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: 2025-12-25 @ 4:56 AM
Ignite Modification Date: 2025-12-26 @ 3:55 AM
NCT ID: NCT01709318
Description: The analysis population consisted of all randomized participants in whom a vaginal ring was inserted.
Frequency Threshold: 5
Time Frame: Up to ~92 days
Study: NCT01709318
Study Brief: A Dose-Finding Study to Evaluate Ovarian Function and Vaginal Bleeding in Next Generation Rings (P06109/MK-8175A/MK-8342B-012)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 900/300 μg/Day Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 900/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. 0 None 0 78 26 78 View
Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 500/300 μg/Day Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 500/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. 0 None 0 79 23 79 View
Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 700/300 μg/Day Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 700/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. 0 None 0 85 20 85 View
Etonogestrel-17β-Estradiol (ENG-E2) 75/300 μg/Day Participants received etonogestrel-17β-estradiol (ENG-E2) 75/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. 0 None 0 77 24 77 View
Etonogestrel-17β-Estradiol (ENG-E2) 100/300 μg/Day Participants received etonogestrel-17β-estradiol (ENG-E2) 100/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. 0 None 0 77 22 77 View
Etonogestrel-17β-Estradiol (ENG-E2) 125/300 μg/Day Participants received etonogestrel-17β-estradiol (ENG-E2) 125/300 μg for three 28-day treatment periods, each treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. 0 None 0 86 25 86 View
NuvaRing® Participants received NuvaRing® (etonogestrel-ethinyl estradiol \[ENG-EE\] 120/15 μg) for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. 0 None 0 178 46 178 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 16.1 View
Dysmenorrhoea SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 16.1 View
Vaginal discharge SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 16.1 View
Acne SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 16.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.1 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 16.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16.1 View