NCT03306264 · ADVERSE EVENTS

Adverse events

Study of ASTX727 vs IV Decitabine in Participants With MDS, CMML, and AML · Source last updated 2024-08-27

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: MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
Other-event reporting threshold: 5%

All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
MDS or CMML: IV Decitabine Participants with MDS or CMML received IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle = 28 days).	24 / 132	127 / 132	2 / 132
MDS or CMML: ASTX727 Participants with MDS or CMML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle = 28 days). From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, participant discontinued treatment, or was withdrawn from the study.	81 / 130	130 / 130	56 / 130
MDS or CMML: Not Treated Participants with MDS or CMML were enrolled in the study but did not receive any study treatment.	0 / 5	0 / 5	0 / 5
AML: IV Decitabine Participants with MDS or CMML received IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycles 1 or 2.	19 / 78	70 / 78	5 / 78
AML: ASTX727 Participants with AML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle = 28 days). From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, participant discontinued treatment, or was withdrawn from the study.	65 / 80	76 / 80	61 / 80
AML: Not Treated Participants with AML were enrolled in the study but did not receive any study treatment.	1 / 2	0 / 2	2 / 2

Group identifiers: EG000: MDS or CMML: IV Decitabine · EG001: MDS or CMML: ASTX727 · EG002: MDS or CMML: Not Treated · EG003: AML: IV Decitabine · EG004: AML: ASTX727 · EG005: AML: Not Treated

Serious adverse events

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

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
8
num At Risk
132
group Id
EG001
num Affected
33
num At Risk
130
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
4
num At Risk
78
group Id
EG004
num Affected
21
num At Risk
80
group Id
EG005
num Affected
0
num At Risk
2
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
1
num At Risk
132
group Id
EG001
num Affected
3
num At Risk
130
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
1
num At Risk
78
group Id
EG004
num Affected
0
num At Risk
80
group Id
EG005
num Affected
0
num At Risk
2
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
0
num At Risk
132
group Id
EG001
num Affected
2
num At Risk
130
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
78
group Id
EG004
num Affected
4
num At Risk
80
group Id
EG005
num Affected
0
num At Risk
2
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
0
num At Risk
132
group Id
EG001
num Affected
2
num At Risk
130
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
78
group Id
EG004
num Affected
1
num At Risk
80
group Id
EG005
num Affected
0
num At Risk
2
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
0
num At Risk
132
group Id
EG001
num Affected
1
num At Risk
130
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
78
group Id
EG004
num Affected
0
num At Risk
80
group Id
EG005
num Affected
0
num At Risk
2
term
Aplasia pure red cell
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
0
num At Risk
132
group Id
EG001
num Affected
1
num At Risk
130
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
78
group Id
EG004
num Affected
0
num At Risk
80
group Id
EG005
num Affected
0
num At Risk
2
term
Thrombotic thrombocytopenic purpura
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
1
num At Risk
132
group Id
EG001
num Affected
0
num At Risk
130
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
78
group Id
EG004
num Affected
1
num At Risk
80
group Id
EG005
num Affected
0
num At Risk
2
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
1
num At Risk
132
group Id
EG001
num Affected
0
num At Risk
130
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
78
group Id
EG004
num Affected
0
num At Risk
80
group Id
EG005
num Affected
0
num At Risk
2
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
0
num At Risk
132
group Id
EG001
num Affected
0
num At Risk
130
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
1
num At Risk
78
group Id
EG004
num Affected
1
num At Risk
80
group Id
EG005
num Affected
0
num At Risk
2
term
Haematotoxicity
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
0
num At Risk
132
group Id
EG001
num Affected
0
num At Risk
130
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
78
group Id
EG004
num Affected
1
num At Risk
80
group Id
EG005
num Affected
0
num At Risk
2
term
Lymphadenitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
0
num At Risk
132
group Id
EG001
num Affected
2
num At Risk
130
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
78
group Id
EG004
num Affected
0
num At Risk
80
group Id
EG005
num Affected
0
num At Risk
2
term
Myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
0
num At Risk
132
group Id
EG001
num Affected
1
num At Risk
130
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
78
group Id
EG004
num Affected
0
num At Risk
80
group Id
EG005
num Affected
0
num At Risk
2
term
Acute coronary syndrome

