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 @ 4:01 PM
Ignite Modification Date: 2025-12-25 @ 2:04 PM
NCT ID: NCT01030666
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT01030666
Study Brief: Effect of Postsurgical Systemic Doxycycline After Regenerative Periodontal Therapy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Doxycycline The patients of the doxycycline group will take 200 mg doxycycline once a day for 7 days after regenerative therapy of an infrabony defects additionally to * modified/simplified papilla preservation flap; scaling * Prefgel/Emdogain * 0.12% chlorhexidine gluconate solution * Ibuprofen 400 mg (if necessary) * 1% chlorhexidine gluconate gel (if necessary) None None 0 28 8 28 View
Placebo The patients of the control group will take placebo once a day for 7 days after regenerative therapy of an infrabony defect additionally to * modified/simplified papilla preservation flap; scaling * Prefgel/Emdogain * 0.12% chlorhexidine gluconate solution * Ibuprofen 400 mg (if necessary) * 1% chlorhexidine gluconate gel (if necessary) None None 0 33 9 33 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
head ache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Nausea SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
tiredness SYSTEMATIC_ASSESSMENT General disorders None View
tooth discomfort/pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
mucosal/skin lesions SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View