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: 2025-12-25 @ 4:58 AM
Ignite Modification Date: 2025-12-26 @ 3:58 AM
NCT ID: NCT02930018
Description: All Adverse Events (Serious and Non-Serious) were monitored for the Safety Population, which included all subjects who received any amount of study drug (total of 1101 subjects). Adverse Events of Special Interest (AESI) were also collected, and included any Adverse Event which occurred within 2 hours of end of drug infusion and which fall under the standardized MedDRA queries of "Angioedema", "Anaphylactic reaction", "Anaphylactic shock" and terms relating to "hypotension".
Frequency Threshold: 5
Time Frame: Adverse Events occurring within 30 days of randomization and all Serious Adverse Events up to the end of study visit (Day 90 visit or death) or until the subject was deemed "lost to follow-up" were reported.
Study: NCT02930018
Study Brief: Safety and Efficacy of Nerinetide (NA-1) in Subjects Undergoing Endovascular Thrombectomy for Stroke
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Drug vehicle only Placebo: Placebo Comparator: Placebo 74 None 198 554 472 554 View
Nerinetide, 2.6 mg/kg Single intravenous infusion of nerinetide over 10 ± 1 minutes 64 None 181 547 474 547 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 20.0 View
Thrombocytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 20.0 View
Acute coronary syndrome NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20.0 View
Angina pectoris NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20.0 View
Arrhythmia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20.0 View
Atrial fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20.0 View
Atrial flutter NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20.0 View
Atrial tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20.0 View
Atrioventricular block NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20.0 View
Bradycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20.0 View
Cardiac arrest NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20.0 View
Cardiac failure congestive NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20.0 View
Cardiac ventricular thrombosis NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20.0 View
Cardiogenic shock NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20.0 View
Intracardiac thrombus NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20.0 View
Mitral valve stenosis NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20.0 View
Myocardial infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20.0 View
Sinus arrest NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20.0 View
Stress cardiomyopathy NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20.0 View
Supraventricular tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20.0 View
Ventricular tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20.0 View
Atrial septal defect NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 20.0 View
Hyperparathyroidism NON_SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 20.0 View
Retinal artery occlusion NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 20.0 View
Retinal detachment NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 20.0 View
Visual impairment NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 20.0 View
Abdominal distension NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Ascites NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Colitis ischaemic NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Dysphagia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Gastric ulcer haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Gastrointestinal haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Intestinal ischaemia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Melaena NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Mouth haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Oesophagitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Pancreatitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Peritoneal haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Complication associated with device NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.0 View
Drug withdrawal syndrome NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.0 View
Non-cardiac chest pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.0 View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.0 View
Vascular stent occlusion NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.0 View
Vessel puncture site haematoma NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.0 View
Vessel puncture site haemorrhage NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.0 View
Vessel puncture site occlusion NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.0 View
Cholangitis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 20.0 View
Cholecystitis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 20.0 View
Drug-induced liver injury NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 20.0 View
Portal vein thrombosis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 20.0 View
Bacteraemia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Cardiac valve abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Cardiac valve vegetation NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Cellulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Empyema NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Endocarditis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Osteomyelitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Pneumonia bacterial NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Septic shock NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Stoma site abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Urosepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Abdominal wound dehiscence NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.0 View
Cerebral hyperperfusion syndrome NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.0 View
Coronary artery restenosis NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.0 View
Endotracheal intubation complication NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.0 View
Facial bones fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.0 View
Fall NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.0 View
Femoral neck fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.0 View
Femur fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.0 View
Gastrostomy tube site complication NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.0 View
Humerus fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.0 View
Reocclusion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.0 View
Rib fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.0 View
Subarachnoid haemorrhage NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.0 View
Subdural haemorrhage NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.0 View
Traumatic intracranial haemorrhage NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.0 View
Vascular access site pseudoaneurysm NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.0 View
Vascular procedure complication NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.0 View
Hepatic enzyme abnormal NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.0 View
Troponin increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.0 View
White blood cell count decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.0 View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20.0 View
Hyperkalaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20.0 View
Muscular weakness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20.0 View
Bronchial carcinoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 20.0 View
Cervix cancer metastatic NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 20.0 View
Gastric cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 20.0 View
Metastasis NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 20.0 View
Myeloid leukaemia NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 20.0 View
Non-small cell lung cancer metastatic NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 20.0 View
Pancreatic carcinoma metastatic NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 20.0 View
Plasma cell myeloma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 20.0 View
Prostate cancer metastatic NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 20.0 View
Renal cell carcinoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 20.0 View
Small intestine adenocarcinoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 20.0 View
Brain oedema NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Carotid arteriosclerosis NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Carotid artery stenosis NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Cerebral haemorrhage NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Encephalopathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Epilepsy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Haemorrhage intracranial NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Haemorrhagic stroke NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Haemorrhagic transformation stroke NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Ischaemic stroke NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Lacunar stroke NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Neurological decompensation NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Presyncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Seizure NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Status epilepticus NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Stroke in evolution NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Syncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Transient ischaemic attack NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Vascular dementia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Alcohol withdrawal syndrome NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20.0 View
Delirium NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20.0 View
Mental status changes NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20.0 View
Post stroke depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20.0 View
Suicidal ideation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20.0 View
Acute kidney injury NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 20.0 View
Azotaemia NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 20.0 View
Calculus urinary NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 20.0 View
Haematuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 20.0 View
Prostatomegaly NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 20.0 View
Aspiration NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.0 View
Choking NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.0 View
Dyspnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.0 View
Epistaxis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.0 View
Haemothorax NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.0 View
Hypoxia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.0 View
Obstructive airways disorder NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.0 View
Pleural effusion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.0 View
Pneumonia aspiration NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.0 View
Pulmonary embolism NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.0 View
Pulmonary oedema NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.0 View
Respiratory distress NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.0 View
Respiratory failure NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.0 View
Angioedema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 20.0 View
Loss of personal independence in daily activities NON_SYSTEMATIC_ASSESSMENT Social circumstances MedDRA 20.0 View
Left atrial appendage occlusion NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 20.0 View
Arteriosclerosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 20.0 View
Brachiocephalic vein thrombosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 20.0 View
Deep vein thrombosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 20.0 View
Haematoma NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 20.0 View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 20.0 View
Hypertensive crisis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 20.0 View
Hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 20.0 View
Peripheral artery aneurysm NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 20.0 View
Peripheral artery occlusion NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 20.0 View
Peripheral artery thrombosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 20.0 View
Peripheral ischaemia NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 20.0 View
Varicose vein NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 20.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Hemorrhagic Transformation Stroke NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 20.0 View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Vascular procedure complication NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.0 View
Atrial fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20.0 View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.0 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Pneumonia aspiration NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.0 View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 20.0 View
Hypokalaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20.0 View
Vessel puncture site hematoma NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.0 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Bradycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20.0 View
Stroke In Evolution NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View