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 @ 2:46 PM
Ignite Modification Date:
2025-12-25 @ 1:15 PM
NCT ID:
NCT01721759
Description:
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
Frequency Threshold:
5
Time Frame:
From the first visit to 100 days after last treatment. Approximately up to 101 months
Study:
NCT01721759
Study Brief:
Study of Nivolumab (BMS-936558) in Patients With Advanced or Metastatic Squamous Cell Nonsmall-cell Lung Cancer Who Have Received At Least 2 Prior Systemic Regimens
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Nivolumab, 3 mg/kg | Participants received nivolumab, 3 mg/kg, intravenously over 60 minutes every 2 weeks (on Day 1 of each cycle) until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study. Every 2-week treatment period was considered to be a cycle. | 108 | None | 88 | 117 | 110 | 117 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 24.0 | View |
| Cardiac tamponade | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 24.0 | View |
| Cardio-respiratory arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 24.0 | View |
| Myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 24.0 | View |
| Pericarditis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 24.0 | View |
| Supraventricular tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 24.0 | View |
| Ventricular tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 24.0 | View |
| Adrenal insufficiency | SYSTEMATIC_ASSESSMENT | Endocrine disorders | 24.0 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | 24.0 | View |
| Superior vena cava syndrome | SYSTEMATIC_ASSESSMENT | Vascular disorders | 24.0 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 24.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 24.0 | View |
| Dysphagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 24.0 | View |
| Gastrointestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 24.0 | View |
| Haematemesis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 24.0 | View |
| Intestinal perforation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 24.0 | View |
| Large intestinal ulcer | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 24.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 24.0 | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | 24.0 | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | 24.0 | View |
| Performance status decreased | SYSTEMATIC_ASSESSMENT | General disorders | 24.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | 24.0 | View |
| Sudden death | SYSTEMATIC_ASSESSMENT | General disorders | 24.0 | View |
| Anaphylactic reaction | SYSTEMATIC_ASSESSMENT | Immune system disorders | 24.0 | View |
| Hypersensitivity | SYSTEMATIC_ASSESSMENT | Immune system disorders | 24.0 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 24.0 | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 24.0 | View |
| Diverticulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 24.0 | View |
| Herpes zoster | SYSTEMATIC_ASSESSMENT | Infections and infestations | 24.0 | View |
| Meningitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 24.0 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | 24.0 | View |
| Pulmonary sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 24.0 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 24.0 | View |
| Septic shock | SYSTEMATIC_ASSESSMENT | Infections and infestations | 24.0 | View |
| Wound infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 24.0 | View |
| Spinal fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 24.0 | View |
| Toxicity to various agents | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 24.0 | View |
| C-reactive protein increased | SYSTEMATIC_ASSESSMENT | Investigations | 24.0 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 24.0 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 24.0 | View |
| Failure to thrive | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 24.0 | View |
| Hypercalcaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 24.0 | View |
| Hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 24.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 24.0 | View |
| Muscular weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 24.0 | View |
| Musculoskeletal chest pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 24.0 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 24.0 | View |
| Pathological fracture | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 24.0 | View |
| Malignant neoplasm progression | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 24.0 | View |
| Meningioma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 24.0 | View |
| Neoplasm progression | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 24.0 | View |
| Skin cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 24.0 | View |
| Tumour pain | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 24.0 | View |
| Brain oedema | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 24.0 | View |
| Cognitive disorder | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 24.0 | View |
| Haemorrhage intracranial | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 24.0 | View |
| Haemorrhagic stroke | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 24.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 24.0 | View |
| Ischaemic stroke | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 24.0 | View |
| Motor dysfunction | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 24.0 | View |
| Peripheral nerve paresis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 24.0 | View |
| Seizure | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 24.0 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 24.0 | View |
| Confusional state | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | 24.0 | View |
| Acute kidney injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 24.0 | View |
| Urinary tract disorder | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 24.0 | View |
| Acute respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 24.0 | View |
| Bronchospasm | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 24.0 | View |
| Chronic obstructive pulmonary disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 24.0 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 24.0 | View |
| Haemoptysis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 24.0 | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 24.0 | View |
| Laryngeal haemorrhage | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 24.0 | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 24.0 | View |
| Pneumonia aspiration | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 24.0 | View |
| Pneumonitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 24.0 | View |
| Pneumothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 24.0 | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 24.0 | View |
| Pulmonary haemorrhage | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 24.0 | View |
| Respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 24.0 | View |
| Tachypnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 24.0 | View |
| Aortic aneurysm rupture | SYSTEMATIC_ASSESSMENT | Vascular disorders | 24.0 | View |
| Deep vein thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | 24.0 | View |
| Embolism | SYSTEMATIC_ASSESSMENT | Vascular disorders | 24.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 24.0 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 24.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 24.0 | View |
| Dry mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 24.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 24.0 | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 24.0 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 24.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 24.0 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | 24.0 | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | 24.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | 24.0 | View |
| Mucosal inflammation | SYSTEMATIC_ASSESSMENT | General disorders | 24.0 | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | 24.0 | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | 24.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | 24.0 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 24.0 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | 24.0 | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 24.0 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 24.0 | View |
| Blood creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | 24.0 | View |
| Weight decreased | SYSTEMATIC_ASSESSMENT | Investigations | 24.0 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 24.0 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 24.0 | View |
| Hypercalcaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 24.0 | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 24.0 | View |
| Hypoalbuminaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 24.0 | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 24.0 | View |
| Hypomagnesaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 24.0 | View |
| Hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 24.0 | View |
| Hypophosphataemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 24.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 24.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 24.0 | View |
| Muscular weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 24.0 | View |
| Musculoskeletal chest pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 24.0 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 24.0 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 24.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 24.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 24.0 | View |
| Neuropathy peripheral | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 24.0 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | 24.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 24.0 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 24.0 | View |
| Haemoptysis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 24.0 | View |
| Nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 24.0 | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 24.0 | View |
| Pneumonitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 24.0 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 24.0 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 24.0 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | 24.0 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | 24.0 | View |