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 @ 1:08 AM
Ignite Modification Date: 2025-12-25 @ 11:19 PM
NCT ID: NCT01263093
Description: None
Frequency Threshold: 4
Time Frame: None
Study: NCT01263093
Study Brief: A Pharmacokinetic Study on the Effect of LY2216684 on the Active Metabolite of Clopidogrel
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
LY2216684 LY2216684: 18-milligram (mg) dose, administered orally, once daily (QD) on Days 1 through 3 Time Frame: Treatment 2; prior to clopidogrel dose on Day 3 None None 0 46 19 46 View
LY2216684 + Clopidogrel LY2216684: 18-milligram (mg) dose, administered orally, once daily (QD) on Days 1 through 3 Clopidogrel: a single 300-mg dose, administered orally on Day 3 Time Frame: Treatment 2; after the clopidogrel dose on Day 3 None None 0 45 11 45 View
Clopidogrel Clopidogrel: a single 300-milligram (mg) dose, administered orally on Day 1 Time Frame: Treatment 1 None None 0 47 12 47 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.1 View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.1 View
Urinary hesitation SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View