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 @ 3:39 AM
Ignite Modification Date: 2025-12-26 @ 2:24 AM
NCT ID: NCT01355302
Description: Safety population included all participants enrolled in Phase 1b of this study, except for those who (a) dropped out prior to receiving study drug, or (b) were without any safety assessments after the first dose of study drug. Treatment-emergent AEs, (onset date or worsening in severity from baseline after first dose of study drug), were reported.
Frequency Threshold: 5
Time Frame: From date of first dose up to 30 days after the last dose of study treatment, up to approximately 1 year 1 month.
Study: NCT01355302
Study Brief: E7050 in Combination With Cisplatin and Capecitabine Versus Cisplatin and Capecitabine Alone in Patients With Advanced or Metastatic Solid Tumors and Previously Untreated Gastric Cancer
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Phase 1b: Golvatinib+Capecitabine+Cisplatin Oral golvatinib (200 mg) was taken at about the same time each day of every 21-day treatment cycle, with or without food. Oral capecitabine (1000 mg/m\^2 tablet) was taken twice a day (2000 mg/m\^2 total daily) with food at about the same time (after golvatinib), on Days 1 through 14 of each 21-day cycle. At least 2 hours after capecitabine was taken, cisplatin (80 mg/m\^2) was administered by intravenous (IV) infusion over 60 minutes (after appropriate hydration or according to the institutional guidelines), on Day 1 of each 21-day cycle. Pretreatment hydration included 1 liter of normal saline by IV infusion over 120 minutes. Posttreatment hydration included 500 mL normal saline over 60 minutes. The dose level of golvatinib was to be escalated (to 300 and 400 mg) for additional cohorts after 3 participants enrolled into a given cohort unless there was a dose-limiting toxicity (DLT) in the first 3 participants. None None 5 7 7 7 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA Version 15.0 View
Psoas abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 15.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 15.0 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA Version 15.0 View
Convulsion SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 15.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 15.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA Version 15.0 View
Electrolyte imbalance SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA Version 15.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 15.0 View
Supraventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 15.0 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 15.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 15.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA Version 15.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 15.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 15.0 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA Version 15.0 View
Palmar-Plantar erythrodysaesthesia Syndrome SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA Version 15.0 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA Version 15.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 15.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 15.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 15.0 View
Hypocalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA Version 15.0 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA Version 15.0 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA Version 15.0 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA Version 15.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 15.0 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 15.0 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 15.0 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 15.0 View
Dizziness SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA Version 15.0 View
Hypoalbuminaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA Version 15.0 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA Version 15.0 View
Hypomagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA Version 15.0 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA Version 15.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA Version 15.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA Version 15.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 15.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA Version 15.0 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA Version 15.0 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 15.0 View
Abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 15.0 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 15.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 15.0 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 15.0 View
Abdominal tenderness SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 15.0 View
Ageusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 15.0 View
Amnesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 15.0 View
Arteriosclerosis coronary artery SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 15.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA Version 15.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA Version 15.0 View
Balance disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 15.0 View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 15.0 View
Breath sounds abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 15.0 View
Catatonia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA Version 15.0 View
Cold sweat SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 15.0 View
Convulsion SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 15.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 15.0 View
Decubitus ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA Version 15.0 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA Version 15.0 View
Diaphragmatic paralysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 15.0 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 15.0 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA Version 15.0 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 15.0 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 15.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 15.0 View
Electrocardiogram st segment elevation SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 15.0 View
Electrolyte imbalance SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA Version 15.0 View
Enteritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 15.0 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 15.0 View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA Version 15.0 View
Eye discharge SYSTEMATIC_ASSESSMENT Eye disorders MedDRA Version 15.0 View
Feeling cold SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 15.0 View
Feeling hot SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 15.0 View
Glossodynia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 15.0 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA Version 15.0 View
Hiccups SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 15.0 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA Version 15.0 View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 15.0 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA Version 15.0 View
Hypophosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA Version 15.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA Version 15.0 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 15.0 View
Increased upper airway secretion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 15.0 View
Lacrimation increased SYSTEMATIC_ASSESSMENT Eye disorders MedDRA Version 15.0 View
Leukocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA Version 15.0 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 15.0 View
Mood swings SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA Version 15.0 View
Mucosal inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 15.0 View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA Version 15.0 View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA Version 15.0 View
Nasal dryness SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 15.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 15.0 View
Neuralgia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 15.0 View
Neuropathy peripheral SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 15.0 View
Nocturia SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA Version 15.0 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 15.0 View
Oral pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 15.0 View
Oropharyngeal candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 15.0 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 15.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 15.0 View
Pallor SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 15.0 View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 15.0 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 15.0 View
Paranasal sinus hypersecretion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 15.0 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 15.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 15.0 View
Proctalgia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 15.0 View
Psoas abscess SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA Version 15.0 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA Version 15.0 View
Rash generalised SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA Version 15.0 View
Renal failure acute SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA Version 15.0 View
Restlessness SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA Version 15.0 View
Scab SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA Version 15.0 View
Scoliosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA Version 15.0 View
Spinal osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA Version 15.0 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 15.0 View
Streptococcal bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 15.0 View
Supraventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 15.0 View
Tachypnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 15.0 View
Trigeminal neuralgia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 15.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 15.0 View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA Version 15.0 View
Wheezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 15.0 View