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 @ 12:12 PM
Ignite Modification Date: 2025-12-25 @ 12:00 PM
NCT ID: NCT00798161
Description: None
Frequency Threshold: 5
Time Frame: Day of first dose until day of last dose plus 7 days
Study: NCT00798161
Study Brief: Safety and Efficacy of Linagliptin (BI 1356) Plus Metformin in Type 2 Diabetes, Factorial Design
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 Patients treated with matching placebo None None 1 72 20 72 View
M500 BID Patients treated with Metformin 500 mg BID None None 3 144 27 144 View
M1000 BID Patients treated with Metformin 1000 mg bis in die (BID) None None 6 147 27 147 View
Lina 5 Patients treated with Linagliptin 5 mg once daily (OD) None None 3 142 31 142 View
L2.5+M500 BID Patients treated with Linagliptin 2.5 mg + Metformin 500 mg bis in die (BID) None None 2 143 31 143 View
L2.5 + M1000 BID Patients treated with Linagliptin 2.5 mg + Metformin 1000 mg bis in die (BID) None None 2 143 36 143 View
OL: L2.5+M1000 BID Open label set: Linagliptin 2.5 mg + Metformin 1000 mg bis in die (BID) None None 1 66 18 66 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Thrombocytopenia None Blood and lymphatic system disorders None View
Angina pectoris None Cardiac disorders None View
Angina unstable None Cardiac disorders None View
Bradycardia None Cardiac disorders None View
Cardiac failure congestive None Cardiac disorders None View
Left ventricular failure None Cardiac disorders None View
Myocardial infarction None Cardiac disorders None View
Myocardial ischaemia None Cardiac disorders None View
Hyperparathyroidism primary None Endocrine disorders None View
Haemorrhoids None Gastrointestinal disorders None View
Erysipelas None Infections and infestations None View
Malaria None Infections and infestations None View
Plasmodium falciparum infection None Infections and infestations None View
Urinary tract infection None Infections and infestations None View
Femoral neck fracture None Injury, poisoning and procedural complications None View
Femur fracture None Injury, poisoning and procedural complications None View
Hyperglycaemia None Metabolism and nutrition disorders None View
Rotator cuff syndrome None Musculoskeletal and connective tissue disorders None View
Bile duct cancer None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Breast cancer stage III None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Hodgkin's disease None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Haematuria None Renal and urinary disorders None View
Nephrolithiasis None Renal and urinary disorders None View
Renal colic None Renal and urinary disorders None View
Hypertension None Vascular disorders None View
Abortion induced SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 13.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Glomerular filtration rate decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View