RECORD: Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes
Official Title
A Long Term, Open Label, Randomised Study in Patients With Type 2 Diabetes, Comparing the Combination of Rosiglitazone and Either Metformin or Sulfonylurea With Metformin Plus Sulfonylurea on Cardiovascular Endpoints and Glycaemia
Acronym
RECORD
Organization
GlaxoSmithKlineINDUSTRY
Status Module
Record Verification Date
Mar 2017
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Apr 2001
Primary Completion Date
Dec 2008Actual
Completion Date
Dec 2008Actual
First Submitted Date
Sep 21, 2006
First Submission Date that Met QC Criteria
Sep 21, 2006
First Posted Date
Sep 22, 2006Estimated
Results Waived
Not provided
Results First Submitted Date
Aug 24, 2009
Results First Submitted that Met QC Criteria
Oct 7, 2009
Results First Posted Date
Nov 13, 2009Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Mar 21, 2017
Last Update Posted Date
Mar 23, 2017Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
GlaxoSmithKlineINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This study is a phase 3b, multicentre, randomised, open label, parallel group study. A 4-week run-in period will be followed by a median of 6 years of treatment with study medication in addition to continuation of background glucose lowering therapy. Patients inadequately controlled on background metformin will be randomised to receive, in addition to metformin, either rosiglitazone or a sulfonylurea(glibenclamide, gliclazide or glimepiride) in a ratio of 1:1. Patients inadequately controlled on background SU will be randomised to receive, in addition to SU, either rosiglitazone or metformin in a ratio of 1:1. Equal numbers of patients receiving background metformin and SU at entry will be entered into the study.
Detailed Description
A RECORD follow-up study is being performed to monitor the incidence of cancer and bone fractures in RECORD patients for a period of 4 years after the end of the main RECORD study (2008 - 2012).
Conditions Module
Conditions
Diabetes Mellitus, Type 2
Keywords
diabetes
CV outcomes
rosiglitazone
Type II diabetes
sulfonylurea
RECORD
metformin
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
4,447Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
rosiglitazone in addition to background metformin
Experimental
Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Drug: Rosiglitazone
Drug: Metformin
rosiglitazone in addition to background sulfonylurea
Experimental
Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Drug: Rosiglitazone
Drug: Sulfonylurea
Sulfonylurea in addition to background metformin
Active Comparator
Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or miconizied equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Drug: Sulfonylurea
Drug: Metformin
Metformin in addition to background sulfonylurea
Active Comparator
Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Rosiglitazone
Drug
Rosiglitazone maximum 8 mg per day
rosiglitazone in addition to background metformin
rosiglitazone in addition to background sulfonylurea
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Cardiovascular Death/Cardiovascular Hospitalisation Events
The number of participants with cardiovascular death events (death due to cardiovascular causes or deaths with insufficient information to rule out a cardiovascular cause) and cardiovascular hospitalisation events (hospitalisation for a cardiovascular event, excluding planned admissions not associated with a worsening of the disease/condition of the participant) was recorded.
Baseline through End of Study (up to 7.5 years)
Independent Re-adjudication Outcome: Number of Participants Who Died Due to Any Cause
All deaths identified during the original record study and discovered after the re-adjudication efforts began were included.
Baseline through End of Study (up to 7.5 years)
Independent Re-adjudication (IR) Outcome: Number of Participants With a First Occurrence of a Major Adverse Cardiovascular Event (MACE) Defined as CV (or Unknown) Death, Non-fatal MI, and Non-fatal Stroke Based on Original RECORD Endpoint Definitions
IR was based on original RECORD endpoint definitions. CV death= no unequivocal non-CV cause (sudden death, death from acute vascular events, heart failure, acute MI, other CV causes, and deaths adjudicated as unknown cause). MI event=hospitalization + elevation of specific cardiac biomarkers above the upper limit of normal + cardiac ischemia symptoms/new pathological electrocardiogram findings. Stroke event=hospitalization + rapidly developed clinical signs of focal/global disturbance of cerebral function for more than 24 hours, with no apparent cause other than a vascular origin.
Baseline through End of Study (up to 7.5 years)
Independent Re-adjudication Outcome: Number of Participants With a First Occurrence of a Major Adverse Cardiovascular Event (MACE) Defined as CV (or Unknown) Death, Non-fatal MI, and Non-fatal Stroke Based on Contemporary Endpoint Definitions
Independent re-adjudication was based on the Standard Data Collection for Cardiovascular Trials Initiative (draft October 2011) endpoint definitions. CV death included death resulting from an acute MI; sudden cardiac death and death due to heart failure, stroke, and to other CV causes. Deaths of unknown cause were counted as CV deaths. MI was defined as evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Stroke was defined as an acute episode of neurological dysfunction caused by focal or global brain, spinal cord, or retinal vascular injury.
Secondary Outcomes
Measure
Description
Time Frame
Number of Participants With Cardiovascular Events and All-cause Deaths
Composites of participants with first cardiovascular (CV) hospitalisations and CV death or all-cause death and individual first events of acute myocardial infarction (MI) , stroke, congestive heart failure (CHF), CV death, and all-cause death.
Baseline through End of Study (up to 7.5 years)
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Patients with type II diabetes mellitus as defined by 1999 World Health Organisation criteria.
Glycated haemoglobin (HbA1c) >7.0 % to = 9.0 % at visit 1.
Use of an oral glucose lowering agent for a minimum of 6 months prior to screening and unchanged for 2 months prior to screening.
Body mass index >25.0 kg/m2.
Exclusion Criteria:
Patients receiving any other glucose lowering therapy which is not metformin or a sulfonylurea.
Patients with systolic blood pressure >180 mmHg or diastolic blood pressure >105 mmHg.
Patients who have required the use of insulin for glycaemic control at any time in the past.
Hospitalisation for any major cardiovascular event in the last 3 months.
Home PD, Jones NP, Pocock SJ, Beck-Nielsen H, Gomis R, Hanefeld M, Komajda M, Curtis P; RECORD Study Group. Rosiglitazone RECORD study: glucose control outcomes at 18 months. Diabet Med. 2007 Jun;24(6):626-34. doi: 10.1111/j.1464-5491.2007.02160.x.
Home PD, Pocock SJ, Beck-Nielsen H, Gomis R, Hanefeld M, Dargie H, Komajda M, Gubb J, Biswas N, Jones NP. Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes (RECORD): study design and protocol. Diabetologia. 2005 Sep;48(9):1726-35. doi: 10.1007/s00125-005-1869-1. Epub 2005 Jul 16.
See Also Links
Label
URL
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
The RECORD observational follow-up (OFU) started at the end of the RECORD study and ran through December 2012. OFU was designed to collect cancer and bone fracture data. Participants were not provided with study medication in the OFU. Data are presented for the entire study (RECORD + OBF) and for OFU alone in the observational OMs.
Recruitment Details
The RECORD study ran from April 2001 through December 2008. Results are presented in the non-re-adjudicated outcome measures (OMs). An independent patient-level re-adjudication of mortality, non-fatal myocardial infarction, and non-fatal stroke began on January 2011 and ran through March 2012. The results are presented in the re-adjudicated OMs.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
RSG in Addition to Background MET
Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Periods
Title
Milestones
Reasons Not Completed
Main Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Drug: Sulfonylurea
Drug: Metformin
Sulfonylurea
Drug
Sulfonylurea (SU) maximum permitted daily dose
Metformin in addition to background sulfonylurea
Sulfonylurea in addition to background metformin
rosiglitazone in addition to background sulfonylurea
Metformin
Drug
Metformin maximum permitted daily dose .
Metformin in addition to background sulfonylurea
Sulfonylurea in addition to background metformin
rosiglitazone in addition to background metformin
Baseline through End of Study (up to 7.5 years)
Independent Re-adjudication Outcome: Number of Participants With a CV (or Unknown) Death, Based on Original RECORD Endpoint Definitions
The number of participants with a CV death (or unknown) as determined by independent re-adjudication using the original RECORD endpoint definitions was recorded. CV death was defined as any death for which an unequivocal non-CV cause could not be established. CV death included death following heart failure, death following acute myocardial infarction (MI), sudden death, death due to acute vascular events, and other CV causes. Deaths due to unknown causes were classified as "unknown deaths," but were counted as CV deaths for the analysis of this endpoint.
Baseline through End of Study (up to 7.5 years)
Independent Re-adjudication Outcome: Number of Participants With a CV (or Unknown) Death, Based on Contemporary Endpoint Definitions
The number of participants with a CV (or unknown) death as determined by independent re-adjudication using the Standard Data Collection for Cardiovascular Trials Initiative (draft October 2011) endpoint definitions was recorded. CV death included death resulting from an acute myocardial infarction (MI), sudden cardiac death, death due to heart failure, death due to stroke, and death due to other CV causes. Deaths of unknown cause were counted as CV deaths.
Baseline through End of Study (up to 7.5 years)
Independent Re-adjudication Outcome: Number of Participants With an Event of Myocardial Infarction (Fatal and Non-fatal), Based on Original RECORD Endpoint Definitions
The number of participants with an MI (fatal or non-fatal) event as determined by independent re-adjudication using the original RECORD endpoint definitions was recorded. An event of MI was defined as hospitalization plus elevation of cardiac biomarkers troponin (TN) I and/or TNT above the upper limit of normal (ULN) or creatinine kinase (CK) MB (M=muscle type; B=brain type) isoenzyme >= 2x the ULN or CK > 2x the ULN plus typical symptoms of cardiac ischemia or new pathological electrocardiogram findings, or cause of death adjudicated as MI.
Baseline through End of Study (up to 7.5 years)
Independent Re-adjudication Outcome: Number of Participants With an Event of Myocardial Infarction (Fatal and Non-fatal), Based on Contemporary Endpoint Definitions
The number of participants with an MI (fatal or non-fatal) event as determined by independent re-adjudication using the Standard Data Collection for Cardiovascular Trials Initiative (draft October 2011) endpoint definitions was recorded. An event of MI was defined as evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia.
Baseline through End of Study (up to 7.5 years)
Independent Re-adjudication Outcome: Number of Participants (Par.) With an Event of Stroke (Fatal and Non-fatal), Based on Original RECORD Endpoint Definitions
Par. with a stroke (fatal or non-fatal) event as determined by independent re-adjudication using the original RECORD endpoint definitions was recorded. A stroke event=hospitalization plus rapidly developed clinical signs of focal (or global) disturbance of cerebral function lasting more than 24 hours (unless interrupted by thrombolysis, surgery, or death), with no apparent cause other than a vascular origin, including par. presenting clinical signs/symptoms suggestive of subarachnoid haemorrhage/intracerebral haemorrhage/cerebral ischemic necrosis or cause of death adjudicated as stroke.
Baseline through End of Study (up to 7.5 years)
Independent Re-adjudication Outcome: Number of Participants With an Event of Stroke (Fatal and Non-fatal), Based on Contemporary Endpoint Definitions
The number of participants with a stroke (fatal or non-fatal) event as determined by independent re-adjudication using the Standard Data Collection for Cardiovascular Trials Initiative (draft October 2011) endpoint definitions was recorded. An event of stroke was defined as an acute episode of neurological dysfunction caused by focal or global brain, spinal cord, or retinal vascular injury.
Baseline through End of Study (up to 7.5 years)
Total Number of Cardiovascular Hospitalisations and Cardiovascular Deaths
The total number of events for individual components of cardiovascular (CV) hospitalisations and cardiovascular deaths were recorded. MI, myocardial infarction.
Baseline through End of Study (up to 7.5 years)
Number of Participants With First Cardiovascular Hospitalisations/Cardiovascular Deaths by Stratum
Participants with first cardiovascular death (death due to cardiovascular causes or deaths with insufficient information to rule out a cardiovascular cause) and cardiovascular hospitalisation (hospitalisation for a cardiovascular event, excluding planned admissions not associated with a worsening of the disease/condition of the participant) were recorded by study stratum.
Baseline through End of Study (up to 7.5 years)
Number of Participants With CV/Microvascular Events
The number of participants with first cardiovascular or microvascular events (renal, foot, eye) were recorded.
Baseline through End of Study (up to 7.5 years)
Number of Participants With Glycaemic Failure Events
Failure of glycaemic control was defined as two consecutive HbA1c values of ≥8.5 percent, or HbA1c ≥8.5percent at a single visit, after which the subject was either moved to the post-randomised treatment phase or triple therapy was started.
Baseline through to end of randomised dual therapy
Number of Participants With Addition of Third Oral Agent/Switch to Insulin
The number of participants with addition of a third oral agent or switch to insulin from randomised dual combination treatment were recorded.
Baseline through End of Study (up to 7.5 years)
The Number of Participants Starting Insulin at Any Time During the Study
The number of participants starting insulin at any time during the study was recorded.
Baseline through End of Study (up to 7.5 years)
Model Adjusted Change From Baseline in HbA1c at Month 60
Model adjusted (adjusted for any imbalances in the baseline values between within stratum treatment groups) change from baseline in HbA1c was calculated as the value at Month 60 minus the Baseline value.
