Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-24 @ 7:56 PM
Ignite Modification Date: 2025-12-25 @ 5:31 PM
NCT ID: NCT04842604
Description: 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.
Frequency Threshold: 5
Time Frame: From initiation of study treatment to study completed from 17-May-2021 to 02-Dec-2022 (approximately 565 days)
Study: NCT04842604
Study Brief: Continuation Study of B1371019(NCT03416179) and B1371012(NCT02367456) Evaluating Azacitidine With Or Without Glasdegib In Patients With Previously Untreated AML, MDS or CMML
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
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. 1 None 2 9 6 9 View
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. 0 None 1 5 3 5 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Febrile neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v25.1 View
Cardiopulmonary failure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v25.1 View
COVID-19 pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Oedema peripheral NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v25.1 View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v25.1 View
Neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v25.1 View
Thrombocytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v25.1 View
Retinal detachment NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA v25.1 View
Colitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v25.1 View
Colitis ulcerative NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v25.1 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v25.1 View
Inguinal hernia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v25.1 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v25.1 View
Corynebacterium bacteraemia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25.1 View
Epstein-Barr virus infection reactivation NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25.1 View
Fall NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v25.1 View
C-reactive protein increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v25.1 View
Platelet count decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v25.1 View