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 @ 2:18 AM
Ignite Modification Date: 2025-12-26 @ 12:48 AM
NCT ID: NCT02097134
Description: The Other Adverse Events field contains Common Terminology Criteria for Adverse Events (CTCAEs) reported on protocol therapy, excluding those that were reported as Serious Adverse Events. The Serious Adverse Events field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs).
Frequency Threshold: 0
Time Frame: Up to 4 months
Study: NCT02097134
Study Brief: Intra-arterial Melphalan in Treating Younger Patients With Unilateral Retinoblastoma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Melphalan Patients receive melphalan intra-arterial (IA) on day 1. Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Melphalan: Given IA 0 None 2 14 3 14 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Gastrointestinal disorders - Other, specify SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anaphylaxis SYSTEMATIC_ASSESSMENT Immune system disorders None View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations None View