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 @ 3:37 PM
Ignite Modification Date: 2025-12-25 @ 1:49 PM
NCT ID: NCT03091192
Description: Systematic assessment due to regular investigator assessment at study visits.
Frequency Threshold: 5
Time Frame: Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Study: NCT03091192
Study Brief: Savolitinib vs. Sunitinib in MET-driven PRCC.
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Savolitinib QD Savolitinib QD 9 None 8 33 25 33 View
Sunitinib QD Sunitinib QD 13 None 8 27 27 27 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.0 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 22.0 View
Drug hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 22.0 View
Thrombotic cerebral infarction SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.0 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 22.0 View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 22.0 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 22.0 View
Ventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 22.0 View
Hypertensive urgency SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 22.0 View
Thrombophlebitis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 22.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22.0 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22.0 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22.0 View
Anal fistula SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Incarcerated umbilical hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Biliary dilatation SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 22.0 View
Cholangitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 22.0 View
Jaundice SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 22.0 View
Condition aggravated SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.0 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Taste disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.0 View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 22.0 View
Capillary leak syndrome SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 22.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 22.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22.0 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Odynophagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Palmar-plantar erythrodysaesthesia syndrome SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 22.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 22.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 22.0 View
Yellow skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 22.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22.0 View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22.0 View
Chronic kidney disease SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 22.0 View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 22.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.0 View
Face oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.0 View
Mucosal inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.0 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.0 View
Peripheral swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.0 View
Amylase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.0 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.0 View
Blood thyroid stimulating hormone decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.0 View
Blood thyroid stimulating hormone increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.0 View
Body temperature increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.0 View
Ejection fraction decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.0 View
Lipase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.0 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.0 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.0 View
Thyroxine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.0 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.0 View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.0 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 22.0 View
Hypoalbuminaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 22.0 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.0 View
Conjuntivitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.0 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 22.0 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 22.0 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 22.0 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 22.0 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 22.0 View
Dyslipidaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 22.0 View