NCT01546038 · ADVERSE EVENTS

Adverse events

A Study To Evaluate PF-04449913 With Chemotherapy In Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome · Source last updated 2020-03-03

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: 4 years
Other-event reporting threshold: 5%

The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All-cause mortality reflects the number of deaths from start of treatment to and including 28 days after last dose. Safety analysis set was evaluated.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Phase 1B: Glasdegib 100 mg + LDAC Participants received oral doses of glasdegib (PF-04449913) tablets 100 milligram (mg) starting on Day 3 of Cycle 1 for pharmacokinetic (PK) assessment purposes and thereafter once daily (QD) and continuously for 28-day cycles (starting on Day 1 for all other cycles). Low dose Ara-C (LDAC) was given at a dose of 20 mg subcutaneously twice daily (BID) on Days 1-10 of the 28-day cycles.	13 / 17	16 / 17	6 / 17
Phase 1B: Glasdegib 200 mg + LDAC Participants received oral doses of glasdegib tablets 200 mg starting on Day 3 of Cycle 1 for PK assessment purposes and thereafter QD and continuously for 28-day cycles (starting on Day 1 for all other cycles). LDAC was given at a dose of 20 mg subcutaneously BID on Days 1-10 of the 28-day cycles. In March 2013, all active participants receiving glasdegib 200 mg were required to reduce dose to 100 mg. Participants who had glasdegib dose reduction were reported as the starting glasdegib dose level received. Two (2) participants in this cohort had dose reduction to 100 mg starting from Cycle 2/Day 1 and Cycle 2/Day 16, respectively.	5 / 6	6 / 6	1 / 6
Phase 1B: Glasdegib 100 mg + Decitabine Participants received oral doses of glasdegib tablets 100 mg starting on Day 2 of Cycle 1 for PK assessment purposes and thereafter QD and continuously for 28-day cycles (starting on Day 1 for all other cycles). Decitabine was given at a dose of 20 mg/m\^2 as an intravenous (IV) infusion over 1 hour on Days 1-5 of the 28-day cycles.	4 / 4	4 / 4	1 / 4
Phase 1B: Glasdegib 200 mg + Decitabine Participants received oral doses of glasdegib tablets 200 mg starting on Day 2 of Cycle 1 for PK assessment purposes and thereafter QD and continuously for 28-day cycles (starting on Day 1 for all other cycles). Decitabine was given at a dose of 20 mg/m\^2 as an IV infusion over 1 hour on Days 1-5 of the 28-day cycles.In March 2013, all active participants receiving glasdegib 200 mg were required to reduce dose to 100 mg. Participants who had glasdegib dose reduction were reported as the starting glasdegib dose level received. Two (2) participants in this cohort had dose reduction to 100 mg starting from Cycle 1/Day 24 and Cycle 5/Day 1, respectively.	2 / 3	3 / 3	0 / 3
Phase 1B: Glasdegib 100 mg + Cytarabine/Daunorubicin Participants received 1-2 cycles of induction (glasdegib and daunorubicin/cytarabine), followed by 2-4 cycles of consolidation (glasdegib and high dose cytarabine) and a maximum of 6 cycles of maintenance (glasdegib alone). Daunorubicin was given on Days 1-3 QD at a dose of 60 mg/m\^2/day by IV together with cytarabine on Days 1-7 at a dose of 100 mg/m\^2/day by continuous IV infusion for each cycle of induction. Cytarabine was given on Days 1, 3, and 5 at a dose of 1 g/m\^2 administered as a 3-hour IV infusion every 12 hours (2 g/m\^2/day) for each cycle of consolidation. Glasdegib tablets 100 mg QD was started on induction Cycle 1/Day -3 and administered continuously QD thereafter for the duration of the study. A cycle was defined as 28 days.	10 / 16	16 / 16	0 / 16
Phase 1B: Glasdegib 200 mg + Cytarabine/Daunorubicin Participants received 1-2 cycles of induction (glasdegib and daunorubicin/cytarabine), followed by 2-4 cycles of consolidation (glasdegib and high dose cytarabine) and a maximum of 6 cycles of maintenance (glasdegib alone). Daunorubicin was given on Days 1-3 QD at a dose of 60 mg/m\^2/day by IV together with cytarabine on Days 1-7 at a dose of 100 mg/m\^2/day by continuous IV infusion for each cycle of induction. Cytarabine was given on Days 1, 3, and 5 at a dose of 1 g/m\^2 administered as a 3-hour IV infusion every 12 hours (2 g/m\^2/day) for each cycle of consolidation. Glasdegib tablets 200 mg QD was started on induction Cycle 1/Day -3 and administered continuously QD thereafter for the duration of the study. A cycle was defined as 28 days.In March 2013, all active participants receiving glasdegib 200 mg were required to reduce dose to 100 mg.One (1) participant in this cohort had dose reduction to 100 mg starting from Consolidation Cycle 1/Day 21.	3 / 6	6 / 6	1 / 6
Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin Participants received 1-2 cycles of induction (glasdegib and daunorubicin/cytarabine), followed by 2-4 cycles of consolidation (glasdegib and high dose cytarabine) and a maximum of 6 cycles of maintenance (glasdegib alone). Daunorubicin was given on Days 1-3 QD at a dose of 60 mg/m\^2/day by IV together with cytarabine on Days 1-7 at a dose of 100 mg/m\^2/day by continuous IV infusion for each cycle of induction. Cytarabine was given on Days 1, 3, and 5 at a dose of 1 g/m\^2 administered as a 3-hour IV infusion every 12 hours (2 g/m\^2/day) for each cycle of consolidation. Glasdegib tablets 100 mg QD was started on induction Cycle 1/Day -3 and administered continuously QD thereafter for the duration of the study. A cycle was defined as 28 days.	35 / 69	69 / 69	5 / 69
Phase 2 Unfit: Glasdegib 100 mg + LDAC Participants received oral doses of glasdegib tablets 100 mg QD in 28-day cycles on a continuous basis, starting on Day 1 of Cycle 1. LDAC was given at a dose of 20 mg subcutaneously BID on Days 1-10 of the 28-day cycles.	68 / 84	82 / 84	26 / 84
Phase 2 Unfit: LDAC Alone Participants received LDAC subcutaneously at a dose of 20 mg BID on Days 1-10 of the 28-day cycles.	32 / 41	39 / 41	17 / 41

