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 @ 4:21 PM
Ignite Modification Date: 2025-12-25 @ 2:17 PM
NCT ID: NCT02452866
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT02452866
Study Brief: Open-Label Study to Evaluate Safety of A Single Dose of SYM-1219
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
SYM-1219 2g SYM-1219 2g single oral dose 0 None 1 321 63 321 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
foot burn SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
loss of consciousness SYSTEMATIC_ASSESSMENT Investigations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Vaginal candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations None View
dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Vaginal discharge SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Vaginal odor SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Vulvovaginal pruritis SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Vulvovaginal discomfort SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Lymphadenopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Chromaturia SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Thermal burn SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Tooth extraction SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Vulvovaginal candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Chlamydia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Fungal infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gonorrhea SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pyelonephritis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Vaginal mycosis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Tooth abscess SYSTEMATIC_ASSESSMENT Infections and infestations None View
Tooth infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Upper respiratory SYSTEMATIC_ASSESSMENT Infections and infestations None View
Acute sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Vulvovaginal mycotic infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bacterial vaginosis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Genital herpes SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cystitis SYSTEMATIC_ASSESSMENT Infections and infestations None View