affected
0
num At Risk
4
num Events
0
group Id
EG011
num Affected
0
num At Risk
15
num Events
0
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
1
num At Risk
3
num Events
1
group Id
EG005
num Affected
1
num At Risk
4
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
3
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
6
num Events
0
group Id
EG010
num Affected
0
num At Risk
4
num Events
0
group Id
EG011
num Affected
0
num At Risk
15
num Events
0
term
Conjunctival haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
3
num Events
2
group Id
EG003
num Affected
1
num At Risk
3
num Events
1
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
4
num Events
0
group Id
EG006
num Affected
1
num At Risk
10
num Events
1
group Id
EG007
num Affected
0
num At Risk
3
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
6
num Events
0
group Id
EG010
num Affected
0
num At Risk
4
num Events
0
group Id
EG011
num Affected
0
num At Risk
15
num Events
0
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
2
num At Risk
3
num Events
5
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
2
num At Risk
3
num Events
2
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
2
num At Risk
3
num Events
2
group Id
EG005
num Affected
0
num At Risk
4
num Events
0
group Id
EG006
num Affected
1
num At Risk
10
num Events
2
group Id
EG007
num Affected
1
num At Risk
3
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
6
num Events
0
group Id
EG010
num Affected
0
num At Risk
4
num Events
0
group Id
EG011
num Affected
1
num At Risk
15
num Events
1
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
1
num At Risk
4
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
3
num Events
0
group Id
EG008
num Affected
1
num At Risk
4
num Events
2
group Id
EG009
num Affected
0
num At Risk
6
num Events
0
group Id
EG010
num Affected
0
num At Risk
4
num Events
0
group Id
EG011
num Affected
0
num At Risk
15
num Events
0
term
Angina bullosa haemorrhagica

Complete source fields

description

event Groups

deaths Num Affected
3
deaths Num At Risk
3
description
All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 20 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle.
id
EG000
other Num Affected
3
other Num At Risk
3
serious Num Affected
0
serious Num At Risk
3
title
Phase 1, Schedule A: 20 mg
deaths Num Affected
3
deaths Num At Risk
3
description
All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 40 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle
id
EG001
other Num Affected
3
other Num At Risk
3
serious Num Affected
2
serious Num At Risk
3
title
Phase 1, Schedule A: 40 mg
deaths Num Affected
3
deaths Num At Risk
3
description
All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 80 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle
id
EG002
other Num Affected
3
other Num At Risk
3
serious Num Affected
2
serious Num At Risk
3
title
Phase 1, Schedule A: 80 mg
deaths Num Affected
3
deaths Num At Risk
3
description
All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 120 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle
id
EG003
other Num Affected
3
other Num At Risk
3
serious Num Affected
0
serious Num At Risk
3
title
Phase 1, Schedule A: 120 mg
deaths Num Affected
3
deaths Num At Risk
3
description
All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 180 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle
id
EG004
other Num Affected
3
other Num At Risk
3
serious Num Affected
2
serious Num At Risk
3
title
Phase 1, Schedule A: 180 mg
deaths Num Affected
4
deaths Num At Risk
4
description
All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 270 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle
id
EG005
other Num Affected
4
other Num At Risk
4
serious Num Affected
3
serious Num At Risk
4
title
Phase 1, Schedule A: 270 mg
deaths Num Affected
9
deaths Num At Risk
10
description
All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 300 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle
id
EG006
other Num Affected
10
other Num At Risk
10
serious Num Affected
8
serious Num At Risk
10
title
Phase 1, Schedule A: 300 mg
deaths Num Affected
3
deaths Num At Risk
3
description
All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 360 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle
id
EG007
other Num Affected
3
other Num At Risk
3
serious Num Affected
3
serious Num At Risk
3
title
Phase 1, Schedule A: 360 mg
deaths Num Affected
4
deaths Num At Risk
4
description
All participants in Phase I, Schedule B, who received NMS-03592088 at the starting dose of 120 mg administered orally once daily for 28 consecutive days, in a 28-day cycle
id
EG008
other Num Affected
4
other Num At Risk
4
serious Num Affected
4
serious Num At Risk
4
title
Phase 1, Schedule B: 120 mg
deaths Num Affected
6
deaths Num At Risk
6
description
All participants in Phase I, Schedule B, who received NMS-03592088 at the starting dose of 180 mg administered orally once daily for 28 consecutive days, in a 28-day cycle
id
EG009
other Num Affected
6
other Num At Risk
6
serious Num Affected
6
serious Num At Risk
6
title
Phase 1, Schedule B: 180 mg
deaths Num Affected
4
deaths Num At Risk
4
description
All participants in Phase I, Schedule B, who received NMS-03592088 at the starting dose of 250 mg administered orally once daily for 28 consecutive days, in a 28-day cycle
id
EG010
other Num Affected
3
other Num At Risk
4
serious Num Affected
4
serious Num At Risk
4
title
Phase 1, Schedule B: 250 mg
deaths Num Affected
9
deaths Num At Risk
15
description
* Participants who have failed standard of care including Venetoclax and Gilteritining based therapies * Participants who have failed standard of care. NMS-03592088 will be administered, on Cycle 1, at 360 mg/day (loading dose) for 5 consecutive days, followed by 150 mg/day (maintenance dose) for 23 consecutive days. The same maintenance dose (150 mg/day) will be administered from Cycle 2 onwards.
id
EG011
other Num Affected
14
other Num At Risk
15
serious Num Affected
14
serious Num At Risk
15
title
Phase 2, Schedule B: 360-150 mg

