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 @ 3:23 PM
Ignite Modification Date: 2025-12-25 @ 1:41 PM
NCT ID: NCT01458392
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT01458392
Study Brief: Study of Dalantercept in Patients With Squamous Cell Carcinoma of the Head and Neck
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Dalantercept 80 mg Subcutaneous 80 mg dose of dalantercept once every 3 weeks. None None 1 2 2 2 View
Dalantercept 0.6 mg/kg Subcutaneous 0.6 mg/kg dose of dalantercept once every 3 weeks. None None 6 13 13 13 View
Dalantercept 1.2 mg/kg Subcutaneous 1.2 mg/kg dose of dalantercept once every 3 weeks. None None 6 31 31 31 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Tongue cancer metastatic SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pneumonia aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pulmonary oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Respiratory distress SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Disease progression SYSTEMATIC_ASSESSMENT General disorders None View
Metastases to central nervous system SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Tumour compression SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Tracheal obstruction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Spinal cord compression SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Suicide attempt SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Renal failure acute SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Balance disorder SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dysarthria SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Radiculopathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Tongue oedema SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gingivitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Glossodynia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Paraesthesia oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Salivary hypersecretion SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Leukocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Lymphadenopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypoalbuminaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypercalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations None View
Weight increased SYSTEMATIC_ASSESSMENT Investigations None View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations None View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Brain natriuretic peptide increased SYSTEMATIC_ASSESSMENT Investigations None View
Lipase increase SYSTEMATIC_ASSESSMENT Investigations None View
Blood urea increased SYSTEMATIC_ASSESSMENT Investigations None View
Protein total decreased SYSTEMATIC_ASSESSMENT Investigations None View
Troponin increased SYSTEMATIC_ASSESSMENT Investigations None View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Flank pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Joint swelling SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain in jaw SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Oral candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Staphylococcal infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Wound infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Abdominal wound dehiscence SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Feeding tube complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Wound haemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Telangiectasia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dermatitis acneiform SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Pericardial effusion SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Left ventricular dysfunction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Lacrimation increased SYSTEMATIC_ASSESSMENT Eye disorders None View
Macular degeneration SYSTEMATIC_ASSESSMENT Eye disorders None View
Pain SYSTEMATIC_ASSESSMENT General disorders None View
Catheter site pain SYSTEMATIC_ASSESSMENT General disorders None View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders None View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dysphonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dysphonia exertional SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Wheezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pulmonary hypertension SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rhonchi SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Sputum increased SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Neuropathy peripheral SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Paresthesia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Tumour pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
N-terminal prohormone brain natriuretic peptide increased SYSTEMATIC_ASSESSMENT Investigations None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders None View
Face oedema SYSTEMATIC_ASSESSMENT General disorders None View
Oedema SYSTEMATIC_ASSESSMENT General disorders None View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders None View
Malaise SYSTEMATIC_ASSESSMENT General disorders None View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders None View