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 @ 2:15 PM
Ignite Modification Date: 2025-12-25 @ 12:53 PM
NCT ID: NCT00513695
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00513695
Study Brief: Sunitinib Malate, Paclitaxel, Doxorubicin Hydrochloride, and Cyclophosphamide Before Surgery in Treating Patients With Stage IIB-IIIC 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
Treatment (Neoadjuvant Chemotherapy Before Surgery) Patients receive neoadjuvant chemotherapy comprising sunitinib malate PO once daily and paclitaxel IV over 1 hour once weekly for 8-12 weeks in the absence of disease progression or unacceptable toxicity. Beginning within 3 weeks of completion of sunitinib malate and paclitaxel, patients receive doxorubicin IV once weekly for 15 weeks, cyclophosphamide PO once daily for 15 weeks, and filgrastim SC on days 2-7 for 16 weeks in the absence of disease progression or unacceptable toxicity. Beginning 3-6 weeks after completion of chemotherapy, patients undergo surgery. sunitinib malate: Given PO paclitaxel: Given IV doxorubicin hydrochloride: Given IV cyclophosphamide: Given PO filgrastim: Given SC therapeutic conventional surgery: Undergo surgery laboratory biomarker analysis: Correlative studies flow cytometry: Correlative studies None None 47 68 67 68 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Neutropenia (ANC) None Blood and lymphatic system disorders None View
Leucopenia None Blood and lymphatic system disorders None View
Fatigue None General disorders None View
Anemia None Blood and lymphatic system disorders None View
Diarrhea None Gastrointestinal disorders None View
ALT elevation None Investigations None View
Rash None Skin and subcutaneous tissue disorders None View
Pain None General disorders None View
Nail changes None Skin and subcutaneous tissue disorders None View
Mucositis None Respiratory, thoracic and mediastinal disorders None View
Nausea None Gastrointestinal disorders None View
Sensory Neuropathy None Nervous system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anemia None Blood and lymphatic system disorders None View
Rash None Skin and subcutaneous tissue disorders None View
Pain None General disorders None View
Hypertension None Vascular disorders None View
Heartburn None Gastrointestinal disorders None View
Nail changes None Skin and subcutaneous tissue disorders None View
Mucositis None Respiratory, thoracic and mediastinal disorders None View
Nausea None Gastrointestinal disorders None View
Mood alteration None Psychiatric disorders None View
Sensory Neuropathy None Nervous system disorders None View
Neutropenia (ANC) None Blood and lymphatic system disorders None View
Leucopenia None Blood and lymphatic system disorders None View
Fatigue None General disorders None View
Diarrhea None Gastrointestinal disorders None View
ALT elevation None Investigations None View