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 @ 9:24 PM
Ignite Modification Date: 2025-12-25 @ 7:10 PM
NCT ID: NCT00727532
Description: None
Frequency Threshold: 0
Time Frame: Adverse events assessed for 28 days prior to surgical resection
Study: NCT00727532
Study Brief: Sorafenib in Treating Patients With Locally Advanced or Metastatic Kidney 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
Sorafenib Sorafenib 400mg orally twice daily on days 1-28 sorafenib tosylate: 400mg by mouth twice daily for 28 consecutive days diffusion-weighted magnetic resonance imaging: At baseline and just prior to surgery after sorafenib treatment None None 1 9 9 9 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pancreatitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAE (3.0) View
Hand-Foot Skin Reaction SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Mucositis/Stomatitis (functional symptomatic) - Oral Cavity SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Elevated Transaminitis SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Hand-Foot Skin reaction SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (3.0) View
Dry Skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Peripheral Sensory Neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Pain SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Anorexia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Elevated creatinine SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
Fever SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Hypocalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Lymphopenia SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
Pruritis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View