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 @ 6:42 PM
Ignite Modification Date: 2025-12-25 @ 4:13 PM
NCT ID: NCT04092257
Description: Adverse events were collected from day one of the study to 4 weeks after completion of the thermocoagulation intervention in participants who received thermocoagulation only. Adverse events were not monitored/assessed in any other participants.
Frequency Threshold: 0
Time Frame: Up to 4 weeks.
Study: NCT04092257
Study Brief: HPV-Based Screen-and-Treat Demonstration Project in Lilongwe
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
HIV Positive -VIA and Thermocoagulation HIV Positive Participants will undergo the same-day VIA and thermocoagulation were included. 1 None 0 22 19 22 View
HIV Negative -VIA and Thermocoagulation HIV HIV-negative participants will undergo the same-day VIA and thermocoagulation were included. 0 None 0 28 21 28 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dysuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (v5.0) View
Vaginal Inflammation NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (v5.0) View
Amenorrhea NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE (v5.0) View
Menorrhagia NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE (v5.0) View
Pelvic pain NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE (v5.0) View
vaginal bleeding NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE (v5.0) View
vaginal discharge NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE (v5.0) View
Vaginal hemorrhage NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE (v5.0) View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (v5.0) View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (v5.0) View