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: NCT00502203
Description: None
Frequency Threshold: 2
Time Frame: 7 years and 11 months
Study: NCT00502203
Study Brief: Paclitaxel and Carboplatin in Women With Malignant Mixed Mullerian Tumors (MMMT) of the Uterus
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 + Carboplatin Paclitaxel 175 mg/m\^2 intravenously (IV) over 3 hours and Carboplatin AUC 5 IV over 1 hour every 21 Days for 6 courses. None None 9 23 23 23 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (2.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Allergic Reaction SYSTEMATIC_ASSESSMENT General disorders CTCAE (2.0) View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (2.0) View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (2.0) View
Anorexia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (2.0) View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (2.0) View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE (2.0) View
Headache SYSTEMATIC_ASSESSMENT General disorders CTCAE (2.0) View
Hypomagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (2.0) View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (2.0) View
Neuropathy (sensory) SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (2.0) View
Neuropathy (hearing) SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (2.0) View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (2.0) View
Neutropenic Fever SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (2.0) View
Mucositis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (2.0) View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (2.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (2.0) View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (2.0) View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (2.0) View