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 @ 4:46 PM
Ignite Modification Date: 2025-12-25 @ 2:32 PM
NCT ID: NCT02666950
Description: Since only one patient was accrued on one arm, patient confidentiality prevents the reporting of results by arm. Each CTCAE term is a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Frequency Threshold: 0
Time Frame: Up to 30 days post-treatment
Study: NCT02666950
Study Brief: WEE1 Inhibitor AZD1775 With or Without Cytarabine in Treating Patients With Advanced Acute Myeloid Leukemia or Myelodysplastic Syndrome
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Arm A + Arm C (AZD1775 Combined With AraC OR AZD1775 Only) Patients receive 20 mg cytarabine (AraC) SC twice daily and 200 mg WEE1 inhibitor (AZD1775) PO daily on days 1-5 and days 8-12 OR receive only 200 mg WEE inhibitor (AZD1775) PO daily on days 1-5, 8-12, 15-19, and 22-26. 3 None 3 3 3 3 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Gastrointestinal disorders - Other, specify SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 12 View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Gastrointestinal disorders - Other, specify SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 12 View
Fever SYSTEMATIC_ASSESSMENT General disorders MedDRA 12 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12 View
White blood cell decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12 View
Infections and infestations - Other, specify SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12 View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12 View