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 @ 1:47 PM
Ignite Modification Date: 2025-12-25 @ 12:41 PM
NCT ID: NCT00444795
Description: The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Frequency Threshold: 5
Time Frame: From the time that the participant signed data privacy statement through and including 28 calendar days after the last administration of the study drug, average of 27.2 weeks.
Study: NCT00444795
Study Brief: Post Marketing Surveillance Study To Observe Safety And Efficacy Of Sutene
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Sutene Participants were administered with Sutene as part of routine clinical practice. The use and dosage recommendations for Sutene were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity. None None 72 617 474 617 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anorexia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders WHO-ART version 092 View
Ascites NON_SYSTEMATIC_ASSESSMENT General disorders WHO-ART version 092 View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders WHO-ART version 092 View
Fever NON_SYSTEMATIC_ASSESSMENT General disorders WHO-ART version 092 View
Oedema NON_SYSTEMATIC_ASSESSMENT General disorders WHO-ART version 092 View
Pain NON_SYSTEMATIC_ASSESSMENT General disorders WHO-ART version 092 View
Systemic inflammatory response syndrome NON_SYSTEMATIC_ASSESSMENT General disorders WHO-ART version 092 View
Cardiac failure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders WHO-ART version 092 View
Cardiomegaly NON_SYSTEMATIC_ASSESSMENT Cardiac disorders WHO-ART version 092 View
Circulatory failure NON_SYSTEMATIC_ASSESSMENT Vascular disorders WHO-ART version 092 View
Congestive heart failure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders WHO-ART version 092 View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders WHO-ART version 092 View
Hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders WHO-ART version 092 View
Convulsions NON_SYSTEMATIC_ASSESSMENT Nervous system disorders WHO-ART version 092 View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders WHO-ART version 092 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders WHO-ART version 092 View
Paralysis NON_SYSTEMATIC_ASSESSMENT Nervous system disorders WHO-ART version 092 View
hypothyroidism NON_SYSTEMATIC_ASSESSMENT Endocrine disorders WHO-ART version 092 View
Abdomen enlarged NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders WHO-ART version 092 View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders WHO-ART version 092 View
Appendicitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders WHO-ART version 092 View
Colitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders WHO-ART version 092 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders WHO-ART version 092 View
Haematemesis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders WHO-ART version 092 View
Haemorrhage rectum NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders WHO-ART version 092 View
Hiccup NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders WHO-ART version 092 View
Ileus NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders WHO-ART version 092 View
Intestinal fistula NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders WHO-ART version 092 View
Melaena NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders WHO-ART version 092 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders WHO-ART version 092 View
Oesophagitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders WHO-ART version 092 View
Pancreatitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders WHO-ART version 092 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders WHO-ART version 092 View
Bilirubinaemia NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders WHO-ART version 092 View
Cholecystitis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders WHO-ART version 092 View
Hepatorenal syndrome NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders WHO-ART version 092 View
Jaundice NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders WHO-ART version 092 View
Hypercalcaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders WHO-ART version 092 View
Hyperkalaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders WHO-ART version 092 View
Hypoglycaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders WHO-ART version 092 View
Hyponatraemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders WHO-ART version 092 View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders WHO-ART version 092 View
Muscle weakness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders WHO-ART version 092 View
Myocardial infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders WHO-ART version 092 View
Pericardial effusion NON_SYSTEMATIC_ASSESSMENT Cardiac disorders WHO-ART version 092 View
Carcinoma of oesophagus NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) WHO-ART version 092 View
Neoplasm malignant NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) WHO-ART version 092 View
Pulmonary carcinoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) WHO-ART version 092 View
Disseminated intravascular coagulation NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders WHO-ART version 092 View
Purpura thrombopenic thrombotic NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders WHO-ART version 092 View
Thrombocytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders WHO-ART version 092 View
Confusion NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders WHO-ART version 092 View
Delirium NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders WHO-ART version 092 View
Mental deficiency NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders WHO-ART version 092 View
