NCT02103478 · ADVERSE EVENTS

Adverse events

Pharmacokinetic Guided Dose Escalation and Dose Confirmation With Oral Decitabine and Oral Cytidine Deaminase Inhibitor (CDAi) in Patients With Myelodysplastic Syndromes (MDS) · 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: Up to 5 years
Other-event reporting threshold: 5%

Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Phase 1 Dose Escalation Cohort 1 Cohort 1 was administered 40 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).	2 / 7	6 / 7	2 / 7
Phase 1 Dose Escalation Cohort 2 Cohort 2 was administered 60 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).	4 / 6	6 / 6	2 / 6
Phase 1 Dose Escalation Cohort 3 Cohort 3 was administered 100 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).	2 / 6	6 / 6	1 / 6
Phase 1 Dose Escalation Cohort 4 Cohort 4 was administered 100 mg oral cedazuridine and 40 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).	6 / 6	6 / 6	1 / 6
Phase 1 Dose Escalation Cohort 5 Cohort 1 was administered 100 mg oral cedazuridine and 30 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).	14 / 19	18 / 19	5 / 19
Phase 2 Dose Confirmation Participants were randomized in a 1:1 ratio to receive either oral cedazuridine (100 mg) + decitabine (35 mg) capsules Dailyx5 in Course 1 followed by IV decitabine (20 mg/m\^2) Dailyx5 in Course 2 (28 days per course) or the converse. In Courses ≥ 3, all participants received cedazuridine and decitabine capsules Dailyx5 in 28-day courses until disease progression, unacceptable toxicity, withdrawal of consent or withdrawal from the study.	39 / 50	48 / 50	29 / 50
Phase 2 Fixed-Dose Combination Participants were randomized in a 1:1 ratio to receive either the fixed-dose combination (FDC) tablet (100 mg cedazuridine/35 mg decitabine) Dailyx5 in Course 1 followed by IV decitabine (20 mg/m\^2) Dailyx5 in Course 2 (28 days per course) or the converse. In Courses ≥ 3, all participants received the FDC tablet Dailyx5 in 28-day courses until disease progression, unacceptable toxicity, withdrawal of consent or withdrawal from the study.	25 / 30	30 / 30	21 / 30

Group identifiers: EG000: Phase 1 Dose Escalation Cohort 1 · EG001: Phase 1 Dose Escalation Cohort 2 · EG002: Phase 1 Dose Escalation Cohort 3 · EG003: Phase 1 Dose Escalation Cohort 4 · EG004: Phase 1 Dose Escalation Cohort 5 · EG005: Phase 2 Dose Confirmation · EG006: Phase 2 Fixed-Dose Combination

Serious adverse events

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

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
5
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
group Id
EG003
num Affected
2
num At Risk
6
num Events
8
group Id
EG004
num Affected
2
num At Risk
19
num Events
2
group Id
EG005
num Affected
17
num At Risk
50
num Events
31
group Id
EG006
num Affected
7
num At Risk
30
num Events
10
term
Febrile neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
1
num At Risk
19
num Events
2
group Id
EG005
num Affected
1
num At Risk
50
num Events
1
group Id
EG006
num Affected
0
num At Risk
30
num Events
0
term
Anemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
1
num At Risk
19
num Events
1
group Id
EG005
num Affected
0
num At Risk
50
num Events
0
group Id
EG006
num Affected
1
num At Risk
30
num Events
1
term
Cardiac arrest
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
19
num Events
0
group Id
EG005
num Affected
1
num At Risk
50
num Events
1
group Id
EG006
num Affected
0
num At Risk
30
num Events
0
term
Cardiogenic shock
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
1
num At Risk
19
num Events
1
group Id
EG005
num Affected
0
num At Risk
50
num Events
0
group Id
EG006
num Affected
0
num At Risk
30
num Events
0
term
Tachycardia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
19
num Events
0
group Id
EG005
num Affected
1
num At Risk
50
num Events
1
group Id
EG006
num Affected
0
num At Risk
30
num Events
0
term
Myocarditis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
19
num Events
0
group Id
EG005
num Affected
1
num At Risk
50
num Events
1
group Id
EG006
num Affected
0
num At Risk
30
num Events
0
term
Palpitations
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
19
num Events
0
group Id
EG005
num Affected
1
num At Risk
50
num Events
1
group Id
EG006
num Affected
0
num At Risk
30
num Events
0
term
Sinus tachycardia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
19
num Events
0
group Id
EG005
num Affected
1
num At Risk
50
num Events
1
group Id
EG006
num Affected
0
num At Risk
30
num Events
0
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
19
num Events
0
group Id
EG005
num Affected
2
num At Risk
50
num Events
3
group Id
EG006
num Affected
1
num At Risk
30
num Events
1
term
Gastrointestinal hemorrhage
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
1
num At Risk
19
num Events
1
group Id
EG005
num Affected
0
num At Risk
50
num Events
0
group Id
EG006
num Affected
0
num At Risk
30
num Events
0
term
Large intestinal obstruction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
1
num At Risk
19
num Events
1
group Id
EG005
num Affected
0
num At Risk
50
num Events
0
group Id
EG006
num Affected
0
num At Risk
30
num Events
0
term
Diarrhea

