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 @ 4:41 AM
Ignite Modification Date: 2025-12-26 @ 3:42 AM
NCT ID: NCT00206518
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00206518
Study Brief: Taxotere and Adriamycin/Cytoxan (AC) Validation in Breast Cancer Patients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
A: Taxotere/Docetaxel Chemotherapy In Arm A, patients will receive single agent Taxotere (100 mg/m2) every 3 weeks for 4 cycles before surgery. Primary surgery will then be conducted, if operable, following completion of neoadjuvant treatment. This will be followed by standard adjuvant AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles. For patients whose BSA is greater than 2.0 m2, the Adriamycin dosage will be calculated using BSA = 2.0 m2. This is done in order to minimize Adriamycin-induced cardiotoxicity. Taxotere/Docetaxel: Taxotere doxorubicin: AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles before surgery. None None 12 83 13 83 View
B: AC Adriamycin/Cytoxan In Arm B, patients will receive AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles before surgery. For patients whose BSA is greater than 2.0 m2, the Adriamycin dosage will be calculated using BSA = 2.0 m2. Primary surgery will then be conducted, if operable, following completion of neoadjuvant treatment. This will be followed by 4 cycles of single agent Taxotere (100 mg/m2) every 3 weeks. Adriamycin/Cytoxan: Adriamycin/Cytoxan None None 5 84 3 84 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
ABDOMINAL PAIN NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
ALLERGIC/REACTION NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
NEUTROPENIA NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
FEVER NON_SYSTEMATIC_ASSESSMENT General disorders None View
GASTRITIS NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
INFECTION NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
RENAL FAILURE NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
NEUTROPENIA NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View