NCT02719574 · ADVERSE EVENTS

Adverse events

Open-label Study of FT-2102 With or Without Azacitidine or Cytarabine in Patients With AML or MDS With an IDH1 Mutation · Source last updated 2026-06-29

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

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

Collection time frame: From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
Other-event reporting threshold: 5%

All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Phase 1: FT-2102 (Single Agent) Participants with AML or MDS received single agent FT-2102 orally BID in 28-day cycles at dose levels of 150 mg until MTD or MED achieved.	10 / 16	15 / 16	4 / 16
Phase 1: Total FT-2102 (Single Agent) Participants with AML or MDS received single agent FT-2102 orally QD and BID in 28-day cycles at the different dose levels (150 mg and ≤ 300 mg) until MTD or MED achieved.	23 / 31	29 / 31	11 / 31
Phase 1: FT-2102 + Azacitidine (Combination Therapy) Participants with AML or MDS received combination therapy (FT-2102 + azacitidine 75 mg/m\^2) orally BID in 28-day cycles at dose levels of 150 mg until MTD or MED achieved.	30 / 39	39 / 39	9 / 39
Phase 1: Total FT-2102; FT-2102 + Azacitidine (Combination Therapy) Participants with AML or MDS received combination therapy (FT-2102 150 mg and ≤ 300 mg and azacitidine administered at the dose of 75 mg/m\^2 for 7 days IV/SC per every 28-day cycle) until treatment discontinuation.	36 / 46	46 / 46	10 / 46
Phase 1: Overall Participants with AML or MDS received single agent (FT-2102), combination therapy (FT-2102 + azacitidine, FT-2102+ LDAC) starting at 150 mg BID dose level until MTD or MED achieved or treatment discontinuation.	60 / 78	76 / 78	21 / 78
Phase 2: Cohort 1; FT-2102 (Single Agent) Participants with R/R AML received single agent of FT-2102 150 mg BID in continuous 28-day cycles.	115 / 153	152 / 153	50 / 153
Phase 2: Cohort 2; FT-2102 (Single Agent) Participants with AML in morphologic CR/CRi after prior therapy with residual IDH1-R132 mutation were received single agent of FT-2102 150 mg BID in continuous 28-day cycles.	6 / 18	18 / 18	0 / 18
Phase 2: Cohort 3; FT-2102 (Single Agent) Participants with R/R AML or MDS who were previously treated with FT-2102 and who underwent HSCT on-study then relapsed post-HSCT received single agent of FT-2102 150 mg BID in continuous 28-day cycles.	4 / 5	5 / 5	2 / 5
Phase 2: Cohort 4; FT-2102 + Azacitidine (Combination Therapy) Participants with R/R AML that is naïve to prior hypomethylating therapy and IDH1 inhibitor therapy received combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.	12 / 20	18 / 20	3 / 20
Phase 2: Cohort 5; FT-2102 + Azacitidine (Combination Therapy) Participants with R/R AML/MDS that have inadequately responded to or have progressed on prior hypo-methylating therapy received combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.	18 / 21	20 / 21	6 / 21
Phase 2: Cohort 6; FT-2102 + Azacitidine (Combination Therapy) Participants with R/R AML/MDS that have been previously treated with single agent FT-2102 as their last therapy prior to study enrolment received combination therapy of azacitidine + FT-2102 150 mg BID in continuous 28-day cycles. Participants from the FT-2102 single agent cohorts of this study allowed to be enrolled in Cohort 6 after their disease progression.	13 / 20	19 / 20	7 / 20
Phase 2: Cohort 7; FT-2102 (Single Agent) Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given single agent of FT-2102 150 mg BID in continuous 28-day cycles.	8 / 10	10 / 10	4 / 10
Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy) Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.	9 / 11	11 / 11	2 / 11

Group identifiers: EG000: Phase 1: FT-2102 (Single Agent) · EG001: Phase 1: Total FT-2102 (Single Agent) · EG002: Phase 1: FT-2102 + Azacitidine (Combination Therapy) · EG003: Phase 1: Total FT-2102; FT-2102 + Azacitidine (Combination Therapy) · EG004: Phase 1: Overall · EG005: Phase 2: Cohort 1; FT-2102 (Single Agent) · EG006: Phase 2: Cohort 2; FT-2102 (Single Agent) · EG007: Phase 2: Cohort 3; FT-2102 (Single Agent) · EG008: Phase 2: Cohort 4; FT-2102 + Azacitidine (Combination Therapy) · EG009: Phase 2: Cohort 5; FT-2102 + Azacitidine (Combination Therapy) · EG010: Phase 2: Cohort 6; FT-2102 + Azacitidine (Combination Therapy) · EG011: Phase 2: Cohort 7; FT-2102 (Single Agent) · EG012: Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy)

