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 @ 3:57 PM
Ignite Modification Date: 2025-12-25 @ 2:00 PM
NCT ID: NCT02408692
Description: None
Frequency Threshold: 0
Time Frame: 30 minutes after study medication dosing.
Study: NCT02408692
Study Brief: Emergency Contraception and Body Weight: Pilot Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Normal BMI ECx1 5 normal weight women (BMI\<25 kg/m2) taking 1.5mg LNG ECx1: At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). After this visit, women with a BMI of \<25 kg/m2 will have completed study participation. None None 0 5 1 5 View
Obese BMI ECx1 5 obese women (BMI \>30 kg/m2) taking 1.5mg LNG ECx1: At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). After this visit, women with a BMI of \<25 kg/m2 will have completed study participation. None None 0 5 0 5 View
Obese BMI ECx2 5 obese women (BMI \>30 kg/m2) taking 3mg LNG ECx2: At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). For women with a BMI of 30kg/m2 and greater, one additional visit will be required and study drug (3 mg of levonorgestrel) will be given and several blood samples will be taken over 2.5 hours) None None 0 5 0 5 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Emesis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View