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 @ 3:55 AM
Ignite Modification Date: 2025-12-26 @ 2:46 AM
NCT ID: NCT01087502
Description: None
Frequency Threshold: 5
Time Frame: 52 weeks
Study: NCT01087502
Study Brief: Safety and Efficacy of Linagliptin in Type-2-diabetes Mellitus Patients With Moderate to Severe Renal Impairment
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/Glimepiride Patients randomized to receive treatment with matching placebo for 12 weeks and then switch to glimepiride for further 40 weeks. None None 36 122 110 122 View
Linagliptin 5 mg Patients randomized to receive treatment with Linagliptin 5mg None None 28 113 95 113 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pneumonia None Infections and infestations MedDRA 15.0 View
Cellulitis None Infections and infestations MedDRA 15.0 View
Gastroenteritis None Infections and infestations MedDRA 15.0 View
Sepsis None Infections and infestations MedDRA 15.0 View
Acarodermatitis None Infections and infestations MedDRA 15.0 View
Gas gangrene None Infections and infestations MedDRA 15.0 View
Labyrinthitis None Infections and infestations MedDRA 15.0 View
Localised infection None Infections and infestations MedDRA 15.0 View
Osteomyelitis None Infections and infestations MedDRA 15.0 View
Device related infection None Infections and infestations MedDRA 15.0 View
Endocarditis enterococcal None Infections and infestations MedDRA 15.0 View
Lymphangitis None Infections and infestations MedDRA 15.0 View
Otitis externa None Infections and infestations MedDRA 15.0 View
Urinary tract infection None Infections and infestations MedDRA 15.0 View
Viral infection None Infections and infestations MedDRA 15.0 View
Small cell lung cancer metastatic None Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.0 View
Basal cell carcinoma None Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.0 View
Tongue neoplasm malignant stage unspecified None Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.0 View
Anaemia None Blood and lymphatic system disorders MedDRA 15.0 View
Hypoglycaemia None Metabolism and nutrition disorders MedDRA 15.0 View
Fluid retention None Metabolism and nutrition disorders MedDRA 15.0 View
Dehydration None Metabolism and nutrition disorders MedDRA 15.0 View
Fluid overload None Metabolism and nutrition disorders MedDRA 15.0 View
Hyperkalaemia None Metabolism and nutrition disorders MedDRA 15.0 View
Hyperglycaemia None Metabolism and nutrition disorders MedDRA 15.0 View
Panic attack None Psychiatric disorders MedDRA 15.0 View
Cerebral infarction None Nervous system disorders MedDRA 15.0 View
Cerebrovascular accident None Nervous system disorders MedDRA 15.0 View
Dizziness None Nervous system disorders MedDRA 15.0 View
Paraesthesia None Nervous system disorders MedDRA 15.0 View
Syncope None Nervous system disorders MedDRA 15.0 View
Brachial plexopathy None Nervous system disorders MedDRA 15.0 View
Retinal haemorrhage None Eye disorders MedDRA 15.0 View
Amaurosis fugax None Eye disorders MedDRA 15.0 View
Ear pain None Ear and labyrinth disorders MedDRA 15.0 View
Cardiac failure congestive None Cardiac disorders MedDRA 15.0 View
Acute myocardial infarction None Cardiac disorders MedDRA 15.0 View
Angina pectoris None Cardiac disorders MedDRA 15.0 View
Angina unstable None Cardiac disorders MedDRA 15.0 View
Atrial fibrillation None Cardiac disorders MedDRA 15.0 View
Bradycardia None Cardiac disorders MedDRA 15.0 View
Diastolic dysfunction None Cardiac disorders MedDRA 15.0 View
Palpitations None Cardiac disorders MedDRA 15.0 View
Myocardial infarction None Cardiac disorders MedDRA 15.0 View
Ventricular extrasystoles None Cardiac disorders MedDRA 15.0 View
Hypertension None Vascular disorders MedDRA 15.0 View
Orthostatic hypotension None Vascular disorders MedDRA 15.0 View
Peripheral ischaemia None Vascular disorders MedDRA 15.0 View
Deep vein thrombosis None Vascular disorders MedDRA 15.0 View
Dyspnoea None Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Acute respiratory failure None Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Pulmonary hypertension None Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Chronic obstructive pulmonary disease None Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Pulmonary embolism None Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Respiratory failure None Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Abdominal pain None Gastrointestinal disorders MedDRA 15.0 View
Diarrhoea None Gastrointestinal disorders MedDRA 15.0 View
Inguinal hernia None Gastrointestinal disorders MedDRA 15.0 View
Vomiting None Gastrointestinal disorders MedDRA 15.0 View
Flatulence None Gastrointestinal disorders MedDRA 15.0 View
Gastrointestinal angiodysplasia None Gastrointestinal disorders MedDRA 15.0 View
Bile duct stenosis None Hepatobiliary disorders MedDRA 15.0 View
Diabetic ulcer None Skin and subcutaneous tissue disorders MedDRA 15.0 View
Skin ulcer None Skin and subcutaneous tissue disorders MedDRA 15.0 View
Arthritis None Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Bursitis None Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Compartment syndrome None Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Rhabdomyolysis None Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Renal failure acute None Renal and urinary disorders MedDRA 15.0 View
Nephrotic syndrome None Renal and urinary disorders MedDRA 15.0 View
Renal failure chronic None Renal and urinary disorders MedDRA 15.0 View
Renal impairment None Renal and urinary disorders MedDRA 15.0 View
Nephropathy toxic None Renal and urinary disorders MedDRA 15.0 View
Chest pain None General disorders MedDRA 15.0 View
Oedema peripheral None General disorders MedDRA 15.0 View
Fatigue None General disorders MedDRA 15.0 View
Liver function test abnormal None Investigations MedDRA 15.0 View
Fall None Injury, poisoning and procedural complications MedDRA 15.0 View
Post procedural haemorrhage None Injury, poisoning and procedural complications MedDRA 15.0 View
Bladder neoplasm None Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.0 View
Bladder transitional cell carcinoma None Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.0 View
Colon cancer None Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.0 View
Prostate cancer None Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.0 View
Pulmonary oedema None Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fall None Injury, poisoning and procedural complications MedDRA 15.0 View
Upper respiratory tract infection None Infections and infestations MedDRA 15.0 View
Urinary tract infection None Infections and infestations MedDRA 15.0 View
Bronchitis None Infections and infestations MedDRA 15.0 View
Influenza None Infections and infestations MedDRA 15.0 View
Hypoglycaemia None Metabolism and nutrition disorders MedDRA 15.0 View
Hyperglycaemia None Metabolism and nutrition disorders MedDRA 15.0 View
Hyperkalaemia None Metabolism and nutrition disorders MedDRA 15.0 View
Headache None Nervous system disorders MedDRA 15.0 View
Dizziness None Nervous system disorders MedDRA 15.0 View
Hypertension None Vascular disorders MedDRA 15.0 View
Cough None Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Constipation None Gastrointestinal disorders MedDRA 15.0 View
Diarrhoea None Gastrointestinal disorders MedDRA 15.0 View
Vomiting None Gastrointestinal disorders MedDRA 15.0 View
Pruritus None Skin and subcutaneous tissue disorders MedDRA 15.0 View
Back pain None Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Pain in extremity None Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Oedema peripheral None General disorders MedDRA 15.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View