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 @ 1:45 AM
Ignite Modification Date: 2025-12-26 @ 12:02 AM
NCT ID: NCT02064894
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT02064894
Study Brief: Oral Analgesic Utilization for CHildhood Musculoskeletal Injuries
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Oral Morphine and Oral Ibuprofen Oral morphine (syrup) 0.2mg/kg (max. 15 mg) and oral ibuprofen (syrup) 10mg/kg (max. 600 mg) both administered once during the 2 hour-study time frame oral morphine and oral ibuprofen: The combination of oral morphine and oral ibuprofen is one of the Experimental arm group None None 0 91 6 91 View
Morphine and Placebo of Ibuprofen Oral morphine 0.2mg/kg (max. 15 mg) and a placebo of ibuprofen both administered once during the 2-hour time frame of the study Oral morphine: Oral morphine 0.2 mg/kg (syrup) up to a maximum dosage of 15 mg, administered once during the study None None 0 188 39 188 View
Ibuprofen and Placebo of Morphine Ibuprofen 10mg/kg (max. 600 mg) and placebo of morphine both administered once during the 2-hour time frame of the study Oral ibuprofen: oral ibuprofen combine to a placebo is the active comparator None None 0 177 38 177 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Drowsiness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Others SYSTEMATIC_ASSESSMENT General disorders None View