NCT04842604 · ADVERSE EVENTS

Adverse events

Continuation Study of B1371019(NCT03416179) and B1371012(NCT02367456) Evaluating Azacitidine With Or Without Glasdegib In Patients With Previously Untreated AML, MDS or CMML · Source last updated 2023-12-18

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

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

Collection time frame: From initiation of study treatment to study completed from 17-May-2021 to 02-Dec-2022 (approximately 565 days)
Other-event reporting threshold: 5%

Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Glasdegib + Azacitidine Participants received glasdegib 100 milligrams (mg) tablet per oral (PO) once a day (QD) in combination with azacitidine 75 mg per meter squared (m\^2)/day as subcutaneous (SC) injection or intravenous (IV) infusion for 7 days every 28 days. Treatment continued until objective disease progression or relapse, death, unacceptable toxicity, or participant refusal, whichever occurred first. Participants were followed up for 28 days after end of study treatment.	2 / 9	6 / 9	1 / 9
Placebo + Azacitidine Participants received placebo matched to Glasdegib in combination with azacitidine 75mg/m\^2/day SC or IV for 7 days every 28 days. Treatment continued until objective disease progression or relapse, death, unacceptable toxicity, or participant refusal, whichever occurred first. Participants were followed up for 28 days after end of study treatment.	1 / 5	3 / 5	0 / 5

Group identifiers: EG000: Glasdegib + Azacitidine · EG001: Placebo + Azacitidine

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 v25.1
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
1
num At Risk
5
term
Febrile neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v25.1
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
5
term
Cardiopulmonary failure
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v25.1
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
5
term
COVID-19 pneumonia

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 v25.1
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
5
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v25.1
stats
group Id
EG000
num Affected
4
num At Risk
9
group Id
EG001
num Affected
2
num At Risk
5
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v25.1
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
5
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v25.1
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
5
term
Retinal detachment
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v25.1
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
5
term
Colitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v25.1
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
5
term
Colitis ulcerative
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v25.1
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
5
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v25.1
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
5
term
Inguinal hernia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v25.1
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
5
term
Vomiting
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA v25.1
stats
group Id
EG000
num Affected
0
num At Risk
9
group Id
EG001
num Affected
1
num At Risk
5
term
Oedema peripheral
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v25.1
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
5
term
Corynebacterium bacteraemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v25.1
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
5
term
Epstein-Barr virus infection reactivation

Complete source fields

description

event Groups

deaths Num Affected
1
deaths Num At Risk
9
description
Participants received glasdegib 100 milligrams (mg) tablet per oral (PO) once a day (QD) in combination with azacitidine 75 mg per meter squared (m\^2)/day as subcutaneous (SC) injection or intravenous (IV) infusion for 7 days every 28 days. Treatment continued until objective disease progression or relapse, death, unacceptable toxicity, or participant refusal, whichever occurred first. Participants were followed up for 28 days after end of study treatment.
id
EG000
other Num Affected
6
other Num At Risk
9
serious Num Affected
2
serious Num At Risk
9
title
Glasdegib + Azacitidine
deaths Num Affected
0
deaths Num At Risk
5
description
Participants received placebo matched to Glasdegib in combination with azacitidine 75mg/m\^2/day SC or IV for 7 days every 28 days. Treatment continued until objective disease progression or relapse, death, unacceptable toxicity, or participant refusal, whichever occurred first. Participants were followed up for 28 days after end of study treatment.
id
EG001
other Num Affected
3
other Num At Risk
5
serious Num Affected
1
serious Num At Risk
5
title
Placebo + Azacitidine

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v25.1
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
5
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v25.1
stats
group Id
EG000
num Affected
4
num At Risk
9
group Id
EG001
num Affected
2
num At Risk
5
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v25.1
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
5
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v25.1
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
5
term
Retinal detachment
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v25.1
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
5
term
Colitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v25.1
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
5
term
Colitis ulcerative
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v25.1
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
5
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v25.1
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
5
term
Inguinal hernia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v25.1
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
5
term
Vomiting
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA v25.1
stats
group Id
EG000
num Affected
0
num At Risk
9
group Id
EG001
num Affected
1
num At Risk
5
term
Oedema peripheral
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v25.1
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
5
term
Corynebacterium bacteraemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v25.1
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
5
term
Epstein-Barr virus infection reactivation

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v25.1
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
1
num At Risk
5
term
Febrile neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v25.1
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
5
term
Cardiopulmonary failure
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v25.1
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
5
term
COVID-19 pneumonia

time Frame

From initiation of study treatment to study completed from 17-May-2021 to 02-Dec-2022 (approximately 565 days)

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Preserved source evidence · Not medical advice