Group identifiers: EG000: Phase 1B: Glasdegib 100 mg + LDAC · EG001: Phase 1B: Glasdegib 200 mg + LDAC · EG002: Phase 1B: Glasdegib 100 mg + Decitabine · EG003: Phase 1B: Glasdegib 200 mg + Decitabine · EG004: Phase 1B: Glasdegib 100 mg + Cytarabine/Daunorubicin · EG005: Phase 1B: Glasdegib 200 mg + Cytarabine/Daunorubicin · EG006: Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin · EG007: Phase 2 Unfit: Glasdegib 100 mg + LDAC · EG008: Phase 2 Unfit: LDAC Alone

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 21.1
stats
group Id
EG000
num Affected
3
num At Risk
17
group Id
EG001
num Affected
3
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
1
num At Risk
3
group Id
EG004
num Affected
1
num At Risk
16
group Id
EG005
num Affected
1
num At Risk
6
group Id
EG006
num Affected
14
num At Risk
69
group Id
EG007
num Affected
24
num At Risk
84
group Id
EG008
num Affected
7
num At Risk
41
term
Febrile neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
16
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
1
num At Risk
69
group Id
EG007
num Affected
0
num At Risk
84
group Id
EG008
num Affected
1
num At Risk
41
term
Acute myocardial infarction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
16
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
69
group Id
EG007
num Affected
0
num At Risk
84
group Id
EG008
num Affected
0
num At Risk
41
term
Cardiac failure congestive
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
1
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
16
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
69
group Id
EG007
num Affected
2
num At Risk
84
group Id
EG008
num Affected
0
num At Risk
41
term
Gastrointestinal haemorrhage
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
16
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
69
group Id
EG007
num Affected
0
num At Risk
84
group Id
EG008
num Affected
0
num At Risk
41
term
Impaired gastric emptying
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
17
group Id
EG001
num Affected
1
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
16
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
69
group Id
EG007
num Affected
1
num At Risk
84
group Id
EG008
num Affected
1
num At Risk
41
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
16
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
69
group Id
EG007
num Affected
0
num At Risk
84
group Id
EG008
num Affected
0
num At Risk
41
term
Neutropenic colitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
17
group Id
EG001
num Affected
1
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
16
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
69
group Id
EG007
num Affected
1
num At Risk
84
group Id
EG008
num Affected
1
num At Risk
41
term
Vomiting
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
3
num At Risk
17
group Id
EG001
num Affected
1
num At Risk
6
group Id
EG002
num Affected
1
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
16
group Id
EG005
num Affected
1
num At Risk
6
group Id
EG006
num Affected
2
num At Risk
69
group Id
EG007
num Affected
10
num At Risk
84
group Id
EG008
num Affected
5
num At Risk
41
term
Disease progression
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
16
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
69
group Id
EG007
num Affected
3
num At Risk
84
group Id
EG008
num Affected
0
num At Risk
41
term
Fatigue
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
1
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
16
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
69
group Id
EG007
num Affected
0
num At Risk
84
group Id
EG008
num Affected
0
num At Risk
41
term
Multiple organ dysfunction syndrome
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
16
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
69
group Id
EG007
num Affected
0
num At Risk
84
group Id
EG008
num Affected
0
num At Risk
41
term
Nodule

