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: 2025-12-25 @ 3:29 AM
Ignite Modification Date: 2025-12-26 @ 2:10 AM
NCT ID: NCT03268005
Description: All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of randomised treatment.
Frequency Threshold: 5
Time Frame: Week 0 to Week 16 + 7 days. All reported adverse events (AEs) are treatment emergent (i.e., TEAE).
Study: NCT03268005
Study Brief: Research Study Comparing a New Medicine "Fast-acting Insulin Aspart" to Another Already Available Medicine "NovoRapid"/"NovoLog" in People With Type 2 Diabetes
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Faster Aspart Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (\< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion. 2 None 38 544 32 544 View
NovoRapid Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (\< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion. 1 None 40 544 33 544 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Accidental overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21 View
Acute coronary syndrome SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 21 View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21 View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21 View
Angina unstable SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21 View
Aortic aneurysm SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21 View
Aortic valve replacement SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 21 View
Arteriosclerosis coronary artery SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21 View
Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21 View
Bile duct obstruction SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 21 View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21 View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21 View
Cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21 View
Cardiac stress test abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 21 View
Carpal tunnel decompression SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 21 View
Cerebellar infarction SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 21 View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21 View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21 View
Coronary artery disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21 View
Cyclic vomiting syndrome SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21 View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21 View
Delusion SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 21 View
Device malfunction SYSTEMATIC_ASSESSMENT Product Issues MedDRA 21 View
Device related sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21 View
Diabetic neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21 View
Duodenal ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21 View
Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21 View
Fibula fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21 View
Gangrene SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21 View
Gastritis erosive SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21 View
Gastroenteritis viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21 View
Haemorrhagic anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21 View
Haemorrhagic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21 View
Hepatocellular carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21 View
Humerus fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21 View
Hypoglycaemic unconsciousness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21 View
Infective exacerbation of chronic obstructive airways disease SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21 View
Invasive ductal breast carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21 View
Iron deficiency anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21 View
Left ventricular failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21 View
Lower respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21 View
Lumbar spinal stenosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21 View
Lung neoplasm malignant SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21 View
Mitral valve incompetence SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21 View
Myocardial ischaemia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21 View
Obstructive pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21 View
Orchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21 View
Osteomyelitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 21 View
Pancreatic carcinoma metastatic SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21 View
Peripheral vascular disorder SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21 View
Pulmonary oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21 View
Rapid eye movements sleep abnormal SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 21 View
Rehabilitation therapy SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 21 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21 View
Respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21 View
Road traffic accident SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21 View
Small intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21 View
Spinal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21 View
Subclavian vein occlusion SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21 View
Transient ischaemic attack SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21 View
Trigger finger SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21 View
Varicose ulceration SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21 View
Vascular parkinsonism SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21 View
Vitrectomy SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 21 View
Vitreous haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 21 View
Wrong product administered SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21 View
Adenocarcinoma of colon SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21 View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 21 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21 View