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 @ 7:59 PM
Ignite Modification Date: 2025-12-25 @ 5:33 PM
NCT ID: NCT03403504
Description: same with clinicaltrials.gov Definitions.
Frequency Threshold: 5
Time Frame: Events will be recorded from the point at which the ICF is signed until 7±1 days after last oxycodone dose in the case of completion/discontinuation from the study. This includes new AEs that are reported within 7±1 days after last oxycodone dosing after the subject's completion/discontinuation visit. AE data has been collected for 35 days since ICF signed up to follow-up visit for study completion of each subject.
Study: NCT03403504
Study Brief: OTR Tablet 10 mg Fasted-state Bioequivalence Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
OTR 10 mg the treatment group with OTR 10 mg 0 None 0 23 7 23 View
OXYCONTIN 10 mg the treatment group with OXYCONTIN 10 mg 0 None 0 23 0 23 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Heart rate decreased NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20.0 View
WBC urine positive NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 20.0 View