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 21.1
stats
group Id
EG000
num Affected
3
num At Risk
17
group Id
EG001
num Affected
1
num At Risk
6
group Id
EG002
num Affected
2
num At Risk
4
group Id
EG003
num Affected
1
num At Risk
3
group Id
EG004
num Affected
4
num At Risk
16
group Id
EG005
num Affected
1
num At Risk
6
group Id
EG006
num Affected
28
num At Risk
69
group Id
EG007
num Affected
37
num At Risk
84
group Id
EG008
num Affected
17
num At Risk
41
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
3
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
8
num At Risk
16
group Id
EG005
num Affected
2
num At Risk
6
group Id
EG006
num Affected
38
num At Risk
69
group Id
EG007
num Affected
8
num At Risk
84
group Id
EG008
num Affected
4
num At Risk
41
term
Febrile neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
1
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
16
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
69
group Id
EG007
num Affected
6
num At Risk
84
group Id
EG008
num Affected
2
num At Risk
41
term
Leukocytosis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
1
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
2
num At Risk
16
group Id
EG005
num Affected
1
num At Risk
6
group Id
EG006
num Affected
9
num At Risk
69
group Id
EG007
num Affected
0
num At Risk
84
group Id
EG008
num Affected
0
num At Risk
41
term
Leukopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
1
num At Risk
16
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
69
group Id
EG007
num Affected
0
num At Risk
84
group Id
EG008
num Affected
0
num At Risk
41
term
Lymphadenitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
7
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
2
num At Risk
4
group Id
EG003
num Affected
2
num At Risk
3
group Id
EG004
num Affected
4
num At Risk
16
group Id
EG005
num Affected
1
num At Risk
6
group Id
EG006
num Affected
15
num At Risk
69
group Id
EG007
num Affected
13
num At Risk
84
group Id
EG008
num Affected
8
num At Risk
41
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
16
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
69
group Id
EG007
num Affected
0
num At Risk
84
group Id
EG008
num Affected
0
num At Risk
41
term
Spleen disorder
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
16
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
69
group Id
EG007
num Affected
0
num At Risk
84
group Id
EG008
num Affected
0
num At Risk
41
term
Splenomegaly
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
6
num At Risk
17
group Id
EG001
num Affected
1
num At Risk
6
group Id
EG002
num Affected
2
num At Risk
4
group Id
EG003
num Affected
1
num At Risk
3
group Id
EG004
num Affected
3
num At Risk
16
group Id
EG005
num Affected
2
num At Risk
6
group Id
EG006
num Affected
23
num At Risk
69
group Id
EG007
num Affected
26
num At Risk
84
group Id
EG008
num Affected
11
num At Risk
41
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
1
num At Risk
16
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
69
group Id
EG007
num Affected
0
num At Risk
84
group Id
EG008
num Affected
0
num At Risk
41
term
Angina pectoris
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
16
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
5
num At Risk
69
group Id
EG007
num Affected
7
num At Risk
84
group Id
EG008
num Affected
1
num At Risk
41
term
Atrial fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
1
num At Risk
16
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
69
group Id
EG007
num Affected
0
num At Risk
84
group Id
EG008
num Affected
0
num At Risk
41
term
Diastolic dysfunction

