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: 2025-12-25 @ 1:34 AM
Ignite Modification Date: 2025-12-25 @ 11:47 PM
NCT ID: NCT01340794
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT01340794
Study Brief: Pazopanib Hydrochloride in Treating Patients With Advanced or Progressive Malignant Pheochromocytoma or Paraganglioma
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 Without Run-in Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28 of a 28 day cycle. None None 2 2 2 2 View
Treatment: Pazopanib With Run-in Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28 of a 28 day cycle. None None 1 4 4 4 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12 View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12 View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12 View
Hematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12 View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 12 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12 View
CPK increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12 View
Cardiac troponin I increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12 View
GGT increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12 View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12 View
Metabolism and nutrition disorders - Other, specify SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12 View
Intracranial hemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12 View
Confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12 View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 12 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Anal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 12 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12 View
Alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12 View
Electrocardiogram QT corrected interval prolonged SYSTEMATIC_ASSESSMENT Investigations MedDRA 12 View
Hemoglobin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12 View
Investigations - Other, specify SYSTEMATIC_ASSESSMENT Investigations MedDRA 12 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12 View
White blood cell decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12 View
Flank pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12 View
Hematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12 View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12 View
Skin hypopigmentation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12 View