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 @ 11:30 PM
Ignite Modification Date: 2025-12-25 @ 9:18 PM
NCT ID: NCT03562156
Description: The safety population was defined as all randomized subjects who received at least 1 dose of investigational product, which was not administered until Day 1. Treatment-emergent adverse events were defined as adverse events that occurred after the subject received her initial dose of investigational product. Adverse event data were not collected during the induction phase.
Frequency Threshold: 2
Time Frame: Day 1 through Week 48
Study: NCT03562156
Study Brief: A Study of Oral Oteseconazole for the Treatment of Patients With Recurrent Vaginal Candidiasis (Yeast Infection)
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 1 placebo capsule once daily for 7 days starting at Day 1, then once weekly for 11 weeks 0 None 3 109 63 109 View
Oteseconazole (VT-1161) 1 oteseconazole 150mg capsule once daily for 7 days starting at Day 1, then once weekly for 11 weeks 0 None 3 217 129 217 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Postoperative wound infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Tubo-ovarian abscess SYSTEMATIC_ASSESSMENT Infections and infestations None View
Endometriosis SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Vaginal haemmorrhage SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Limb traumatic amputation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Chlamydial infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Vaginal infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Vulvovaginal candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Vulvitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal pain lower SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vulvovaginal pruritus SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Metrorrhagia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Menorrhagia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bacterial vaginosis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cystitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations None View
Genital herpes SYSTEMATIC_ASSESSMENT Infections and infestations None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Blood creatine phosphokinase increased SYSTEMATIC_ASSESSMENT Investigations None View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders None View
Procedural pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Pelvic pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Vaginal discharge SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Acne SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View