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 @ 5:21 PM
Ignite Modification Date: 2025-12-25 @ 2:56 PM
NCT ID: NCT00193050
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00193050
Study Brief: Weekly Gemcitabine, Epirubicin, and Docetaxel in Locally Advanced or Inflammatory 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
Intervention In the neoadjuvant setting, patients were administered gemcitabine (800 mg/m2 IV days 1 and 8), epirubicin (75 mg/m2 IV day 1), and docetaxel (30 mg/m2 IV days 1 and 8)repeated every 21 days for 4 cycles Patients then had either mastectomy or breast conservation surgery and pathologic treatment responses were assessed. After surgery, 4 cycles of adjuvant gemcitabine (1000 mg/m2 IV days 1 and 8) and docetaxel (35 mg/m2 IV days 1 and 8) were administered at 21 day intervals. After completion of chemotherapy, local regional radiation therapy and/or anti-estrogen therapy was administered per standard guidelines. 38 None 17 110 71 110 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Fever SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Infection - Other SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Nausea/Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Infection - Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Esophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Febrile Neutropenia SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Hemoglobin SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hemoglobin SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Neutrophils SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Platelets SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View