Complete source fields

description

event Groups

deaths Num Affected
6
deaths Num At Risk
17
description
Participants received oral doses of glasdegib (PF-04449913) tablets 100 milligram (mg) starting on Day 3 of Cycle 1 for pharmacokinetic (PK) assessment purposes and thereafter once daily (QD) and continuously for 28-day cycles (starting on Day 1 for all other cycles). Low dose Ara-C (LDAC) was given at a dose of 20 mg subcutaneously twice daily (BID) on Days 1-10 of the 28-day cycles.
id
EG000
other Num Affected
16
other Num At Risk
17
serious Num Affected
13
serious Num At Risk
17
title
Phase 1B: Glasdegib 100 mg + LDAC
deaths Num Affected
1
deaths Num At Risk
6
description
Participants received oral doses of glasdegib tablets 200 mg starting on Day 3 of Cycle 1 for PK assessment purposes and thereafter QD and continuously for 28-day cycles (starting on Day 1 for all other cycles). LDAC was given at a dose of 20 mg subcutaneously BID on Days 1-10 of the 28-day cycles. In March 2013, all active participants receiving glasdegib 200 mg were required to reduce dose to 100 mg. Participants who had glasdegib dose reduction were reported as the starting glasdegib dose level received. Two (2) participants in this cohort had dose reduction to 100 mg starting from Cycle 2/Day 1 and Cycle 2/Day 16, respectively.
id
EG001
other Num Affected
6
other Num At Risk
6
serious Num Affected
5
serious Num At Risk
6
title
Phase 1B: Glasdegib 200 mg + LDAC
deaths Num Affected
1
deaths Num At Risk
4
description
Participants received oral doses of glasdegib tablets 100 mg starting on Day 2 of Cycle 1 for PK assessment purposes and thereafter QD and continuously for 28-day cycles (starting on Day 1 for all other cycles). Decitabine was given at a dose of 20 mg/m\^2 as an intravenous (IV) infusion over 1 hour on Days 1-5 of the 28-day cycles.
id
EG002
other Num Affected
4
other Num At Risk
4
serious Num Affected
4
serious Num At Risk
4
title
Phase 1B: Glasdegib 100 mg + Decitabine
deaths Num Affected
0
deaths Num At Risk
3
description
Participants received oral doses of glasdegib tablets 200 mg starting on Day 2 of Cycle 1 for PK assessment purposes and thereafter QD and continuously for 28-day cycles (starting on Day 1 for all other cycles). Decitabine was given at a dose of 20 mg/m\^2 as an IV infusion over 1 hour on Days 1-5 of the 28-day cycles.In March 2013, all active participants receiving glasdegib 200 mg were required to reduce dose to 100 mg. Participants who had glasdegib dose reduction were reported as the starting glasdegib dose level received. Two (2) participants in this cohort had dose reduction to 100 mg starting from Cycle 1/Day 24 and Cycle 5/Day 1, respectively.
id
EG003
other Num Affected
3
other Num At Risk
3
serious Num Affected
2
serious Num At Risk
3
title
Phase 1B: Glasdegib 200 mg + Decitabine
deaths Num Affected
0
deaths Num At Risk
16
description
Participants received 1-2 cycles of induction (glasdegib and daunorubicin/cytarabine), followed by 2-4 cycles of consolidation (glasdegib and high dose cytarabine) and a maximum of 6 cycles of maintenance (glasdegib alone). Daunorubicin was given on Days 1-3 QD at a dose of 60 mg/m\^2/day by IV together with cytarabine on Days 1-7 at a dose of 100 mg/m\^2/day by continuous IV infusion for each cycle of induction. Cytarabine was given on Days 1, 3, and 5 at a dose of 1 g/m\^2 administered as a 3-hour IV infusion every 12 hours (2 g/m\^2/day) for each cycle of consolidation. Glasdegib tablets 100 mg QD was started on induction Cycle 1/Day -3 and administered continuously QD thereafter for the duration of the study. A cycle was defined as 28 days.
id
EG004
other Num Affected
16
other Num At Risk
16
serious Num Affected
10
serious Num At Risk
16
title
Phase 1B: Glasdegib 100 mg + Cytarabine/Daunorubicin
deaths Num Affected
1
deaths Num At Risk
6
description
Participants received 1-2 cycles of induction (glasdegib and daunorubicin/cytarabine), followed by 2-4 cycles of consolidation (glasdegib and high dose cytarabine) and a maximum of 6 cycles of maintenance (glasdegib alone). Daunorubicin was given on Days 1-3 QD at a dose of 60 mg/m\^2/day by IV together with cytarabine on Days 1-7 at a dose of 100 mg/m\^2/day by continuous IV infusion for each cycle of induction. Cytarabine was given on Days 1, 3, and 5 at a dose of 1 g/m\^2 administered as a 3-hour IV infusion every 12 hours (2 g/m\^2/day) for each cycle of consolidation. Glasdegib tablets 200 mg QD was started on induction Cycle 1/Day -3 and administered continuously QD thereafter for the duration of the study. A cycle was defined as 28 days.In March 2013, all active participants receiving glasdegib 200 mg were required to reduce dose to 100 mg.One (1) participant in this cohort had dose reduction to 100 mg starting from Consolidation Cycle 1/Day 21.
id
EG005
other Num Affected
6
other Num At Risk
6
serious Num Affected
3
serious Num At Risk
6
title
Phase 1B: Glasdegib 200 mg + Cytarabine/Daunorubicin
deaths Num Affected
5
deaths Num At Risk
69
description
Participants received 1-2 cycles of induction (glasdegib and daunorubicin/cytarabine), followed by 2-4 cycles of consolidation (glasdegib and high dose cytarabine) and a maximum of 6 cycles of maintenance (glasdegib alone). Daunorubicin was given on Days 1-3 QD at a dose of 60 mg/m\^2/day by IV together with cytarabine on Days 1-7 at a dose of 100 mg/m\^2/day by continuous IV infusion for each cycle of induction. Cytarabine was given on Days 1, 3, and 5 at a dose of 1 g/m\^2 administered as a 3-hour IV infusion every 12 hours (2 g/m\^2/day) for each cycle of consolidation. Glasdegib tablets 100 mg QD was started on induction Cycle 1/Day -3 and administered continuously QD thereafter for the duration of the study. A cycle was defined as 28 days.
id
EG006
other Num Affected
69
other Num At Risk
69
serious Num Affected
35
serious Num At Risk
69
title
Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin
deaths Num Affected
26
deaths Num At Risk
84
description
Participants received oral doses of glasdegib tablets 100 mg QD in 28-day cycles on a continuous basis, starting on Day 1 of Cycle 1. LDAC was given at a dose of 20 mg subcutaneously BID on Days 1-10 of the 28-day cycles.
id
EG007
other Num Affected
82
other Num At Risk
84
serious Num Affected
68
serious Num At Risk
84
title
Phase 2 Unfit: Glasdegib 100 mg + LDAC
deaths Num Affected
17
deaths Num At Risk
41
description
Participants received LDAC subcutaneously at a dose of 20 mg BID on Days 1-10 of the 28-day cycles.
id
EG008
other Num Affected
39
other Num At Risk
41
serious Num Affected
32
serious Num At Risk
41
title
Phase 2 Unfit: LDAC Alone

