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: 2025-12-26 @ 11:12 AM
Ignite Modification Date: 2025-12-26 @ 11:12 AM
NCT ID: NCT02998528
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: All-cause mortality was assessed from first dose to primary completion (up to approximately 54 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose of neoadjuvant therapy (up to approximately 5.5 months).
Study: NCT02998528
Study Brief: A Neoadjuvant Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Versus Chemotherapy Alone in Early Stage Non-Small Cell Lung Cancer (NSCLC)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Arm A: Nivo 3 mg/kg + Ipi 1 mg/kg Participants received nivolumab 3 mg/kg IV over 30 minutes every 2 weeks for up to 3 doses (ie, 6 weeks of treatment; each cycle is 14 days). In Cycle 1 Day 1 only, nivolumab will be followed by a single dose of ipilimumab 1 mg/kg IV over 30 minutes. Following definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator. 30 None 30 111 102 111 View
Arm B: Platinum Doublet Chemo Participants receive investigator-choice of platinum doublet chemotherapy regimens in 3-week cycles up to a maximum of 3 cycles of IV chemotherapy (ie, 9 weeks of treatment; each cycle is 21 days). Following definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator. 76 None 58 208 200 208 View
Arm C: Nivo 360 mg + Platinum Doublet Chemo Participants receive nivolumab 360 mg IV + platinum doublet chemotherapy in 3-week cycles up to a maximum of 3 cycles of IV chemotherapy (ie, 9 weeks of treatment; each cycle is 21 days). Following definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator. 35 None 52 176 157 176 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders 24.0 View
Coagulopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders 24.0 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders 24.0 View
Myelosuppression SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders 24.0 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders 24.0 View
Pancytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders 24.0 View
Sickle cell anaemia with crisis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders 24.0 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders 24.0 View
Arteriosclerosis coronary artery SYSTEMATIC_ASSESSMENT Cardiac disorders 24.0 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders 24.0 View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders 24.0 View
Cardiac ventricular thrombosis SYSTEMATIC_ASSESSMENT Cardiac disorders 24.0 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders 24.0 View
Myocardial ischaemia SYSTEMATIC_ASSESSMENT Cardiac disorders 24.0 View
Myocarditis SYSTEMATIC_ASSESSMENT Cardiac disorders 24.0 View
Stress cardiomyopathy SYSTEMATIC_ASSESSMENT Cardiac disorders 24.0 View
Adrenal insufficiency SYSTEMATIC_ASSESSMENT Endocrine disorders 24.0 View
Hypophysitis SYSTEMATIC_ASSESSMENT Endocrine disorders 24.0 View
Inappropriate antidiuretic hormone secretion SYSTEMATIC_ASSESSMENT Endocrine disorders 24.0 View
Ocular myasthenia SYSTEMATIC_ASSESSMENT Eye disorders 24.0 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 24.0 View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 24.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 24.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 24.0 View
Gastric ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 24.0 View
Haematochezia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 24.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 24.0 View
Oesophageal perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 24.0 View
Small intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 24.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 24.0 View
Death SYSTEMATIC_ASSESSMENT General disorders 24.0 View
General physical health deterioration SYSTEMATIC_ASSESSMENT General disorders 24.0 View
Malaise SYSTEMATIC_ASSESSMENT General disorders 24.0 View
Drug-induced liver injury SYSTEMATIC_ASSESSMENT Hepatobiliary disorders 24.0 View
Hepatitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders 24.0 View
Anaphylactic reaction SYSTEMATIC_ASSESSMENT Immune system disorders 24.0 View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders 24.0 View
Bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations 24.0 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations 24.0 View
Empyema SYSTEMATIC_ASSESSMENT Infections and infestations 24.0 View
Enterocolitis infectious SYSTEMATIC_ASSESSMENT Infections and infestations 24.0 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations 24.0 View
Infectious pleural effusion SYSTEMATIC_ASSESSMENT Infections and infestations 24.0 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations 24.0 View
Klebsiella bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations 24.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations 24.0 View
Pleural infection SYSTEMATIC_ASSESSMENT Infections and infestations 24.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations 24.0 View
Pneumonia bacterial SYSTEMATIC_ASSESSMENT Infections and infestations 24.0 View
Pneumonia influenzal SYSTEMATIC_ASSESSMENT Infections and infestations 24.0 View
Post procedural infection SYSTEMATIC_ASSESSMENT Infections and infestations 24.0 View
Pyelonephritis acute SYSTEMATIC_ASSESSMENT Infections and infestations 24.0 View
Respiratory tract infection 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
Subcutaneous abscess SYSTEMATIC_ASSESSMENT Infections and infestations 24.0 View
Tuberculosis SYSTEMATIC_ASSESSMENT Infections and infestations 24.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations 24.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations 24.0 View
Wound infection SYSTEMATIC_ASSESSMENT Infections and infestations 24.0 View
Cardiac function disturbance postoperative SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 24.0 View
Overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 24.0 View
