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 @ 6:40 PM
Ignite Modification Date: 2025-12-25 @ 4:11 PM
NCT ID: NCT02411357
Description: None
Frequency Threshold: 0
Time Frame: 6 months
Study: NCT02411357
Study Brief: Improving Effective Contraceptive Use Among Opioid-maintained Women: Stage II
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Usual Care The usual care condition received usual care consisting of a general information brochure about contraceptive methods and contact information for community contraceptive service facilities. 0 None 1 48 26 48 View
Contraceptive Services The contraceptive services condition were offered onsite contraceptive services adapted from the World Health Organization including 6 months of follow-up visits to assess method satisfaction. 0 None 3 48 42 48 View
Contraceptive Services + Incentives The contraceptive services + incentives condition were offered onsite contraceptive services adapted from the World Health Organization including 6 months of follow-up visit to assess method satisfaction plus financial incentives for attending follow-up visits. 0 None 1 42 36 42 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Opioid overdose SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Bowel obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Cardiac arrest secondary to probable bupropion overdose SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Hospitalization for depression/suicidality SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Ruptured ectopic pregnancy SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Infection secondary to surgical incision SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Adverse events not categorized by organ system SYSTEMATIC_ASSESSMENT General disorders None View