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 @ 4:33 AM
Ignite Modification Date: 2025-12-26 @ 3:35 AM
NCT ID: NCT02693418
Description: None
Frequency Threshold: 0
Time Frame: 7 days
Study: NCT02693418
Study Brief: Duration of Effect of Acidform Gel on Vaginal pH
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Acidform Gel, Group A Administration of a single vaginal dose of Acidform gel (5 g) Acidform 5 g: Effect of 5 g vaginally administered Acidform on pH over 7 days 0 None 0 22 16 22 View
Acidform Gel, Group B Administration of a single vaginal dose of Acidform gel (4 g) Acidform 4 g: Effect of 4 g vaginally administered Acidform on pH over 7 days 0 None 0 21 13 21 View
Acidform Gel, Group C Administration of a single vaginal dose of Acidform gel (3 g) Acidform 3 g: Effect of 3 g vaginally administered Acidform on pH over 7 days 0 None 0 21 16 21 View
Placebo Gel, Group D Administration of a single dose of hydroxyethylcellulose (HEC) placebo gel (4 g) Placebo 4 g: Effect of 4 g of vaginally administered HEC placebo gel on pH over 7 days 0 None 0 20 13 20 View
No Intervention, Group E No vaginal product administered 0 None 0 21 10 21 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (17.0) View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (17.0) View
Muscle Spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (17.0) View
Sciatica SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (17.0) View
Micturition urgency SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (17.0) View
Pollakiuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (17.0) View
Cervical discharge SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (17.0) View
Cervix disorder SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (17.0) View
Cervix inflamation SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (17.0) View
Dysmenorrhoea SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (17.0) View
Menstruation irregular SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (17.0) View
Vaginal discharge SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (17.0) View
Vaginal haemorrhage SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (17.0) View
Vulvovaginal burning sensation SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (17.0) View
Vulvovaginal discomfort SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (17.0) View
Vulvovaginal pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (17.0) View
Vulvovaginal pruritus SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (17.0) View
Vaginal odour SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (17.0) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (17.0) View