Adverse Events Module

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 @ 4:07 PM
Ignite Modification Date: 2025-12-25 @ 2:08 PM
NCT ID: NCT03026166
Description: None
Frequency Threshold: 5
Time Frame: From the first dose of study drug until 100 days after the last dose of study drug; median duration of treatment was 65 days and 53 days in each cohort respectively. All-cause mortality is reported through the end of follow-up; maximum time on study was 115 weeks.
Study: NCT03026166
Study Brief: A Study of Rovalpituzumab Tesirine Administered in Combination With Nivolumab and With or Without Ipilimumab for Adults With Extensive-Stage Small Cell Lung Cancer
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Cohort 1: Rovalpituzumab Tesirine and Nivolumab Participants received 2 doses of 0.3 mg/kg rovalpituzumab tesirine by intravenous (IV) infusion 6 weeks apart (Day 1 of Cycles 1 and 3), and 2 doses of 360 mg nivolumab IV 3 weeks apart beginning on Cycle 2 (Day 1 of Cycles 2 and 3). Participants then received maintenance therapy with 480 mg nivolumab IV once every 4 weeks from Cycle 4 until disease progression. 26 None 23 30 30 30 View
Cohort 2: Rovalpituzumab Tesirine and Nivolumab + Ipilimumab Participants received 2 doses of 0.3 mg/kg rovalpituzumab tesirine IV 6 weeks apart (Day 1 of Cycles 1 and 3), nivolumab 1 mg/kg every 3 weeks for 4 cycles beginning on Cycle 2 (Day 1 of Cycles 2-5), and ipilimumab 1 mg/kg IV every 3 weeks for 4 cycles beginning on Cycle 2 (Day 1 of Cycles 2-5). After a 6-week washout, participants then received maintenance therapy with 480 mg nivolumab IV once every 4 weeks from Cycle 6 until disease progression. 8 None 9 12 12 12 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Disseminated intravascular coagulation SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 20.1 View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20.1 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20.1 View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20.1 View
Cardiac tamponade SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20.1 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20.1 View
Pericardial effusion SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20.1 View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20.1 View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.1 View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.1 View
Condition aggravated SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.1 View
Face oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.1 View
Generalised oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.1 View
Autoimmune hepatitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 20.1 View
Drug-induced liver injury SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 20.1 View
Hepatocellular injury SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 20.1 View
Empyema SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.1 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.1 View
Pneumonia fungal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.1 View
Respiratory tract infection bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.1 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.1 View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.1 View
Femoral neck fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.1 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.1 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20.1 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20.1 View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20.1 View
Malignant neoplasm progression SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 20.1 View
Ischaemic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.1 View
Peroneal nerve palsy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.1 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 20.1 View
Acute respiratory distress syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.1 View
Acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.1 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.1 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.1 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.1 View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.1 View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.1 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.1 View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 20.1 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 20.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Productive cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.1 View
Pulmonary hypertension SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.1 View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.1 View
Wheezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.1 View
Blister SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 20.1 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 20.1 View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 20.1 View
Photosensitivity reaction SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 20.1 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 20.1 View
Pruritus generalised SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 20.1 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 20.1 View
Rash macular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 20.1 View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 20.1 View
Subacute cutaneous lupus erythematosus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 20.1 View
Flushing SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 20.1 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 20.1 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 20.1 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 20.1 View
Leukocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 20.1 View
Lymphopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 20.1 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 20.1 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 20.1 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20.1 View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20.1 View
Pericardial effusion SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20.1 View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20.1 View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20.1 View
Hyperthyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 20.1 View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 20.1 View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 20.1 View
Dry eye SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 20.1 View
Eye pruritus SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 20.1 View
Eyelid oedema SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 20.1 View
Ocular hyperaemia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 20.1 View
Periorbital oedema SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 20.1 View
Retinopathy SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 20.1 View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 20.1 View
Visual impairment SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 20.1 View
Xerophthalmia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 20.1 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.1 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.1 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.1 View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.1 View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.1 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.1 View
Eructation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.1 View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.1 View
Lip dry SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.1 View
Retching SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.1 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.1 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.1 View
Face oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.1 View
Localised oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.1 View
Mucosal inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.1 View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.1 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.1 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.1 View
Hepatic function abnormal SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 20.1 View
Hepatocellular injury SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 20.1 View
Liver injury SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 20.1 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.1 View
Conjunctivitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.1 View
Hordeolum SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.1 View
Oral candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.1 View
Pneumonia bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.1 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.1 View
Skin bacterial infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.1 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.1 View
Viral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.1 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.1 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.1 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.1 View
Amylase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.1 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.1 View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.1 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.1 View
Blood creatine phosphokinase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.1 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.1 View
Blood lactate dehydrogenase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.1 View
Blood thyroid stimulating hormone decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.1 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20.1 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20.1 View
Hypercalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20.1 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20.1 View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20.1 View
Hyperlipasaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20.1 View
Hyperphosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20.1 View
Hypoalbuminaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20.1 View
Hypocalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20.1 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20.1 View
Hypomagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20.1 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20.1 View
Hypophosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20.1 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20.1 View
Flank pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20.1 View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20.1 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20.1 View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20.1 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20.1 View
Tumour pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 20.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.1 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.1 View
Hemiparesis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.1 View
Hyperaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.1 View
Neuralgia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.1 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20.1 View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20.1 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20.1 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20.1 View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 20.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.1 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.1 View
Dyspnoea exertional SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.1 View
Hiccups SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.1 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.1 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.1 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.1 View