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 @ 11:47 PM
Ignite Modification Date:
2025-12-25 @ 9:41 PM
NCT ID:
NCT04099251
Description:
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Frequency Threshold:
5
Time Frame:
Participants were assessed for all-cause mortality from their randomization to primary completion, (up to approximately 32 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 32 months)
Study:
NCT04099251
Study Brief:
Effectiveness Study of Nivolumab Compared to Placebo in Prevention of Recurrent Melanoma After Complete Resection of Stage IIB/C Melanoma
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 | Participants received 480 mg IV Nivolumab in an approximately 30-minute infusion on Day 1 of each 4-week treatment cycle until unacceptable toxicity, withdrawal of consent, completion of 12 months of treatment (from first dose of study treatment), disease recurrence, or the study ends, whichever occurred first. Participants began study treatment (Cycle 1) within 3 calendar days of randomization. Subsequent cycles were initiated within ± 3 days of the target visit date. | 14 | None | 95 | 524 | 464 | 524 | View |
| Placebo | Nivolumab matched placebo (0.9% Sodium Chloride for Injection/5% Dextrose for Injection) IV in a 30-minute infusion on Day 1 of each 4-week treatment cycle until unacceptable toxicity, withdrawal of consent, completion of 12 months of treatment (from first dose of study treatment), disease recurrence, or the study ends, whichever occurred first. | 8 | None | 37 | 264 | 194 | 264 | View |
| Open-Label Nivolumab | In the event of disease recurrence, participants on the blinded nivolumab or placebo portion will be offered the option to receive open-label on-protocol nivolumab treatment. Participants received 480 mg IV Nivolumab in an approximately 30-minute infusion on Day 1 of each 4-week treatment cycle until unacceptable toxicity, recurrence/progression, withdrawal of consent, completion of 12 months of treatment from first dose of open-label study treatment, whichever occurred first. | 2 | None | 5 | 30 | 20 | 30 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 25.0 | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 25.0 | View |
| Acute myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 25.0 | View |
| Angina unstable | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 25.0 | View |
| Cardiac arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 25.0 | View |
| Cardiac failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 25.0 | View |
| Coronary artery disease | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 25.0 | View |
| Left ventricular failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 25.0 | View |
| Myocardial ischaemia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 25.0 | View |
| Myocarditis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 25.0 | View |
| Adrenal insufficiency | SYSTEMATIC_ASSESSMENT | Endocrine disorders | 25.0 | View |
| Hyperthyroidism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | 25.0 | View |
| Hypophysitis | SYSTEMATIC_ASSESSMENT | Endocrine disorders | 25.0 | View |
| Hypopituitarism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | 25.0 | View |
| Lymphocytic hypophysitis | SYSTEMATIC_ASSESSMENT | Endocrine disorders | 25.0 | View |
| Glaucoma | SYSTEMATIC_ASSESSMENT | Eye disorders | 25.0 | View |
| Uveitis | SYSTEMATIC_ASSESSMENT | Eye disorders | 25.0 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 25.0 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 25.0 | View |
| Autoimmune colitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 25.0 | View |
| Autoimmune enteropathy | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 25.0 | View |
| Autoimmune pancreatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 25.0 | View |
| Colitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 25.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 25.0 | View |
| Enterocolitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 25.0 | View |
| Hiatus hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 25.0 | View |
| Inguinal hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 25.0 | View |
| Lower gastrointestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 25.0 | View |
| Oesophagitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 25.0 | View |
| Pancreatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 25.0 | View |
| Volvulus | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 25.0 | View |
| General physical health deterioration | SYSTEMATIC_ASSESSMENT | General disorders | 25.0 | View |
| Generalised oedema | SYSTEMATIC_ASSESSMENT | General disorders | 25.0 | View |
| Impaired healing | SYSTEMATIC_ASSESSMENT | General disorders | 25.0 | View |
| Malaise | SYSTEMATIC_ASSESSMENT | General disorders | 25.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | 25.0 | View |
| Sudden death | SYSTEMATIC_ASSESSMENT | General disorders | 25.0 | View |
| Autoimmune hepatitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | 25.0 | View |
| Hepatitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | 25.0 | View |
| Hepatotoxicity | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | 25.0 | View |
| Contrast media allergy | SYSTEMATIC_ASSESSMENT | Immune system disorders | 25.0 | View |
| Abscess limb | SYSTEMATIC_ASSESSMENT | Infections and infestations | 25.0 | View |
| Appendicitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 25.0 | View |
| Breast cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 25.0 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 25.0 | View |
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | 25.0 | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 25.0 | View |
| Diverticulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 25.0 | View |
| Erysipelas | SYSTEMATIC_ASSESSMENT | Infections and infestations | 25.0 | View |
| Herpes simplex encephalitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 25.0 | View |
| Infected lymphocele | SYSTEMATIC_ASSESSMENT | Infections and infestations | 25.0 | View |
| Infected seroma | SYSTEMATIC_ASSESSMENT | Infections and infestations | 25.0 | View |
| Infective keratitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 25.0 | View |
| Osteomyelitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 25.0 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | 25.0 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 25.0 | View |
| Urosepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 25.0 | View |
| Cervical vertebral fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 25.0 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 25.0 | View |
| Post procedural haematoma | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 25.0 | View |
| Subdural haematoma | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 25.0 | View |
| Tendon injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 25.0 | View |
| Upper limb fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 25.0 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | 25.0 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | 25.0 | View |
| Hepatic enzyme abnormal | SYSTEMATIC_ASSESSMENT | Investigations | 25.0 | View |
| Hepatic enzyme increased | SYSTEMATIC_ASSESSMENT | Investigations | 25.0 | View |
| Lipase increased | SYSTEMATIC_ASSESSMENT | Investigations | 25.0 | View |
| Troponin increased | SYSTEMATIC_ASSESSMENT | Investigations | 25.0 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 25.0 | View |
| Diabetes mellitus | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 25.0 | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 25.0 | View |
| Hypoglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 25.0 | View |
| Hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 25.0 | View |
| Hypophosphataemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 25.0 | View |
| Ketoacidosis | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 25.0 | View |
| Protein deficiency | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 25.0 | View |
| Steroid diabetes | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 25.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 25.0 | View |
| Autoimmune myositis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 25.0 | View |
| Bone lesion | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 25.0 | View |
| Costochondritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 25.0 | View |
| Groin pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 25.0 | View |
| Immune-mediated myositis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 25.0 | View |
| Lumbar spinal stenosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 25.0 | View |
| Muscular weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 25.0 | View |
| Myositis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 25.0 | View |
| Osteoarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 25.0 | View |
| Osteolysis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 25.0 | View |
| Rhabdomyolysis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 25.0 | View |
| Spondylolisthesis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 25.0 | View |
| Basal cell carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 25.0 | View |
| Invasive breast carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 25.0 | View |
| Lentigo maligna | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 25.0 | View |
| Malignant melanoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 25.0 | View |
| Malignant neoplasm progression | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 25.0 | View |
| Melanoma recurrent | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 25.0 | View |
| Meningioma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 25.0 | View |
| Metastatic malignant melanoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 25.0 | View |
| Neoplasm malignant | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 25.0 | View |
| Vascular neoplasm | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 25.0 | View |
| Cerebrovascular disorder | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 25.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 25.0 | View |
| Embolic stroke | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 25.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 25.0 | View |
| Polyneuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 25.0 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 25.0 | View |
| Transient ischaemic attack | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 25.0 | View |
| Suicidal ideation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | 25.0 | View |
| Acute kidney injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 25.0 | View |
| Chronic kidney disease | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 25.0 | View |
| Nephritis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 25.0 | View |
| Nephritis allergic | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 25.0 | View |
| Nephrolithiasis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 25.0 | View |
| Urinary retention | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 25.0 | View |
| Benign prostatic hyperplasia | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | 25.0 | View |
| Ovarian cyst | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | 25.0 | View |
| Ovarian hyperstimulation syndrome | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | 25.0 | View |
| Acute respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 25.0 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 25.0 | View |
| Dyspnoea exertional | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 25.0 | View |
| Interstitial lung disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 25.0 | View |
| Pneumonitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 25.0 | View |
| Pneumothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 25.0 | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 25.0 | View |
| Pulmonary mass | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 25.0 | View |
| Respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 25.0 | View |
| Urticaria | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 25.0 | View |
| Circulatory collapse | SYSTEMATIC_ASSESSMENT | Vascular disorders | 25.0 | View |
| Deep vein thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | 25.0 | View |
| Hypertensive urgency | SYSTEMATIC_ASSESSMENT | Vascular disorders | 25.0 | View |
| Lymphocele | SYSTEMATIC_ASSESSMENT | Vascular disorders | 25.0 | View |
| Peripheral artery aneurysm | SYSTEMATIC_ASSESSMENT | Vascular disorders | 25.0 | View |
| Vasculitis | SYSTEMATIC_ASSESSMENT | Vascular disorders | 25.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hyperthyroidism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | 25.0 | View |
| Hypothyroidism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | 25.0 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 25.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 25.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 25.0 | View |
| Dry mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 25.0 | View |
| Eructation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 25.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 25.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 25.0 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | 25.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | 25.0 | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | 25.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | 25.0 | View |
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | 25.0 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 25.0 | View |
| Infusion related reaction | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 25.0 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | 25.0 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | 25.0 | View |
| Blood bilirubin increased | SYSTEMATIC_ASSESSMENT | Investigations | 25.0 | View |
| Blood creatine phosphokinase increased | SYSTEMATIC_ASSESSMENT | Investigations | 25.0 | View |
| Lipase increased | SYSTEMATIC_ASSESSMENT | Investigations | 25.0 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 25.0 | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 25.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 25.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 25.0 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 25.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 25.0 | View |
| Confusional state | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | 25.0 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | 25.0 | View |
| Haematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 25.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 25.0 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 25.0 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 25.0 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 25.0 | View |
| Rash maculo-papular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 25.0 | View |
| Embolism | SYSTEMATIC_ASSESSMENT | Vascular disorders | 25.0 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | 25.0 | View |