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 @ 4:52 PM
Ignite Modification Date: 2025-12-25 @ 2:35 PM
NCT ID: NCT00635050
Description: None
Frequency Threshold: 0
Time Frame: At baseline, every 2 weeks during chemotherapy and Avastin, every 3 weeks during postoperative Avastin, every 6 months afterward though 5 years of followup, then annually to 10 years of followup.
Study: NCT00635050
Study Brief: Therapy for Locally Advanced Breast Cancer Using Doxil, Paclitaxel, and Cyclophosphamide With Avastin
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Doxil, Paclitaxel, Cyclophosphamide + Avastin Two staged phase II single arm trial to evaluate the pathologic complete response rate to sequential dose dense chemotherapy using Doxil, paclitaxel and cyclophosphamide with concurrent Avastin in patients with advanced invasive breast cancer. Doxil, Paclitaxel, Cyclophosphamide, Avastin: Regimen A: Sequential Doxil 25 mg/m2 every 2 weeks for 3 doses will be followed by paclitaxel 175 mg/m2 i.v. every 2 weeks for 3 doses, then by cyclophosphamide 600 mg/M 2 i.v. every 2 weeks for 3 doses. Avastin 10 mg/kg i.v. every 2 weeks will be given concurrently with all 3 agents. Patients who experience \<pCR to primary chemotherapy will receive an additional year of Avastin at the same dose equivalent beginning 6-8 weeks after definitive operation. Regimen B: Sequential Doxil 30 mg/m2 every 2 weeks for 3 doses will be followed by paclitaxel 175 mg/m2 i.v. every 2 weeks for 3 doses, then by cyclophosphamide 600 mg/m 2 i.v. every 2 weeks for 3 doses. Avastin 10 mg/kg i.v. every 2 week None None 1 32 23 32 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
hospitalization SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
hand-foot syndrome SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
mucositis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
hypertension SYSTEMATIC_ASSESSMENT General disorders None View
neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View