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
Gastrointestinal disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
0
num At Risk
16
num Events
0
group Id
EG001
num Affected
0
num At Risk
31
num Events
0
group Id
EG002
num Affected
0
num At Risk
39
num Events
0
group Id
EG003
num Affected
0
num At Risk
46
num Events
0
group Id
EG004
num Affected
0
num At Risk
78
num Events
0
group Id
EG005
num Affected
0
num At Risk
153
num Events
0
group Id
EG006
num Affected
0
num At Risk
18
num Events
0
group Id
EG007
num Affected
0
num At Risk
5
num Events
0
group Id
EG008
num Affected
0
num At Risk
20
num Events
0
group Id
EG009
num Affected
0
num At Risk
21
num Events
0
group Id
EG010
num Affected
0
num At Risk
20
num Events
0
group Id
EG011
num Affected
1
num At Risk
10
num Events
2
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
0
num At Risk
16
num Events
0
group Id
EG001
num Affected
0
num At Risk
31
num Events
0
group Id
EG002
num Affected
0
num At Risk
39
num Events
0
group Id
EG003
num Affected
0
num At Risk
46
num Events
0
group Id
EG004
num Affected
0
num At Risk
78
num Events
0
group Id
EG005
num Affected
0
num At Risk
153
num Events
0
group Id
EG006
num Affected
0
num At Risk
18
num Events
0
group Id
EG007
num Affected
0
num At Risk
5
num Events
0
group Id
EG008
num Affected
0
num At Risk
20
num Events
0
group Id
EG009
num Affected
0
num At Risk
21
num Events
0
group Id
EG010
num Affected
0
num At Risk
20
num Events
0
group Id
EG011
num Affected
0
num At Risk
10
num Events
0
term
Acute coronary syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
0
num At Risk
16
num Events
0
group Id
EG001
num Affected
0
num At Risk
31
num Events
0
group Id
EG002
num Affected
0
num At Risk
39
num Events
0
group Id
EG003
num Affected
0
num At Risk
46
num Events
0
group Id
EG004
num Affected
0
num At Risk
78
num Events
0
group Id
EG005
num Affected
2
num At Risk
153
num Events
2
group Id
EG006
num Affected
0
num At Risk
18
num Events
0
group Id
EG007
num Affected
0
num At Risk
5
num Events
0
group Id
EG008
num Affected
0
num At Risk
20
num Events
0
group Id
EG009
num Affected
0
num At Risk
21
num Events
0
group Id
EG010
num Affected
0
num At Risk
20
num Events
0
group Id
EG011
num Affected
0
num At Risk
10
num Events
0
term
Acute febrile neutrophilic dermatosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
0
num At Risk
16
num Events
0
group Id
EG001
num Affected
0
num At Risk
31
num Events
0
group Id
EG002
num Affected
1
num At Risk
39
num Events
1
group Id
EG003
num Affected
1
num At Risk
46
num Events
1
group Id
EG004
num Affected
2
num At Risk
78
num Events
2
group Id
EG005
num Affected
2
num At Risk
153
num Events
2
group Id
EG006
num Affected
0
num At Risk
18
num Events
0
group Id
EG007
num Affected
0
num At Risk
5
num Events
0
group Id
EG008
num Affected
0
num At Risk
20
num Events
0
group Id
EG009
num Affected
0
num At Risk
21
num Events
0
group Id
EG010
num Affected
0
num At Risk
20
num Events
0
group Id
EG011
num Affected
1
num At Risk
10
num Events
1
term
Acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
1
num At Risk
16
num Events
1
group Id
EG001
num Affected
2
num At Risk
31
num Events
2
group Id
EG002
num Affected
2
num At Risk
39
num Events
2
group Id
EG003
num Affected
4
num At Risk
46
num Events
4
group Id
EG004
num Affected
6
num At Risk
78
num Events
6
group Id
EG005
num Affected
14
num At Risk
153
num Events
16
group Id
EG006
num Affected
0
num At Risk
18
num Events
0
group Id
EG007
num Affected
0
num At Risk
5
num Events
0
group Id
EG008
num Affected
1
num At Risk
20
num Events
1
group Id
EG009
num Affected
2
num At Risk
21
num Events
2
group Id
EG010
num Affected
0
num At Risk
20
num Events
0
group Id
EG011
num Affected
2
num At Risk
10
num Events
2
term
Acute promyelocytic leukaemia differentiation syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
0
num At Risk
16
num Events
0
group Id
EG001
num Affected
0
num At Risk
31
num Events
0
group Id
EG002
num Affected
0
num At Risk
39
num Events
0
group Id
EG003
num Affected
0
num At Risk
46
num Events
0
group Id
EG004
num Affected
0
num At Risk
78
num Events
0
group Id
EG005
num Affected
1
num At Risk
153
num Events
1
group Id
EG006
num Affected
0
num At Risk
18
num Events
0
group Id
EG007
num Affected
0
num At Risk
5
num Events
0
group Id
EG008
num Affected
0
num At Risk
20
num Events
0
group Id
EG009
num Affected
0
num At Risk
21
num Events
0
group Id
EG010
num Affected
0
num At Risk
20
num Events
0
group Id
EG011
num Affected
0
