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 @ 4:16 PM
Ignite Modification Date: 2025-12-25 @ 2:14 PM
NCT ID: NCT02465866
Description: None
Frequency Threshold: 5
Time Frame: Up to day 72
Study: NCT02465866
Study Brief: A Four-Period, Four-Treatment, Four-Way Relative Bioavailability Study of CL-108 Under Fed and Fasted Conditions
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Treatment A: CL-108 (Fasted) CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition None None 0 19 3 19 View
Treatment B: CL-108 (Fed) CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition None None 0 20 11 20 View
Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted) Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition None None 0 20 20 20 View
Treatment D: Vicoprofen, Ultracet and Phenergan (Fed) Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition None None 0 19 2 19 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (Unspecified) View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (Unspecified) View
Glossodynia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (Unspecified) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (Unspecified) View
Oral pruritus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (Unspecified) View
Vessel puncture site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA (Unspecified) View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (Unspecified) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (Unspecified) View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (Unspecified) View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (Unspecified) View
Hot flush SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (Unspecified) View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (Unspecified) View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (Unspecified) View
Euphoric mood SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (Unspecified) View
Orthostatic hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (Unspecified) View