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 @ 12:14 AM
Ignite Modification Date: 2025-12-25 @ 10:16 PM
NCT ID: NCT01047358
Description: The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Frequency Threshold: 1
Time Frame: From first dose of Aromasin through the end of the study for an average of 5.6 months.
Study: NCT01047358
Study Brief: Post Marketing Surveillance Study To Observe Safety And Efficacy Of Aromasin In The Patients With Early Or Advanced 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
Aromasin Participants were included if they had early breast cancer for adjuvant hormonal therapy or advanced breast cancer for second-line hormonal therapy after anti-estrogen therapy and were prescribed Aromasin for the first time. Aromasin was administered as part of routine care. The use and dosage recommendations for Aromasin were based on the approved local product document. Any adjustments were made solely according to medical and therapeutic necessity. None None 2 206 40 206 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
CONDITION AGGRAVATED NON_SYSTEMATIC_ASSESSMENT General disorders WHO-ART v092 View
ASTHENIA NON_SYSTEMATIC_ASSESSMENT General disorders WHO-ART v092 View
HEPATIC NEOPLASM NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) WHO-ART v092 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
LEG PAIN NON_SYSTEMATIC_ASSESSMENT General disorders WHO-ART v092 View
OEDEMA PERIPHERAL NON_SYSTEMATIC_ASSESSMENT General disorders WHO-ART v092 View
HEADACHE NON_SYSTEMATIC_ASSESSMENT Nervous system disorders WHO-ART v092 View
BILIRUBINAEMIA NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders WHO-ART v092 View
SERUM GLUTAMIC OXALOACETIC TRANSAMINASE INCREASED NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders WHO-ART v092 View
SERUM GLUTAMIC PYRUVIC TRANSAMINASE INCREASED NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders WHO-ART v092 View
PHOSPHATASE ALKALINE INCREASED NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders WHO-ART v092 View
ARTHRALGIA NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders WHO-ART v092 View
BACK PAIN NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders WHO-ART v092 View
MUSCULOSKELETAL PAIN NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders WHO-ART v092 View
SKELETAL PAIN NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders WHO-ART v092 View
ANOREXIA NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders WHO-ART v092 View
DEPRESSION NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders WHO-ART v092 View
INSOMNIA NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders WHO-ART v092 View
COUGHING NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders WHO-ART v092 View
DYSPNOEA NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders WHO-ART v092 View
PHARYNGITIS NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders WHO-ART v092 View
LYMPHOEDEMA NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders WHO-ART v092 View