num At Risk
10
num Events
0
term
Acute psychosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
0
num At Risk
16
num Events
0
group Id
EG001
num Affected
0
num At Risk
31
num Events
0
group Id
EG002
num Affected
0
num At Risk
39
num Events
0
group Id
EG003
num Affected
0
num At Risk
46
num Events
0
group Id
EG004
num Affected
0
num At Risk
78
num Events
0
group Id
EG005
num Affected
1
num At Risk
153
num Events
1
group Id
EG006
num Affected
0
num At Risk
18
num Events
0
group Id
EG007
num Affected
0
num At Risk
5
num Events
0
group Id
EG008
num Affected
0
num At Risk
20
num Events
0
group Id
EG009
num Affected
0
num At Risk
21
num Events
0
group Id
EG010
num Affected
0
num At Risk
20
num Events
0
group Id
EG011
num Affected
0
num At Risk
10
num Events
0
term
Acute respiratory distress syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
0
num At Risk
16
num Events
0
group Id
EG001
num Affected
1
num At Risk
31
num Events
1
group Id
EG002
num Affected
0
num At Risk
39
num Events
0
group Id
EG003
num Affected
0
num At Risk
46
num Events
0
group Id
EG004
num Affected
1
num At Risk
78
num Events
1
group Id
EG005
num Affected
0
num At Risk
153
num Events
0
group Id
EG006
num Affected
0
num At Risk
18
num Events
0
group Id
EG007
num Affected
0
num At Risk
5
num Events
0
group Id
EG008
num Affected
0
num At Risk
20
num Events
0
group Id
EG009
num Affected
0
num At Risk
21
num Events
0
group Id
EG010
num Affected
0
num At Risk
20
num Events
0
group Id
EG011
num Affected
0
num At Risk
10
num Events
0
term
Acute respiratory failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
0
num At Risk
16
num Events
0
group Id
EG001
num Affected
1
num At Risk
31
num Events
1
group Id
EG002
num Affected
0
num At Risk
39
num Events
0
group Id
EG003
num Affected
0
num At Risk
46
num Events
0
group Id
EG004
num Affected
1
num At Risk
78
num Events
1
group Id
EG005
num Affected
1
num At Risk
153
num Events
1
group Id
EG006
num Affected
0
num At Risk
18
num Events
0
group Id
EG007
num Affected
0
num At Risk
5
num Events
0
group Id
EG008
num Affected
1
num At Risk
20
num Events
1
group Id
EG009
num Affected
0
num At Risk
21
num Events
0
group Id
EG010
num Affected
0
num At Risk
20
num Events
0
group Id
EG011
num Affected
0
num At Risk
10
num Events
0
term
Anal abscess
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
0
num At Risk
16
num Events
0
group Id
EG001
num Affected
0
num At Risk
31
num Events
0
group Id
EG002
num Affected
0
num At Risk
39
num Events
0
group Id
EG003
num Affected
0
num At Risk
46
num Events
0
group Id
EG004
num Affected
0
num At Risk
78
num Events
0
group Id
EG005
num Affected
1
num At Risk
153
num Events
1
group Id
EG006
num Affected
0
num At Risk
18
num Events
0
group Id
EG007
num Affected
0
num At Risk
5
num Events
0
group Id
EG008
num Affected
0
num At Risk
20
num Events
0
group Id
EG009
num Affected
0
num At Risk
21
num Events
0
group Id
EG010
num Affected
0
num At Risk
20
num Events
0
group Id
EG011
num Affected
0
num At Risk
10
num Events
0
term
Anal fistula
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
0
num At Risk
16
num Events
0
group Id
EG001
num Affected
0
num At Risk
31
num Events
0
group Id
EG002
num Affected
0
num At Risk
39
num Events
0
group Id
EG003
num Affected
0
num At Risk
46
num Events
0
group Id
EG004
num Affected
0
num At Risk
78
num Events
0
group Id
EG005
num Affected
0
num At Risk
153
num Events
0
group Id
EG006
num Affected
0
num At Risk
18
num Events
0
group Id
EG007
num Affected
0
num At Risk
5
num Events
0
group Id
EG008
num Affected
0
num At Risk
20
num Events
0
group Id
EG009
num Affected
0
num At Risk
21
num Events
0
group Id
EG010
num Affected
0
num At Risk
20
num Events
0
group Id
EG011
num Affected
1
num At Risk
10
num Events
1
term
Angioedema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
0
num At Risk
16
num Events
0
group Id
EG001
num Affected
0
num At Risk
31
num Events
0
group Id
EG002
num Affected
1
num At Risk
39
num Events
1
group Id
EG003
num Affected
1
num At Risk
46
num Events
1
group Id
EG004
num Affected
1
num At Risk
78
num Events
1
group Id
EG005
num Affected
0
num At Risk
153
num Events
0
group Id
EG006
num Affected
0
num At Risk
18
num Events
0
group Id
EG007
num Affected
0
num At Risk
5
num Events
0
group Id
EG008
num Affected
0
num At Risk
20
num Events
0
group Id
EG009
num Affected
0
num At Risk
21
num Events
0
group Id
EG010
num Affected
0
num At Risk
20
num Events
0
group Id
EG011
num Affected
0
num At Risk
10
num Events
0
term
Ankle fracture

