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 @ 6:51 PM
Ignite Modification Date: 2025-12-25 @ 4:24 PM
NCT ID: NCT03320057
Description: Patients: A medical problem that required patients to go to the hospital, emergency department or a doctor's office (other than regularly scheduled follow-up visit) since receiving the abortion pill. Pharmacists: Any untoward/unfavorable medical occurrence, including any abnormal sign, symptom, or disease, temporally associated with participation in training, mifepristone dispensing, or survey data collection, whether or not considered related to their participation in the research.
Frequency Threshold: 0
Time Frame: Patients: Up to 6 weeks after initial visit Pharmacists: study duration including training, mifepristone dispensing, survey data collection (approximately 24 months)
Study: NCT03320057
Study Brief: Medication Abortion Via Pharmacy Dispensing
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Medication Abortion Patients Oral mifepristone 200 mg, followed by misoprostol 800 mcg administered buccally (at 24-48 hours following mifepristone) or vaginally (as soon as 6 hours following mifepristone) Mifepristone: Patients will receive Mifeprex® (mifepristone) by pharmacy rather than standard care at clinic visit 0 None 0 260 4 260 View
Pharmacists Pharmacists providing services at one of the study pharmacies during the study and consenting to training 0 None 0 60 0 60 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pelvic Inflammatory Disease SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Swelling in cheeks SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dehydration SYSTEMATIC_ASSESSMENT General disorders None View
Heavy uterine bleeding SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View