Other reported adverse events

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

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
52
num At Risk
132
group Id
EG001
num Affected
90
num At Risk
130
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
30
num At Risk
78
group Id
EG004
num Affected
47
num At Risk
80
group Id
EG005
num Affected
0
num At Risk
2
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
45
num At Risk
132
group Id
EG001
num Affected
79
num At Risk
130
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
8
num At Risk
78
group Id
EG004
num Affected
27
num At Risk
80
group Id
EG005
num Affected
0
num At Risk
2
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
47
num At Risk
132
group Id
EG001
num Affected
72
num At Risk
130
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
21
num At Risk
78
group Id
EG004
num Affected
41
num At Risk
80
group Id
EG005
num Affected
0
num At Risk
2
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
23
num At Risk
132
group Id
EG001
num Affected
37
num At Risk
130
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
4
num At Risk
78
group Id
EG004
num Affected
9
num At Risk
80
group Id
EG005
num Affected
0
num At Risk
2
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
5
num At Risk
132
group Id
EG001
num Affected
8
num At Risk
130
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
78
group Id
EG004
num Affected
0
num At Risk
80
group Id
EG005
num Affected
0
num At Risk
2
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
2
num At Risk
132
group Id
EG001
num Affected
7
num At Risk
130
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
1
num At Risk
78
group Id
EG004
num Affected
7
num At Risk
80
group Id
EG005
num Affected
0
num At Risk
2
term
Febrile Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
1
num At Risk
132
group Id
EG001
num Affected
7
num At Risk
130
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
78
group Id
EG004
num Affected
0
num At Risk
80
group Id
EG005
num Affected
0
num At Risk
2
term
Conjunctival Haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
26
num At Risk
132
group Id
EG001
num Affected
64
num At Risk
130
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
8
num At Risk
78
group Id
EG004
num Affected
15
num At Risk
80
group Id
EG005
num Affected
0
num At Risk
2
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
23
num At Risk
132
group Id
EG001
num Affected
63
num At Risk
130
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
4
num At Risk
78
group Id
EG004
num Affected
17
num At Risk
80
group Id
EG005
num Affected
0
num At Risk
2
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
14
num At Risk
132
group Id
EG001
num Affected
54
num At Risk
130
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
1
num At Risk
78
group Id
EG004
num Affected
17
num At Risk
80
group Id
EG005
num Affected
0
num At Risk
2
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
4
num At Risk
132
group Id
EG001
num Affected
26
num At Risk
130
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
3
num At Risk
78
group Id
EG004
num Affected
10
num At Risk
80
group Id
EG005
num Affected
0
num At Risk
2
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
5
num At Risk
132
group Id
EG001
num Affected
23
num At Risk
130
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
78
group Id
EG004
num Affected
0
num At Risk
80
group Id
EG005
num Affected
0
num At Risk
2
term
Stomatitis

Complete source fields

description

event Groups

deaths Num Affected
2
deaths Num At Risk
132
description
Participants with MDS or CMML received IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle = 28 days).
id
EG000
other Num Affected
127
other Num At Risk
132
serious Num Affected
24
serious Num At Risk
132
title
MDS or CMML: IV Decitabine
deaths Num Affected
56
deaths Num At Risk
130
description
Participants with MDS or CMML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle = 28 days). From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, participant discontinued treatment, or was withdrawn from the study.
id
EG001
other Num Affected
130
other Num At Risk
130
serious Num Affected
81
serious Num At Risk
130
title
MDS or CMML: ASTX727
deaths Num Affected
0
deaths Num At Risk
5
description
Participants with MDS or CMML were enrolled in the study but did not receive any study treatment.
id
EG002
other Num Affected
0
other Num At Risk
5
serious Num Affected
0
serious Num At Risk
5
title
MDS or CMML: Not Treated
deaths Num Affected
5
deaths Num At Risk
78
description
Participants with MDS or CMML received IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycles 1 or 2.
id
EG003
other Num Affected
70
other Num At Risk
78
serious Num Affected
19
serious Num At Risk
78
title
AML: IV Decitabine
deaths Num Affected
61
deaths Num At Risk
80
description
Participants with AML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle = 28 days). From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, participant discontinued treatment, or was withdrawn from the study.
id
EG004
other Num Affected
76
other Num At Risk
80
serious Num Affected
65
serious Num At Risk
80
title
AML: ASTX727
deaths Num Affected
2
deaths Num At Risk
2
description
Participants with AML were enrolled in the study but did not receive any study treatment.
id
EG005
other Num Affected
0
other Num At Risk
2
serious Num Affected
1
serious Num At Risk
2
title
AML: Not Treated