Baseline and Month 60 of randomised dual therapy treatment period
Model Adjusted Change From Baseline in Fasting Plasma Glucose at Month 60
Model adjusted (adjusted for any imbalances in the baseline values between within stratum treatment groups) change from baseline in fasting plasma glucose was calculated as the value at Month 60 minus the Baseline value.
Baseline to Month 60 of the randomised dual therapy treatment period
Model Adjusted Mean Change From Baseline in Insulin and Pro-insulin at Month 60
Model adjusted (adjusted for any imbalances in the baseline values between within stratum treatment groups) change from baseline in insulin and pro-insulin was calculated as the value at Month 60 minus the Baseline value.
Baseline to Month 60 of the randomised dual therapy treatment period
Number of HbA1c and Fasting Plasma Glucose (FPG) Responders at Month 60
Number of responders, i.e., participants meeting glycaemic targets (HbA1c less than or equal to 7 percent, FPG less than or equal to 7 mmol/L)
Baseline to Month 60 of the randomised dual therapy treatment period
Model Adjusted Ratio to Baseline (Expressed as a Percentage) Homeostasis Model Assessment (HOMA) Beta Cell Function and Insulin Sensitivity at Month 60
The model adjusted (adjusted for any imbalances in the baseline [BL] values between within stratum treatment groups) ratio to BL in HOMA beta-cell function and insulin sensitivity was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100*[GM^-1]).
Baseline to Month 60 of the randomised dual therapy treatment phase
Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Total Cholesterol (TC), Low-density Lipoprotein (LDL) Cholesterol, High-density Lipoprotein (HDL) Cholesterol, Triglycerides, and Free Fatty Acids (FFAs) at Month 60
The model adjusted (adjusted for any imbalances in the baseline [BL] values between within stratum treatment groups) ratio to BL in TC, LDL cholesterol, HDL cholesterol, triglycerides, and FFAs was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100*[GM^-1]).
Baseline to Month 60 of the randomised dual therapy treatment phase
Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Total Cholesterol (TC):High-density Lipoprotein (HDL) Cholesterol and Low-density Lipoprotein (LDL) Cholesterol:HDL Cholesterol Ratios at Month 60
The model adjusted (adjusted for any imbalances in the baseline [BL] values between within stratum treatment groups) ratio to BL in TC:HDL cholesterol and LDL cholesterol:HDL cholesterol was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100*[GM^-1]).
Baseline to Month 60 of the randomised dual therapy treatment period
Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Apolipoprotein B (Apo-B) at Month 60
The model adjusted (adjusted for any imbalances in the baseline [BL] values between within stratum treatment groups) ratio to BL in Apo-B was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100*[GM^-1]).
Baseline to Month 60 of the randomised dual therapy treatment period
Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Urinary Albumin Creatinine Ratio at Month 60
The model adjusted (adjusted for any imbalances in the baseline [BL] values between within stratum treatment groups) ratio to BL in urinary albumin creatinine ratio was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100*[GM^-1]).
Baseline to Month 60 of the randomised dual therapy treatment phase
Model Adjusted Change From Baseline in Body Weight at Month 60
Model adjusted (adjusted for any imbalances in the baseline values between within stratum treatment groups) change from baseline in body weight was calculated as the value at Month 60 minus the Baseline value.
Baseline to Month 60 of the randomised dual therapy treatment phase
Model Adjusted Change From Baseline in Alanine Aminotransferase at Month 60
Model adjusted (adjusted for any imbalances in the baseline values between within stratum treatment groups) change from baseline in alanine aminotransferase was calculated as the value at Month 60 minus the Baseline value.
Baseline to Month 60 of the randomised dual therapy treatment phase
Model Adjusted Change From Baseline in Waist Circumference at Month 60
Model adjusted (adjusted for any imbalances in the baseline values between within stratum treatment groups) change from baseline in waist circumference was calculated as the value at Month 60 minus the Baseline value.
Baseline to Month 60 of the randomised dual therapy treatment phase
Model Adjusted Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Month 60
Model adjusted (adjusted for any imbalances in the baseline values between within treatment groups) change from baseline in SBP and DBP was calculated as the value at Month 60 minus the Baseline value.
Baseline to Month 60 of the randomised dual therapy treatment phase
Model Adjusted Ratio to Baseline (Expressed as a Percentage) for C-Reactive Protein at Month 60
The model adjusted (adjusted for any imbalances in the baseline [BL] values between within stratum treatment groups) ratio to BL in C-Reactive Protein was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100*[GM^-1]).
Baseline to Month 60 of the randomised dual therapy treatment phase
Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Fibrinogen at Month 60
The model adjusted (adjusted for any imbalances in the baseline [BL] values between within stratum treatment groups) ratio to BL in fibrinogen was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100*[GM^-1]).
Baseline to Month 60 of the randomised dual therapy treatment phase
Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Plasminogen Activator Inhibitor-1 (PAI-1) Antigen at Month 60
The model adjusted (adjusted for any imbalances in the baseline [BL] values between within stratum treatment groups) ratio to BL in plasminogen activator inhibitor-1 (PAI-1) antigen was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100*[GM^-1]).
Baseline to Month 60 of the randomised dual therapy treatment phase
Number of Participants With the Indicated Type of Neoplasm/Cancer Event Reported as a Serious Adverse Event (SAE) or Death: Main Study + Observational Follow-up Combined
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. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. 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. 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.
From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
Number of Participants With the Indicated Type of Neoplasm/Cancer Event Reported as a Serious Adverse Event (SAE) or Death: Observational Follow-up
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. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. 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. 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.
From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)
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
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. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the OFU. The neoplasms/cancer events of bladder, breast, colon, liver, pancreatic, prostate cancer, and melanoma were pre-specified as cancers of interest for the OFU. 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. 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.
From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
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
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. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the OFU. The neoplasms/cancer events of bladder, breast, colon, liver, pancreatic, prostate cancer, and melanoma were pre-specified as cancers of interest for the OFU. 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. 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.
From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)
Number of Participants Who Died Due to the Indicated Cancer-related Event: Main Study + Observational Follow-up Combined
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. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. 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. 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.
From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
Number of Participants Who Died Due to the Indicated Cancer-related Event: Observational Follow-up
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. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. 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. 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.
From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)
Number of Participants With a Bone Fracture Event - Overall and by Gender: Main Study and Observational Follow-up Combined
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. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant.
From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
Number of Participants With a Bone Fracture Event - Overall and by Gender: Observational Follow-up
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. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant.
From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)
Number of Participants With a Bone Fracture Event Reported as the Indicated Serious Adverse Event (by Higher Level Group Term) or Death: Main Study + Observational Follow-up Combined
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. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the OFU. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. 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. 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.
From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
Number of Participants With a Bone Fracture Event Reported as the Indicated Serious Adverse Event (by Higher Level Group Term) or Death: Observational Follow-up
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. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the OFU. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. 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. 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.
From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)
Number of Participants With an Event of Death Due to a Bone Fracture-related Event: Main Study + Observational Follow-up Combined
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. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant.
From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
Number of Participants With the Indicated Bone Fracture by Fracture Site: Main Study + Observational Follow-up Combined
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. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date that had the same Higher Level Group Term (HLGT) for fracture location, per participant.
From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
Number of Participants With the Indicated Bone Fracture by Fracture Site: Observational Follow-up
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. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date that had the same Higher Level Group Term (HLGT) for fracture location, per participant.
From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)
Number of Participants With Potentially High Morbidity Fractures: Main Study + Observational Follow-up Combined
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. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. The following bone fractures were grouped and were identified as potentially high morbidity bone fractures: hip, pelvis, upper leg, vertebral (lumbar spine, thoracic spine, cervical spine, spine - site unknown).
From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
Number of Participants With Potentially High Morbidity Fracture Events and Non-high Morbidity Fracture Events, in Participants With Prior Hand/Upper Arm/Foot Fractures (H/UA/FF): Main Study + Observational Follow-up Combined
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. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. The following bone fractures were grouped and were identified as potentially high morbidity bone fractures: hip, pelvis, upper leg, vertebral (lumbar spine, thoracic spine, cervical spine, spine - site unknown).
From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
Number of Participants With Bone Fracture Events of the Indicated Cause: Main Study + Observational Follow-up Combined
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. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant.
From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
Number of Participants With Bone Fracture Events of the Indicated Cause: Observational Follow-up
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. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. The indicated fracture outcome was pre-specified in the CRF and included "Unknown" as a category. Fracture events with missing outcome data were reported as "Data unavailable."
From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)
Number of Bone Fracture Events With the Indicated Outcome: Main Study + Observational Follow-up Combined
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. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. The indicated fracture outcome was pre-specified in the CRF and included "Unknown" as a category. Fracture events with missing outcome data were reported as "Data unavailable."
From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
Number of Bone Fracture Events With the Indicated Outcome: Observational Follow-up
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. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. The indicated fracture outcome was pre-specified in the CRF and included "Unknown" as a category. Fracture events with missing outcome data were reported as "Data unavailable."
From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up
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. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. 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. 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.
From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)
Home PD, Pocock SJ, Beck-Nielsen H, Gomis R, Hanefeld M, Jones NP, Komajda M, McMurray JJ; RECORD Study Group. Rosiglitazone evaluated for cardiovascular outcomes--an interim analysis. N Engl J Med. 2007 Jul 5;357(1):28-38. doi: 10.1056/NEJMoa073394. Epub 2007 Jun 5.
Home PD, Pocock SJ, Beck-Nielsen H, Curtis PS, Gomis R, Hanefeld M, Jones NP, Komajda M, McMurray JJ; RECORD Study Team. Rosiglitazone evaluated for cardiovascular outcomes in oral agent combination therapy for type 2 diabetes (RECORD): a multicentre, randomised, open-label trial. Lancet. 2009 Jun 20;373(9681):2125-35. doi: 10.1016/S0140-6736(09)60953-3. Epub 2009 Jun 6.
Komajda M, Curtis P, Hanefeld M, Beck-Nielsen H, Pocock SJ, Zambanini A, Jones NP, Gomis R, Home PD; RECORD Study Group. Effect of the addition of rosiglitazone to metformin or sulfonylureas versus metformin/sulfonylurea combination therapy on ambulatory blood pressure in people with type 2 diabetes: a randomized controlled trial (the RECORD study). Cardiovasc Diabetol. 2008 Apr 24;7:10. doi: 10.1186/1475-2840-7-10.
Jones NP, Curtis PS, Home PD. Cancer and bone fractures in observational follow-up of the RECORD study. Acta Diabetol. 2015 Jun;52(3):539-46. doi: 10.1007/s00592-014-0691-y. Epub 2014 Dec 19.
MacDonald MR, Petrie MC, Home PD, Komajda M, Jones NP, Beck-Nielsen H, Gomis R, Hanefeld M, Pocock SJ, Curtis PS, McMurray JJ. Incidence and prevalence of unrecognized myocardial infarction in people with diabetes: a substudy of the Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycemia in Diabetes (RECORD) study. Diabetes Care. 2011 Jun;34(6):1394-6. doi: 10.2337/dc10-2398. Epub 2011 May 11.
For additional information about this study please refer to the GSK Clinical Study Register
For additional information about this study please refer to the GSK Clinical Study Register
FG001
SU in Addition to Background MET
Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
FG002
RSG in Addition to Background SU
Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
FG003
MET in Addition to Background SU
Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
FG004
Combined RSG: Observational Follow-up
Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
FG005
Combined MET/SU: Observational Follow-up
Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
FG0001117 subjects
FG0011105 subjects
FG0021103 subjects
FG0031122 subjects
FG0040 subjects
FG0050 subjects
COMPLETED
FG000939 subjects
FG001906 subjects
FG002896 subjects
FG003892 subjects
FG0040 subjects
FG0050 subjects
NOT COMPLETED
FG000178 subjects
FG001199 subjects
FG002207 subjects
FG003230 subjects
FG0040 subjects
FG0050 subjects
Type
Comment
Reasons
Death
FG00057 subjects
FG00167 subjects
FG00254 subjects
FG00372 subjects
FG0040 subjects
FG0050 subjects
Adverse Event
FG0005 subjects
FG0018 subjects
FG00210 subjects
FG00311 subjects
FG004
Lost to Follow-up
FG00029 subjects
FG00129 subjects
FG00225 subjects
FG00326 subjects
FG004
Withdrawal by Subject
FG00046 subjects
FG00156 subjects
FG00272 subjects
FG00370 subjects
FG004
Moved to survival status follow-up only
FG00027 subjects
FG00125 subjects
FG00232 subjects
FG00336 subjects
Participant moved
FG0003 subjects
FG0012 subjects
FG0023 subjects
FG0033 subjects
FG004
Poor compliance
FG0003 subjects
FG0012 subjects
FG0022 subjects
FG0031 subjects
FG004
Prohibited glucose lowering medication
FG0000 subjects
FG0013 subjects
FG0020 subjects
FG0031 subjects
FG004
Site closed
FG0004 subjects
FG0014 subjects
FG0024 subjects
FG0038 subjects
FG004
Entry criteria violation
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG004
Participant did not take study drug
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Physician Decision
FG0002 subjects
FG0012 subjects
FG0021 subjects
FG0031 subjects
FG004
Participant completed study at visit 27
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Personal reasons
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Risk of heart failure
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Investigator refused to log temperature
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Reason unspecified
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Observational Follow-up
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041280 subjects665 from "RSG in Addition to Background MET" arm; 615 from "RGS in Addition to Background SU" arm.
