Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 3:53 AM
Ignite Modification Date: 2025-12-26 @ 2:42 AM
NCT ID: NCT02867202
Description: Among 171 participants who were initially recruited, 18 were excluded from analysis; 8 patients declined to participate and 10 patients did not meet the inclusion criteria. 30 participants subsequently refused to undergo the second-look hysteroscopy, and 5 subjects were also excluded for protocol violation. 17 women in the study reported side effects. 15 subjects suffered from moderate to severe postoperative pain; 12in the COOK balloon stent group and 3 in the IUD plus Foley catheter group.
Frequency Threshold: 2.3
Time Frame: 6 months to 1 year
Study: NCT02867202
Study Brief: Adjuvant Therapy for Intrauterine Adhesions Between Two Groups
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Intrauterine Balloon After the completion of hysteroscopic adhesiolysis, intrauterine balloon was inserted and inflated with 3-5 mL normal saline which was removed after 1 week. And hysteroscopy was taken out again after two or three menstrual cycles to evaluate the uterine adhesions. 0 None 0 83 21 83 View
IUD Plus Foley Catheter Intrauterine Contraceptive Device Plus Foley Catheter are inserted into the uterine after a hysteroscopic adhesiolysis. Foley Catheter is removed after three days while IUD removed at the second hysteroscopy. Uterine adhesions were judged again at the second hysteroscopy. 0 None 0 88 32 88 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
suffered from moderate to severe postoperative pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.0 View
refuse to have second-look hysteroscopy SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.0 View
Protocol violation SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.0 View
Declined to participate SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.0 View
Not meeting inclusion criteria SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.0 View