Participants were not provided with study medication in the OFU. At the end of the main study, all study medication was stopped. The OFU was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Number of Participants With a Bone Fracture Event - Overall and by Gender: Main Study and Observational Follow-up Combined.Number of Participants Who Died Due to the Indicated Cancer-related Event: Observational Follow-up.Number of Participants Who Died Due to the Indicated Cancer-related Event: Main Study + Observational Follow-up Combined.Number of Participants With the Indicated Type of Malignant Neoplasms/Cancer Events Reported as an SAE or Death by Location (Including Location of Special Interest): Observational Follow-up.In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE. An SAE is defined as any event that is fatal life threatening disabling/incapacitating results in hospitalization (excluding elective surgery or routine clinical procedures) prolongs a hospital stay is associated with a congenital abnormality cancer is associated with an overdose. The neoplasms/cancer events of bladder, breast, colon, liver, pancreatic, prostate cancer, and melanoma were pre-specified as cancers of interest for the OFU. The observational follow-up (OFU) was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study.
Number of Participants With the Indicated Type of Malignant Neoplasms/Cancer Events Reported as an SAE or Death by Location (Including Location of Special Interest): Main Study + Observational Follow-up Combined.Number of Participants With the Indicated Type of Neoplasm/Cancer Event Reported as a Serious Adverse Event (SAE) or Death: Observational Follow-up.Participants were not provided with study medication in the observational follow-up instead, anti-diabetic treatment was prescribed at the investigator's discretion. The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Why Should I Register and Submit Results?.
0 kommentar(er)
