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 @ 12:05 AM
Ignite Modification Date: 2025-12-25 @ 10:03 PM
NCT ID: NCT01153958
Description: An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
Frequency Threshold: 0
Time Frame: Baseline up to 2 months post-treatment
Study: NCT01153958
Study Brief: Colposeptine for the Treatment of Bacterial Vaginosis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Metronidazole Metronidazole 400 milligram (mg) orally twice daily for 7 consecutive days None None 0 67 10 67 View
Colposeptine Colposeptine 1 capsule transvaginally daily for 12 consecutive days. None None 0 66 8 66 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dyspnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Abdominal Pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Vulvovaginal Pruritus NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Abdominal Pain Upper NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Vulvovaginal Candidiasis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Endodontic Procedure NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA View
Vulvovaginitis Trichomonal NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Bone Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Pelvic Pain NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View