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
3
num At Risk
17
group Id
EG001
num Affected
1
num At Risk
6
group Id
EG002
num Affected
2
num At Risk
4
group Id
EG003
num Affected
1
num At Risk
3
group Id
EG004
num Affected
4
num At Risk
16
group Id
EG005
num Affected
1
num At Risk
6
group Id
EG006
num Affected
28
num At Risk
69
group Id
EG007
num Affected
37
num At Risk
84
group Id
EG008
num Affected
17
num At Risk
41
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
3
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
8
num At Risk
16
group Id
EG005
num Affected
2
num At Risk
6
group Id
EG006
num Affected
38
num At Risk
69
group Id
EG007
num Affected
8
num At Risk
84
group Id
EG008
num Affected
4
num At Risk
41
term
Febrile neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
1
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
16
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
69
group Id
EG007
num Affected
6
num At Risk
84
group Id
EG008
num Affected
2
num At Risk
41
term
Leukocytosis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
1
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
2
num At Risk
16
group Id
EG005
num Affected
1
num At Risk
6
group Id
EG006
num Affected
9
num At Risk
69
group Id
EG007
num Affected
0
num At Risk
84
group Id
EG008
num Affected
0
num At Risk
41
term
Leukopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
1
num At Risk
16
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
69
group Id
EG007
num Affected
0
num At Risk
84
group Id
EG008
num Affected
0
num At Risk
41
term
Lymphadenitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
7
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
2
num At Risk
4
group Id
EG003
num Affected
2
num At Risk
3
group Id
EG004
num Affected
4
num At Risk
16
group Id
EG005
num Affected
1
num At Risk
6
group Id
EG006
num Affected
15
num At Risk
69
group Id
EG007
num Affected
13
num At Risk
84
group Id
EG008
num Affected
8
num At Risk
41
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
16
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
69
group Id
EG007
num Affected
0
num At Risk
84
group Id
EG008
num Affected
0
num At Risk
41
term
Spleen disorder
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
16
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
69
group Id
EG007
num Affected
0
num At Risk
84
group Id
EG008
num Affected
0
num At Risk
41
term
Splenomegaly
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
6
num At Risk
17
group Id
EG001
num Affected
1
num At Risk
6
group Id
EG002
num Affected
2
num At Risk
4
group Id
EG003
num Affected
1
num At Risk
3
group Id
EG004
num Affected
3
num At Risk
16
group Id
EG005
num Affected
2
num At Risk
6
group Id
EG006
num Affected
23
num At Risk
69
group Id
EG007
num Affected
26
num At Risk
84
group Id
EG008
num Affected
11
num At Risk
41
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
1
num At Risk
16
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
69
group Id
EG007
num Affected
0
num At Risk
84
group Id
EG008
num Affected
0
num At Risk
41
term
Angina pectoris
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
16
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
5
num At Risk
69
group Id
EG007
num Affected
7
num At Risk
84
group Id
EG008
num Affected
1
num At Risk
41
term
Atrial fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
1
num At Risk
16
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
69
group Id
EG007
num Affected
0
num At Risk
84
group Id
EG008
num Affected
0
num At Risk
41
term
Diastolic dysfunction