FG0051250 subjects647 from "SU in Addition to Background MET" arm; 603 from "MET in Addition to Background SU" arm.
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
RSG in Addition to Background MET
Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
BG001
SU in Addition to Background MET
Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
BG002
RSG in Addition to Background SU
Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
BG003
MET in Addition to Background SU
Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
BG004
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0001117
BG0011105
BG0021103
BG0031122
BG0044447
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00057.0± 8.02
BG00157.2± 8.14
BG00259.8± 8.26
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000516
BG001521
BG002
Race/Ethnicity, Customized
Number
participants
Title
Denominators
Categories
White
Title
Measurements
BG0001105
BG0011087
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants With Cardiovascular Death/Cardiovascular Hospitalisation Events
The number of participants with cardiovascular death events (death due to cardiovascular causes or deaths with insufficient information to rule out a cardiovascular cause) and cardiovascular hospitalisation events (hospitalisation for a cardiovascular event, excluding planned admissions not associated with a worsening of the disease/condition of the participant) was recorded.
Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication
Posted
Number
participants
Baseline through End of Study (up to 7.5 years)
ID
Title
Description
OG000
Combined RSG
Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
OG001
Combined MET/SU
Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Units
Counts
Participants
OG0002220
OG0012227
Title
Denominators
Categories
Title
Measurements
OG000321
OG001323
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Hazard Ratio (HR)
0.99
95
0.85
1.16
Non-Inferiority or Equivalence
Non-inferiority margin of 1.2 for the upper limit of the 95 percent confidence interval in time to event analysis comparing RSG to MET/SU stratified by background medication
Secondary
Number of Participants With Cardiovascular Events and All-cause Deaths
Composites of participants with first cardiovascular (CV) hospitalisations and CV death or all-cause death and individual first events of acute myocardial infarction (MI) , stroke, congestive heart failure (CHF), CV death, and all-cause death.
Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication
Posted
Number
participants
Baseline through End of Study (up to 7.5 years)
ID
Title
Description
OG000
Combined RSG
Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
OG001
Combined MET/SU
Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Secondary
Total Number of Cardiovascular Hospitalisations and Cardiovascular Deaths
The total number of events for individual components of cardiovascular (CV) hospitalisations and cardiovascular deaths were recorded. MI, myocardial infarction.
Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication
Posted
Number
Number of events
Baseline through End of Study (up to 7.5 years)
ID
Title
Description
OG000
Combined RSG
Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
OG001
Combined MET/SU
Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Secondary
Number of Participants With First Cardiovascular Hospitalisations/Cardiovascular Deaths by Stratum
Participants with first cardiovascular death (death due to cardiovascular causes or deaths with insufficient information to rule out a cardiovascular cause) and cardiovascular hospitalisation (hospitalisation for a cardiovascular event, excluding planned admissions not associated with a worsening of the disease/condition of the participant) were recorded by study stratum.
Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication
Posted
Number
partcipants
Baseline through End of Study (up to 7.5 years)
ID
Title
Description
OG000
RSG in Addition to Background MET
Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
OG001
SU in Addition to Background MET
Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Secondary
Number of Participants With CV/Microvascular Events
The number of participants with first cardiovascular or microvascular events (renal, foot, eye) were recorded.
Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication
Posted
Number
participants
Baseline through End of Study (up to 7.5 years)
ID
Title
Description
OG000
Combined RSG
Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
OG001
Combined MET/SU
Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Secondary
Number of Participants With Glycaemic Failure Events
Failure of glycaemic control was defined as two consecutive HbA1c values of ≥8.5 percent, or HbA1c ≥8.5percent at a single visit, after which the subject was either moved to the post-randomised treatment phase or triple therapy was started.
Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication
Posted
Number
participants
Baseline through to end of randomised dual therapy
ID
Title
Description
OG000
RSG in Addition to Background MET
Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
OG001
SU in Addition to Background MET
Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
OG002
Secondary
Number of Participants With Addition of Third Oral Agent/Switch to Insulin
The number of participants with addition of a third oral agent or switch to insulin from randomised dual combination treatment were recorded.
Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication
Posted
Number
participants
Baseline through End of Study (up to 7.5 years)
ID
Title
Description
OG000
RSG in Addition to Background MET
Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
OG001
SU in Addition to Background MET
Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
OG002
RSG in Addition to Background SU
Secondary
The Number of Participants Starting Insulin at Any Time During the Study
The number of participants starting insulin at any time during the study was recorded.
Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication
Posted
Number
participants
Baseline through End of Study (up to 7.5 years)
ID
Title
Description
OG000
RSG in Addition to Background MET
Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
OG001
SU in Addition to Background MET
Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
OG002
RSG in Addition to Background SU
Secondary
Model Adjusted Change From Baseline in HbA1c at Month 60
Model adjusted (adjusted for any imbalances in the baseline values between within stratum treatment groups) change from baseline in HbA1c was calculated as the value at Month 60 minus the Baseline value.
Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication
Posted
Mean
Standard Error
Percent
Baseline and Month 60 of randomised dual therapy treatment period
ID
Title
Description
OG000
RSG in Addition to Background MET
Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
OG001
SU in Addition to Background MET
Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
OG002
Secondary
Model Adjusted Change From Baseline in Fasting Plasma Glucose at Month 60
Model adjusted (adjusted for any imbalances in the baseline values between within stratum treatment groups) change from baseline in fasting plasma glucose was calculated as the value at Month 60 minus the Baseline value.
Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication
Posted
Mean
Standard Error
mmol/L (millimoles/Liter)
Baseline to Month 60 of the randomised dual therapy treatment period
ID
Title
Description
OG000
RSG in Addition to Background MET
Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
OG001
SU in Addition to Background MET
Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Secondary
Model Adjusted Mean Change From Baseline in Insulin and Pro-insulin at Month 60
Model adjusted (adjusted for any imbalances in the baseline values between within stratum treatment groups) change from baseline in insulin and pro-insulin was calculated as the value at Month 60 minus the Baseline value.
Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication
Posted
Mean
Standard Error
picamoles/liter (pmol/L)
Baseline to Month 60 of the randomised dual therapy treatment period
ID
Title
Description
OG000
RSG in Addition to Background MET
Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
OG001
SU in Addition to Background MET
Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Secondary
Number of HbA1c and Fasting Plasma Glucose (FPG) Responders at Month 60
Number of responders, i.e., participants meeting glycaemic targets (HbA1c less than or equal to 7 percent, FPG less than or equal to 7 mmol/L)
Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication
Posted
Number
participants
Baseline to Month 60 of the randomised dual therapy treatment period
ID
Title
Description
OG000
RSG in Addition to Background MET
Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
OG001
SU in Addition to Background MET
Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
OG002
RSG in Addition to Background SU
Secondary
Model Adjusted Ratio to Baseline (Expressed as a Percentage) Homeostasis Model Assessment (HOMA) Beta Cell Function and Insulin Sensitivity at Month 60
The model adjusted (adjusted for any imbalances in the baseline [BL] values between within stratum treatment groups) ratio to BL in HOMA beta-cell function and insulin sensitivity was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100*[GM^-1]).
Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication
Posted
Geometric Mean
95% Confidence Interval
percent change
Baseline to Month 60 of the randomised dual therapy treatment phase
ID
Title
Description
OG000
RSG in Addition to Background MET
Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
OG001
SU in Addition to Background MET
Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Secondary
Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Total Cholesterol (TC), Low-density Lipoprotein (LDL) Cholesterol, High-density Lipoprotein (HDL) Cholesterol, Triglycerides, and Free Fatty Acids (FFAs) at Month 60
The model adjusted (adjusted for any imbalances in the baseline [BL] values between within stratum treatment groups) ratio to BL in TC, LDL cholesterol, HDL cholesterol, triglycerides, and FFAs was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100*[GM^-1]).
Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication
Posted
Geometric Mean
95% Confidence Interval
percent change
Baseline to Month 60 of the randomised dual therapy treatment phase
ID
Title
Description
OG000
RSG in Addition to Background MET
Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
OG001
SU in Addition to Background MET
Secondary
Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Total Cholesterol (TC):High-density Lipoprotein (HDL) Cholesterol and Low-density Lipoprotein (LDL) Cholesterol:HDL Cholesterol Ratios at Month 60
The model adjusted (adjusted for any imbalances in the baseline [BL] values between within stratum treatment groups) ratio to BL in TC:HDL cholesterol and LDL cholesterol:HDL cholesterol was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100*[GM^-1]).
Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication
Posted
Geometric Mean
95% Confidence Interval
percent change
Baseline to Month 60 of the randomised dual therapy treatment period
ID
Title
Description
OG000
RSG in Addition to Background MET
Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
OG001
SU in Addition to Background MET
Secondary
Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Apolipoprotein B (Apo-B) at Month 60
The model adjusted (adjusted for any imbalances in the baseline [BL] values between within stratum treatment groups) ratio to BL in Apo-B was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100*[GM^-1]).
Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication
Posted
Geometric Mean
95% Confidence Interval
percent change
Baseline to Month 60 of the randomised dual therapy treatment period
ID
Title
Description
OG000
RSG in Addition to Background MET
Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
OG001
SU in Addition to Background MET
Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Secondary
Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Urinary Albumin Creatinine Ratio at Month 60
The model adjusted (adjusted for any imbalances in the baseline [BL] values between within stratum treatment groups) ratio to BL in urinary albumin creatinine ratio was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100*[GM^-1]).
Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication
Posted
Geometric Mean
95% Confidence Interval
percent change
Baseline to Month 60 of the randomised dual therapy treatment phase
ID
Title
Description
OG000
RSG in Addition to Background MET
Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
OG001
SU in Addition to Background MET
Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Secondary
Model Adjusted Change From Baseline in Body Weight at Month 60
Model adjusted (adjusted for any imbalances in the baseline values between within stratum treatment groups) change from baseline in body weight was calculated as the value at Month 60 minus the Baseline value.
Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication
Posted
Mean
Standard Error
kilograms
Baseline to Month 60 of the randomised dual therapy treatment phase
ID
Title
Description
OG000
RSG in Addition to Background MET
Participants inadequately controlled on background MET were randomised to receive RSG, in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
OG001
SU in Addition to Background MET
Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or miconizied equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
OG002
Secondary
Model Adjusted Change From Baseline in Alanine Aminotransferase at Month 60
Model adjusted (adjusted for any imbalances in the baseline values between within stratum treatment groups) change from baseline in alanine aminotransferase was calculated as the value at Month 60 minus the Baseline value.
Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication
Posted
Mean
95% Confidence Interval
U/L (Units/Liter)
Baseline to Month 60 of the randomised dual therapy treatment phase
ID
Title
Description
OG000
RSG in Addition to Background MET
Participants inadequately controlled on background MET were randomised to receive RSG, in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
OG001
SU in Addition to Background MET
Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or miconizied equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
OG002
Secondary
Model Adjusted Change From Baseline in Waist Circumference at Month 60
Model adjusted (adjusted for any imbalances in the baseline values between within stratum treatment groups) change from baseline in waist circumference was calculated as the value at Month 60 minus the Baseline value.
Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication
Posted
Mean
Standard Error
cm (centimeters)
Baseline to Month 60 of the randomised dual therapy treatment phase
ID
Title
Description
OG000
RSG in Addition to Background MET
Participants inadequately controlled on background MET were randomised to receive RSG, in addition to MET. RSG was initiated as a 4mg once daily dose and was increased to a maximum dose of 8mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
OG001
SU in Addition to Background MET
Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15mg per day or miconizied equivalent of 10.5mg per day; gliclazide 240mg per day and glimepiride 4mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
OG002
Secondary
Model Adjusted Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Month 60
Model adjusted (adjusted for any imbalances in the baseline values between within treatment groups) change from baseline in SBP and DBP was calculated as the value at Month 60 minus the Baseline value.
Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication
Posted
Mean
Standard Error
mmHg (millimeters of mercury)
Baseline to Month 60 of the randomised dual therapy treatment phase
ID
Title
Description
OG000
RSG in Addition to Background MET
Participants inadequately controlled on background MET were randomised to receive RSG, in addition to MET. RSG was initiated as a 4mg once daily dose and was increased to a maximum dose of 8mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
OG001
SU in Addition to Background MET
Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15mg per day or miconizied equivalent of 10.5mg per day; gliclazide 240mg per day and glimepiride 4mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Secondary
Model Adjusted Ratio to Baseline (Expressed as a Percentage) for C-Reactive Protein at Month 60
The model adjusted (adjusted for any imbalances in the baseline [BL] values between within stratum treatment groups) ratio to BL in C-Reactive Protein was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100*[GM^-1]).
Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication
Posted
Geometric Mean
95% Confidence Interval
percent change
Baseline to Month 60 of the randomised dual therapy treatment phase
ID
Title
Description
OG000
RSG in Addition to Background MET
Participants inadequately controlled on background MET were randomised to receive RSG, in addition to MET. RSG was initiated as a 4mg once daily dose and was increased to a maximum dose of 8mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
OG001
SU in Addition to Background MET
Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15mg per day or miconizied equivalent of 10.5mg per day; gliclazide 240mg per day and glimepiride 4mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Secondary
Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Fibrinogen at Month 60
The model adjusted (adjusted for any imbalances in the baseline [BL] values between within stratum treatment groups) ratio to BL in fibrinogen was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100*[GM^-1]).
Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication
Posted
Geometric Mean
95% Confidence Interval
percent change
Baseline to Month 60 of the randomised dual therapy treatment phase
ID
Title
Description
OG000
RSG in Addition to Background MET
Participants inadequately controlled on background MET were randomised to receive RSG, in addition to MET. RSG was initiated as a 4mg once daily dose and was increased to a maximum dose of 8mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
OG001
SU in Addition to Background MET
Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15mg per day or miconizied equivalent of 10.5mg per day; gliclazide 240mg per day and glimepiride 4mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Secondary
Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Plasminogen Activator Inhibitor-1 (PAI-1) Antigen at Month 60
The model adjusted (adjusted for any imbalances in the baseline [BL] values between within stratum treatment groups) ratio to BL in plasminogen activator inhibitor-1 (PAI-1) antigen was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100*[GM^-1]).
Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication
Posted
Geometric Mean
95% Confidence Interval
percent change
Baseline to Month 60 of the randomised dual therapy treatment phase
ID
Title
Description
OG000
RSG in Addition to Background MET
Participants inadequately controlled on background MET were randomised to receive RSG, in addition to MET. RSG was initiated as a 4mg once daily dose and was increased to a maximum dose of 8mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
OG001
SU in Addition to Background MET
Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15mg per day or miconizied equivalent of 10.5mg per day; gliclazide 240mg per day and glimepiride 4mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Primary
Independent Re-adjudication Outcome: Number of Participants Who Died Due to Any Cause
All deaths identified during the original record study and discovered after the re-adjudication efforts began were included.
Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication
Posted
Number
participants
Baseline through End of Study (up to 7.5 years)
ID
Title
Description
OG000
Combined RSG
Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent
OG001
Combined MET/SU
Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Primary
Independent Re-adjudication (IR) Outcome: Number of Participants With a First Occurrence of a Major Adverse Cardiovascular Event (MACE) Defined as CV (or Unknown) Death, Non-fatal MI, and Non-fatal Stroke Based on Original RECORD Endpoint Definitions
IR was based on original RECORD endpoint definitions. CV death= no unequivocal non-CV cause (sudden death, death from acute vascular events, heart failure, acute MI, other CV causes, and deaths adjudicated as unknown cause). MI event=hospitalization + elevation of specific cardiac biomarkers above the upper limit of normal + cardiac ischemia symptoms/new pathological electrocardiogram findings. Stroke event=hospitalization + rapidly developed clinical signs of focal/global disturbance of cerebral function for more than 24 hours, with no apparent cause other than a vascular origin.
Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication
Posted
Number
participants
Baseline through End of Study (up to 7.5 years)
ID
Title
Description
OG000
Combined RSG
Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent
OG001
Combined MET/SU
Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Primary
Independent Re-adjudication Outcome: Number of Participants With a First Occurrence of a Major Adverse Cardiovascular Event (MACE) Defined as CV (or Unknown) Death, Non-fatal MI, and Non-fatal Stroke Based on Contemporary Endpoint Definitions
Independent re-adjudication was based on the Standard Data Collection for Cardiovascular Trials Initiative (draft October 2011) endpoint definitions. CV death included death resulting from an acute MI; sudden cardiac death and death due to heart failure, stroke, and to other CV causes. Deaths of unknown cause were counted as CV deaths. MI was defined as evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Stroke was defined as an acute episode of neurological dysfunction caused by focal or global brain, spinal cord, or retinal vascular injury.
Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication
Posted
Number
participants
Baseline through End of Study (up to 7.5 years)
ID
Title
Description
OG000
Combined RSG
Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent
OG001
Combined MET/SU
Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Primary
Independent Re-adjudication Outcome: Number of Participants With a CV (or Unknown) Death, Based on Original RECORD Endpoint Definitions
The number of participants with a CV death (or unknown) as determined by independent re-adjudication using the original RECORD endpoint definitions was recorded. CV death was defined as any death for which an unequivocal non-CV cause could not be established. CV death included death following heart failure, death following acute myocardial infarction (MI), sudden death, death due to acute vascular events, and other CV causes. Deaths due to unknown causes were classified as "unknown deaths," but were counted as CV deaths for the analysis of this endpoint.
Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication
Posted
Number
participants
Baseline through End of Study (up to 7.5 years)
ID
Title
Description
OG000
Combined RSG
Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent
OG001
Combined MET/SU
Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Primary
Independent Re-adjudication Outcome: Number of Participants With a CV (or Unknown) Death, Based on Contemporary Endpoint Definitions
The number of participants with a CV (or unknown) death as determined by independent re-adjudication using the Standard Data Collection for Cardiovascular Trials Initiative (draft October 2011) endpoint definitions was recorded. CV death included death resulting from an acute myocardial infarction (MI), sudden cardiac death, death due to heart failure, death due to stroke, and death due to other CV causes. Deaths of unknown cause were counted as CV deaths.
Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication
Posted
Number
participants
Baseline through End of Study (up to 7.5 years)
ID
Title
Description
OG000
Combined RSG
Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent
OG001
Combined MET/SU
Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Primary
Independent Re-adjudication Outcome: Number of Participants With an Event of Myocardial Infarction (Fatal and Non-fatal), Based on Original RECORD Endpoint Definitions
The number of participants with an MI (fatal or non-fatal) event as determined by independent re-adjudication using the original RECORD endpoint definitions was recorded. An event of MI was defined as hospitalization plus elevation of cardiac biomarkers troponin (TN) I and/or TNT above the upper limit of normal (ULN) or creatinine kinase (CK) MB (M=muscle type; B=brain type) isoenzyme >= 2x the ULN or CK > 2x the ULN plus typical symptoms of cardiac ischemia or new pathological electrocardiogram findings, or cause of death adjudicated as MI.
Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication
Posted
Number
participants
Baseline through End of Study (up to 7.5 years)
ID
Title
Description
OG000
Combined RSG
Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent
OG001
Combined MET/SU
Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Primary
Independent Re-adjudication Outcome: Number of Participants With an Event of Myocardial Infarction (Fatal and Non-fatal), Based on Contemporary Endpoint Definitions
The number of participants with an MI (fatal or non-fatal) event as determined by independent re-adjudication using the Standard Data Collection for Cardiovascular Trials Initiative (draft October 2011) endpoint definitions was recorded. An event of MI was defined as evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia.
Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication
Posted
Number
participants
Baseline through End of Study (up to 7.5 years)
ID
Title
Description
OG000
Combined RSG
Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent
OG001
Combined MET/SU
Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Primary
Independent Re-adjudication Outcome: Number of Participants (Par.) With an Event of Stroke (Fatal and Non-fatal), Based on Original RECORD Endpoint Definitions
Par. with a stroke (fatal or non-fatal) event as determined by independent re-adjudication using the original RECORD endpoint definitions was recorded. A stroke event=hospitalization plus rapidly developed clinical signs of focal (or global) disturbance of cerebral function lasting more than 24 hours (unless interrupted by thrombolysis, surgery, or death), with no apparent cause other than a vascular origin, including par. presenting clinical signs/symptoms suggestive of subarachnoid haemorrhage/intracerebral haemorrhage/cerebral ischemic necrosis or cause of death adjudicated as stroke.
Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication
Posted
Number
participants
Baseline through End of Study (up to 7.5 years)
ID
Title
Description
OG000
Combined RSG
Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent
OG001
Combined MET/SU
Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Primary
Independent Re-adjudication Outcome: Number of Participants With an Event of Stroke (Fatal and Non-fatal), Based on Contemporary Endpoint Definitions
The number of participants with a stroke (fatal or non-fatal) event as determined by independent re-adjudication using the Standard Data Collection for Cardiovascular Trials Initiative (draft October 2011) endpoint definitions was recorded. An event of stroke was defined as an acute episode of neurological dysfunction caused by focal or global brain, spinal cord, or retinal vascular injury.
Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication
Posted
Number
participants
Baseline through End of Study (up to 7.5 years)
ID
Title
Description
OG000
Combined RSG
Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent
OG001
Combined MET/SU
Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Secondary
Number of Participants With the Indicated Type of Neoplasm/Cancer Event Reported as a Serious Adverse Event (SAE) or Death: Main Study + Observational Follow-up Combined
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. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. 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. 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.
ITT Population. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).
Posted
Number
participants
From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
ID
Title
Description
OG000
Combined RSG: Main Study and Observational Follow-up
Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
Secondary
Number of Participants With the Indicated Type of Neoplasm/Cancer Event Reported as a Serious Adverse Event (SAE) or Death: Observational Follow-up
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. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. 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. 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.
Observational Follow-up Population: all participants from the ITT Population of the RECORD study who provided data during the observational follow-up. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).
Posted
Number
participants
From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)
ID
Title
Description
OG000
Combined RSG: Observational Follow-up
Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
Secondary
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
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. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the OFU. The neoplasms/cancer events of bladder, breast, colon, liver, pancreatic, prostate cancer, and melanoma were pre-specified as cancers of interest for the OFU. 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. 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.
ITT Population. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).
Posted
Number
participants
From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
ID
Title
Description
OG000
Combined RSG: Main Study and Observational Follow-up
Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
Secondary
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
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. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the OFU. The neoplasms/cancer events of bladder, breast, colon, liver, pancreatic, prostate cancer, and melanoma were pre-specified as cancers of interest for the OFU. 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. 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.
Observational Follow-up Population: all participants from the ITT Population of the RECORD study who provided data during the observational follow-up. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).
Posted
Number
participants
From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)
ID
Title
Description
OG000
Combined RSG: Observational Follow-up
Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
Secondary
Number of Participants Who Died Due to the Indicated Cancer-related Event: Main Study + Observational Follow-up Combined
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. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. 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. 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.
ITT Population. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).
Posted
Number
participants
From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
ID
Title
Description
OG000
Combined RSG: Main Study and Observational Follow-up
Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
Secondary
Number of Participants Who Died Due to the Indicated Cancer-related Event: Observational Follow-up
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. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. 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. 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.
Observational Follow-up Population: all participants from the ITT Population of the RECORD study who provided data during the observational follow-up. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).
Posted
Number
participants
From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)
ID
Title
Description
OG000
Combined RSG: Observational Follow-up
Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
Secondary
Number of Participants With a Bone Fracture Event - Overall and by Gender: Main Study and Observational Follow-up Combined
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. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant.
ITT Population. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).
Posted
Number
participants
From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
ID
Title
Description
OG000
Combined RSG: Main Study and Observational Follow-up
Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
OG001
Combined MET/SU: Main Study and Observational Follow-up
Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
Secondary
Number of Participants With a Bone Fracture Event - Overall and by Gender: Observational Follow-up
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. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant.
Observational Follow-up Population: all participants from the ITT Population of the RECORD study who provided data during the observational follow-up. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).
Posted
Number
participants
From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)
ID
Title
Description
OG000
Combined RSG: Observational Follow-up
Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
OG001
Combined MET/SU: Observational Follow-up
Secondary
Number of Participants With a Bone Fracture Event Reported as the Indicated Serious Adverse Event (by Higher Level Group Term) or Death: Main Study + Observational Follow-up Combined
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. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the OFU. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. 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. 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.
ITT Population. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).
Posted
Number
participants
From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
ID
Title
Description
OG000
Combined RSG: Main Study and Observational Follow-up
Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
Secondary
Number of Participants With a Bone Fracture Event Reported as the Indicated Serious Adverse Event (by Higher Level Group Term) or Death: Observational Follow-up
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. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the OFU. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. 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. 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.
Observational Follow-up Population: all participants from the ITT Population of the RECORD study who provided data during the observational follow-up. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).
Posted
Number
participants
From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)
ID
Title
Description
OG000
Combined RSG: Observational Follow-up
Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
Secondary
Number of Participants With an Event of Death Due to a Bone Fracture-related Event: Main Study + Observational Follow-up Combined
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. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant.
ITT Population. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).
Posted
Number
participants
From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
ID
Title
Description
OG000
Combined RSG: Main Study and Observational Follow-up
Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
OG001
Combined MET/SU: Main Study and Observational Follow-up
Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
Secondary
Number of Participants With the Indicated Bone Fracture by Fracture Site: Main Study + Observational Follow-up Combined
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. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date that had the same Higher Level Group Term (HLGT) for fracture location, per participant.
ITT Population. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).
Posted
Number
participants
From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
ID
Title
Description
OG000
Combined RSG: Main Study and Observational Follow-up
Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
OG001
Combined MET/SU: Main Study and Observational Follow-up
Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
Secondary
Number of Participants With the Indicated Bone Fracture by Fracture Site: Observational Follow-up
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. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date that had the same Higher Level Group Term (HLGT) for fracture location, per participant.
Observational Follow-up Population: all participants from the ITT Population of the RECORD study who provided data during the observational follow-up. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).
Posted
Number
participants
From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)
ID
Title
Description
OG000
Combined RSG: Observational Follow-up
Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
OG001
Combined MET/SU: Observational Follow-up
Secondary
Number of Participants With Potentially High Morbidity Fractures: Main Study + Observational Follow-up Combined
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. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. The following bone fractures were grouped and were identified as potentially high morbidity bone fractures: hip, pelvis, upper leg, vertebral (lumbar spine, thoracic spine, cervical spine, spine - site unknown).