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 19.1
stats
group Id
EG000
num Affected
1
num At Risk
16
num Events
1
group Id
EG001
num Affected
5
num At Risk
31
num Events
5
group Id
EG002
num Affected
3
num At Risk
39
num Events
3
group Id
EG003
num Affected
4
num At Risk
46
num Events
5
group Id
EG004
num Affected
9
num At Risk
78
num Events
10
group Id
EG005
num Affected
2
num At Risk
153
num Events
3
group Id
EG006
num Affected
1
num At Risk
18
num Events
1
group Id
EG007
num Affected
0
num At Risk
5
num Events
0
group Id
EG008
num Affected
0
num At Risk
20
num Events
0
group Id
EG009
num Affected
1
num At Risk
21
num Events
1
group Id
EG010
num Affected
1
num At Risk
20
num Events
1
group Id
EG011
num Affected
0
num At Risk
10
num Events
0
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
0
num At Risk
16
num Events
0
group Id
EG001
num Affected
1
num At Risk
31
num Events
1
group Id
EG002
num Affected
7
num At Risk
39
num Events
9
group Id
EG003
num Affected
9
num At Risk
46
num Events
11
group Id
EG004
num Affected
10
num At Risk
78
num Events
12
group Id
EG005
num Affected
15
num At Risk
153
num Events
17
group Id
EG006
num Affected
0
num At Risk
18
num Events
0
group Id
EG007
num Affected
2
num At Risk
5
num Events
2
group Id
EG008
num Affected
2
num At Risk
20
num Events
3
group Id
EG009
num Affected
1
num At Risk
21
num Events
1
group Id
EG010
num Affected
2
num At Risk
20
num Events
2
group Id
EG011
num Affected
2
num At Risk
10
num Events
3
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
0
num At Risk
16
num Events
0
group Id
EG001
num Affected
3
num At Risk
31
num Events
3
group Id
EG002
num Affected
1
num At Risk
39
num Events
1
group Id
EG003
num Affected
1
num At Risk
46
num Events
1
group Id
EG004
num Affected
4
num At Risk
78
num Events
4
group Id
EG005
num Affected
7
num At Risk
153
num Events
9
group Id
EG006
num Affected
2
num At Risk
18
num Events
2
group Id
EG007
num Affected
0
num At Risk
5
num Events
0
group Id
EG008
num Affected
0
num At Risk
20
num Events
0
group Id
EG009
num Affected
0
num At Risk
21
num Events
0
group Id
EG010
num Affected
1
num At Risk
20
num Events
1
group Id
EG011
num Affected
1
num At Risk
10
num Events
1
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
2
num At Risk
16
num Events
2
group Id
EG001
num Affected
3
num At Risk
31
num Events
3
group Id
EG002
num Affected
2
num At Risk
39
num Events
2
group Id
EG003
num Affected
3
num At Risk
46
num Events
3
group Id
EG004
num Affected
6
num At Risk
78
num Events
6
group Id
EG005
num Affected
7
num At Risk
153
num Events
15
group Id
EG006
num Affected
0
num At Risk
18
num Events
0
group Id
EG007
num Affected
0
num At Risk
5
num Events
0
group Id
EG008
num Affected
0
num At Risk
20
num Events
0
group Id
EG009
num Affected
1
num At Risk
21
num Events
1
group Id
EG010
num Affected
0
num At Risk
20
num Events
0
group Id
EG011
num Affected
0
num At Risk
10
num Events
0
term
Acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
2
num At Risk
16
num Events
2
group Id
EG001
num Affected
2
num At Risk
31
num Events
2
group Id
EG002
num Affected
4
num At Risk
39
num Events
5
group Id
EG003
num Affected
4
num At Risk
46
num Events
5
group Id
EG004
num Affected
6
num At Risk
78
num Events
7
group Id
EG005
num Affected
11
num At Risk
153
num Events
11
group Id
EG006
num Affected
0
num At Risk
18
num Events
0
group Id
EG007
num Affected
2
num At Risk
5
num Events
2
group Id
EG008
num Affected
2
num At Risk
20
num Events
2
group Id
EG009
num Affected
0
num At Risk
21
num Events
0
group Id
EG010
num Affected
0
num At Risk
20
num Events
0
group Id
EG011
num Affected
0
num At Risk
10
num Events
0
term
Acute promyelocytic leukaemia differentiation syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
3
num At Risk
16
num Events
9
group Id
EG001
num Affected
3
num At Risk
31
num Events
9
group Id
EG002
num Affected
6
num At Risk
39
num Events
6
group Id
EG003
num Affected
7
num At Risk
46
num Events
7
group Id
EG004
num Affected
11
num At Risk
78
num Events
17
group Id
EG005
num Affected
18
num At Risk
153
num Events
38
group Id
EG006
num Affected
2
num At Risk
18
num Events
5
group Id
EG007
num Affected
1
num At Risk
5
num Events
1
group Id
EG008
num Affected
0
num At Risk
20
num Events
0
group Id
EG009
num Affected
2
num At Risk
21
num Events
3
group Id
EG010
num Affected
2
num At Risk
20
num Events
3
group Id
EG011
num Affected
0
num At Risk
10
num Events
0
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
1
num At Risk
16
num Events
1
group Id
EG001
num Affected
1
num At Risk
31
num Events
1
group Id
EG002
num Affected
1
num At Risk
39
num Events
1
group Id
EG003
num Affected
1
num At Risk
46
num Events
1
group Id
EG004
num Affected
2
num At Risk
78
num Events
2
group Id
EG005
num Affected
7
num At Risk
153
num Events
8
group Id
EG006
num Affected
0
num At Risk
18
num Events
0
group Id
EG007
num Affected
0
num At Risk
5
num Events
0
group Id
EG008
num Affected
0
num At Risk
20
num Events
0
group Id
EG009
num Affected
0
num At Risk
21
num Events
0
group Id
EG010
num Affected
1
num At Risk
20
num Events
1
group Id
EG011
num Affected
1
num At Risk
10
num Events
1
term
Amylase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
0
num At Risk
16
num Events
0
group Id
EG001
num Affected
1
num At Risk
31
num Events
1
group Id
EG002
num Affected
0
num At Risk
39
num Events
0
group Id
EG003
num Affected
0
num At Risk
46
num Events
0
group Id
EG004
num Affected
1
num At Risk
78
num Events
1
group Id
EG005
num Affected
0
num At Risk
153
num Events
0
group Id
EG006
num Affected
0
num At Risk
18
num Events
0
group Id
EG007
num Affected
0
num At Risk
5
num Events
0
group Id
EG008
num Affected
0
num At Risk
20
num Events
0
group Id
EG009
num Affected
1
num At Risk
21
num Events
1
group Id
EG010
num Affected
1
num At Risk
20
num Events
1
group Id
EG011
num Affected
0
num At Risk
10
num Events
0
term
Anal incontinence
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
1
num At Risk
16
num Events
2
group Id
EG001
num Affected
2
num At Risk
31
num Events
3
group Id
EG002
num Affected
1
num At Risk
39
num Events
1
group Id
EG003
num Affected
1
num At Risk
46
num Events
1
group Id
EG004
num Affected
3
num At Risk
78
num Events
4
group Id
EG005
num Affected
2
num At Risk
153
num Events
2
group Id
EG006
num Affected
0
num At Risk
18
num Events
0
group Id
EG007
num Affected
1
num At Risk
5
num Events
1
group Id
EG008
num Affected
0
num At Risk
20
num Events
0
group Id
EG009
num Affected
1
num At Risk
21
num Events
1
group Id
EG010
num Affected
0
num At Risk
20
num Events
0
group Id
EG011
num Affected
0
num At Risk
10
num Events
0
term
Angina bullosa haemorrhagica
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
1
num At Risk
16
num Events
1
group Id
EG001
num Affected
2
num At Risk
31
num Events
2
group Id
EG002
num Affected
5
num At Risk
39
num Events
5
group Id
EG003
num Affected
6
num At Risk
46
num Events
6
group Id
EG004
num Affected
9
num At Risk
78
num Events
9
group Id
EG005
num Affected
7
num At Risk
153
num Events
7
group Id
EG006
num Affected
0
num At Risk
18
num Events
0
group Id
EG007
num Affected
0
num At Risk
5
num Events
0
group Id
EG008
num Affected
2
num At Risk
20
num Events
2
group Id
EG009
num Affected
1
num At Risk
21
num Events
1
group Id
EG010
num Affected
1
num At Risk
20
num Events
1
group Id
EG011
num Affected
1
num At Risk
10
num Events
2
term
Anxiety
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
2
num At Risk
16
num Events
2
group Id
EG001
num Affected
5
num At Risk
31
num Events
9
group Id
EG002
num Affected
8
num At Risk
39
num Events
14
group Id
EG003
num Affected
8
num At Risk
46
num Events
14
group Id
EG004
num Affected
13
num At Risk
78
num Events
23
group Id
EG005
num Affected
10
num At Risk
153
num Events
14
group Id
EG006
num Affected
2
num At Risk
18
num Events
2
group Id
EG007
num Affected
0
num At Risk
5
num Events
0
group Id
EG008
num Affected
0
num At Risk
20
num Events
0
group Id
EG009
num Affected
2
num At Risk
21
num Events
2
group Id
EG010
num Affected
1
num At Risk
20
num Events
1
group Id
EG011
num Affected
0
num At Risk
10
num Events
0
term
Arthralgia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
4
num At Risk
16
num Events
8
group Id
EG001
num Affected
5
num At Risk
31
num Events
9
group Id
EG002
num Affected
5
num At Risk
39
num Events
8
group Id
EG003
num Affected
5
num At Risk
46
num Events
8
group Id
EG004
num Affected
11
num At Risk
78
num Events
18
group Id
EG005
num Affected
14
num At Risk
153
num Events
27
group Id
EG006
num Affected
2
num At Risk
18
num Events
3
group Id
EG007
num Affected
1
num At Risk
5
num Events
1
group Id
EG008
num Affected
0
num At Risk
20
num Events
0
group Id
EG009
num Affected
2
num At Risk
21
num Events
2
group Id
EG010
num Affected
1
num At Risk
20
num Events
2
group Id
EG011
num Affected
0
num At Risk
10
num Events
0
term
Aspartate aminotransferase increased

