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 @ 4:33 AM
Ignite Modification Date: 2025-12-26 @ 3:35 AM
NCT ID: NCT00790218
Description: None
Frequency Threshold: 0
Time Frame: Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
Study: NCT00790218
Study Brief: A Phase 1-2 Study of CF102 in Patients With Advanced Hepatocellular Carcinoma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
CF102 1mg CF102: CF102 capsules twice daily by mouth None None 3 6 6 6 View
CF102 5mg CF102: CF102 capsules twice daily by mouth None None 6 6 6 6 View
CF102 25mg CF102: CF102 capsules twice daily by mouth None None 3 7 7 7 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v 9.0 View
UTI NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v 9.0 View
Thrombus - left leg NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA v 9.0 View
Pathological fracture sacrum NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v 9.0 View
Fistula NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v 9.0 View
Ascites NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v 9.0 View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v 9.0 View
Inflammation - knee NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v 9.0 View
Hospitalization due to ascites paracentesis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v 9.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v 9.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v 9.0 View
Asthenia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v 9.0 View
Decreased appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v 9.0 View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v 9.0 View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v 9.0 View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v 9.0 View
Chest pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v 9.0 View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v 9.0 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v 9.0 View
Muscle contracture NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v 9.0 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v 9.0 View
Pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v 9.0 View
Acne NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v 9.0 View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v 9.0 View
Ascites NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v 9.0 View
Cerebral haemorrhage NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v 9.0 View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v 9.0 View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v 9.0 View
Dry mouth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v 9.0 View
Dysgeusia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v 9.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v 9.0 View
Hyperhidrosis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v 9.0 View
Hyponatraemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v 9.0 View
Influenza NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v 9.0 View
Neuropathy peripheral NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v 9.0 View
Nipple pain NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA v 9.0 View
Oedema NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v 9.0 View
Oedema peripheral NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v 9.0 View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v 9.0 View
Pelvic pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v 9.0 View
Petechiae NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v 9.0 View
Rash pruritic NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v 9.0 View
Rhinitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v 9.0 View
Thrombosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA v 9.0 View
Viral infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v 9.0 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v 9.0 View
Hypersensitivity NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA v 9.0 View
Cerebrovascular accident NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v 9.0 View
Abdominal distension NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v 9.0 View
Bone pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v 9.0 View
Cellulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v 9.0 View
General Physical Health Deterioration NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v 9.0 View
Hepatic Cirrhosis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA v 9.0 View
Hand fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v 9.0 View
Pollakiuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA v 9.0 View
Oliguria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA v 9.0 View
Hyperkalaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v 9.0 View
Cardiac arrest NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v 9.0 View
Fungal Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v 9.0 View
Presyncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v 9.0 View
Umbilical hernia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v 9.0 View
Haematochezia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v 9.0 View
Renal failure NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA v 9.0 View
Portal vein thrombosis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA v 9.0 View
Hepatic encephalopathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v 9.0 View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v 9.0 View
Syncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v 9.0 View
Haemorrhoids NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v 9.0 View
Sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v 9.0 View
Oropharyngeal pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v 9.0 View
Abdominal distension NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v 9.0 View
Buttock Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v 9.0 View
Dyspnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v 9.0 View
Sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v 9.0 View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA v 9.0 View
Dyspnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v 9.0 View
Urinary Retention NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA v 9.0 View
Gastrointestinal Haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v 9.0 View
Anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v 9.0 View
Haematuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA v 9.0 View
Pathological Fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v 9.0 View
Epistaxis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v 9.0 View