Post procedural complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 24.0 View
Post procedural haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 24.0 View
Post procedural haemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 24.0 View
Postoperative delirium SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 24.0 View
Postoperative respiratory failure SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 24.0 View
Postoperative wound complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 24.0 View
Procedural haemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 24.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations 24.0 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations 24.0 View
Glycosylated haemoglobin increased SYSTEMATIC_ASSESSMENT Investigations 24.0 View
Hepatic enzyme abnormal SYSTEMATIC_ASSESSMENT Investigations 24.0 View
Transaminases increased SYSTEMATIC_ASSESSMENT Investigations 24.0 View
Decreased appetite 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
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 24.0 View
Myositis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 24.0 View
Cancer pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) 24.0 View
Endometrial cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) 24.0 View
Malignant neoplasm progression SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) 24.0 View
Renal cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) 24.0 View
Tumour pseudoprogression SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) 24.0 View
Carotid artery stenosis SYSTEMATIC_ASSESSMENT Nervous system disorders 24.0 View
Cerebral infarction SYSTEMATIC_ASSESSMENT Nervous system disorders 24.0 View
Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders 24.0 View
Ischaemic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders 24.0 View
Myasthenia gravis SYSTEMATIC_ASSESSMENT Nervous system disorders 24.0 View
Neuropathy peripheral SYSTEMATIC_ASSESSMENT Nervous system disorders 24.0 View
Posterior reversible encephalopathy syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders 24.0 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders 24.0 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders 24.0 View
Prostatitis SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders 24.0 View
Atelectasis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 24.0 View
Bronchopleural fistula 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
Chylothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal 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
Epistaxis 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
Interstitial lung disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 24.0 View
Lung opacity 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 fistula SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 24.0 View
Pulmonary mass SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 24.0 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 24.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 24.0 View
Aortic rupture SYSTEMATIC_ASSESSMENT Vascular disorders 24.0 View
Arterial thrombosis 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
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders 24.0 View
Iliac artery occlusion SYSTEMATIC_ASSESSMENT Vascular disorders 24.0 View
Subclavian vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders 24.0 View
Thrombophlebitis superficial SYSTEMATIC_ASSESSMENT Vascular disorders 24.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders 24.0 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders 24.0 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders 24.0 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders 24.0 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders 24.0 View
Tinnitus SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders 24.0 View
Hyperthyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders 24.0 View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders 24.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 24.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 24.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 24.0 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 24.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 24.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders 24.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders 24.0 View
Malaise SYSTEMATIC_ASSESSMENT General disorders 24.0 View
Non-cardiac chest pain 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
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations 24.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations 24.0 View
Incision site pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 24.0 View
Procedural pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 24.0 View
Wound complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 24.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations 24.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations 24.0 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations 24.0 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations 24.0 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations 24.0 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations 24.0 View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations 24.0 View
Decreased appetite 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
Hypomagnesaemia 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
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 24.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders 24.0 View
Dysgeusia 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
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric 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
Hiccups SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 24.0 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue 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