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 @ 11:59 AM
Ignite Modification Date: 2025-12-25 @ 11:56 AM
NCT ID: NCT00796861
Description: 1 subject withdrew consent before beginning treatment; only 3 subjects participated in treatment.
Frequency Threshold: 0
Time Frame: None
Study: NCT00796861
Study Brief: Trial of Sunitinib for Refractory Malignant Ascites
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Single Arm Sunitinib (50mg PO daily x 4 wks + 2 wks rest x 3 cycles if able to tolerate tx Sunitinib: Patients will be given Sunitinib 50 mg orally daily for four weeks, followed by a two week holiday. For patients tolerating treatment, three cycles of treatment will be given (18 weeks total). 3 None 0 3 3 3 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Weakness None General disorders None View
Nausea None General disorders None View
Vomiting None General disorders None View
Tremors None General disorders None View
Feeling cold None General disorders None View
Dry skin None Skin and subcutaneous tissue disorders None View
Increased aspartate aminotransferase (AST) level None Hepatobiliary disorders None View
Urinary retention None Renal and urinary disorders None View
Anorexia None General disorders None View
Hyperkalemia None General disorders None View
Increased Hemoglobin count None General disorders None View
Decreased white blood cell count None General disorders None View
Ulcer None Skin and subcutaneous tissue disorders None View
Fatigue None General disorders None View
Decreased appetite None General disorders None View
Erythematous macular erruption None Skin and subcutaneous tissue disorders None View
Insomnia None General disorders None View
UTI None General disorders None View
Stenotrophomas (3+) lesion right thigh None Skin and subcutaneous tissue disorders None View
Skin ulcers None Skin and subcutaneous tissue disorders None View
Increased creatinine level None Renal and urinary disorders None View
Constipation None Gastrointestinal disorders None View
Labial exoriation None Skin and subcutaneous tissue disorders None View
Hyponatremia None General disorders None View
Hypocalcemia None General disorders None View
Decreased Albumin level None General disorders None View
Hypoglycemia None General disorders None View
Decreased platelet count None General disorders None View
Fissures None Skin and subcutaneous tissue disorders None View