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 @ 5:17 PM
Ignite Modification Date:
2025-12-25 @ 2:54 PM
NCT ID:
NCT03098550
Description:
None
Frequency Threshold:
5
Time Frame:
From first dose to 100 days post last dose (up to 36 months)
Study:
NCT03098550
Study Brief:
A Study to Test the Safety and Effectiveness of Nivolumab Combined With Daratumumab in Patients With Pancreatic, Non-Small Cell Lung or Triple Negative Breast Cancers, That Have Advanced or Have Spread
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 + Daratumumab (TNBC) | Triple-negative breast cancer (TNBC) treated with Triple-negative breast cancer (TNBC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24) | 29 | None | 36 | 41 | 40 | 41 | View |
| Nivolumab + Daratumumab (NSCLC) | Non-small cell lung cancer (NSCLC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24) | 11 | None | 17 | 21 | 21 | 21 | View |
| Nivolumab + Daratumumab (PAC) | Pancreatic adenocarcinoma cancer (PAC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24) | 36 | None | 36 | 43 | 41 | 43 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 23.1 | View |
| Febrile bone marrow aplasia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 23.1 | View |
| Acute coronary syndrome | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 23.1 | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 23.1 | View |
| Cardiac tamponade | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 23.1 | View |
| Cardio-respiratory arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 23.1 | View |
| Pericardial effusion | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 23.1 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 23.1 | View |
| Colitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 23.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 23.1 | View |
| Gastrointestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 23.1 | View |
| Ileus paralytic | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 23.1 | View |
| Intestinal ischaemia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 23.1 | View |
| Intestinal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 23.1 | View |
| Upper gastrointestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 23.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 23.1 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | 23.1 | View |
| Death | SYSTEMATIC_ASSESSMENT | General disorders | 23.1 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | 23.1 | View |
| Generalised oedema | SYSTEMATIC_ASSESSMENT | General disorders | 23.1 | View |
| Multiple organ dysfunction syndrome | SYSTEMATIC_ASSESSMENT | General disorders | 23.1 | View |
| Non-cardiac chest pain | SYSTEMATIC_ASSESSMENT | General disorders | 23.1 | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | 23.1 | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | 23.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | 23.1 | View |
| Cholestasis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | 23.1 | View |
| Hepatic failure | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | 23.1 | View |
| Hepatitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | 23.1 | View |
| Hyperbilirubinaemia | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | 23.1 | View |
| Drug hypersensitivity | SYSTEMATIC_ASSESSMENT | Immune system disorders | 23.1 | View |
| Bacteraemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | 23.1 | View |
| Device related infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 23.1 | View |
| Enterocolitis infectious | SYSTEMATIC_ASSESSMENT | Infections and infestations | 23.1 | View |
| Lung abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | 23.1 | View |
| Nosocomial infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 23.1 | View |
| Peritonitis bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | 23.1 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | 23.1 | View |
| Respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 23.1 | View |
| Septic shock | SYSTEMATIC_ASSESSMENT | Infections and infestations | 23.1 | View |
| Skin infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 23.1 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 23.1 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 23.1 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 23.1 | View |
| Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 23.1 | View |
| Infusion related reaction | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 23.1 | View |
| Lower limb fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 23.1 | View |
| C-reactive protein increased | SYSTEMATIC_ASSESSMENT | Investigations | 23.1 | View |
| General physical condition abnormal | SYSTEMATIC_ASSESSMENT | Investigations | 23.1 | View |
| Liver function test abnormal | SYSTEMATIC_ASSESSMENT | Investigations | 23.1 | View |
| Procalcitonin increased | SYSTEMATIC_ASSESSMENT | Investigations | 23.1 | View |
| Transaminases increased | SYSTEMATIC_ASSESSMENT | Investigations | 23.1 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 23.1 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 23.1 | View |
| Diabetes mellitus | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 23.1 | View |
| Hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 23.1 | View |
| Flank pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 23.1 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 23.1 | View |
| Cancer pain | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 23.1 | View |
| Malignant neoplasm progression | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 23.1 | View |
| Metastases to central nervous system | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 23.1 | View |
| Metastases to spinal cord | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 23.1 | View |
| Pancreatic carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 23.1 | View |
| Tumour pain | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 23.1 | View |
| Tumour thrombosis | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 23.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 23.1 | View |
| Hepatic encephalopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 23.1 | View |
| Ischaemic stroke | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 23.1 | View |
| Seizure | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 23.1 | View |
| Confusional state | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | 23.1 | View |
| Disorientation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | 23.1 | View |
| Acute kidney injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 23.1 | View |
| Haematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 23.1 | View |
| Urinary incontinence | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 23.1 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 23.1 | View |
| Dyspnoea exertional | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 23.1 | View |
| Haemoptysis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 23.1 | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 23.1 | View |
| Pneumonitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 23.1 | View |
| Pneumothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 23.1 | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 23.1 | View |
| Pulmonary oedema | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 23.1 | View |
| Respiratory distress | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 23.1 | View |
| Respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 23.1 | View |
| Rash papular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 23.1 | View |
| Embolism | SYSTEMATIC_ASSESSMENT | Vascular disorders | 23.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 23.1 | View |
| Lymphopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 23.1 | View |
| Hypothyroidism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | 23.1 | View |
| Vision blurred | SYSTEMATIC_ASSESSMENT | Eye disorders | 23.1 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 23.1 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 23.1 | View |
| Ascites | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 23.1 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 23.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 23.1 | View |
| Dry mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 23.1 | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 23.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 23.1 | View |
| Stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 23.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 23.1 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | 23.1 | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | 23.1 | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | 23.1 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | 23.1 | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | 23.1 | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | 23.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | 23.1 | View |
| Hypersensitivity | SYSTEMATIC_ASSESSMENT | Immune system disorders | 23.1 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 23.1 | View |
| Infusion related reaction | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 23.1 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | 23.1 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | 23.1 | View |
| Blood alkaline phosphatase increased | SYSTEMATIC_ASSESSMENT | Investigations | 23.1 | View |
| Blood bilirubin increased | SYSTEMATIC_ASSESSMENT | Investigations | 23.1 | View |
| Gamma-glutamyltransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | 23.1 | View |
| Lymphocyte count decreased | SYSTEMATIC_ASSESSMENT | Investigations | 23.1 | View |
| Weight decreased | SYSTEMATIC_ASSESSMENT | Investigations | 23.1 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 23.1 | View |
| Hypoalbuminaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 23.1 | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 23.1 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 23.1 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 23.1 | View |
| Bone pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 23.1 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 23.1 | View |
| Neck pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 23.1 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 23.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 23.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 23.1 | View |
| Somnolence | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 23.1 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | 23.1 | View |
| Sleep disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | 23.1 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 23.1 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 23.1 | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 23.1 | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 23.1 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 23.1 | View |
| Flushing | SYSTEMATIC_ASSESSMENT | Vascular disorders | 23.1 | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 23.1 | View |
| Conjunctival haemorrhage | SYSTEMATIC_ASSESSMENT | Eye disorders | 23.1 | View |
| Eye pruritus | SYSTEMATIC_ASSESSMENT | Eye disorders | 23.1 | View |
| Ocular discomfort | SYSTEMATIC_ASSESSMENT | Eye disorders | 23.1 | View |
| Colitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 23.1 | View |
| Flatulence | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 23.1 | View |
| Gastrooesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 23.1 | View |
| Mucosal inflammation | SYSTEMATIC_ASSESSMENT | General disorders | 23.1 | View |
| Non-cardiac chest pain | SYSTEMATIC_ASSESSMENT | General disorders | 23.1 | View |
| Oral fungal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 23.1 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | 23.1 | View |
| Respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 23.1 | View |
| Tooth infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 23.1 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 23.1 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 23.1 | View |
| Vascular access site pain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 23.1 | View |
| Blood albumin decreased | SYSTEMATIC_ASSESSMENT | Investigations | 23.1 | View |
| Blood lactate dehydrogenase increased | SYSTEMATIC_ASSESSMENT | Investigations | 23.1 | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | 23.1 | View |
| Transaminases increased | SYSTEMATIC_ASSESSMENT | Investigations | 23.1 | View |
| Flank pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 23.1 | View |
| Muscle spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 23.1 | View |
| Malignant neoplasm progression | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 23.1 | View |
| Dysgeusia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 23.1 | View |
| Paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 23.1 | View |
| Tremor | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 23.1 | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | 23.1 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | 23.1 | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 23.1 | View |
| Productive cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 23.1 | View |
| Rhinorrhoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 23.1 | View |
| Dry skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 23.1 | View |
| Erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 23.1 | View |
| Hyperhidrosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 23.1 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 23.1 | View |
| White blood cell count decreased | SYSTEMATIC_ASSESSMENT | Investigations | 23.1 | View |
| Hyperkalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 23.1 | View |
| Hypomagnesaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 23.1 | View |
| Rash pruritic | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 23.1 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | 23.1 | View |
| Lymphoedema | SYSTEMATIC_ASSESSMENT | Vascular disorders | 23.1 | View |