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 @ 11:16 PM
Ignite Modification Date: 2025-12-25 @ 8:55 PM
NCT ID: NCT02084056
Description: None
Frequency Threshold: 5
Time Frame: From the first drug administration for at least 7 days after the last drug administration, up to 47 days.
Study: NCT02084056
Study Brief: Bioequivalence of a FDC Tablet of Linagliptin/Metformin (2.5mg/1000mg) Extended Release in Healthy Subjects.
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
L+M 2000 Fasted 5 mg linagliptin/2000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fasted) orally with 240 mL of water after an overnight fast of at least 10 h. None None 0 56 20 56 View
FDC 2000 Fasted 5 mg linagliptin and 2000 mg metformin XR FDC (given as 2 tablet 2.5 mg linagliptin and 1000 mg metformin XR) orally with 240 mL of water after an overnight fast of at least 10 h. None None 0 58 24 58 View
L+M 2000 Fed 5 mg linagliptin/2000 mg metformin XR given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fed) orally with 240 mL of water after a high-fat, high-calorie meal. None None 0 16 8 16 View
FDC 2000 Fed 5 mg linagliptin and 2000 mg metformin XR FDC (given as 2 tablet 2.5 mg linagliptin and 1000 mg metformin XR) orally with 240 mL of water after a high-fat, high-calorie meal. None None 0 16 5 16 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.0 View
Retching SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.0 View
Discomfort SYSTEMATIC_ASSESSMENT General disorders MedDRA 17.0 View
Influenza like illness SYSTEMATIC_ASSESSMENT General disorders MedDRA 17.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 17.0 View
Muscle tightness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 17.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 17.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 17.0 View
Dysmenorrhoea SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 17.0 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 17.0 View