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 @ 9:26 PM
Ignite Modification Date:
2025-12-25 @ 7:11 PM
NCT ID:
NCT01599832
Description:
All serious adverse events are reported. For other adverse events, those that occurred in \>5% of patients are reported.
Frequency Threshold:
5
Time Frame:
None
Study:
NCT01599832
Study Brief:
Dynamic Contrast-Enhanced Magnetic Resonance Imaging in Measuring Effects of Pazopanib Hydrochloride in Patients With 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 |
|---|---|---|---|---|---|---|---|---|
| Treatment (Pazopanib Hydrochloride, DCE-MRI) | Patients receive pazopanib hydrochloride PO QD in the absence of disease progression or unacceptable toxicity. Patients undergo dynamic contrast-enhanced MRI at baseline, day 8, and prior to courses 3, 5, and 7. pazopanib hydrochloride: Given PO laboratory biomarker analysis: Correlative studies dynamic contrast-enhanced magnetic resonance imaging: Undergo dynamic contrast-enhanced magnetic resonance imaging pharmacogenomic studies: Correlative studies | None | None | 8 | 20 | 16 | 20 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | NCI v4.01 | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | NCI v4.01 | View |
| Diarrhea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI v4.01 | View |
| Muscle Weakness lower limb | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | NCI v4.01 | View |
| Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | NCI v4.01 | View |
| Alanine aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | NCI v4.01 | View |
| Neoplasms benign, malignant, and unspecified | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | NCI v4.01 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Alanine aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | NCI v4.01 | View |
| Alkaline phosphatase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | NCI v4.01 | View |
| Anemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NCI v4.01 | View |
| Anorexia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI v4.01 | View |
| Aspartate aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | NCI v4.01 | View |
| Blood bilirubin increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | NCI v4.01 | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI v4.01 | View |
| Diarrhea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI v4.01 | View |
| Dysgeusia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | NCI v4.01 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | NCI v4.01 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | NCI v4.01 | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | NCI v4.01 | View |
| Hypoalbuminemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI v4.01 | View |
| Hyponatremia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI v4.01 | View |
| Hypophosphatemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI v4.01 | View |
| Mucositis oral | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI v4.01 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI v4.01 | View |
| Proteinuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | NCI v4.01 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI v4.01 | View |
| Hypercalcemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI v4.01 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | NCI v4.01 | View |
| Weight loss | NON_SYSTEMATIC_ASSESSMENT | Investigations | NCI v4.01 | View |
| Creatinine increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | NCI v4.01 | View |
| Platelet count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | NCI v4.01 | View |
| chronic kidney disease | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | NCI v4.01 | View |
| Hematuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | NCI v4.01 | View |
| Hypoglycemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI v4.01 | View |
| White blood cell decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | NCI v4.01 | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI v4.01 | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | NCI v4.01 | View |
| Non-cardiac chest pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | NCI v4.01 | View |
| Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | NCI v4.01 | View |
| Hair color change | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | NCI v4.01 | View |