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
2
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
3
num At Risk
3
num Events
14
group Id
EG003
num Affected
1
num At Risk
3
num Events
4
group Id
EG004
num Affected
1
num At Risk
3
num Events
4
group Id
EG005
num Affected
2
num At Risk
4
num Events
9
group Id
EG006
num Affected
2
num At Risk
10
num Events
2
group Id
EG007
num Affected
1
num At Risk
3
num Events
2
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
2
num At Risk
6
num Events
2
group Id
EG010
num Affected
0
num At Risk
4
num Events
0
group Id
EG011
num Affected
0
num At Risk
15
num Events
0
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
1
num At Risk
3
num Events
1
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
1
num At Risk
4
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
3
num Events
0
group Id
EG008
num Affected
1
num At Risk
4
num Events
1
group Id
EG009
num Affected
1
num At Risk
6
num Events
1
group Id
EG010
num Affected
0
num At Risk
4
num Events
0
group Id
EG011
num Affected
1
num At Risk
15
num Events
1
term
Haemorrhagic diathesis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
2
num At Risk
3
num Events
3
group Id
EG001
num Affected
1
num At Risk
3
num Events
1
group Id
EG002
num Affected
1
num At Risk
3
num Events
2
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
1
num At Risk
4
num Events
1
group Id
EG006
num Affected
1
num At Risk
10
num Events
1
group Id
EG007
num Affected
0
num At Risk
3
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
6
num Events
1
group Id
EG010
num Affected
0
num At Risk
4
num Events
0
group Id
EG011
num Affected
0
num At Risk
15
num Events
0
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
2
num At Risk
3
num Events
6
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
2
num At Risk
3
num Events
2
group Id
EG005
num Affected
0
num At Risk
4
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
3
num Events
2
group Id
EG008
num Affected
2
num At Risk
4
num Events
2
group Id
EG009
num Affected
1
num At Risk
6
num Events
1
group Id
EG010
num Affected
0
num At Risk
4
num Events
0
group Id
EG011
num Affected
1
num At Risk
15
num Events
1
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
1
num At Risk
3
num Events
1
group Id
EG005
num Affected
1
num At Risk
4
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
3
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
6
num Events
0
group Id
EG010
num Affected
0
num At Risk
4
num Events
0
group Id
EG011
num Affected
1
num At Risk
15
num Events
1
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
3
num Events
1
group Id
EG002
num Affected
2
num At Risk
3
num Events
3
group Id
EG003
num Affected
1
num At Risk
3
num Events
3
group Id
EG004
num Affected
1
num At Risk
3
num Events
2
group Id
EG005
num Affected
2
num At Risk
4
num Events
2
group Id
EG006
num Affected
1
num At Risk
10
num Events
1
group Id
EG007
num Affected
2
num At Risk
3
num Events
3
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
2
num At Risk
6
num Events
3
group Id
EG010
num Affected
1
num At Risk
4
num Events
1
group Id
EG011
num Affected
2
num At Risk
15
num Events
2
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
1
num At Risk
3
num Events
1
group Id
EG005
num Affected
0
num At Risk
4
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
3
num Events
1
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
1
num At Risk
6
num Events
2
group Id
EG010
num Affected
0
num At Risk
4
num Events
0
group Id
EG011
num Affected
0
num At Risk
15
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
2
num At Risk
3
num Events
2
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
4
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
3
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
6
num Events
0
group Id
EG010
num Affected
0
num At Risk
4
num Events
0
group Id
EG011
num Affected
0
num At Risk
15
num Events
0
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
1
num At Risk
3
num Events
1
group Id
EG005
num Affected
1
num At Risk
4
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
3
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
6
num Events
0
group Id
EG010
num Affected
0
num At Risk
4
num Events
0
group Id
EG011
num Affected
0
num At Risk
15
num Events
0
term
Conjunctival haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
3
num Events
2
group Id
EG003
num Affected
1
num At Risk
3
num Events
1
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
4
num Events
0
group Id
EG006
num Affected
1
num At Risk
10
num Events
1
group Id
EG007
num Affected
0
num At Risk
3
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
6
num Events
0
group Id
EG010
num Affected
0
num At Risk
4
num Events
0
group Id
EG011
num Affected
0
num At Risk
15
num Events
0
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
2
num At Risk
3
num Events
5
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
2
num At Risk
3
num Events
2
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
2
num At Risk
3
num Events
2
group Id
EG005
num Affected
0
num At Risk
4
num Events
0
group Id
EG006
num Affected
1
num At Risk
10
num Events
2
group Id
EG007
num Affected
1
num At Risk
3
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
6
num Events
0
group Id
EG010
num Affected
0
num At Risk
4
num Events
0
group Id
EG011
num Affected
1
num At Risk
15
num Events
1
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
1
num At Risk
4
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
3
num Events
0
group Id
EG008
num Affected
1
num At Risk
4
num Events
2
group Id
EG009
num Affected
0
num At Risk
6
num Events
0
group Id
EG010
num Affected
0
num At Risk
4
num Events
0
group Id
EG011
num Affected
0
num At Risk
15
num Events
0
term
Angina bullosa haemorrhagica