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
52
num At Risk
132
group Id
EG001
num Affected
90
num At Risk
130
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
30
num At Risk
78
group Id
EG004
num Affected
47
num At Risk
80
group Id
EG005
num Affected
0
num At Risk
2
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
45
num At Risk
132
group Id
EG001
num Affected
79
num At Risk
130
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
8
num At Risk
78
group Id
EG004
num Affected
27
num At Risk
80
group Id
EG005
num Affected
0
num At Risk
2
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
47
num At Risk
132
group Id
EG001
num Affected
72
num At Risk
130
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
21
num At Risk
78
group Id
EG004
num Affected
41
num At Risk
80
group Id
EG005
num Affected
0
num At Risk
2
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
23
num At Risk
132
group Id
EG001
num Affected
37
num At Risk
130
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
4
num At Risk
78
group Id
EG004
num Affected
9
num At Risk
80
group Id
EG005
num Affected
0
num At Risk
2
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
5
num At Risk
132
group Id
EG001
num Affected
8
num At Risk
130
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
78
group Id
EG004
num Affected
0
num At Risk
80
group Id
EG005
num Affected
0
num At Risk
2
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
2
num At Risk
132
group Id
EG001
num Affected
7
num At Risk
130
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
1
num At Risk
78
group Id
EG004
num Affected
7
num At Risk
80
group Id
EG005
num Affected
0
num At Risk
2
term
Febrile Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
1
num At Risk
132
group Id
EG001
num Affected
7
num At Risk
130
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
78
group Id
EG004
num Affected
0
num At Risk
80
group Id
EG005
num Affected
0
num At Risk
2
term
Conjunctival Haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
26
num At Risk
132
group Id
EG001
num Affected
64
num At Risk
130
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
8
num At Risk
78
group Id
EG004
num Affected
15
num At Risk
80
group Id
EG005
num Affected
0
num At Risk
2
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
23
num At Risk
132
group Id
EG001
num Affected
63
num At Risk
130
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
4
num At Risk
78
group Id
EG004
num Affected
17
num At Risk
80
group Id
EG005
num Affected
0
num At Risk
2
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
14
num At Risk
132
group Id
EG001
num Affected
54
num At Risk
130
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
1
num At Risk
78
group Id
EG004
num Affected
17
num At Risk
80
group Id
EG005
num Affected
0
num At Risk
2
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
4
num At Risk
132
group Id
EG001
num Affected
26
num At Risk
130
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
3
num At Risk
78
group Id
EG004
num Affected
10
num At Risk
80
group Id
EG005
num Affected
0
num At Risk
2
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
5
num At Risk
132
group Id
EG001
num Affected
23
num At Risk
130
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
78
group Id
EG004
num Affected
0
num At Risk
80
group Id
EG005
num Affected
0
num At Risk
2
term
Stomatitis

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
8
num At Risk
132
group Id
EG001
num Affected
33
num At Risk
130
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
4
num At Risk
78
group Id
EG004
num Affected
21
num At Risk
80
group Id
EG005
num Affected
0
num At Risk
2
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
1
num At Risk
132
group Id
EG001
num Affected
3
num At Risk
130
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
1
num At Risk
78
group Id
EG004
num Affected
0
num At Risk
80
group Id
EG005
num Affected
0
num At Risk
2
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
0
num At Risk
132
group Id
EG001
num Affected
2
num At Risk
130
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
78
group Id
EG004
num Affected
4
num At Risk
80
group Id
EG005
num Affected
0
num At Risk
2
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
0
num At Risk
132
group Id
EG001
num Affected
2
num At Risk
130
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
78
group Id
EG004
num Affected
1
num At Risk
80
group Id
EG005
num Affected
0
num At Risk
2
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
0
num At Risk
132
group Id
EG001
num Affected
1
num At Risk
130
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
78
group Id
EG004
num Affected
0
num At Risk
80
group Id
EG005
num Affected
0
num At Risk
2
term
Aplasia pure red cell
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
0
num At Risk
132
group Id
EG001
num Affected
1
num At Risk
130
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
78
group Id
EG004
num Affected
0
num At Risk
80
group Id
EG005
num Affected
0
num At Risk
2
term
Thrombotic thrombocytopenic purpura
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
1
num At Risk
132
group Id
EG001
num Affected
0
num At Risk
130
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
78
group Id
EG004
num Affected
1
num At Risk
80
group Id
EG005
num Affected
0
num At Risk
2
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
1
num At Risk
132
group Id
EG001
num Affected
0
num At Risk
130
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
78
group Id
EG004
num Affected
0
num At Risk
80
group Id
EG005
num Affected
0
num At Risk
2
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
0
num At Risk
132
group Id
EG001
num Affected
0
num At Risk
130
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
1
num At Risk
78
group Id
EG004
num Affected
1
num At Risk
80
group Id
EG005
num Affected
0
num At Risk
2
term
Haematotoxicity
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
0
num At Risk
132
group Id
EG001
num Affected
0
num At Risk
130
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
78
group Id
EG004
num Affected
1
num At Risk
80
group Id
EG005
num Affected
0
num At Risk
2
term
Lymphadenitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
0
num At Risk
132
group Id
EG001
num Affected
2
num At Risk
130
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
78
group Id
EG004
num Affected
0
num At Risk
80
group Id
EG005
num Affected
0
num At Risk
2
term
Myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
0
num At Risk
132
group Id
EG001
num Affected
1
num At Risk
130
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
78
group Id
EG004
num Affected
0
num At Risk
80
group Id
EG005
num Affected
0
num At Risk
2
term
Acute coronary syndrome

time Frame

MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years

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

Preserved source evidence · Not medical advice