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 @ 12:00 AM
Ignite Modification Date: 2025-12-25 @ 9:58 PM
NCT ID: NCT00871858
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00871858
Study Brief: Anastrozole or Fulvestrant in Treating Postmenopausal Patients With 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
Arm A (ANA) Patients receive oral anastrozole as 1 mg film-coated tablets, once daily for 6 months. anastrozole: Given orally 6 None 2 60 48 60 View
Arm B (FULV) Patients receive fulvestrant intramuscularly ( 250 mg/5 ml solution) on days 1, 14, and 28 and then once a month thereafter until 6 months. fulvestrant: Given intramuscularly 6 None 3 58 43 58 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Clear cell kidney cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) CTCAE (5.0) View
Bronchial infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (5.0) View
Ankle fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE (5.0) View
Endometrial atrophy SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE (5.0) View
Programmed peritoneal dialysis SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (5.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (5.0) View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE (5.0) View
Weight gain SYSTEMATIC_ASSESSMENT Investigations CTCAE (5.0) View
Injection site reaction SYSTEMATIC_ASSESSMENT General disorders CTCAE (5.0) View
Hot flashes SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (5.0) View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (5.0) View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (5.0) View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (5.0) View
MYALGIA SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (5.0) View