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 @ 4:57 AM
Ignite Modification Date: 2025-12-26 @ 3:57 AM
NCT ID: NCT03230318
Description: None
Frequency Threshold: 5
Time Frame: All AEs were assessed from first day of treatment and until 28-35-day post-treatment follow-up period. The AE assessment period for the whole study lasted up to 50 months.
Study: NCT03230318
Study Brief: Derazantinib in Subjects With FGFR2 Gene Fusion-, Mutation- or Amplification- Positive Inoperable or Advanced Intrahepatic Cholangiocarcinoma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Substudy 2 Substudy 2 comprised of patients with with inoperable or advanced iCCA with FGFR2 mutations or amplifications Derazantinib was administered orally at 300 mg once daily 25 None 16 44 43 44 View
Substudy 1 Substudy 1 comprised of patients with inoperable or advanced iCCA with FGFR2 fusions Derazantinib was administered orally at 300 mg once daily 74 None 37 103 103 103 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Bronchial obstruction SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v.25.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v.25.0 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v.25.0 View
Laryngeal oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v.25.0 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v.25.0 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v.25.0 View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v.25.0 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v.25.0 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v.25.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v.25.0 View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v.25.0 View
Diverticular perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v.25.0 View
Gastric perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v.25.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v.25.0 View
Oesophageal varices haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v.25.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v.25.0 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA v.25.0 View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA v.25.0 View
Renal tubular necrosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA v.25.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v.25.0 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v.25.0 View
Arthritis bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v.25.0 View
Bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v.25.0 View
COVID-19 pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v.25.0 View
Intervertebral discitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v.25.0 View
Meningitis bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v.25.0 View
Peritonitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v.25.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v.25.0 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v.25.0 View
Sialoadenitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v.25.0 View
Subcutaneous abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v.25.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v.25.0 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v.25.0 View
Traumatic intracranial haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v.25.0 View
Tumour haemorrhage SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA v.25.0 View
Liver transplant SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA v.25.0 View
Peripheral arterial occlusive disease SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA v.25.0 View
Vena cava thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA v.25.0 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA v.25.0 View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA v.25.0 View
Disease progression SYSTEMATIC_ASSESSMENT General disorders MedDRA v.25.0 View
General physical health deterioration SYSTEMATIC_ASSESSMENT General disorders MedDRA v.25.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA v.25.0 View
Cholangitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA v.25.0 View
Hepatic failure SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA v.25.0 View
Hyperbilirubinaemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA v.25.0 View
Jaundice cholestatic SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA v.25.0 View
Prostatitis SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA v.25.0 View
Device occlusion SYSTEMATIC_ASSESSMENT Product Issues MedDRA v.25.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA v.25.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA v.25.0 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA v.25.0 View
Atrioventricular block second degree SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v.25.0 View
Bundle branch block left SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v.25.0 View
Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v.25.0 View
Hepatic encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v.25.0 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v.25.0 View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v.25.0 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v.25.0 View
Visual acuity reduced SYSTEMATIC_ASSESSMENT Eye disorders MedDRA v.25.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA v.25.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA v.25.0 View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA v.25.0 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA v.25.0 View
Blood phosphorus increased SYSTEMATIC_ASSESSMENT Investigations MedDRA v.25.0 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA v.25.0 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA v.25.0 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA v.25.0 View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA v.25.0 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v.25.0 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v.25.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v.25.0 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v.25.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v.25.0 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v.25.0 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v.25.0 View
Cornea verticillata SYSTEMATIC_ASSESSMENT Eye disorders MedDRA v.25.0 View
Dry eye SYSTEMATIC_ASSESSMENT Eye disorders MedDRA v.25.0 View
Keratitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA v.25.0 View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA v.25.0 View
Visual acuity reduced SYSTEMATIC_ASSESSMENT Eye disorders MedDRA v.25.0 View
Visual impairment SYSTEMATIC_ASSESSMENT Eye disorders MedDRA v.25.0 View
Xerophthalmia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA v.25.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v.25.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v.25.0 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v.25.0 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v.25.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v.25.0 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v.25.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v.25.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v.25.0 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v.25.0 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v.25.0 View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v.25.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v.25.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v.25.0 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v.25.0 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v.25.0 View
Nail discolouration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v.25.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v.25.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v.25.0 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v.25.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v.25.0 View
Hypercalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v.25.0 View
Hyperphosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v.25.0 View
Hypoalbuminaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v.25.0 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v.25.0 View
Vitamin D deficiency SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v.25.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v.25.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA v.25.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA v.25.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA v.25.0 View
Mucosal inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA v.25.0 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA v.25.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA v.25.0 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA v.25.0 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA v.25.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA v.25.0 View