ITT Population. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).
Posted
Number
participants
From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
ID
Title
Description
OG000
Combined RSG: Main Study and Observational Follow-up
Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
OG001
Combined MET/SU: Main Study and Observational Follow-up
Secondary
Number of Participants With Potentially High Morbidity Fracture Events and Non-high Morbidity Fracture Events, in Participants With Prior Hand/Upper Arm/Foot Fractures (H/UA/FF): Main Study + Observational Follow-up Combined
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. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. The following bone fractures were grouped and were identified as potentially high morbidity bone fractures: hip, pelvis, upper leg, vertebral (lumbar spine, thoracic spine, cervical spine, spine - site unknown).
ITT Population. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).
Posted
Number
participants
From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
ID
Title
Description
OG000
Combined RSG: Main Study and Observational Follow-up
Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
Secondary
Number of Participants With Bone Fracture Events of the Indicated Cause: Main Study + Observational Follow-up Combined
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. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant.
ITT Population. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).
Posted
Number
participants
From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
ID
Title
Description
OG000
Combined RSG: Main Study and Observational Follow-up
Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
OG001
Combined MET/SU: Main Study and Observational Follow-up
Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
Secondary
Number of Participants With Bone Fracture Events of the Indicated Cause: Observational Follow-up
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. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. The indicated fracture outcome was pre-specified in the CRF and included "Unknown" as a category. Fracture events with missing outcome data were reported as "Data unavailable."
Observational Follow-up Population: all participants from the ITT Population of the RECORD study who provided data during the observational follow-up. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).
Posted
Number
participants
From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)
ID
Title
Description
OG000
Combined RSG: Observational Follow-up
Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
OG001
Secondary
Number of Bone Fracture Events With the Indicated Outcome: Main Study + Observational Follow-up Combined
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. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. The indicated fracture outcome was pre-specified in the CRF and included "Unknown" as a category. Fracture events with missing outcome data were reported as "Data unavailable."
ITT Population. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).
Posted
Number
bone fracture events
From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
ID
Title
Description
OG000
Combined RSG: Main Study and Observational Follow-up
Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
OG001
Combined MET/SU: Main Study and Observational Follow-up
Secondary
Number of Bone Fracture Events With the Indicated Outcome: Observational Follow-up
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. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. The indicated fracture outcome was pre-specified in the CRF and included "Unknown" as a category. Fracture events with missing outcome data were reported as "Data unavailable."
Observational Follow-up Population: all participants from the ITT Population of the RECORD study who provided data during the observational follow-up. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).
Posted
Number
bone fracture events
From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)
ID
Title
Description
OG000
Combined RSG: Observational Follow-up
Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
OG001
Secondary
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up
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. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. 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. 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.
Observational Follow-up Population: all participants from the ITT Population of the RECORD study who provided data during the observational follow-up. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).
Posted
Number
participants
From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)
ID
Title
Description
OG000
Combined RSG: Observational Follow-up
Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
Time Frame
In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years).
Description
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. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
RSG in Addition to Background MET
Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
424
1,117
1,117
1,117
EG001
SU in Addition to Background MET
Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
428
1,105
1,105
1,105
EG002
RSG in Addition to Background SU
Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
427
1,103
1,103
1,103
EG003
MET in Addition to Background SU
Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
431
1,122
1,122
1,122
EG004
Combined RSG: Observational Follow-up
Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
99
1,280
0
1,280
EG005
Combined MET/SU: Observational Follow-up
Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
76
1,250
0
1,250
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Myocardial Infarction
Cardiac disorders
MedDRA
Systematic Assessment
EG00025 affected1,117 at risk
EG00122 affected1,105 at risk
EG00229 affected1,103 at risk
EG00323 affected1,122 at risk
EG0040 affected1,280 at risk
EG0051 affected1,250 at risk
Cardiac Failure Congestive
Cardiac disorders
MedDRA
Systematic Assessment
EG00025 affected1,117 at risk
EG00118 affected1,105 at risk
EG00223 affected1,103 at risk
EG003
Angina Pectoris
Cardiac disorders
MedDRA
Systematic Assessment
EG00023 affected1,117 at risk
EG00118 affected1,105 at risk
EG00223 affected1,103 at risk
EG003
Angina Unstable
Cardiac disorders
MedDRA
Systematic Assessment
EG00016 affected1,117 at risk
EG00120 affected1,105 at risk
EG00221 affected1,103 at risk
EG003
Atrial Fibrillation
Cardiac disorders
MedDRA
Systematic Assessment
EG00020 affected1,117 at risk
EG00115 affected1,105 at risk
EG00213 affected1,103 at risk
EG003
Acute Myocardial Infarction
Cardiac disorders
MedDRA
Systematic Assessment
EG00012 affected1,117 at risk
EG0016 affected1,105 at risk
EG00211 affected1,103 at risk
EG003
Cardiac Failure
Cardiac disorders
MedDRA
Systematic Assessment
EG00016 affected1,117 at risk
EG0011 affected1,105 at risk
EG00213 affected1,103 at risk
EG003
Coronary Artery Disease
Cardiac disorders
MedDRA
Systematic Assessment
EG0009 affected1,117 at risk
EG0016 affected1,105 at risk
EG0027 affected1,103 at risk
EG003
Myocardial Ischaemia
Cardiac disorders
MedDRA
Systematic Assessment
EG0007 affected1,117 at risk
EG0015 affected1,105 at risk
EG0027 affected1,103 at risk
EG003
Coronary Artery Stenosis
Cardiac disorders
MedDRA
Systematic Assessment
EG0004 affected1,117 at risk
EG0018 affected1,105 at risk
EG0025 affected1,103 at risk
EG003
Cardiac Failure Acute
Cardiac disorders
MedDRA
Systematic Assessment
EG0003 affected1,117 at risk
EG0012 affected1,105 at risk
EG0023 affected1,103 at risk
EG003
Arrythmia
Cardiac disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0014 affected1,105 at risk
EG0022 affected1,103 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0013 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Acute Coronary Syndrome
Cardiac disorders
MedDRA
Systematic Assessment
EG0003 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Arteriosclerosis Coronary Artery
Cardiac disorders
MedDRA
Systematic Assessment
EG0002 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA
Systematic Assessment
EG0002 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Atrioventricular Block Complete
Cardiac disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0012 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Cardiac Arrest
Cardiac disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0012 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Aortic Valve Disease
Cardiac disorders
MedDRA
Systematic Assessment
EG0002 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Sick Sinus Syndrome
Cardiac disorders
MedDRA
Systematic Assessment
EG0002 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Atrial Flutter
Cardiac disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0011 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Cardiac Disorder
Cardiac disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Silent Myocardial Infarction
Cardiac disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Mitral Valve Incompetence
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0012 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Atrial Tachycardia
Cardiac disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Atrioventricular Block Second Degree
Cardiac disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0022 affected1,103 at risk
EG003
Cardiac Failure Chronic
Cardiac disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Cardiomegaly
Cardiac disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Cardiovascular disorder
Cardiac disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Cor pulmonale
Cardiac disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Left Ventricular Failure
Cardiac disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Mitral Valve Disease
Cardiac disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Pericarditis
Cardiac disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Right Ventricular Failure
Cardiac disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Sinus Bradycardia
Cardiac disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Ventricular Arrhythmia
Cardiac disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Ventricular Fibrillation
Cardiac disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Congestive Cardiomyopathy
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Sinus Tachycardia
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0022 affected1,103 at risk
EG003
Supraventricular Tachycardia
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0022 affected1,103 at risk
EG003
Tachyarrhythmia
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Aortic Valve Stenosis
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0022 affected1,103 at risk
EG003
Coronary Artery Occlusion
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Extrasystoles
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Pericardial Effusion
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Tachycardia Paroxysmal
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Ventricular Extrasystoles
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Atrioventricular Block
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Bradyarrhythmia
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Cardiac Fibrillation
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Cardiac Flutter
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Cardiomyopathy
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Adams-Stokes Syndrome
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Hypertensive Cardiomyopathy
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Left Ventricular Hypertrophy
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Myocardial Fibrosis
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Supraventricular Extrasystoles
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Tricuspid Valve Incompetence
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Pnuemonia
Infections and infestations
MedDRA
Systematic Assessment
EG00021 affected1,117 at risk
EG00115 affected1,105 at risk
EG00211 affected1,103 at risk
EG003
Erysipelas
Infections and infestations
MedDRA
Systematic Assessment
EG0006 affected1,117 at risk
EG0017 affected1,105 at risk
EG0026 affected1,103 at risk
EG003
Sepsis
Infections and infestations
MedDRA
Systematic Assessment
EG0006 affected1,117 at risk
EG0015 affected1,105 at risk
EG0024 affected1,103 at risk
EG003
Cellulitis
Infections and infestations
MedDRA
Systematic Assessment
EG0004 affected1,117 at risk
EG0016 affected1,105 at risk
EG0023 affected1,103 at risk
EG003
Bronchitis
Infections and infestations
MedDRA
Systematic Assessment
EG0002 affected1,117 at risk
EG0016 affected1,105 at risk
EG0024 affected1,103 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0016 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Urinary Tract Infection
Infections and infestations
MedDRA
Systematic Assessment
EG0004 affected1,117 at risk
EG0012 affected1,105 at risk
EG0023 affected1,103 at risk
EG003
Lower Respiratory Tract Infection
Infections and infestations
MedDRA
Systematic Assessment
EG0002 affected1,117 at risk
EG0014 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Bronchopnuemonia
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0015 affected1,105 at risk
EG0024 affected1,103 at risk
EG003
Gangrene
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0014 affected1,105 at risk
EG0023 affected1,103 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA
Systematic Assessment
EG0002 affected1,117 at risk
EG0011 affected1,105 at risk
EG0022 affected1,103 at risk
EG003
Abdominal Abscess
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0012 affected1,105 at risk
EG0022 affected1,103 at risk
EG003
Post Procedural Infection
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0012 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Urosepsis
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0012 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Localised Infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0013 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Postoperative Wound Infection
Infections and infestations
MedDRA
Systematic Assessment
EG0002 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Anal Abscess
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Orchitis
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Pyelonephritis Acute
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0012 affected1,105 at risk
EG0023 affected1,103 at risk
EG003
Sinusitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0012 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Abscess Intestinal
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Appendiceal Abscess
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Bacterial Infection
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Brochiectasis
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Campylobacter Gastroenteritis
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Cholecystitis Infective
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Encephalitis Viral
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Endocarditis Viral
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Herpes Zoster
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Infective Exacercbatn of Chronic Obstructive Airways Disease
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Infective Thrombosis
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Joint Abscess
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Laryngitis
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Liver Abscess
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Mastitis
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Myocardiac Abscess
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Osteomyelitis
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0022 affected1,103 at risk
EG003
Pelvic Infection
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Phlebitis Infective
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Retroperitoneal Abscess
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Staphylococcal Infection
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Toxoplasmosis
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Upper Respiratory Tract Infection
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Viral Infection
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Wound Infection
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Appendicitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0024 affected1,103 at risk
EG003
Arthritis Bacterial
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Catheter Sepsis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Conjunctivitis Viral
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Cystitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Enteritis Infectious
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Gastroenteritis Bacterial
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Groin Abscess
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Hepatitis C
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Herpes Zoster Oticus
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Infective Myositis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Intestinal Gangrene
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Lobar Pneumonia
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0024 affected1,103 at risk
EG003
Lung Infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Lyme Disease
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Mastoiditis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Meningitis Viral
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Necrotising Fasciitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Otitis Media Acute
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Pancreatic Abscess
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Peridiverticulitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Periumbilical Abscess
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Pneumococcal Infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Pneumonia Bacterial
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Post Procedural Sepsis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Pyelonephritis Chronic
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Scrotal Abscess
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Sialoadenitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Staphylococcal Sepsis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Respiratory Tract Infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0023 affected1,103 at risk
EG003
Pulmonary Tuberculosis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0022 affected1,103 at risk
EG003
Abdominal Wall Infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Abscess
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Device Related Infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Escherichia Sepsis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Extradural Abscess
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Furuncle
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Hepatitis Viral
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Infected Cyst
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Pneumonia Legionella
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Pyelocystitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Tracheobronchitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Urethritis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Arteriosclerotic Gangrene
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Blister Infected
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Carbuncle
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Colostomy Infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Diabetic Gangrene
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Ear Infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Gastroenteritis Salmonella
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Helicobacter gastritis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Herpes Ophthalmic
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Keratitis herpetic
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Meningitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Peritoneal Infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Pyothorax
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Subcutaneous Abscess
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Prostate Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG00010 affected1,117 at risk
EG0019 affected1,105 at risk
EG0025 affected1,103 at risk
EG003
Basal Cell Carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0006 affected1,117 at risk
EG0014 affected1,105 at risk
EG0024 affected1,103 at risk
EG003
Colon cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0004 affected1,117 at risk
EG0015 affected1,105 at risk
EG0023 affected1,103 at risk
EG003
Breast Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0004 affected1,117 at risk
EG0013 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Breast Cancer Female
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0003 affected1,117 at risk
EG0014 affected1,105 at risk
EG0023 affected1,103 at risk
EG003
Renal Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0015 affected1,105 at risk
EG0023 affected1,103 at risk
EG003
Pancreatic Carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0016 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Metastases to Liver
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0003 affected1,117 at risk
EG0012 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Lung Neoplasm Malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0015 affected1,105 at risk
EG0026 affected1,103 at risk
EG003
Gallbladder Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0003 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Rectal cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0003 affected1,117 at risk
