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: 2025-12-26 @ 10:44 PM
Ignite Modification Date: 2025-12-26 @ 10:44 PM
NCT ID: NCT00729612
Description: All toxicities were assessed using Common Terminology for Adverse Events (CTCAE) version 3.0
Frequency Threshold: 5
Time Frame: None
Study: NCT00729612
Study Brief: Paclitaxel Albumin-Stabilized Nanoparticle Formulation and Carboplatin in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung 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
Treatment (Nab-paclitaxel, Carboplatin) Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and carboplatin IV over 1-2 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. None None 2 63 63 63 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Dehydration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE version 3.0 View
Death NOS SYSTEMATIC_ASSESSMENT General disorders CTCAE version 3.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE version 3.0 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE version 3.0 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE version 3.0 View
Leukopenia/Lymphopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE version 3.0 View
Febrile Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE version 3.0 View
Sensory Neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE version 3.0 View
Dehydration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE version 3.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE version 3.0 View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE version 3.0 View