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
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
4
num At Risk
7
num Events
16
group Id
EG001
num Affected
3
num At Risk
6
num Events
4
group Id
EG002
num Affected
4
num At Risk
6
num Events
11
group Id
EG003
num Affected
3
num At Risk
6
num Events
7
group Id
EG004
num Affected
10
num At Risk
19
num Events
34
group Id
EG005
num Affected
27
num At Risk
50
num Events
67
group Id
EG006
num Affected
15
num At Risk
30
num Events
59
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
3
num At Risk
7
num Events
13
group Id
EG001
num Affected
2
num At Risk
6
num Events
12
group Id
EG002
num Affected
4
num At Risk
6
num Events
4
group Id
EG003
num Affected
1
num At Risk
6
num Events
4
group Id
EG004
num Affected
6
num At Risk
19
num Events
24
group Id
EG005
num Affected
28
num At Risk
50
num Events
125
group Id
EG006
num Affected
12
num At Risk
30
num Events
53
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
4
num At Risk
7
num Events
8
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
group Id
EG002
num Affected
2
num At Risk
6
num Events
2
group Id
EG003
num Affected
3
num At Risk
6
num Events
6
group Id
EG004
num Affected
5
num At Risk
19
num Events
16
group Id
EG005
num Affected
16
num At Risk
50
num Events
46
group Id
EG006
num Affected
8
num At Risk
30
num Events
23
term
Anemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
6
group Id
EG001
num Affected
2
num At Risk
6
num Events
6
group Id
EG002
num Affected
1
num At Risk
6
num Events
2
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
4
num At Risk
19
num Events
24
group Id
EG005
num Affected
12
num At Risk
50
num Events
47
group Id
EG006
num Affected
11
num At Risk
30
num Events
45
term
Leukopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
1
num At Risk
6
num Events
1
group Id
EG004
num Affected
0
num At Risk
19
num Events
0
group Id
EG005
num Affected
0
num At Risk
50
num Events
0
group Id
EG006
num Affected
0
num At Risk
30
num Events
0
term
Lymphadenopathy
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
1
num At Risk
19
num Events
1
group Id
EG005
num Affected
5
num At Risk
50
num Events
7
group Id
EG006
num Affected
5
num At Risk
30
num Events
6
term
Febrile neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
19
num Events
0
group Id
EG005
num Affected
0
num At Risk
50
num Events
0
group Id
EG006
num Affected
0
num At Risk
30
num Events
0
term
Thrombocytosis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
1
num At Risk
6
num Events
1
group Id
EG004
num Affected
2
num At Risk
19
num Events
2
group Id
EG005
num Affected
0
num At Risk
50
num Events
0
group Id
EG006
num Affected
0
num At Risk
30
num Events
0
term
Sinus tachycardia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
1
num At Risk
19
num Events
1
group Id
EG005
num Affected
0
num At Risk
50
num Events
0
group Id
EG006
num Affected
0
num At Risk
30
num Events
0
term
Bradycardia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
1
num At Risk
19
num Events
1
group Id
EG005
num Affected
0
num At Risk
50
num Events
0
group Id
EG006
num Affected
0
num At Risk
30
num Events
0
term
Pericardial effusion
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
1
num At Risk
19
num Events
1
group Id
EG005
num Affected
0
num At Risk
50
num Events
0
group Id
EG006
num Affected
0
num At Risk
30
num Events
0
term
Sinus bradycardia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
19
num Events
0
group Id
EG005
num Affected
0
num At Risk
50
num Events
0
group Id
EG006
num Affected
0
num At Risk
30
num Events
0
term
Vertigo

Complete source fields

description

Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.