Complete source fields

description

event Groups

deaths Num Affected
4
deaths Num At Risk
16
description
Participants with AML or MDS received single agent FT-2102 orally BID in 28-day cycles at dose levels of 150 mg until MTD or MED achieved.
id
EG000
other Num Affected
15
other Num At Risk
16
serious Num Affected
10
serious Num At Risk
16
title
Phase 1: FT-2102 (Single Agent)
deaths Num Affected
11
deaths Num At Risk
31
description
Participants with AML or MDS received single agent FT-2102 orally QD and BID in 28-day cycles at the different dose levels (150 mg and ≤ 300 mg) until MTD or MED achieved.
id
EG001
other Num Affected
29
other Num At Risk
31
serious Num Affected
23
serious Num At Risk
31
title
Phase 1: Total FT-2102 (Single Agent)
deaths Num Affected
9
deaths Num At Risk
39
description
Participants with AML or MDS received combination therapy (FT-2102 + azacitidine 75 mg/m\^2) orally BID in 28-day cycles at dose levels of 150 mg until MTD or MED achieved.
id
EG002
other Num Affected
39
other Num At Risk
39
serious Num Affected
30
serious Num At Risk
39
title
Phase 1: FT-2102 + Azacitidine (Combination Therapy)
deaths Num Affected
10
deaths Num At Risk
46
description
Participants with AML or MDS received combination therapy (FT-2102 150 mg and ≤ 300 mg and azacitidine administered at the dose of 75 mg/m\^2 for 7 days IV/SC per every 28-day cycle) until treatment discontinuation.
id
EG003
other Num Affected
46
other Num At Risk
46
serious Num Affected
36
serious Num At Risk
46
title
Phase 1: Total FT-2102; FT-2102 + Azacitidine (Combination Therapy)
deaths Num Affected
21
deaths Num At Risk
78
description
Participants with AML or MDS received single agent (FT-2102), combination therapy (FT-2102 + azacitidine, FT-2102+ LDAC) starting at 150 mg BID dose level until MTD or MED achieved or treatment discontinuation.
id
EG004
other Num Affected
76
other Num At Risk
78
serious Num Affected
60
serious Num At Risk
78
title
Phase 1: Overall
deaths Num Affected
50
deaths Num At Risk
153
description
Participants with R/R AML received single agent of FT-2102 150 mg BID in continuous 28-day cycles.
id
EG005
other Num Affected
152
other Num At Risk
153
serious Num Affected
115
serious Num At Risk
153
title
Phase 2: Cohort 1; FT-2102 (Single Agent)
deaths Num Affected
0
deaths Num At Risk
18
description
Participants with AML in morphologic CR/CRi after prior therapy with residual IDH1-R132 mutation were received single agent of FT-2102 150 mg BID in continuous 28-day cycles.
id
EG006
other Num Affected
18
other Num At Risk
18
serious Num Affected
6
serious Num At Risk
18
title
Phase 2: Cohort 2; FT-2102 (Single Agent)
deaths Num Affected
2
deaths Num At Risk
5
description
Participants with R/R AML or MDS who were previously treated with FT-2102 and who underwent HSCT on-study then relapsed post-HSCT received single agent of FT-2102 150 mg BID in continuous 28-day cycles.
id
EG007
other Num Affected
5
other Num At Risk
5
serious Num Affected
4
serious Num At Risk
5
title
Phase 2: Cohort 3; FT-2102 (Single Agent)
deaths Num Affected
3
deaths Num At Risk
20
description
Participants with R/R AML that is naïve to prior hypomethylating therapy and IDH1 inhibitor therapy received combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
id
EG008
other Num Affected
18
other Num At Risk
20
serious Num Affected
12
serious Num At Risk
20
title
Phase 2: Cohort 4; FT-2102 + Azacitidine (Combination Therapy)
deaths Num Affected
6
deaths Num At Risk
21
description
Participants with R/R AML/MDS that have inadequately responded to or have progressed on prior hypo-methylating therapy received combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
id
EG009
other Num Affected
20
other Num At Risk
21
serious Num Affected
18
serious Num At Risk
21
title
Phase 2: Cohort 5; FT-2102 + Azacitidine (Combination Therapy)
deaths Num Affected
7
deaths Num At Risk
20
description
Participants with R/R AML/MDS that have been previously treated with single agent FT-2102 as their last therapy prior to study enrolment received combination therapy of azacitidine + FT-2102 150 mg BID in continuous 28-day cycles. Participants from the FT-2102 single agent cohorts of this study allowed to be enrolled in Cohort 6 after their disease progression.
id
EG010
other Num Affected
19
other Num At Risk
20
serious Num Affected
13
serious Num At Risk
20
title
Phase 2: Cohort 6; FT-2102 + Azacitidine (Combination Therapy)
deaths Num Affected
4
deaths Num At Risk
10
description
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given single agent of FT-2102 150 mg BID in continuous 28-day cycles.
id
EG011
other Num Affected
10
other Num At Risk
10
serious Num Affected
8
serious Num At Risk
10
title
Phase 2: Cohort 7; FT-2102 (Single Agent)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
1
num At Risk
16
num Events
1
group Id
EG001
num Affected
5
num At Risk
31
num Events
5
group Id
EG002
num Affected
3
num At Risk
39
num Events
3
group Id
EG003
num Affected
4
num At Risk
46
num Events
5
group Id
EG004
num Affected
9
num At Risk
78
num Events
10
group Id
EG005
num Affected
2
num At Risk
153
num Events
3
group Id
EG006
num Affected
1
num At Risk
18
num Events
1
group Id
EG007
num Affected
0
num At Risk
5
num Events
0
group Id
EG008
num Affected
0
num At Risk
20
num Events
0
group Id
EG009
num Affected
1
num At Risk
21
num Events
1
group Id
EG010
num Affected
1
num At Risk
20
num Events
1
group Id
EG011
num Affected
0
num At Risk
10
num Events
0
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
0
num At Risk
16
num Events
0
group Id
EG001
num Affected
1
num At Risk
31
num Events
1
group Id
EG002
num Affected
7
num At Risk
39
num Events
9
group Id
EG003
num Affected
9
num At Risk
46
num Events
11
group Id
EG004
num Affected
10
num At Risk
78
num Events
12
group Id
EG005
num Affected
15
num At Risk
153
num Events
17
group Id
EG006
num Affected
0
num At Risk
18
num Events
0
group Id
EG007
num Affected
2
num At Risk
5
num Events
2
group Id
EG008
num Affected
2
num At Risk
20
num Events
3
group Id
EG009
num Affected
1
num At Risk
21
num Events
1
group Id
EG010
num Affected
2
num At Risk
20
num Events
2
group Id
EG011
num Affected
2
num At Risk
10
num Events
3
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
0
num At Risk
16
num Events
0
group Id
EG001
num Affected
3
num At Risk
31
num Events
3
group Id
EG002
num Affected
1
num At Risk
39
num Events
1
group Id
EG003
num Affected
1
num At Risk
46
num Events
1
group Id
EG004
num Affected
4
num At Risk
78
num Events
4
group Id
EG005
num Affected
7
num At Risk
153
num Events
9
group Id
EG006
num Affected
2
num At Risk
18
num Events
2
group Id
EG007
num Affected
0
num At Risk
5
num Events
0
group Id
EG008
num Affected
0
num At Risk
20
num Events
0
group Id
EG009
num Affected
0
num At Risk
21
num Events