EG0011 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Squamous Cell Carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0003 affected1,117 at risk
EG0011 affected1,105 at risk
EG0023 affected1,103 at risk
EG003
Gastric Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0002 affected1,117 at risk
EG0012 affected1,105 at risk
EG0025 affected1,103 at risk
EG003
Malignant Melanoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0002 affected1,117 at risk
EG0012 affected1,105 at risk
EG0022 affected1,103 at risk
EG003
Colon Neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0002 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Uterine Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0012 affected1,105 at risk
EG0023 affected1,103 at risk
EG003
Uterine Leiomyoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0012 affected1,105 at risk
EG0022 affected1,103 at risk
EG003
Lung Neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0002 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Meningioma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0002 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Thyroid Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0002 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Bladder Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0011 affected1,105 at risk
EG0022 affected1,103 at risk
EG003
Hepatic Neoplasm Malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Myelodysplastic Syndrome
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Ovarian Neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Renal Cell Carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0011 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Thyroid Neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Endometrial Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0012 affected1,105 at risk
EG0023 affected1,103 at risk
EG003
Prostatic Adenoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0012 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Angiomyolipoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Benign Salivary Gland Neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Chronic Lymphocytic Leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0022 affected1,103 at risk
EG003
Gastrointestinal Carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Hairy Cell Leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Lung Adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Metastases to Abdominal Cavity
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Nasal Cavity Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Ovarian Adenoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Pancreatic Neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Thyroid Adenoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Transitional Cell Carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Abdominal Wall Neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Adrenocortical Carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Bladder Transitional Cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Brain Neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Breast Cancer Metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Breast Neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Bronchial Carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Colon Cancer Stage III
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Colorectal Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0022 affected1,103 at risk
EG003
Epiglottic Carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Glioblastoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Keratoacanthoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Lipoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Metastases to Lung
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Metastases to Lymph Nodes
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Metastatic Neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Myeloproliferative Disorder
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Non-Hodgkin's Lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Oesophageal Adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Oesophageal Carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Ovarian Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0023 affected1,103 at risk
EG003
Ovarian Cancer Metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Pancreatic Carcinoma Stage IV
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Papilloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Rectal Cancer Metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Renal Adenoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Tonsil cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Uterine Leiomyosarcoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Metastases to Central Nervous System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0023 affected1,103 at risk
EG003
Bladder Neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0022 affected1,103 at risk
EG003
Lung Cancer Metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0022 affected1,103 at risk
EG003
Rectal Neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Benign Lung Neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Fibroma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Lip Neoplasm Malignant Stage Unspecified
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Metastases to Peritoneum
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Metastatic Malignant melanoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Neoplasm Prostate
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Pharyngeal Neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Skin Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Vulval Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Bile Duct Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Cervix Carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Hair Follicle Tumour Benign
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Hepatic Cancer Metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Malignant Mesenchymoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Meningioma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Metastases to Bone
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Metastases to Breast
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Metastases to Spine
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Metastatic Renal Cell Carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Neoplasm Malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Ovarian Fibroma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Rectal Adenoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Testicular Neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Tongue Neoplasm Malignant Stage Unspecified
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Cerebrovascular Accident
Nervous system disorders
MedDRA
Systematic Assessment
EG00018 affected1,117 at risk
EG00125 affected1,105 at risk
EG00221 affected1,103 at risk
EG003
Transient Ischaemic Attack
Nervous system disorders
MedDRA
Systematic Assessment
EG00011 affected1,117 at risk
EG00114 affected1,105 at risk
EG00211 affected1,103 at risk
EG003
Syncope
Nervous system disorders
MedDRA
Systematic Assessment
EG0005 affected1,117 at risk
EG0012 affected1,105 at risk
EG0023 affected1,103 at risk
EG003
Sciatica
Nervous system disorders
MedDRA
Systematic Assessment
EG0003 affected1,117 at risk
EG0012 affected1,105 at risk
EG0022 affected1,103 at risk
EG003
Carotid Artery Stenosis
Nervous system disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0014 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Diabetic Neuropathy
Nervous system disorders
MedDRA
Systematic Assessment
EG0003 affected1,117 at risk
EG0011 affected1,105 at risk
EG0023 affected1,103 at risk
EG003
Ischaemic stroke
Nervous system disorders
MedDRA
Systematic Assessment
EG0003 affected1,117 at risk
EG0011 affected1,105 at risk
EG0022 affected1,103 at risk
EG003
Epilepsy
Nervous system disorders
MedDRA
Systematic Assessment
EG0003 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Syncope Vasovagal
Nervous system disorders
MedDRA
Systematic Assessment
EG0002 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Carpal Tunnel syndrome
Nervous system disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0012 affected1,105 at risk
EG0022 affected1,103 at risk
EG003
Headache
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0013 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Cerebral Haemorrhage
Nervous system disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Dementia
Nervous system disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Facial Paresis
Nervous system disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Global Amnesia
Nervous system disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Hemiparesis
Nervous system disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0011 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Loss of Consciousness
Nervous system disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Cerebral Infarction
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0012 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Cognitive Disorder
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0012 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Vertebrobasilar Insufficiency
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0012 affected1,105 at risk
EG0024 affected1,103 at risk
EG003
Aphasia
Nervous system disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Haemorrhage Intracranial
Nervous system disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Hemiplegia
Nervous system disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Hyperaesthesia
Nervous system disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Intracranial Haematoma
Nervous system disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Migraine
Nervous system disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Multiple Sclerosis
Nervous system disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Radiculopathy
Nervous system disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Vascular Dementia
Nervous system disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Vascular Encephalopathy
Nervous system disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Demyelination
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Haemorrhagic Stroke
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Hypoxic Encephalopathy
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Ischaemic Cerebral Infarction
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Normal Pressure Hydrocephalus
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Paralysis
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Paraparesis
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Presyncope
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Reversible Ischaemic Neurological Deficit
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Ruptured Cerebral Aneurysm
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Tension Headache
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Cerebral Ischaemia
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0024 affected1,103 at risk
EG003
Brain Oedema
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Cerebrovascular Insufficiency
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Cervicobrachial Syndrome
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Hypertonia
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Neuralgia
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Polyneuropathy
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Radiculitis lumbosacral
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Carotid Arteriosclerosis
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Cerebral Arteriosclerosis
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Cerebrovascular Disorder
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Convulsion
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Encephalopathy
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Facial Palsy
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Hypertensive Encephalopathy
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Hypokinesia
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Lumbar Radiculopathy
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Metabolic Encephalopathy
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Nerve Compression
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Nerve Root Compression
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Parkinsonism
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Abdominal Pain
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0005 affected1,117 at risk
EG0015 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Pancreatitis Acute
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0006 affected1,117 at risk
EG0013 affected1,105 at risk
EG0024 affected1,103 at risk
EG003
Gastrointestinal Haemorrhage
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0003 affected1,117 at risk
EG0013 affected1,105 at risk
EG0022 affected1,103 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0003 affected1,117 at risk
EG0012 affected1,105 at risk
EG0023 affected1,103 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0002 affected1,117 at risk
EG0012 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0002 affected1,117 at risk
EG0011 affected1,105 at risk
EG0022 affected1,103 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0002 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Duodenal ulcer Haemorrhage
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0002 affected1,117 at risk
EG0011 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Gastric Ulcer Haemorrhage
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0002 affected1,117 at risk
EG0011 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Umbilical Hernia
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0002 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Crohn's Disease
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0002 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0002 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Colitis Ulcerative
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Duodenal ulcer
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0011 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Gastric Polyps
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Hiatus Hernia
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0011 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0011 affected1,105 at risk
EG0023 affected1,103 at risk
EG003
Diverticulum
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0012 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0012 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Gastric Haemorrhage
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0012 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Intestinal Perforation
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0012 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0012 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Abdominal Hernia Obstructive
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Abdominal Pain Upper
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Dental caries
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Diverticulum Intestinal
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Faeces Discoloured
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Gastric Dysplasia
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Gastric Ulcer
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0022 affected1,103 at risk
EG003
Gastritis Haemorrhagic
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Gastrointestinal Inflammation
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Gastrooesophageal Reflux Disease
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0022 affected1,103 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Haemorrhoidal Haemorrhage
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Intestinal Fistula
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Melaena
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Pancreatic Pseudocyst
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Peritoneal Disorder
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Proctalgia
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Splenic Artery Aneurysm
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Upper Gastrointestinal Haemorrhage
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Abdominal Hernia
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0022 affected1,103 at risk
EG003
Anal Fistula
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Appendicitis Perforated
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Colonic Fistula
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Colonic Polyp
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Diverticular Perforation
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Diverticulitis Intestinal Haemorrhagic
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Duodenal Perforation
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0022 affected1,103 at risk
EG003
Intestinal Obstruction
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Mechanical Ileus
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Reflux Oesophagitis
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Small Intestinal Haemorrhage
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Pancreatitis Chronic
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0022 affected1,103 at risk
EG003
Gastric Ulcer Perforation
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0022 affected1,103 at risk
EG003
Abdominal Adhesions
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Gastroduodenitis
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Pancreatic Cyst
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Pancreatitis Necrotising
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Peptic Ulcer Perforation
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Duodenal Fistula
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Gastroduodenal Ulcer
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Intestinal Haemorrhage
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Pancreatic necrosis
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Peritonitis
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Rectal Haemorrhage
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Rectal Polyp
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Salivary Gland Calculus
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Barrett's oesophagus
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Duodenitis Haemorrhagic
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Enterocele
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Enterocolitis
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Faecaloma
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Gastrointestinal Disorder
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Haematemesis
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Intestinal Polyp
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Intra-abdominal haemorrhage
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Peptic Ulcer Haemorrhage
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Small Intestinal Obstruction
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Ankle Fracture
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0004 affected1,117 at risk
EG0012 affected1,105 at risk
EG0022 affected1,103 at risk
EG003
Road Traffic Accident
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0015 affected1,105 at risk
EG0024 affected1,103 at risk
EG003
Humerus Fracture
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0005 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0004 affected1,117 at risk
EG0011 affected1,105 at risk
EG0023 affected1,103 at risk
EG003
Radius Fracture
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0003 affected1,117 at risk
EG0012 affected1,105 at risk
EG0023 affected1,103 at risk
EG003
Rib Fracture
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0003 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Upper Limb Fracture
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0003 affected1,117 at risk
EG0011 affected1,105 at risk
EG0022 affected1,103 at risk
EG003
Hip Fracture
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0002 affected1,117 at risk
EG0012 affected1,105 at risk
EG0022 affected1,103 at risk
EG003
Post Procedural Complication
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0002 affected1,117 at risk
EG0011 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Thermal Burn
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0002 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Head Injury
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0012 affected1,105 at risk
EG0022 affected1,103 at risk
EG003
Joint Dislocation
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0012 affected1,105 at risk
EG0022 affected1,103 at risk
EG003
Meniscus Lesion
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0012 affected1,105 at risk
EG0025 affected1,103 at risk
EG003
Concussion
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0002 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Drug Toxicity
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0002 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Excoriation
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0002 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Facial Bones Fracture
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0002 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Overdose
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0002 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Skin Laceration
