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 @ 8:03 PM
Ignite Modification Date: 2025-12-25 @ 5:35 PM
NCT ID: NCT00941304
Description: Analysis based on Safety population; all subjects who received any study drug
Frequency Threshold: 5
Time Frame: From study drug administration (day 1) to follow-up visit (day 6 to 10)
Study: NCT00941304
Study Brief: Study of Buprenorphine HCl Buccal Film in the Treatment of Dental Pain
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
0.25-mg Buprenorphine HCl Buccal Film, M2 Buprenorphine HCl buccal film 0.25-mg modified formulation 2, placebo buccal film, and placebo oral capsule None None 0 31 9 31 View
0.5-mg Buprenorphine HCl Buccal Film, M2 Buprenorphine HCl buccal film 0.5-mg modified formulation 2, placebo buccal film, and placebo oral capsule None None 0 30 18 30 View
0.5-mg Buprenorphine HCl Buccal Film, M1 Buprenorphine HCl buccal film 0.5-mg modified formulation 1, placebo buccal film, and placebo oral capsule None None 0 31 25 31 View
Placebo Placebo oral capsule and 2 placebo buccal films None None 0 30 3 30 View
Oxycodone 5 mg Oxycodone 5-mg oral capsule and 2 placebo buccal films None None 0 31 6 31 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Alveolar osteitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
Hyperhidrosis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12.1 View