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 @ 2:02 AM
Ignite Modification Date: 2025-12-26 @ 12:26 AM
NCT ID: NCT01483560
Description: Definition used same as clinical trials.gov
Frequency Threshold: 0
Time Frame: Adverse event data collected from the date of consent until 30 days post last IMP dose, an average of 3 years.
Study: NCT01483560
Study Brief: REducing With MetfOrmin Vascular Adverse Lesions in Type 1 Diabetes (REMOVAL)
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 Placebo: 3 years duration 209 of the 428 randomised were assigned to Placebo 2 None 31 209 52 209 View
Metformin Oral Metformin (as Glucophage 500mg x 2 bd) titrated from initial 500mg to target 2000mg daily Metformin: 3 years treatment duration 219 of 428 randomised were assigned to Metformin Group 5 None 34 219 112 219 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Metabolic and nutrition SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Infections and Infestations SYSTEMATIC_ASSESSMENT Infections and infestations None View
Neoplasms SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Cerebral haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Gastrointestinal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Respiratory SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cardiac SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Coronary artery bypass graft SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Musculoskeletal SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Sudden Death SYSTEMATIC_ASSESSMENT General disorders None View
Angiogram SYSTEMATIC_ASSESSMENT Investigations None View
Circulatory collapse SYSTEMATIC_ASSESSMENT Vascular disorders None View
Blood and Lymphatic SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Immune System Disorder SYSTEMATIC_ASSESSMENT Immune system disorders None View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders None View
hypoglycaemic coma SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Transient Ischaemic Attack SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
lung lobectomy SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
coronary stent insertion SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Amputation revision SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Surgery (unspecified) SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Coronary angioplasty SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Spinal fusion Surgery SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Aortic valve repair SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Chest Pain SYSTEMATIC_ASSESSMENT General disorders None View
Blood Glucose Fluctuation SYSTEMATIC_ASSESSMENT Investigations None View
Ischaemic Necrosis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Peripheral Ischaemia SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Gastrointestinal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Cardiovascular SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Neurological SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hypersensitivity to Metformin SYSTEMATIC_ASSESSMENT Product Issues None View
Opthalmic adverse events SYSTEMATIC_ASSESSMENT Eye disorders None View