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 @ 4:21 PM
Ignite Modification Date:
2025-12-25 @ 2:17 PM
NCT ID:
NCT02905266
Description:
None
Frequency Threshold:
5
Time Frame:
From first dose to 100 days following administration of the last dose (approximately 27 months).
Study:
NCT02905266
Study Brief:
A Safety and Efficacy Study of Multiple Administration Regimens for Nivolumab Plus Ipilimumab in Subjects With 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 |
|---|---|---|---|---|---|---|---|---|
| Fixed Ratio Combination | Concomitant administration of Nivolumab and Ipilimumab (1:3 protein-mass ratio) every 3 weeks for 4 doses followed by Nivolumab flat dose in the Maintenance Phase | 14 | None | 35 | 53 | 51 | 53 | View |
| Sequential Combination | Sequential administration of Nivolumab and Ipilimumab every 3 weeks for 4 doses followed by Nivolumab flat dose in the Maintenance Phase | 14 | None | 35 | 53 | 51 | 53 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Angina pectoris | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 22.1 | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 22.1 | View |
| Adrenal insufficiency | SYSTEMATIC_ASSESSMENT | Endocrine disorders | 22.1 | View |
| Hypophysitis | SYSTEMATIC_ASSESSMENT | Endocrine disorders | 22.1 | View |
| Thyroiditis | SYSTEMATIC_ASSESSMENT | Endocrine disorders | 22.1 | View |
| Iridocyclitis | SYSTEMATIC_ASSESSMENT | Eye disorders | 22.1 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 22.1 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 22.1 | View |
| Ascites | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 22.1 | View |
| Autoimmune colitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 22.1 | View |
| Colitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 22.1 | View |
| Cyclic vomiting syndrome | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 22.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 22.1 | View |
| Duodenitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 22.1 | View |
| Enteritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 22.1 | View |
| Erosive duodenitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 22.1 | View |
| Gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 22.1 | View |
| Immune-mediated enterocolitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 22.1 | View |
| Intestinal perforation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 22.1 | View |
| Melaena | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 22.1 | View |
| Pancreatitis acute | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 22.1 | View |
| Rectal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 22.1 | View |
| Small intestinal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 22.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 22.1 | View |
| Adverse drug reaction | SYSTEMATIC_ASSESSMENT | General disorders | 22.1 | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | 22.1 | View |
| General physical health deterioration | SYSTEMATIC_ASSESSMENT | General disorders | 22.1 | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | 22.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | 22.1 | View |
| Acute hepatic failure | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | 22.1 | View |
| Autoimmune hepatitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | 22.1 | View |
| Cholangitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | 22.1 | View |
| Hepatic function abnormal | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | 22.1 | View |
| Hepatitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | 22.1 | View |
| Hepatocellular injury | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | 22.1 | View |
| Hypertransaminasaemia | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | 22.1 | View |
| Autoimmune disorder | SYSTEMATIC_ASSESSMENT | Immune system disorders | 22.1 | View |
| Drug hypersensitivity | SYSTEMATIC_ASSESSMENT | Immune system disorders | 22.1 | View |
| Anal abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | 22.1 | View |
| Bacterial infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 22.1 | View |
| Erysipelas | SYSTEMATIC_ASSESSMENT | Infections and infestations | 22.1 | View |
| Gastroenteritis viral | SYSTEMATIC_ASSESSMENT | Infections and infestations | 22.1 | View |
| Lower respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 22.1 | View |
| Meningitis aseptic | SYSTEMATIC_ASSESSMENT | Infections and infestations | 22.1 | View |
| Parotitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 22.1 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | 22.1 | View |
| Respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 22.1 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 22.1 | View |
| Urosepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 22.1 | View |
| Infusion related reaction | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 22.1 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | 22.1 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | 22.1 | View |
| Liver function test abnormal | SYSTEMATIC_ASSESSMENT | Investigations | 22.1 | View |
| Pancreatic enzymes increased | SYSTEMATIC_ASSESSMENT | Investigations | 22.1 | View |
| Pneumocystis test positive | SYSTEMATIC_ASSESSMENT | Investigations | 22.1 | View |
| Transaminases increased | SYSTEMATIC_ASSESSMENT | Investigations | 22.1 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 22.1 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 22.1 | View |
| Haematoma muscle | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 22.1 | View |
| Basal cell carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 22.1 | View |
| Bowen's disease | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 22.1 | View |
| Lip squamous cell carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 22.1 | View |
| Lymphoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 22.1 | View |
| Malignant neoplasm progression | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 22.1 | View |
| Squamous cell carcinoma of skin | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 22.1 | View |
| Facial paralysis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 22.1 | View |
| Guillain-Barre syndrome | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 22.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 22.1 | View |
| Meningorrhagia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 22.1 | View |
| Motor neurone disease | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 22.1 | View |
| Spinal cord compression | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 22.1 | View |
| Dysuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 22.1 | View |
| Glomerulonephritis rapidly progressive | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 22.1 | View |
| Hydronephrosis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 22.1 | View |
| Tubulointerstitial nephritis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 22.1 | View |
| Urinary tract obstruction | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 22.1 | View |
| Ovarian cyst | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | 22.1 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 22.1 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 22.1 | View |
| Interstitial lung disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 22.1 | View |
| Pneumonitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 22.1 | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 22.1 | View |
| Dermatitis bullous | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 22.1 | View |
| Thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | 22.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 22.1 | View |
| Hyperthyroidism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | 22.1 | View |
| Hypophysitis | SYSTEMATIC_ASSESSMENT | Endocrine disorders | 22.1 | View |
| Hypothyroidism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | 22.1 | View |
| Thyroiditis | SYSTEMATIC_ASSESSMENT | Endocrine disorders | 22.1 | View |
| Abdominal distension | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 22.1 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 22.1 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 22.1 | View |
| Colitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 22.1 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 22.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 22.1 | View |
| Dry mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 22.1 | View |
| Gastrooesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 22.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 22.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 22.1 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | 22.1 | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | 22.1 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | 22.1 | View |
| Influenza like illness | SYSTEMATIC_ASSESSMENT | General disorders | 22.1 | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | 22.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | 22.1 | View |
| Hepatitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | 22.1 | View |
| Hepatocellular injury | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | 22.1 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 22.1 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 22.1 | View |
| Oral herpes | SYSTEMATIC_ASSESSMENT | Infections and infestations | 22.1 | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 22.1 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 22.1 | View |
| Infusion related reaction | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 22.1 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | 22.1 | View |
| Amylase increased | SYSTEMATIC_ASSESSMENT | Investigations | 22.1 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | 22.1 | View |
| Blood lactate dehydrogenase increased | SYSTEMATIC_ASSESSMENT | Investigations | 22.1 | View |
| Gamma-glutamyltransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | 22.1 | View |
| Lipase increased | SYSTEMATIC_ASSESSMENT | Investigations | 22.1 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 22.1 | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 22.1 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 22.1 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 22.1 | View |
| Musculoskeletal pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 22.1 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 22.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 22.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 22.1 | View |
| Paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 22.1 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | 22.1 | View |
| Sleep disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | 22.1 | View |
| Dysuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 22.1 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 22.1 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 22.1 | View |
| Nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 22.1 | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 22.1 | View |
| Erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 22.1 | View |
| Hyperhidrosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 22.1 | View |
| Lichenoid keratosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 22.1 | View |
| Night sweats | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 22.1 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 22.1 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 22.1 | View |
| Rash pruritic | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 22.1 | View |
| Vitiligo | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 22.1 | View |
| Deep vein thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | 22.1 | View |