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 @ 6:32 PM
Ignite Modification Date: 2025-12-25 @ 4:02 PM
NCT ID: NCT00727857
Description: One participant was randomized to Metformin 850 mg but inadvertently received Pioglitazone 15 mg. Analyses performed on Efficacy Variables were based on Randomized Treatment; analyses on Safety Variables were based on Actual Treatment Received.
Frequency Threshold: 3
Time Frame: Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication and on or prior to 14 days after the permanent discontinuation of the double-blind study medication.
Study: NCT00727857
Study Brief: Efficacy and Safety of Pioglitazone and Metformin Combination Therapy in Treating Type 2 Diabetes Mellitus.
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Metformin 850 mg BID Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks. None None 5 209 95 209 View
Pioglitazone 15 mg/Metformin 850 mg BID Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks None None 2 201 84 201 View
Pioglitazone 15 mg BID Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks None None 3 190 61 190 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Leukocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.0 View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Diverticulum intestinal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Cholecystitis chronic SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 11.0 View
Diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.0 View
Hypoglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.0 View
Endometriosis SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 11.0 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Oedema Peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Glycosylated haemoglobin SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.0 View