event Groups

deaths Num Affected
2
deaths Num At Risk
7
description
Cohort 1 was administered 40 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
id
EG000
other Num Affected
6
other Num At Risk
7
serious Num Affected
2
serious Num At Risk
7
title
Phase 1 Dose Escalation Cohort 1
deaths Num Affected
2
deaths Num At Risk
6
description
Cohort 2 was administered 60 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
id
EG001
other Num Affected
6
other Num At Risk
6
serious Num Affected
4
serious Num At Risk
6
title
Phase 1 Dose Escalation Cohort 2
deaths Num Affected
1
deaths Num At Risk
6
description
Cohort 3 was administered 100 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
id
EG002
other Num Affected
6
other Num At Risk
6
serious Num Affected
2
serious Num At Risk
6
title
Phase 1 Dose Escalation Cohort 3
deaths Num Affected
1
deaths Num At Risk
6
description
Cohort 4 was administered 100 mg oral cedazuridine and 40 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
id
EG003
other Num Affected
6
other Num At Risk
6
serious Num Affected
6
serious Num At Risk
6
title
Phase 1 Dose Escalation Cohort 4
deaths Num Affected
5
deaths Num At Risk
19
description
Cohort 1 was administered 100 mg oral cedazuridine and 30 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
id
EG004
other Num Affected
18
other Num At Risk
19
serious Num Affected
14
serious Num At Risk
19
title
Phase 1 Dose Escalation Cohort 5
deaths Num Affected
29
deaths Num At Risk
50
description
Participants were randomized in a 1:1 ratio to receive either oral cedazuridine (100 mg) + decitabine (35 mg) capsules Dailyx5 in Course 1 followed by IV decitabine (20 mg/m\^2) Dailyx5 in Course 2 (28 days per course) or the converse. In Courses ≥ 3, all participants received cedazuridine and decitabine capsules Dailyx5 in 28-day courses until disease progression, unacceptable toxicity, withdrawal of consent or withdrawal from the study.
id
EG005
other Num Affected
48
other Num At Risk
50
serious Num Affected
39
serious Num At Risk
50
title
Phase 2 Dose Confirmation
deaths Num Affected
21
deaths Num At Risk
30
description
Participants were randomized in a 1:1 ratio to receive either the fixed-dose combination (FDC) tablet (100 mg cedazuridine/35 mg decitabine) Dailyx5 in Course 1 followed by IV decitabine (20 mg/m\^2) Dailyx5 in Course 2 (28 days per course) or the converse. In Courses ≥ 3, all participants received the FDC tablet Dailyx5 in 28-day courses until disease progression, unacceptable toxicity, withdrawal of consent or withdrawal from the study.
id
EG006
other Num Affected
30
other Num At Risk
30
serious Num Affected
25
serious Num At Risk
30
title
Phase 2 Fixed-Dose Combination