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
3
num At Risk
17
group Id
EG001
num Affected
3
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
1
num At Risk
3
group Id
EG004
num Affected
1
num At Risk
16
group Id
EG005
num Affected
1
num At Risk
6
group Id
EG006
num Affected
14
num At Risk
69
group Id
EG007
num Affected
24
num At Risk
84
group Id
EG008
num Affected
7
num At Risk
41
term
Febrile neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
16
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
1
num At Risk
69
group Id
EG007
num Affected
0
num At Risk
84
group Id
EG008
num Affected
1
num At Risk
41
term
Acute myocardial infarction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
16
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
69
group Id
EG007
num Affected
0
num At Risk
84
group Id
EG008
num Affected
0
num At Risk
41
term
Cardiac failure congestive
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
1
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
16
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
69
group Id
EG007
num Affected
2
num At Risk
84
group Id
EG008
num Affected
0
num At Risk
41
term
Gastrointestinal haemorrhage
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
16
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
69
group Id
EG007
num Affected
0
num At Risk
84
group Id
EG008
num Affected
0
num At Risk
41
term
Impaired gastric emptying
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
17
group Id
EG001
num Affected
1
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
16
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
69
group Id
EG007
num Affected
1
num At Risk
84
group Id
EG008
num Affected
1
num At Risk
41
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
16
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
69
group Id
EG007
num Affected
0
num At Risk
84
group Id
EG008
num Affected
0
num At Risk
41
term
Neutropenic colitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
17
group Id
EG001
num Affected
1
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
16
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
69
group Id
EG007
num Affected
1
num At Risk
84
group Id
EG008
num Affected
1
num At Risk
41
term
Vomiting
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
3
num At Risk
17
group Id
EG001
num Affected
1
num At Risk
6
group Id
EG002
num Affected
1
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
16
group Id
EG005
num Affected
1
num At Risk
6
group Id
EG006
num Affected
2
num At Risk
69
group Id
EG007
num Affected
10
num At Risk
84
group Id
EG008
num Affected
5
num At Risk
41
term
Disease progression
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
16
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
69
group Id
EG007
num Affected
3
num At Risk
84
group Id
EG008
num Affected
0
num At Risk
41
term
Fatigue
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
1
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
16
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
69
group Id
EG007
num Affected
0
num At Risk
84
group Id
EG008
num Affected
0
num At Risk
41
term
Multiple organ dysfunction syndrome
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
16
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
69
group Id
EG007
num Affected
0
num At Risk
84
group Id
EG008
num Affected
0
num At Risk
41
term
Nodule

time Frame

4 years

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Preserved source evidence · Not medical advice