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 @ 5:09 PM
Ignite Modification Date: 2025-12-25 @ 2:47 PM
NCT ID: NCT02214550
Description: We used a survey with prespecified questions. Please note, all-cause mortality or serious \& other AEs were not monitored in the "no intervention arms". In the intervention arms, no formal query for mortality or serious AE was done, but we did monitor for them. For nonserious AEs, we report the frequency of ever reporting any queried event over the entire period. Participants varied in total AE form completion. Participants in the "D+COS-no OC" group did not receive AE questionnaires.
Frequency Threshold: 0
Time Frame: Surveys of adverse events were collected monthly over 1 Year
Study: NCT02214550
Study Brief: Chronic Pain Risk Associated With Menstrual Period Pain
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
D+COS-no OC 10 participants in the Dysmenorrhea + COS group will not receive an OC intervention. Monthly questionnaires will be completed for 1 yr. QST will be repeated at 6 months and 12 months. A yearly follow-up questionnaire will be completed for 5 years. 0 None 0 5 0 0 View
D+COS-cyclic Microgestin 1/20 26 participants in the Dysmenorrhea + COS group will receive cyclic OC. Monthly questionnaires will be completed for 1 yr. QST will be repeated at 6 months and 12 months. A yearly follow-up questionnaire will be completed for 5 years. cyclic microgestin 1/20: Cyclic OC Use - Participants will ingest pills containing active hormones for 21 days followed by 7 days of no pills, and then the cycle will repeat 0 None 0 4 4 4 View
D+COS-continuous Microgestin 1/20 26 participants in the Dysmenorrhea + COS group will receive continuous OC. Monthly questionnaires will be completed for 1 yr. QST will be repeated at 6 months and 12 months. A yearly follow-up questionnaire will be completed for 5 years. continuous microgestin 1/20: Continuous OC use - Pills containing hormones will be taken every day for 1 year 0 None 0 8 8 8 View
PBS-continuous Microgestin 1/20 26 participants in the Painful Bladder Syndrome group will receive continuous OC. Monthly questionnaires will be completed for 1 yr. QST will be repeated at 6 months and 12 months. A yearly follow-up questionnaire will be completed for 5 years. continuous microgestin 1/20: Continuous OC use - Pills containing hormones will be taken every day for 1 year 0 None 0 6 6 6 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Spotting (between periods) SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Breast Tenderness SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Depressed, sad a lot SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Irritable SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Darkening of the skin or face SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Decreased sex drive SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Changes in vision SYSTEMATIC_ASSESSMENT Eye disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Weight Gain SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View