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 @ 4:50 AM
Ignite Modification Date: 2025-12-26 @ 3:51 AM
NCT ID: NCT03209518
Description: At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to survey treatment.
Frequency Threshold: 0.5
Time Frame: Up to Week 24
Study: NCT03209518
Study Brief: Special Drug Use Surveillance of Leuprorelin for Injection Kit 22.5 mg in "Premenopausal Breast Cancer"
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Leuprorelin Acetate 22.5 mg Usually, for adults, 22.5 mg of Leuprorelin acetate was subcutaneously administered once every 24 weeks. Refer to the Precautions section of the package insert. Participants received Leuprorelin as part of routine medical care. 0 None 0 310 20 310 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA Ver. 21.1 View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA Ver. 21.1 View
Injection site pruritus SYSTEMATIC_ASSESSMENT General disorders MedDRA Ver. 21.1 View
Hot flush SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA Ver. 21.1 View
Injection site induration SYSTEMATIC_ASSESSMENT General disorders MedDRA Ver. 21.1 View