0
group Id
EG010
num Affected
1
num At Risk
20
num Events
1
group Id
EG011
num Affected
1
num At Risk
10
num Events
1
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
2
num At Risk
16
num Events
2
group Id
EG001
num Affected
3
num At Risk
31
num Events
3
group Id
EG002
num Affected
2
num At Risk
39
num Events
2
group Id
EG003
num Affected
3
num At Risk
46
num Events
3
group Id
EG004
num Affected
6
num At Risk
78
num Events
6
group Id
EG005
num Affected
7
num At Risk
153
num Events
15
group Id
EG006
num Affected
0
num At Risk
18
num Events
0
group Id
EG007
num Affected
0
num At Risk
5
num Events
0
group Id
EG008
num Affected
0
num At Risk
20
num Events
0
group Id
EG009
num Affected
1
num At Risk
21
num Events
1
group Id
EG010
num Affected
0
num At Risk
20
num Events
0
group Id
EG011
num Affected
0
num At Risk
10
num Events
0
term
Acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
2
num At Risk
16
num Events
2
group Id
EG001
num Affected
2
num At Risk
31
num Events
2
group Id
EG002
num Affected
4
num At Risk
39
num Events
5
group Id
EG003
num Affected
4
num At Risk
46
num Events
5
group Id
EG004
num Affected
6
num At Risk
78
num Events
7
group Id
EG005
num Affected
11
num At Risk
153
num Events
11
group Id
EG006
num Affected
0
num At Risk
18
num Events
0
group Id
EG007
num Affected
2
num At Risk
5
num Events
2
group Id
EG008
num Affected
2
num At Risk
20
num Events
2
group Id
EG009
num Affected
0
num At Risk
21
num Events
0
group Id
EG010
num Affected
0
num At Risk
20
num Events
0
group Id
EG011
num Affected
0
num At Risk
10
num Events
0
term
Acute promyelocytic leukaemia differentiation syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
3
num At Risk
16
num Events
9
group Id
EG001
num Affected
3
num At Risk
31
num Events
9
group Id
EG002
num Affected
6
num At Risk
39
num Events
6
group Id
EG003
num Affected
7
num At Risk
46
num Events
7
group Id
EG004
num Affected
11
num At Risk
78
num Events
17
group Id
EG005
num Affected
18
num At Risk
153
num Events
38
group Id
EG006
num Affected
2
num At Risk
18
num Events
5
group Id
EG007
num Affected
1
num At Risk
5
num Events
1
group Id
EG008
num Affected
0
num At Risk
20
num Events
0
group Id
EG009
num Affected
2
num At Risk
21
num Events
3
group Id
EG010
num Affected
2
num At Risk
20
num Events
3
group Id
EG011
num Affected
0
num At Risk
10
num Events
0
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
1
num At Risk
16
num Events
1
group Id
EG001
num Affected
1
num At Risk
31
num Events
1
group Id
EG002
num Affected
1
num At Risk
39
num Events
1
group Id
EG003
num Affected
1
num At Risk
46
num Events
1
group Id
EG004
num Affected
2
num At Risk
78
num Events
2
group Id
EG005
num Affected
7
num At Risk
153
num Events
8
group Id
EG006
num Affected
0
num At Risk
18
num Events
0
group Id
EG007
num Affected
0
num At Risk
5
num Events
0
group Id
EG008
num Affected
0
num At Risk
20
num Events
0
group Id
EG009
num Affected
0
num At Risk
21
num Events
0
group Id
EG010
num Affected
1
num At Risk
20
num Events
1
group Id
EG011
num Affected
1
num At Risk
10
num Events
1
term
Amylase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
0
num At Risk
16
num Events
0
group Id
EG001
num Affected
1
num At Risk
31
num Events
1
group Id
EG002
num Affected
0
num At Risk
39
num Events
0
group Id
EG003
num Affected
0
num At Risk
46
num Events
0
group Id
EG004
num Affected
1
num At Risk
78
num Events
1
group Id
EG005
num Affected
0
num At Risk
153
num Events
0
group Id
EG006
num Affected
0
num At Risk
18
num Events
0
group Id
EG007
num Affected
0
num At Risk
5
num Events
0
group Id
EG008
num Affected
0
num At Risk
20
num Events
0
group Id
EG009
num Affected
1
num At Risk
21
num Events
1
group Id
EG010
num Affected
1
num At Risk
20
num Events
1
group Id
EG011
num Affected
0
num At Risk
10
num Events
0
term
Anal incontinence
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
1
num At Risk
16
num Events
2
group Id
EG001
num Affected
2
num At Risk
31
num Events
3
group Id
EG002
num Affected
1
num At Risk
39
num Events
1
group Id
EG003
num Affected
1
num At Risk
46
num Events
1
group Id
EG004
num Affected
3
num At Risk
78
num Events
4
group Id
EG005
num Affected
2
num At Risk
153
num Events
2
group Id
EG006
num Affected
0
num At Risk
18
num Events
0
group Id
EG007
num Affected
1
num At Risk
5
num Events
1
group Id
EG008
num Affected
0
num At Risk
20
num Events
0
group Id
EG009
num Affected
1
num At Risk
21
num Events
1
group Id
EG010
num Affected
0
num At Risk
20
num Events
0
group Id
EG011
num Affected
0
num At Risk
10
num Events
0
term
Angina bullosa haemorrhagica
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
1
num At Risk
16
num Events
1
group Id
EG001
num Affected
2
num At Risk
31
num Events
2
group Id
EG002
num Affected
5
num At Risk
39
num Events
5
group Id
EG003
num Affected
6
num At Risk
46
num Events
6
group Id
EG004
num Affected
9
num At Risk
78
num Events
9
group Id
EG005
num Affected
7
num At Risk
153
num Events
7
group Id
EG006
num Affected
0
num At Risk
18
num Events
0
group Id
EG007
num Affected
0
num At Risk
5
num Events
0
group Id
EG008
num Affected
2
num At Risk
20
num Events
2
group Id
EG009
num Affected
1
num At Risk
21
num Events
1
group Id
EG010
num Affected
1
num At Risk
20
num Events
1
group Id
EG011
num Affected
1
num At Risk
10
num Events
2
term
Anxiety
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
2
num At Risk
16
num Events
2
group Id
EG001
num Affected
5
num At Risk
31
num Events
9
group Id
EG002
num Affected
8
num At Risk
39
num Events
14
group Id
EG003
num Affected
8
num At Risk
46
num Events
14
group Id
EG004
num Affected
13
num At Risk
78
num Events
23
group Id
EG005
num Affected
10
num At Risk
153
num Events
14
group Id
EG006
num Affected
2
num At Risk
18
num Events
2
group Id
EG007
num Affected
0
num At Risk
5
num Events
0
group Id
EG008
num Affected
0
num At Risk
20
num Events
0
group Id
EG009
num Affected
2
num At Risk
21
num Events
2
group Id
EG010
num Affected
1
num At Risk
20
num Events
1
group Id
EG011
num Affected
0
num At Risk
10
num Events
0
term
Arthralgia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
4
num At Risk
16
num Events
8
group Id
EG001
num Affected
5
num At Risk
31
num Events
9
group Id
EG002
num Affected
5
num At Risk
39
num Events
8
group Id
EG003
num Affected
5
num At Risk
46
num Events
8
group Id
EG004
num Affected
11
num At Risk
78
num Events
18
group Id
EG005
num Affected
14
num At Risk
153
num Events
27
group Id
EG006
num Affected
2
num At Risk
18
num Events
3
group Id
EG007
num Affected
1
num At Risk
5
num Events
1
group Id
EG008
num Affected
0
num At Risk
20
num Events
0
group Id
EG009
num Affected
2
num At Risk
21
num Events
2
group Id
EG010
num Affected
1
num At Risk
20
num Events
2
group Id
EG011
num Affected
0
num At Risk
10
num Events
0
term
Aspartate aminotransferase increased

