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: 2025-12-24 @ 5:05 PM
Ignite Modification Date: 2025-12-25 @ 2:44 PM
NCT ID: NCT01117350
Description: The population analyzed was the safety population defined for each of the 2 periods (comparative and extension) as the patients treated with at least one dose of the study treatment during the considered period.
Frequency Threshold: 5
Time Frame: Adverse events were collected throughout the study from the time the patient signed the informed consent until 7 days after the last dose of study treatment.
Study: NCT01117350
Study Brief: Efficacy Assessment of Insulin Glargine Versus LiraglutidE After Oral Agents Failure
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Comparative Period: Insulin Glargine Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days None None 11 484 92 484 View
Comparative Period: Liraglutide Liraglutide dose: 0.6 mg/day during the first week, 1.2 mg/day during the second week and 1.8 mg/day until week 24 (comparative period) None None 15 481 239 481 View
Extension Period: Insulin Glargine Following a treatment with liraglutide during the comparative period, those patients have received insulin glargine during the extension period. Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days None None 5 160 22 160 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Atrioventricular block second degree NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Cardiac arrest NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Faecaloma NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Pancreatitis acute NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Small intestinal obstruction NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Chest pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Cholecystitis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Cellulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Cystitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Diabetic gangrene NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Osteomyelitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Blood glucose increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Breast cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Non-Hodgkin's lymphoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Pancreatic carcinoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Oliguria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Pleurisy NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Endocarditis bacterial NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Intervertebral disc protrusion NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Rotator cuff syndrome NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Prostate cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Thyroid cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Carpal tunnel syndrome NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Cerebrovascular accident NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Ischaemic stroke NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Presyncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Suicidal behaviour NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Chronic obstructive pulmonary disease NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Dyspepsia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Decreased appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View