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 @ 2:34 AM
Ignite Modification Date: 2025-12-26 @ 1:10 AM
NCT ID: NCT01288534
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT01288534
Study Brief: Hypofractionated Stereotactic Body Radiation Therapy (SBRT)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Radiation Treatment Radiation Therapy: Patients will receive 5 fractions of radiation (you will not receive radiation therapy on two consecutive days). Each fraction size will be 7.4 Gy. The total dose will be 37 Gy. The 5 treatments will be scheduled to be delivered 2 fractions per business week (Monday through Friday). The total duration of treatment will be no shorter than 15 days and no longer than 19 days. None None 5 68 62 68 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anemia None Blood and lymphatic system disorders None View
Cardiac disorders - Other None Cardiac disorders None View
Restrictive cardiomyopathy None Cardiac disorders None View
Gastric ulcer None Gastrointestinal disorders None View
Gastrointestinal disorders - Other None Gastrointestinal disorders None View
Fracture None Injury, poisoning and procedural complications None View
Respiratory failure None Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal pain None Gastrointestinal disorders None View
Constipation None Gastrointestinal disorders None View
Diarrhea None Gastrointestinal disorders None View
Fecal incontinence None Gastrointestinal disorders None View
Flatulence None Gastrointestinal disorders None View
Gastrointestinal disorders - Other None Gastrointestinal disorders None View
Hemorrhoidal hemorrhage None Gastrointestinal disorders None View
Nausea None Gastrointestinal disorders None View
Proctitis None Gastrointestinal disorders None View
Rectal hemorrhage None Gastrointestinal disorders None View
Fatigue None General disorders None View
Arthritis None Musculoskeletal and connective tissue disorders None View
Back pain None Musculoskeletal and connective tissue disorders None View
Libido decreased None Psychiatric disorders None View
Cystitis noninfective None Renal and urinary disorders None View
Hematuria None Renal and urinary disorders None View
Renal and urinary disorders - Other None Renal and urinary disorders None View
Urinary frequency None Renal and urinary disorders None View
Urinary incontinence None Renal and urinary disorders None View
Urinary retention None Renal and urinary disorders None View
Urinary tract pain None Renal and urinary disorders None View
Urinary urgency None Renal and urinary disorders None View
Erectile dysfunction None Reproductive system and breast disorders None View
Genital edema None Reproductive system and breast disorders None View
Perineal pain None Reproductive system and breast disorders None View
Prostatic pain None Reproductive system and breast disorders None View
Reproductive system and breast disorders - Other None Reproductive system and breast disorders None View
Testicular pain None Reproductive system and breast disorders None View