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
4
num At Risk
7
num Events
16
group Id
EG001
num Affected
3
num At Risk
6
num Events
4
group Id
EG002
num Affected
4
num At Risk
6
num Events
11
group Id
EG003
num Affected
3
num At Risk
6
num Events
7
group Id
EG004
num Affected
10
num At Risk
19
num Events
34
group Id
EG005
num Affected
27
num At Risk
50
num Events
67
group Id
EG006
num Affected
15
num At Risk
30
num Events
59
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
3
num At Risk
7
num Events
13
group Id
EG001
num Affected
2
num At Risk
6
num Events
12
group Id
EG002
num Affected
4
num At Risk
6
num Events
4
group Id
EG003
num Affected
1
num At Risk
6
num Events
4
group Id
EG004
num Affected
6
num At Risk
19
num Events
24
group Id
EG005
num Affected
28
num At Risk
50
num Events
125
group Id
EG006
num Affected
12
num At Risk
30
num Events
53
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
4
num At Risk
7
num Events
8
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
group Id
EG002
num Affected
2
num At Risk
6
num Events
2
group Id
EG003
num Affected
3
num At Risk
6
num Events
6
group Id
EG004
num Affected
5
num At Risk
19
num Events
16
group Id
EG005
num Affected
16
num At Risk
50
num Events
46
group Id
EG006
num Affected
8
num At Risk
30
num Events
23
term
Anemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
6
group Id
EG001
num Affected
2
num At Risk
6
num Events
6
group Id
EG002
num Affected
1
num At Risk
6
num Events
2
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
4
num At Risk
19
num Events
24
group Id
EG005
num Affected
12
num At Risk
50
num Events
47
group Id
EG006
num Affected
11
num At Risk
30
num Events
45
term
Leukopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
1
num At Risk
6
num Events
1
group Id
EG004
num Affected
0
num At Risk
19
num Events
0
group Id
EG005
num Affected
0
num At Risk
50
num Events
0
group Id
EG006
num Affected
0
num At Risk
30
num Events
0
term
Lymphadenopathy
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
1
num At Risk
19
num Events
1
group Id
EG005
num Affected
5
num At Risk
50
num Events
7
group Id
EG006
num Affected
5
num At Risk
30
num Events
6
term
Febrile neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
19
num Events
0
group Id
EG005
num Affected
0
num At Risk
50
num Events
0
group Id
EG006
num Affected
0
num At Risk
30
num Events
0
term
Thrombocytosis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
1
num At Risk
6
num Events
1
group Id
EG004
num Affected
2
num At Risk
19
num Events
2
group Id
EG005
num Affected
0
num At Risk
50
num Events
0
group Id
EG006
num Affected
0
num At Risk
30
num Events
0
term
Sinus tachycardia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
1
num At Risk
19
num Events
1
group Id
EG005
num Affected
0
num At Risk
50
num Events
0
group Id
EG006
num Affected
0
num At Risk
30
num Events
0
term
Bradycardia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
1
num At Risk
19
num Events
1
group Id
EG005
num Affected
0
num At Risk
50
num Events
0
group Id
EG006
num Affected
0
num At Risk
30
num Events
0
term
Pericardial effusion
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
1
num At Risk
19
num Events
1
group Id
EG005
num Affected
0
num At Risk
50
num Events
0
group Id
EG006
num Affected
0
num At Risk
30
num Events
0
term
Sinus bradycardia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
19
num Events
0
group Id
EG005
num Affected
0
num At Risk
50
num Events
0
group Id
EG006
num Affected
0
num At Risk
30
num Events
0
term
Vertigo

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
5
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
group Id
EG003
num Affected
2
num At Risk
6
num Events
8
group Id
EG004
num Affected
2
num At Risk
19
num Events
2
group Id
EG005
num Affected
17
num At Risk
50
num Events
31
group Id
EG006
num Affected
7
num At Risk
30
num Events
10
term
Febrile neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
1
num At Risk
19
num Events
2
group Id
EG005
num Affected
1
num At Risk
50
num Events
1
group Id
EG006
num Affected
0
num At Risk
30
num Events
0
term
Anemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
1
num At Risk
19
num Events
1
group Id
EG005
num Affected
0
num At Risk
50
num Events
0
group Id
EG006
num Affected
1
num At Risk
30
num Events
1
term
Cardiac arrest
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
19
num Events
0
group Id
EG005
num Affected
1
num At Risk
50
num Events
1
group Id
EG006
num Affected
0
num At Risk
30
num Events
0
term
Cardiogenic shock
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
1
num At Risk
19
num Events
1
group Id
EG005
num Affected
0
num At Risk
50
num Events
0
group Id
EG006
num Affected
0
num At Risk
30
num Events
0
term
Tachycardia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
19
num Events
0
group Id
EG005
num Affected
1
num At Risk
50
num Events
1
group Id
EG006
num Affected
0
num At Risk
30
num Events
0
term
Myocarditis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
19
num Events
0
group Id
EG005
num Affected
1
num At Risk
50
num Events
1
group Id
EG006
num Affected
0
num At Risk
30
num Events
0
term
Palpitations
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
19
num Events
0
group Id
EG005
num Affected
1
num At Risk
50
num Events
1
group Id
EG006
num Affected
0
num At Risk
30
num Events
0
term
Sinus tachycardia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
19
num Events
0
group Id
EG005
num Affected
1
num At Risk
50
num Events
1
group Id
EG006
num Affected
0
num At Risk
30
num Events
0
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
19
num Events
0
group Id
EG005
num Affected
2
num At Risk
50
num Events
3
group Id
EG006
num Affected
1
num At Risk
30
num Events
1
term
Gastrointestinal hemorrhage
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
1
num At Risk
19
num Events
1
group Id
EG005
num Affected
0
num At Risk
50
num Events
0
group Id
EG006
num Affected
0
num At Risk
30
num Events
0
term
Large intestinal obstruction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
1
num At Risk
19
num Events
1
group Id
EG005
num Affected
0
num At Risk
50
num Events
0
group Id
EG006
num Affected
0
num At Risk
30
num Events
0
term
Diarrhea

time Frame

Up to 5 years

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

Preserved source evidence · Not medical advice