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 @ 2:15 AM
Ignite Modification Date: 2025-12-26 @ 12:44 AM
NCT ID: NCT06181760
Description: None
Frequency Threshold: 5
Time Frame: Subjects were monitored throughout the study for adverse reactions to the study drug and/or procedures from the time of informed consent through end of study (either through Day 8 for the fasted cohorts or through Day 17 for the fed cohort).
Study: NCT06181760
Study Brief: A Study to Evaluate the Safety of Fenretinide in Healthy Volunteers
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Fenretinide 600 mg/m^2 (Second Intervention) Single oral dose of fenretinide, 600 mg/m\^2 under fed conditions 0 None 0 3 0 3 View
Placebo (Second Intervention) Single oral dose of placebo capsules under fed conditions 0 None 0 1 0 1 View
Placebo (First Intervention) Single oral dose of placebo capsules under fasted conditions 0 None 0 7 2 7 View
Fenretinide 300 mg/m^2 (First Intervention) Single oral dose of fenretinide, 300 mg/m\^2 under fasted conditions 0 None 0 6 1 6 View
Fenretinide 600 mg/m^2 (First Intervention) Single oral dose of fenretinide, 600 mg/m\^2 under fasted conditions 0 None 0 6 2 6 View
Fenretinide 900 mg/m^2 (First Intervention) Single oral dose of fenretinide, 900 mg/m\^2 under fasted conditions 0 None 0 6 3 6 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26.1 View
neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 26.1 View
Photophobia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 26.1 View
vascular access site thrombosis SYSTEMATIC_ASSESSMENT General disorders MedDRA 26.1 View
musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 26.1 View
lethargy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 26.1 View
dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 26.1 View
Haematoma muscle SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 26.1 View