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
0
num At Risk
16
num Events
0
group Id
EG001
num Affected
0
num At Risk
31
num Events
0
group Id
EG002
num Affected
0
num At Risk
39
num Events
0
group Id
EG003
num Affected
0
num At Risk
46
num Events
0
group Id
EG004
num Affected
0
num At Risk
78
num Events
0
group Id
EG005
num Affected
0
num At Risk
153
num Events
0
group Id
EG006
num Affected
0
num At Risk
18
num Events
0
group Id
EG007
num Affected
0
num At Risk
5
num Events
0
group Id
EG008
num Affected
0
num At Risk
20
num Events
0
group Id
EG009
num Affected
0
num At Risk
21
num Events
0
group Id
EG010
num Affected
0
num At Risk
20
num Events
0
group Id
EG011
num Affected
1
num At Risk
10
num Events
2
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
0
num At Risk
16
num Events
0
group Id
EG001
num Affected
0
num At Risk
31
num Events
0
group Id
EG002
num Affected
0
num At Risk
39
num Events
0
group Id
EG003
num Affected
0
num At Risk
46
num Events
0
group Id
EG004
num Affected
0
num At Risk
78
num Events
0
group Id
EG005
num Affected
0
num At Risk
153
num Events
0
group Id
EG006
num Affected
0
num At Risk
18
num Events
0
group Id
EG007
num Affected
0
num At Risk
5
num Events
0
group Id
EG008
num Affected
0
num At Risk
20
num Events
0
group Id
EG009
num Affected
0
num At Risk
21
num Events
0
group Id
EG010
num Affected
0
num At Risk
20
num Events
0
group Id
EG011
num Affected
0
num At Risk
10
num Events
0
term
Acute coronary syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
0
num At Risk
16
num Events
0
group Id
EG001
num Affected
0
num At Risk
31
num Events
0
group Id
EG002
num Affected
0
num At Risk
39
num Events
0
group Id
EG003
num Affected
0
num At Risk
46
num Events
0
group Id
EG004
num Affected
0
num At Risk
78
num Events
0
group Id
EG005
num Affected
2
num At Risk
153
num Events
2
group Id
EG006
num Affected
0
num At Risk
18
num Events
0
group Id
EG007
num Affected
0
num At Risk
5
num Events
0
group Id
EG008
num Affected
0
num At Risk
20
num Events
0
group Id
EG009
num Affected
0
num At Risk
21
num Events
0
group Id
EG010
num Affected
0
num At Risk
20
num Events
0
group Id
EG011
num Affected
0
num At Risk
10
num Events
0
term
Acute febrile neutrophilic dermatosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
0
num At Risk
16
num Events
0
group Id
EG001
num Affected
0
num At Risk
31
num Events
0
group Id
EG002
num Affected
1
num At Risk
39
num Events
1
group Id
EG003
num Affected
1
num At Risk
46
num Events
1
group Id
EG004
num Affected
2
num At Risk
78
num Events
2
group Id
EG005
num Affected
2
num At Risk
153
num Events
2
group Id
EG006
num Affected
0
num At Risk
18
num Events
0
group Id
EG007
num Affected
0
num At Risk
5
num Events
0
group Id
EG008
num Affected
0
num At Risk
20
num Events
0
group Id
EG009
num Affected
0
num At Risk
21
num Events
0
group Id
EG010
num Affected
0
num At Risk
20
num Events
0
group Id
EG011
num Affected
1
num At Risk
10
num Events
1
term
Acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
1
num At Risk
16
num Events
1
group Id
EG001
num Affected
2
num At Risk
31
num Events
2
group Id
EG002
num Affected
2
num At Risk
39
num Events
2
group Id
EG003
num Affected
4
num At Risk
46
num Events
4
group Id
EG004
num Affected
6
num At Risk
78
num Events
6
group Id
EG005
num Affected
14
num At Risk
153
num Events
16
group Id
EG006
num Affected
0
num At Risk
18
num Events
0
group Id
EG007
num Affected
0
num At Risk
5
num Events
0
group Id
EG008
num Affected
1
num At Risk
20
num Events
1
group Id
EG009
num Affected
2
num At Risk
21
num Events
2
group Id
EG010
num Affected
0
num At Risk
20
num Events
0
group Id
EG011
num Affected
2
num At Risk
10
num Events
2
term
Acute promyelocytic leukaemia differentiation syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
0
num At Risk
16
num Events
0
group Id
EG001
num Affected
0
num At Risk
31
num Events
0
group Id
EG002
num Affected
0
num At Risk
39
num Events
0
group Id
EG003
num Affected
0
num At Risk
46
num Events
0
group Id
EG004
num Affected
0
num At Risk
78
num Events
0
group Id
EG005
num Affected
1
num At Risk
153
num Events
1
group Id
EG006
num Affected
0
num At Risk
18
num Events
0
group Id
EG007
num Affected
0
num At Risk
5
num Events
0
group Id
EG008
num Affected
0
num At Risk
20
num Events
0
group Id
EG009
num Affected
0
num At Risk
21
num Events
0
group Id
EG010
num Affected
0
num At Risk
20
num Events
0
group Id
EG011
num Affected
0
num At Risk
10
num Events
0
term
Acute psychosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
0
num At Risk
16
num Events
