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 @ 11:45 PM
Ignite Modification Date: 2025-12-25 @ 9:38 PM
NCT ID: NCT02394951
Description: Common Terminology Criteria for Adverse Events - CTCAE version 4.0
Frequency Threshold: 5
Time Frame: 11 weeks
Study: NCT02394951
Study Brief: Pregabalin in CIPN
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Pregabalin Pregabalin administered for 4 weeks, titrated to highest tolerated dose up to 600 mg/day. Pregabalin: Anticonvulsant Placebo: Identical, matching inactive substance 0 None 1 25 23 25 View
Placebo Identical, matching inactive substance administered for 4 weeks following the same dosing regimen. Pregabalin: Anticonvulsant Placebo: Identical, matching inactive substance 0 None 0 25 21 25 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Small bowel obstruction NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Dry Mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Edema SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Weight Gain NON_SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Blurred Vision SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (4.0) View
Gait Disturbance NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Spasticity NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Rash maculo-papular NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View