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 @ 11:15 PM
Ignite Modification Date: 2025-12-25 @ 8:52 PM
NCT ID: NCT02515656
Description: None
Frequency Threshold: 2
Time Frame: 22 days
Study: NCT02515656
Study Brief: Assessment of the Efficacy of POLYGYNAX® in the Empirical Treatment of Infectious Vaginitis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
POLYGYNAX® Name : POLYGYNAX® Active components : nystatin 100 000 IU + neomycin sulphate 35 000 IU + polymyxin B sulphate 35 000 IU Dosage : 1 capsule intravaginally per day (administered at bedtime lying down) 12 vaginal soft capsules POLYGYNAX® 0 None 1 325 18 325 View
Miconazole + Placebo Name : GYNODAKTARIN® Active components : miconazole nitrate 400 mg Dosage : 1 capsule intravaginally per day (administered at bedtime, lying down) 3 vaginal soft capsules followed by 9 placebo vaginal soft capsules GYNODAKTARIN® Placebo 0 None 0 328 5 328 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Patient pregnant exposed to study medications NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (19.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (19.0) View