0
group Id
EG001
num Affected
0
num At Risk
31
num Events
0
group Id
EG002
num Affected
0
num At Risk
39
num Events
0
group Id
EG003
num Affected
0
num At Risk
46
num Events
0
group Id
EG004
num Affected
0
num At Risk
78
num Events
0
group Id
EG005
num Affected
1
num At Risk
153
num Events
1
group Id
EG006
num Affected
0
num At Risk
18
num Events
0
group Id
EG007
num Affected
0
num At Risk
5
num Events
0
group Id
EG008
num Affected
0
num At Risk
20
num Events
0
group Id
EG009
num Affected
0
num At Risk
21
num Events
0
group Id
EG010
num Affected
0
num At Risk
20
num Events
0
group Id
EG011
num Affected
0
num At Risk
10
num Events
0
term
Acute respiratory distress syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
0
num At Risk
16
num Events
0
group Id
EG001
num Affected
1
num At Risk
31
num Events
1
group Id
EG002
num Affected
0
num At Risk
39
num Events
0
group Id
EG003
num Affected
0
num At Risk
46
num Events
0
group Id
EG004
num Affected
1
num At Risk
78
num Events
1
group Id
EG005
num Affected
0
num At Risk
153
num Events
0
group Id
EG006
num Affected
0
num At Risk
18
num Events
0
group Id
EG007
num Affected
0
num At Risk
5
num Events
0
group Id
EG008
num Affected
0
num At Risk
20
num Events
0
group Id
EG009
num Affected
0
num At Risk
21
num Events
0
group Id
EG010
num Affected
0
num At Risk
20
num Events
0
group Id
EG011
num Affected
0
num At Risk
10
num Events
0
term
Acute respiratory failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
0
num At Risk
16
num Events
0
group Id
EG001
num Affected
1
num At Risk
31
num Events
1
group Id
EG002
num Affected
0
num At Risk
39
num Events
0
group Id
EG003
num Affected
0
num At Risk
46
num Events
0
group Id
EG004
num Affected
1
num At Risk
78
num Events
1
group Id
EG005
num Affected
1
num At Risk
153
num Events
1
group Id
EG006
num Affected
0
num At Risk
18
num Events
0
group Id
EG007
num Affected
0
num At Risk
5
num Events
0
group Id
EG008
num Affected
1
num At Risk
20
num Events
1
group Id
EG009
num Affected
0
num At Risk
21
num Events
0
group Id
EG010
num Affected
0
num At Risk
20
num Events
0
group Id
EG011
num Affected
0
num At Risk
10
num Events
0
term
Anal abscess
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
0
num At Risk
16
num Events
0
group Id
EG001
num Affected
0
num At Risk
31
num Events
0
group Id
EG002
num Affected
0
num At Risk
39
num Events
0
group Id
EG003
num Affected
0
num At Risk
46
num Events
0
group Id
EG004
num Affected
0
num At Risk
78
num Events
0
group Id
EG005
num Affected
1
num At Risk
153
num Events
1
group Id
EG006
num Affected
0
num At Risk
18
num Events
0
group Id
EG007
num Affected
0
num At Risk
5
num Events
0
group Id
EG008
num Affected
0
num At Risk
20
num Events
0
group Id
EG009
num Affected
0
num At Risk
21
num Events
0
group Id
EG010
num Affected
0
num At Risk
20
num Events
0
group Id
EG011
num Affected
0
num At Risk
10
num Events
0
term
Anal fistula
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
0
num At Risk
16
num Events
0
group Id
EG001
num Affected
0
num At Risk
31
num Events
0
group Id
EG002
num Affected
0
num At Risk
39
num Events
0
group Id
EG003
num Affected
0
num At Risk
46
num Events
0
group Id
EG004
num Affected
0
num At Risk
78
num Events
0
group Id
EG005
num Affected
0
num At Risk
153
num Events
0
group Id
EG006
num Affected
0
num At Risk
18
num Events
0
group Id
EG007
num Affected
0
num At Risk
5
num Events
0
group Id
EG008
num Affected
0
num At Risk
20
num Events
0
group Id
EG009
num Affected
0
num At Risk
21
num Events
0
group Id
EG010
num Affected
0
num At Risk
20
num Events
0
group Id
EG011
num Affected
1
num At Risk
10
num Events
1
term
Angioedema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
0
num At Risk
16
num Events
0
group Id
EG001
num Affected
0
num At Risk
31
num Events
0
group Id
EG002
num Affected
1
num At Risk
39
num Events
1
group Id
EG003
num Affected
1
num At Risk
46
num Events
1
group Id
EG004
num Affected
1
num At Risk
78
num Events
1
group Id
EG005
num Affected
0
num At Risk
153
num Events
0
group Id
EG006
num Affected
0
num At Risk
18
num Events
0
group Id
EG007
num Affected
0
num At Risk
5
num Events
0
group Id
EG008
num Affected
0
num At Risk
20
num Events
0
group Id
EG009
num Affected
0
num At Risk
21
num Events
0
group Id
EG010
num Affected
0
num At Risk
20
num Events
0
group Id
EG011
num Affected
0
num At Risk
10
num Events
0
term
Ankle fracture

time Frame

From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)

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

Preserved source evidence · Not medical advice