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 @ 6:31 PM
Ignite Modification Date: 2025-12-25 @ 4:01 PM
NCT ID: NCT02104557
Description: Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Frequency Threshold: 0
Time Frame: Baseline up to a maximum of 12 months
Study: NCT02104557
Study Brief: Post Marketing Surveillance Study For Sayana®
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Sayana Participants were administered with Sayana (medroxyprogesterone acetate) as part of routine practice in Korean health care centers by accredited physicians per the local product document. 0 None 1 337 80 337 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Vaginal haemorrhage NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders WHO-ART, Version 092 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pelvic pain NON_SYSTEMATIC_ASSESSMENT General disorders WHO-ART, Version 092 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders WHO-ART, Version 092 View
Tremor NON_SYSTEMATIC_ASSESSMENT Nervous system disorders WHO-ART, Version 092 View
Weight increase NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders WHO-ART, Version 092 View
Skeletal pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders WHO-ART, Version 092 View
Amenorrhoea NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders WHO-ART, Version 092 View
Breast pain NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders WHO-ART, Version 092 View
Metrorrhagia NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders WHO-ART, Version 092 View
Vaginal haemorrhage NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders WHO-ART, Version 092 View
Common cold NON_SYSTEMATIC_ASSESSMENT Immune system disorders WHO-ART, Version 092 View
Alopecia NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders WHO-ART, Version 092 View
Pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders WHO-ART, Version 092 View
Flushing NON_SYSTEMATIC_ASSESSMENT Cardiac disorders WHO-ART, Version 092 View