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0002 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Incisional Hernia
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0011 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Injury
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0011 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Joint Injury
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Post Procedural haemorrhage
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0011 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Tibia fracture
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0011 affected1,105 at risk
EG0023 affected1,103 at risk
EG003
Wound Dehiscence
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Device Failure
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0012 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Femoral Neck Fracture
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0012 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Accidental Overdose
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0022 affected1,103 at risk
EG003
Alcohol Poisoning
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Cardiac Valve Replacement Complication
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Cartilage Injury
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Clavicle Fracture
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Dislocation of Joint Prosthesis
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Gun Shot Wound
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Laceration
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Limb Injury
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Lower Limb Fracture
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Lumbar Vertebral Fracture
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Lung Injury
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Multiple Fractures
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Near Drowning
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Post Procedural Fistula
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Postoperative Ileus
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Postoperative Wound Complication
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Skull Fracture
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Thoracic Vertebral Fracture
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Accident
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Acetabulum Fracture
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Anastomotic Leak
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Femur Fracture
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0025 affected1,103 at risk
EG003
Hand Fracture
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
In-Stent Arterial Restenosis
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Multiple Injuries
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0022 affected1,103 at risk
EG003
Muscle Rupture
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Pelvic Fracture
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Spinal Compression Fracture
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Stent Occlusion
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Traumatic Brain Injury
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Wound
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Ulna fracture
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0023 affected1,103 at risk
EG003
Foot Fracture
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0022 affected1,103 at risk
EG003
Spinal Fracture
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Tendon Rupture
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0022 affected1,103 at risk
EG003
Brain Contusion
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Subdural Haematoma
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Arthropod Sting
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Asbestosis
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Cervical Vertebral Fracture
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Epiphyseal Fracture
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Eyeball Rupture
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Intentional Overdose
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Joint Sprain
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Open Wound
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Post Procedural Haematoma
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Shunt Occlusion
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Synovial Rupture
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Wrist Fracture
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Fibula Fracture
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Limb Crushing Injury
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Limb Traumatic Amputation
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Operative Haemorrhage
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Patella Fracture
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Post Laminectomy Syndrome
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Post-Traumatic Pain
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Postoperative Hernia
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Traumatic Haematoma
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Hypertension
Vascular disorders
MedDRA
Systematic Assessment
EG0007 affected1,117 at risk
EG00110 affected1,105 at risk
EG00210 affected1,103 at risk
EG003
Thrombosis
Vascular disorders
MedDRA
Systematic Assessment
EG0003 affected1,117 at risk
EG0012 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Deep Vein Thrombosis
Vascular disorders
MedDRA
Systematic Assessment
EG0002 affected1,117 at risk
EG0013 affected1,105 at risk
EG0023 affected1,103 at risk
EG003
Aortic Stenosis
Vascular disorders
MedDRA
Systematic Assessment
EG0003 affected1,117 at risk
EG0011 affected1,105 at risk
EG0022 affected1,103 at risk
EG003
Intermittent Claudication
Vascular disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0013 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Varicose Vein
Vascular disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0014 affected1,105 at risk
EG0022 affected1,103 at risk
EG003
Aortic Aneurysm
Vascular disorders
MedDRA
Systematic Assessment
EG0002 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Essential Hypertension
Vascular disorders
MedDRA
Systematic Assessment
EG0002 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Hypovolaemic Shock
Vascular disorders
MedDRA
Systematic Assessment
EG0002 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Thrombophlebitis
Vascular disorders
MedDRA
Systematic Assessment
EG0002 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Femoral Artery Occlusion
Vascular disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0011 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Hypertensive Crisis
Vascular disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0011 affected1,105 at risk
EG0022 affected1,103 at risk
EG003
Hypotension
Vascular disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Shock
Vascular disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Iliac Artery Stenosis
Vascular disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0012 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Peripheral Ischaemia
Vascular disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0012 affected1,105 at risk
EG0022 affected1,103 at risk
EG003
Accelerated Hypertension
Vascular disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Arteriosclerosis obliterans
Vascular disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Artery Dissection
Vascular disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Circulatory Collapse
Vascular disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0022 affected1,103 at risk
EG003
Diabetic Microangiopathy
Vascular disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Haematoma
Vascular disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Orthostatic Hypotension
Vascular disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Shock Haemorrhagic
Vascular disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Aortic Aneurysm Rupture
Vascular disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Arterial Occlusive Disease
Vascular disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Arterial Stenosis
Vascular disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Arterial Stenosis Limb
Vascular disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Cardiovascular Insufficiency
Vascular disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Extremity Necrosis
Vascular disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Femoral Arterial Stenosis
Vascular disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Labile Hypertension
Vascular disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Malignant Hypertension
Vascular disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Peripheral Arterial Occlusive Disease
Vascular disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0023 affected1,103 at risk
EG003
Peripheral Vascular Disorder
Vascular disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0025 affected1,103 at risk
EG003
Thrombophlebitis Superficial
Vascular disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Venous Insufficiency
Vascular disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Venous Thrombosis Limb
Vascular disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Arteriosclerosis
Vascular disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Arterial Thrombosis Limb
Vascular disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Angiopathy
Vascular disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Arterial Disorder
Vascular disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Ischaemia
Vascular disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Lymphoedema
Vascular disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Phlebitis
Vascular disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Venous Thrombosis
Vascular disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Diabetic Microangiopathy
Vascular disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Haemorrhage
Vascular disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG00016 affected1,117 at risk
EG00112 affected1,105 at risk
EG00213 affected1,103 at risk
EG003
Back Pain
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0003 affected1,117 at risk
EG0014 affected1,105 at risk
EG0023 affected1,103 at risk
EG003
Intervertebral Disc Protrusion
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0002 affected1,117 at risk
EG0015 affected1,105 at risk
EG0026 affected1,103 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0004 affected1,117 at risk
EG0011 affected1,105 at risk
EG0023 affected1,103 at risk
EG003
Spinal Column Stenosis
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0002 affected1,117 at risk
EG0011 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Bursitis
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0012 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0013 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0002 affected1,117 at risk
EG0010 affected1,105 at risk
EG0023 affected1,103 at risk
EG003
Musculoskeletal Pain
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0002 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Osteochondrosis
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0002 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Dupuytren's Contracture
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0011 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Metatarsalgia
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Musculoskeletal Chest Pain
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0011 affected1,105 at risk
EG0022 affected1,103 at risk
EG003
Spinal Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0012 affected1,105 at risk
EG0023 affected1,103 at risk
EG003
Diabetic Amyotrophy
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Gouty Arthritis
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Intervertebral Disc Degeneration
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Senile Osteoporosis
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Tendonitis
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Foot Deformity
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Rheumatic Fever
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Rheumatoid Arthritis
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Intervertebral Disc Disorder
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Musculoskeletal Pain
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0022 affected1,103 at risk
EG003
Bone Pain
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Compartment Syndrome
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Rotator Cuff Syndrome
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Polymyalgia Rheumatica
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Arthropathy
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Groin Pain
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Haemarthrosis
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Pain in Extremity
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Periarthritis
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Costochondritis
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Exostosis
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Mobility Decreased
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Psoriatic Arthropathy
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Sacroiliitis
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Pulmonary Embolism
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0006 affected1,117 at risk
EG0019 affected1,105 at risk
EG0024 affected1,103 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0003 affected1,117 at risk
EG0018 affected1,105 at risk
EG0024 affected1,103 at risk
EG003
Chronic Obstructive Pulmonary Disease
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0004 affected1,117 at risk
EG0013 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0004 affected1,117 at risk
EG0012 affected1,105 at risk
EG0022 affected1,103 at risk
EG003
Respiratory Failure
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0003 affected1,117 at risk
EG0013 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Sleep Apnoea Syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0012 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Bronchitis Chronic
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0011 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Pulmonary Oedema
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0011 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0012 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Nasal Polyps
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0012 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Nasal Septum Deviation
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0012 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Alveolitis Fibrosing
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Pneumonia Aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Pulmonary Hypertension
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0022 affected1,103 at risk
EG003
Respiratory Acidosis
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Dyspnoea Exertional
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0022 affected1,103 at risk
EG003
Lung Consolidation
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Nasal Turbinate Hypertrophy
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Respiratory Distress
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Tracheal Stenosis
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Pleural Effusion
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0024 affected1,103 at risk
EG003
Pleurisy
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0022 affected1,103 at risk
EG003
Lung Disorder
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Pulmonary Fibrosis
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Acute Pulmonary Oedema
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Dysnoea Paroxysmal Nocturnal
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Nocturnal Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Pleuritic Pain
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Hydrothorax
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Respiratory Alkalosis
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Non-Cardiac Chest Pain
General disorders
MedDRA
Systematic Assessment
EG00014 affected1,117 at risk
EG00112 affected1,105 at risk
EG0025 affected1,103 at risk
EG003
Death
General disorders
MedDRA
Systematic Assessment
EG0005 affected1,117 at risk
EG0013 affected1,105 at risk
EG0022 affected1,103 at risk
EG003
Pyrexia
General disorders
MedDRA
Systematic Assessment
EG0004 affected1,117 at risk
EG0012 affected1,105 at risk
EG0023 affected1,103 at risk
EG003
Sudden Death
General disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0013 affected1,105 at risk
EG0024 affected1,103 at risk
EG003
Inflammation
General disorders
MedDRA
Systematic Assessment
EG0002 affected1,117 at risk
EG0010 affected1,105 at risk
EG0022 affected1,103 at risk
EG003
Multi-Organ Failure
General disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0011 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Sudden Cardiac Death
General disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0011 affected1,105 at risk
EG0022 affected1,103 at risk
EG003
Chest pain
General disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0012 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Gait Disturbance
General disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0012 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Hernia Obstructive
General disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Chest Discomfort
General disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
General Physical Health Deterioration
General disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Pain
General disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Drowning
General disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Oedema
General disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Oedema Peripheral
General disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Tenderness
General disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Brain Death
General disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA
Systematic Assessment
EG00015 affected1,117 at risk
EG00113 affected1,105 at risk
EG0029 affected1,103 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA
Systematic Assessment
EG0005 affected1,117 at risk
EG0015 affected1,105 at risk
EG0024 affected1,103 at risk
EG003
Cholecystitis Acute
Hepatobiliary disorders
MedDRA
Systematic Assessment
EG0002 affected1,117 at risk
EG0012 affected1,105 at risk
EG0025 affected1,103 at risk
EG003
Liver Disorder
Hepatobiliary disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Biliary Colic
Hepatobiliary disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0022 affected1,103 at risk
EG003
Cholangitis
Hepatobiliary disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Cholecystitis Chronic
Hepatobiliary disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Hepatic Failure
Hepatobiliary disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Bile Duct Obstruction
Hepatobiliary disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Bile Duct Stone
Hepatobiliary disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Hepatic Steatosis
Hepatobiliary disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Jaundice
Hepatobiliary disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Jaundice Cholestatic
Hepatobiliary disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Hepatic Cirrhosis
Hepatobiliary disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Gallbladder Polyp
Hepatobiliary disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Cholestasis
Hepatobiliary disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Hepatitis
Hepatobiliary disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Hepatitis Alcoholic
Hepatobiliary disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Post Cholecystectomy Syndrome
Hepatobiliary disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0005 affected1,117 at risk
EG0015 affected1,105 at risk
EG00210 affected1,103 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0019 affected1,105 at risk
EG0026 affected1,103 at risk
EG003
Diabetes Mellitus
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0004 affected1,117 at risk
EG0015 affected1,105 at risk
EG00210 affected1,103 at risk
EG003
Diabetes Mellitus Inadequate Control
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0002 affected1,117 at risk
EG0013 affected1,105 at risk
EG0022 affected1,103 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0012 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Diabetic Foot
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0012 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Acidosis
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Metabolic Acidosis
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Anorexia
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Haemochromatosis
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Obesity
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Cachexia
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Diabetic Complication
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Hypeonatraemia
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Podagra
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Increased Insulin Requirement
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA
Systematic Assessment
EG0003 affected1,117 at risk
EG0018 affected1,105 at risk