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
4
num Events
0
group Id
EG006
num Affected
2
num At Risk
10
num Events
2
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
2
num At Risk
6
num Events
2
group Id
EG010
num Affected
1
num At Risk
4
num Events
1
group Id
EG011
num Affected
4
num At Risk
15
num Events
4
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
1
num At Risk
4
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
3
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
6
num Events
0
group Id
EG010
num Affected
0
num At Risk
4
num Events
0
group Id
EG011
num Affected
0
num At Risk
15
num Events
0
term
Haemorrhagic diathesis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
4
num Events
0
group Id
EG006
num Affected
1
num At Risk
10
num Events
1
group Id
EG007
num Affected
0
num At Risk
3
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
6
num Events
0
group Id
EG010
num Affected
0
num At Risk
4
num Events
0
group Id
EG011
num Affected
0
num At Risk
15
num Events
0
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
1
num At Risk
3
num Events
1
group Id
EG005
num Affected
0
num At Risk
4
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
3
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
6
num Events
0
group Id
EG010
num Affected
0
num At Risk
4
num Events
0
group Id
EG011
num Affected
0
num At Risk
15
num Events
0
term
Diplopia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
1
num At Risk
4
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
3
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
6
num Events
0
group Id
EG010
num Affected
0
num At Risk
4
num Events
0
group Id
EG011
num Affected
0
num At Risk
15
num Events
0
term
Gingival bleeding
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
2
num At Risk
4
num Events
3
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
2
num At Risk
3
num Events
3
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
1
num At Risk
6
num Events
1
group Id
EG010
num Affected
0
num At Risk
4
num Events
0
group Id
EG011
num Affected
2
num At Risk
15
num Events
2
term
Upper gastrointestinal haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
4
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
3
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
6
num Events
0
group Id
EG010
num Affected
0
num At Risk
4
num Events
0
group Id
EG011
num Affected
0
num At Risk
15
num Events
0
term
Decreased activity
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
1
num At Risk
3
num Events
1
group Id
EG005
num Affected
0
num At Risk
4
num Events
0
group Id
EG006
num Affected
1
num At Risk
10
num Events
2
group Id
EG007
num Affected
1
num At Risk
3
num Events
1
group Id
EG008
num Affected
2
num At Risk
4
num Events
2
group Id
EG009
num Affected
0
num At Risk
6
num Events
0
group Id
EG010
num Affected
1
num At Risk
4
num Events
1
group Id
EG011
num Affected
1
num At Risk
15
num Events
1
term
Disease progression
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
1
num At Risk
3
num Events
2
group Id
EG005
num Affected
0
num At Risk
4
num Events
0
group Id
EG006
num Affected
1
num At Risk
10
num Events
2
group Id
EG007
num Affected
0
num At Risk
3
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
6
num Events
0
group Id
EG010
num Affected
0
num At Risk
4
num Events
0
group Id
EG011
num Affected
0
num At Risk
15
num Events
0
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
1
num At Risk
3
num Events
1
group Id
EG005
num Affected
1
num At Risk
4
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
3
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
6
num Events
0
group Id
EG010
num Affected
0
num At Risk
4
num Events
0
group Id
EG011
num Affected
0
num At Risk
15
num Events
0
term
Bronchopulmonary aspergillosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
4
num Events
0
group Id
EG006
num Affected
1
num At Risk
10
num Events
2
group Id
EG007
num Affected
0
num At Risk
3
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
6
num Events
0
group Id
EG010
num Affected
0
num At Risk
4
num Events
0
group Id
EG011
num Affected
0
num At Risk
15
num Events
0
term
Cellulitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
4
num Events
0
group Id
EG006
num Affected
1
num At Risk
10
num Events
2
group Id
EG007
num Affected
0
num At Risk
3
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
6
num Events
0
group Id
EG010
num Affected
0
num At Risk
4
num Events
0
group Id
EG011
num Affected
0
num At Risk
15
num Events
0
term
Clostridium difficile colitis

time Frame

Adverse events were collected from screening visit and assessed up to 18 months

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

Preserved source evidence · Not medical advice