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: 2025-12-25 @ 4:08 AM
Ignite Modification Date: 2025-12-26 @ 3:05 AM
NCT ID: NCT02478320
Description: Part 2 Tumor-specific expansion (trial was terminated before this part was reached)
Frequency Threshold: 0
Time Frame: Adverse events were collected after the first dose until end of treatment, death, or loss to follow up, maximum 18 months
Study: NCT02478320
Study Brief: Phase II Study of Ilorasertib (ABT348) in Patients With CDKN2A Deficient Solid Tumors
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Part 1 For evaluation of response rate in patients with cancers harboring CDKN2A deletion or mutation 1 None 5 9 7 9 View
Part 2 Tumor-specific Expansion For evaluation of response rate in a specific tumor type harboring CDKN2A deletion or mutation 0 None 0 0 0 0 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Uncontrolled pain SYSTEMATIC_ASSESSMENT General disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Cervical stenosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Oral mucositis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dehydration SYSTEMATIC_ASSESSMENT General disorders None View
Confusion SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Decreased white count SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
AST SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Bilirubin SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Knee pain SYSTEMATIC_ASSESSMENT General disorders None View
Change of skin sensitivity SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Low ANC SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View