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 @ 4:20 AM
Ignite Modification Date: 2025-12-26 @ 3:21 AM
NCT ID: NCT00317720
Description: Analysis including Adverse Event reporting was pooled for the two Phase I/II trials: MDACC ClinicalTrials.gov ID: NCT00317720; and BIDMC with DFCI ClinicalTrials.gov ID NCT00458237.
Frequency Threshold: 5
Time Frame: Adverse events assessments graded according to National Cancer Institute Common Toxicity Criteria for Adverse Events, version 3.0 were performed at 3-week intervals and treatment completion. Overall study period was 3 years and 4 months.
Study: NCT00317720
Study Brief: Trastuzumab and RAD001 in Patients With Human Epidermal Growth Receptor 2 (HER-2) Overexpressing 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
Trastuzumab + RAD001 Trastuzumab loading dose is 8 mg/kg daily; maintenance dose = 6 mg/kg once per 21 day cycle. RAD001 10 mg PO (by mouth) daily. None None 47 47 47 47 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Lymphopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Hyperglycemia SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Hypokalemia SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Hyperlipidemia SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Infection SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Mucositis SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Transaminitis SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Thrombosis/embolism SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (3.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Lymphopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Hyperglycemia SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Hypokalemia SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Hyperlipidemia SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Infection SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Mucositis SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Transaminitis SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View