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 @ 6:28 PM
Ignite Modification Date: 2025-12-25 @ 3:58 PM
NCT ID: NCT02357368
Description: None
Frequency Threshold: 0
Time Frame: Information on adverse events was collected from the time of giving consent to participate through Study Visit 4 (Week 17).
Study: NCT02357368
Study Brief: Impact of Hormonal Contraception on HIV Acquisition and Transmission Risk
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Depot Medroxyprogesterone Acetate (DMPA) Participants receiving DMPA administered every 12 weeks at the standard dose of 150 mg intramuscular injection, beginning from Week 3 of study enrollment and repeated at Week 15 0 None 0 19 1 19 View
Etonogestrel Impant (Eng-Implant) Participants receiving a standard nexplanon rod implant that was placed at study Week 3 by a trained clinician 0 None 0 18 0 18 View
Levonorgestrel Intrauterine Device (Lng-IUD) Participants receiving a standard Mirena IUD that was placed at study Week 3 by a trained clinician 0 None 0 14 1 14 View
ParaGard® T 380A Intrauterine Copper Contraceptive Participants receiving a standard ParaGuard IUD that was placed at study week 3 by a trained clinician 0 None 0 8 1 8 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Extended spotting 7 days before start of menstrual cycle NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Extended menstrual bleeding with blood clots NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Heavy irregular menstrual bleeding NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View