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 @ 7:32 PM
Ignite Modification Date: 2025-12-25 @ 5:14 PM
NCT ID: NCT00499603
Description: Serious Adverse Events reported include Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 and Grade 4 combined within each arm. Other Adverse Events were not assessed.
Frequency Threshold: 5
Time Frame: 3 years and 9 months
Study: NCT00499603
Study Brief: Paclitaxel Followed by FEC Versus Paclitaxel and RAD001 Followed by FEC In Women 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
Paclitaxel + FEC Paclitaxel 80 mg/m\^2 intravenously (IV) on day 1(+/- 2 days) of each week, followed by four cycles of combination 5-Fluorouracil at 500 mg/m\^2, Epirubicin at 100 mg/m\^2 and Cyclophosphamide at 500 mg/m\^2 (FEC) on day 1 every 3 weeks (+/- 7 days). 5-Fluorouracil : 500 mg/m\^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles. Paclitaxel : 80 mg/m\^2 by vein once weekly over 1 hour on day 1(+/- 2 days) each week for 3 weeks and for 12 cycles. Cyclophosphamide : 500 mg/m\^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles. Epirubicin : 100 mg/m\^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles. None None 27 27 0 0 View
Paclitaxel + RAD001 + FEC Paclitaxel + RAD001 Followed by FEC (5-Fluorouracil + Epirubicin + Cyclophosphamide) 5-Fluorouracil : 500 mg/m\^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles. Paclitaxel : 80 mg/m\^2 by vein once weekly over 1 hour on day 1(+/- 2 days) each week for 3 weeks and for 12 cycles. RAD001 : 30 mg by mouth weekly on Days 1, 8, \& 15 for 12 cycles. Cyclophosphamide : 500 mg/m\^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles. Epirubicin : 100 mg/m\^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles. None None 23 23 0 0 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Increased leukocytes SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Syncope SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Fatigue SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
GI Disturbaces SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Neuropathy SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (3.0) View
Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) 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
Nail changes SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Edema of extremities SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Hyperglycemia SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Hypokalemia SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
Small bowel obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Pulmonary embolus SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Other Events(If Any):