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 @ 11:34 PM
Ignite Modification Date: 2025-12-25 @ 9:24 PM
NCT ID: NCT03211156
Description: The safety data collection was targeted to collect serious and non-serious adverse events and congenital anomalies / birth defects as applicable that occurred after the first dose of treatment through Visit 2 (Day 15-21). Adverse events were captured by subject report/interview and clinical assessments, including clinician-conducted pelvic examination.
Frequency Threshold: 0
Time Frame: Unsolicited non-serious AEs and SAE were collected through Visit 2 (Day 15-21) after the first dose of treatment.
Study: NCT03211156
Study Brief: Treatment of Gardnerella Vaginalis Vaginal Colonization With Amoxicillin
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Participants received Amoxicillin placebo 2 capsules orally twice a day for 7 days, n=49 Placebo: Placebo 0 None 0 47 3 47 View
Amoxicillin Participants received Amoxicillin 2 x 250 mg capsules orally twice a day for 7 days, n=48 Amoxicillin: Amoxicillin is an aminopenicillin antibiotic 0 None 0 45 10 45 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.1 View
Allergic reaction to excipient SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 22.1 View
Atypical pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.1 View
Bacterial vaginosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.1 View
Vulvovaginal candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.1 View
Potassium hydroxide preparation positive SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.1 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22.1 View
Urine odour abnormal SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 22.1 View
Vaginal discharge SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 22.1 View
Vulvovaginal pruritus SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 22.1 View