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 @ 12:16 AM
Ignite Modification Date: 2025-12-25 @ 10:19 PM
NCT ID: NCT02128958
Description: Serious adverse event classification based on the FDA regulatory definition of a serious AE.
Frequency Threshold: 5
Time Frame: AEs were recorded for each subject at the start of Cycle 1 Day 1 visit and followed to the 28-day Follow-Up Visit (28 days post End of Dosing) for up to 1 year/ Open-Label (OL) Follow-Up Visit (28 days post OL End of Dosing) for an average of 1 year. For observed toxicity thought to be at least possibly related to study drug was not resolved by the 28-day Follow-Up Visit/OL Follow-Up Visit, the subject was followed until the event resolved or stabilized, for an average of up to 24 months.
Study: NCT02128958
Study Brief: Phase 2, Randomized, Double-Blind, Placebo-Controlled of the Efficacy and Safety of CF102 in Hepatocellular Carcinoma (HCC)
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 CF102 25 mg capsules administered orally BID 34 None 37 50 46 50 View
Placebo Tablets of CF102 Placebo capsules administered orally BID 24 None 20 28 26 28 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Subileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Abdominal adhesions SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Peritoneal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Oesophageal varices haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Hyperbilirubinaemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 21.0 View
Hepatic failure SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 21.0 View
Hepatic cirrhosis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 21.0 View
Coma SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Hepatic Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Ischaemic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Multiple organ dysfunction syndrome SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Disease Progression SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.0 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.0 View
Cardio-respiratory arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.0 View
Hepatic enzyme increased/ SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Bilirubin conjugated increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Hepatocellular carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21.0 View
Malignant neoplasm progression/ SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21.0 View
Metastases to lung SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21.0 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Vena cava thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.0 View
Subclavian vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.0 View
Superior vena cava occlusion SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.0 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.0 View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 21.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.0 View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Disease Progression SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Hepatic failure SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 21.0 View
Hyperbilirubinaemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 21.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Blood thyroid stimulating hormone increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Tri-iodothyronine free decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Weight increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Hypoalbuminaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Hepatocellular carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Hepatic encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View