Haemolytic-uraemic syndrome NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders WHO-ART version 092 View
Dyspnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders WHO-ART version 092 View
Haemoptysis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders WHO-ART version 092 View
Pleural effusion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders WHO-ART version 092 View
Pneumothorax NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders WHO-ART version 092 View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders WHO-ART version 092 View
Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations WHO-ART version 092 View
Sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations WHO-ART version 092 View
Shock septic NON_SYSTEMATIC_ASSESSMENT Vascular disorders WHO-ART version 092 View
Malnutrition NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders WHO-ART version 092 View
Laceration NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications WHO-ART version 092 View
Post-operative wound infection NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications WHO-ART version 092 View
Surgical intervention NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures WHO-ART version 092 View
Dermatitis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders WHO-ART version 092 View
Azotaemia NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders WHO-ART version 092 View
Haematuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders WHO-ART version 092 View
Renal failure acute NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders WHO-ART version 092 View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders WHO-ART version 092 View
Haemorrhage intracranial NON_SYSTEMATIC_ASSESSMENT Vascular disorders WHO-ART version 092 View
Haemorrhage nos NON_SYSTEMATIC_ASSESSMENT Vascular disorders WHO-ART version 092 View
Thromboembolism NON_SYSTEMATIC_ASSESSMENT Vascular disorders WHO-ART version 092 View
Thrombophlebitis deep NON_SYSTEMATIC_ASSESSMENT Vascular disorders WHO-ART version 092 View
Conjunctivitis NON_SYSTEMATIC_ASSESSMENT Eye disorders WHO-ART version 092 View
Leukocytosis NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders WHO-ART version 092 View
Asthenia NON_SYSTEMATIC_ASSESSMENT General disorders WHO-ART version 092 View
Condition aggravated NON_SYSTEMATIC_ASSESSMENT General disorders WHO-ART version 092 View
Death NON_SYSTEMATIC_ASSESSMENT General disorders WHO-ART version 092 View
Gastric carcinoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) WHO-ART version 092 View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders WHO-ART version 092 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Face oedema NON_SYSTEMATIC_ASSESSMENT General disorders WHO-ART version 092 View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders WHO-ART version 092 View
Fever NON_SYSTEMATIC_ASSESSMENT General disorders WHO-ART version 092 View
Oedema NON_SYSTEMATIC_ASSESSMENT General disorders WHO-ART version 092 View
Oedema periorbital NON_SYSTEMATIC_ASSESSMENT General disorders WHO-ART version 092 View
Palmar-plantar erythrodysaesthesia NON_SYSTEMATIC_ASSESSMENT General disorders WHO-ART version 092 View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders WHO-ART version 092 View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders WHO-ART version 092 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders WHO-ART version 092 View
Hypothyroidism NON_SYSTEMATIC_ASSESSMENT Endocrine disorders WHO-ART version 092 View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders WHO-ART version 092 View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders WHO-ART version 092 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders WHO-ART version 092 View
Dyspepsia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders WHO-ART version 092 View
Mucositis nos NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders WHO-ART version 092 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders WHO-ART version 092 View
Stomatitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders WHO-ART version 092 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders WHO-ART version 092 View
Jaundice NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders WHO-ART version 092 View
Serum glutamate pyruvate transaminase increased NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders WHO-ART version 092 View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders WHO-ART version 092 View
Myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders WHO-ART version 092 View
Coughing NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders WHO-ART version 092 View
Dyspnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders WHO-ART version 092 View
Epistaxis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders WHO-ART version 092 View
Pharyngitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders WHO-ART version 092 View
Azotaemia NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders WHO-ART version 092 View
Granulocytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders WHO-ART version 092 View
Leucopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders WHO-ART version 092 View
Anorexia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders WHO-ART version 092 View
Asthenia NON_SYSTEMATIC_ASSESSMENT General disorders WHO-ART version 092 View
Chest pain NON_SYSTEMATIC_ASSESSMENT General disorders WHO-ART version 092 View
Serum glutamic-oxaloacetic transaminase increased NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders WHO-ART version 092 View
Thrombocytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders WHO-ART version 092 View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders WHO-ART version 092 View