EG0022 affected1,103 at risk
EG003
Renal Failure Acute
Renal and urinary disorders
MedDRA
Systematic Assessment
EG0003 affected1,117 at risk
EG0018 affected1,105 at risk
EG0022 affected1,103 at risk
EG003
Renal Failure
Renal and urinary disorders
MedDRA
Systematic Assessment
EG0003 affected1,117 at risk
EG0014 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Renal Colic
Renal and urinary disorders
MedDRA
Systematic Assessment
EG0002 affected1,117 at risk
EG0012 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Urinary Retention
Renal and urinary disorders
MedDRA
Systematic Assessment
EG0002 affected1,117 at risk
EG0011 affected1,105 at risk
EG0022 affected1,103 at risk
EG003
Calculus Ureteric
Renal and urinary disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0012 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Calculus Urinary
Renal and urinary disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0012 affected1,105 at risk
EG0022 affected1,103 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0012 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Cystitis Noninfective
Renal and urinary disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0012 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Acute Prerenal Failure
Renal and urinary disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Urethral Fistula
Renal and urinary disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Urinary Bladder Haemorrhage
Renal and urinary disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Bladder Perforation
Renal and urinary disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Diabetic Nephropathy
Renal and urinary disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Urinary Tract Obstruction
Renal and urinary disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Urethral Stenosis
Renal and urinary disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0022 affected1,103 at risk
EG003
Renal Cyst
Renal and urinary disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Albuminuria
Renal and urinary disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Calculus Bladder
Renal and urinary disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Renal Pain
Renal and urinary disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Urinary Incontinence
Renal and urinary disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Urinary Tract Inflammation
Renal and urinary disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Azotaemia
Renal and urinary disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Calculus Urethral
Renal and urinary disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Ketonuria
Renal and urinary disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Renal Embolism
Renal and urinary disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Urine Flow Decreased
Renal and urinary disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Benign Prostatic Hyperplasia
Reproductive system and breast disorders
MedDRA
Systematic Assessment
EG0003 affected1,117 at risk
EG0016 affected1,105 at risk
EG0026 affected1,103 at risk
EG003
Uterine Prolapse
Reproductive system and breast disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0014 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Cystocele
Reproductive system and breast disorders
MedDRA
Systematic Assessment
EG0002 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Rectocele
Reproductive system and breast disorders
MedDRA
Systematic Assessment
EG0002 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Breast Disorder
Reproductive system and breast disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Cervical Polyp
Reproductive system and breast disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Endometrial Hypertrophy
Reproductive system and breast disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Menometrorrhagia
Reproductive system and breast disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Ovarian Cyst
Reproductive system and breast disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Peyronie's Disease
Reproductive system and breast disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Prostatitis
Reproductive system and breast disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Testicular Pain
Reproductive system and breast disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Vaginal Prolapse
Reproductive system and breast disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Fibrocystic Breast Disease
Reproductive system and breast disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Metrorrhagia
Reproductive system and breast disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Vaginal Cyst
Reproductive system and breast disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Vulvovaginal Dryness
Reproductive system and breast disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Epididymitis
Reproductive system and breast disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0022 affected1,103 at risk
EG003
Uterine Polyp
Reproductive system and breast disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Orchitis Noninfective
Reproductive system and breast disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Pelvic Pain
Reproductive system and breast disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Pelvic Peritoneal Adhesions
Reproductive system and breast disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Postmenopausal Haemorrhage
Reproductive system and breast disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Prostatic Obstruction
Reproductive system and breast disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Vulvovaginal Pruritus
Reproductive system and breast disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Prostatism
Reproductive system and breast disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Vaginal Haemorrhage
Reproductive system and breast disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Vaginal Polyp
Reproductive system and breast disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Vulval Leukoplakia
Reproductive system and breast disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Cataract
Eye disorders
MedDRA
Systematic Assessment
EG0005 affected1,117 at risk
EG0013 affected1,105 at risk
EG00212 affected1,103 at risk
EG003
Retinal Detachment
Eye disorders
MedDRA
Systematic Assessment
EG0002 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Angle Closure Glaucoma
Eye disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Maculopathy
Eye disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Glaucoma
Eye disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Cataract Nuclear
Eye disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Inflammation of Lacrimal Passage
Eye disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Retinal Haemorrhage
Eye disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Vitreous Haemorrhage
Eye disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Diabetic Retinopathy
Eye disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Eye Haemorrhage
Eye disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Dacryostenosis Acquired
Eye disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Exudative Retinopathy
Eye disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Macular Degeneration
Eye disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Optic Atrophy
Eye disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Keratitis
Eye disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Lens Dislocation
Eye disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Retinal Vein Thrombosis
Eye disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA
Systematic Assessment
EG0008 affected1,117 at risk
EG0012 affected1,105 at risk
EG0024 affected1,103 at risk
EG003
Iron Deficiency Anaemia
Blood and lymphatic system disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0013 affected1,105 at risk
EG0022 affected1,103 at risk
EG003
Hypocoagulable State
Blood and lymphatic system disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Idiopathic Thrombocytopenic Purpura
Blood and lymphatic system disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Autoimmune Thrombocytopenia
Blood and lymphatic system disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Haemolytic Anaemia
Blood and lymphatic system disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Depression
Psychiatric disorders
MedDRA
Systematic Assessment
EG0002 affected1,117 at risk
EG0014 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Confusional State
Psychiatric disorders
MedDRA
Systematic Assessment
EG0003 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Alcohol Abuse
Psychiatric disorders
MedDRA
Systematic Assessment
EG0002 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Suicide Attempt
Psychiatric disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Mania
Psychiatric disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Bipolar Disorder
Psychiatric disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Completed Suicide
Psychiatric disorders
MedDRa
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Dysthymic Disorder
Psychiatric disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA
Systematic Assessment
EG0003 affected1,117 at risk
EG0014 affected1,105 at risk
EG0026 affected1,103 at risk
EG003
Hypoacusis
Ear and labyrinth disorders
MedDRA
Systematic Assessment
EG0002 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Otosclerosis
Ear and labyrinth disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Sudden Hearing Loss
Ear and labyrinth disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Vestibular Disorder
Ear and labyrinth disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Vestibular Neuronitis
Ear and labyrinth disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Vertigo Positional
Ear and labyrinth disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Goitre
Endocrine disorders
MedDRA
Systematic Assessment
EG0002 affected1,117 at risk
EG0012 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0011 affected1,105 at risk
EG0022 affected1,103 at risk
EG003
Hyperparathyroidism
Endocrine disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Hyperparathyroidism Primary
Endocrine disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Parathyroid Gland Enlargement
Endocrine disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Toxic Nodular Goitre
Endocrine disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Adrenal Mass
Endocrine disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Basedow's Disease
Endocrine disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Angioedema
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0003 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Drug Eruption
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Hyperkeratosis
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Skin Ulcer
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Dermatitis Allergic
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Decubitus Ulcer
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Skin Lesion
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Lichen Planus
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Pityriasis Rubra Pilaris
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Blood glucose Increased
Investigations
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0011 affected1,105 at risk
EG0022 affected1,103 at risk
EG003
Electrocardiogram T Wave Abnormal
Investigations
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Blood Pressure Increased
Investigations
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Liver Function Test Abnormal
Investigations
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Weight Decreased
Investigations
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Blood Creatinine Increased
Investigations
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Blood Urea Increased
Investigations
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Haemoglobin Decreased
Investigations
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Chest X-ray Abnormal
Investigations
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Drug Hypersensitivity
Immune system disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0023 affected1,103 at risk
EG003
Anaphylactic Reaction
Immune system disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Corneal Dystrophy
Congenital, familial and genetic disorders
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Hydrocele
Congenital, familial and genetic disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Gastrointestinal Angiodysplasia
Congenital, familial and genetic disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Abortion Spontaneous
Pregnancy, puerperium and perinatal conditions
MedDRA
Systematic Assessment
EG0001 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Otitis media
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Splenic abscess
Infections and infestations
MedDRa
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Disorientation
Psychiatric disorders
MedDRa
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0021 affected1,103 at risk
EG003
Anxiety
Psychiatric disorders
MedDRa
Systematic Assessment
EG0000 affected1,117 at risk
EG0011 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Gastric neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Acute myeloid leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Biliary neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Bone neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Endometrial cancer stage I
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Lung squamous cell carcinoma stage unspecified
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Malignant neoplasm of pleura
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Metastases to skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Metastases to testicle
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Rectal cancer stage II
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
T-cell lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Biliary cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Gastrointestinal neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Laryngeal cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Metastasis
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Rectal cancer recurrent
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Small cell lung cancer stage unspecified
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Forearm fracture
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Comminuted fracture
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Craniocerebral injury
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Pubis fracture
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Sternal fracture
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Subdural haemorrhage
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Dysplasia
General disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Hepatic lesion
Hepatobiliary disorders
MedDRA
Systematic Assessment
EG0000 affected1,117 at risk
EG0010 affected1,105 at risk
EG0020 affected1,103 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Hypertension
Vascular disorders
MedDRA
Systematic Assessment
EG000345 affected1,117 at risk
EG001372 affected1,105 at risk
EG002302 affected1,103 at risk
EG003319 affected1,122 at risk
EG0040 affected1,280 at risk
EG0050 affected1,250 at risk
Nasopharyngitis
Infections and infestations
MedDRA
Systematic Assessment
EG000216 affected1,117 at risk
EG001202 affected1,105 at risk
EG002121 affected1,103 at risk
EG003
Hyperlipidaemia
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG000236 affected1,117 at risk
EG001144 affected1,105 at risk
EG002193 affected1,103 at risk
EG003
Back Pain
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG000153 affected1,117 at risk
EG001143 affected1,105 at risk
EG00295 affected1,103 at risk
EG003
Bronchitis
Infections and infestations
MedDRA
Systematic Assessment
EG000139 affected1,117 at risk
EG001128 affected1,105 at risk
EG002136 affected1,103 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG000119 affected1,117 at risk
EG001126 affected1,105 at risk
EG00298 affected1,103 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG00051 affected1,117 at risk
EG001190 affected1,105 at risk
EG002162 affected1,103 at risk
EG003
Influenza
Infections and infestations
MedDRA
Systematic Assessment
EG000110 affected1,117 at risk
EG001129 affected1,105 at risk
EG002106 affected1,103 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG000121 affected1,117 at risk
EG00178 affected1,105 at risk
EG002155 affected1,103 at risk
EG003
Oedema peripheral
General disorders
MedDRA
Systematic Assessment
EG000144 affected1,117 at risk
EG00147 affected1,105 at risk
EG002133 affected1,103 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG00060 affected1,117 at risk
EG00181 affected1,105 at risk
EG00244 affected1,103 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG00081 affected1,117 at risk
EG00179 affected1,105 at risk
EG00261 affected1,103 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA
Systematic Assessment
EG000105 affected1,117 at risk
EG00145 affected1,105 at risk
EG00255 affected1,103 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG00051 affected1,117 at risk
EG00197 affected1,105 at risk
EG00249 affected1,103 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA
Systematic Assessment
EG00066 affected1,117 at risk
EG00166 affected1,105 at risk
EG00259 affected1,103 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA
Systematic Assessment
EG00073 affected1,117 at risk
EG00155 affected1,105 at risk
EG00234 affected1,103 at risk
EG003
Headache
Nervous system disorders
MedDRA
Systematic Assessment
EG00066 affected1,117 at risk
EG00161 affected1,105 at risk
EG00258 affected1,103 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG00059 affected1,117 at risk
EG00167 affected1,105 at risk
EG00254 affected1,103 at risk
EG003
Dyslipidaemia
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG00073 affected1,117 at risk
EG00145 affected1,105 at risk
EG00281 affected1,103 at risk
EG003
Cataract
Eye disorders
MedDRA
Systematic Assessment
EG00051 affected1,117 at risk
EG00166 affected1,105 at risk
EG00256 affected1,103 at risk
EG003
Depression
Psychiatric disorders
MedDRA
Systematic Assessment
EG00067 affected1,117 at risk
EG00147 affected1,105 at risk
EG00234 affected1,103 at risk
EG003
Dizziness
Nervous system disorders
MedDRA
Systematic Assessment
EG00060 affected1,117 at risk
EG00138 affected1,105 at risk
EG00246 affected1,103 at risk
EG003
Diabetic neuropathy
Nervous system disorders
MedDRA
Systematic Assessment
EG00054 affected1,117 at risk
EG00153 affected1,105 at risk
EG00287 affected1,103 at risk
EG003
Diabetic retinopathy
Eye disorders
MedDRA
Systematic Assessment
EG00044 affected1,117 at risk
EG00153 affected1,105 at risk
EG00251 affected1,103 at risk
EG003
Viral infection
Infections and infestations
MedDRA
Systematic Assessment
EG00054 affected1,117 at risk
EG00145 affected1,105 at risk
EG00256 affected1,103 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG000102 affected1,117 at risk
EG00182 affected1,105 at risk
EG00262 affected1,103 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
OG003
MET in Addition to Background SU
Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Units
Counts
Participants
OG0001117
OG0011105
OG0021103
OG0031122
Title
Denominators
Categories
Title
Measurements
OG000158
OG001154
OG002163
OG003169
Units
Counts
Participants
OG0002220
OG0012227
Title
Denominators
Categories
Participants with a CV/Microvascular event
Title
Measurements
OG000363
OG001385
Participants with any microvascular event
Title
Measurements
OG00059
OG00178
Participants with any eye event
Title
Measurements
OG00042
OG00152
Participants with any foot event
Title
Measurements
OG00019
OG00128
Participants with any renal event
Title
Measurements
OG0000
OG0010
RSG in Addition to Background SU
Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
OG003
MET in Addition to Background SU
Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Units
Counts
Participants
OG0001117
OG0011105
OG0021103
OG0031122
Title
Denominators
Categories
Title
Measurements
OG000281
OG001451
OG002365
OG003424
Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
OG003
MET in Addition to Background SU
Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Units
Counts
Participants
OG0001117
OG0011105
OG0021103
OG0031122
Title
Denominators
Categories
Participants with an event
Title
Measurements
OG000295
OG001183
OG002344
OG003171
First Event - Triple Therapy
Title
Measurements
OG000257
OG0017
OG002296
OG003
First Event - Insulin
Title
Measurements
OG00038
OG001176
OG00249
OG003
Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
OG003
MET in Addition to Background SU
Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Units
Counts
Participants
OG0001117
OG0011105
OG0021103
OG0031122
Title
Denominators
Categories
Title
Measurements
OG000126
OG001276
OG002168
OG003259
RSG in Addition to Background SU
Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
OG003
MET in Addition to Background SU
Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Units
Counts
Participants
OG0001096
OG0011079
OG0021073
OG0031079
Title
Denominators
Categories
Title
Measurements
OG000-0.14± 0.035
OG0010.17± 0.042
OG002-0.24± 0.039
OG003-0.10± 0.039
OG002
RSG in Addition to Background SU
Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
OG003
MET in Addition to Background SU
Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Units
Counts
Participants
OG0001095
OG0011078
OG0021074
OG0031079
Title
Denominators
Categories
Title
Measurements
OG000-1.38± 0.073
OG001-0.29± 0.090
OG002-2.00± 0.085
OG003-0.94± 0.094
OG002
RSG in Addition to Background SU
Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
OG003
MET in Addition to Background SU
Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Units
Counts
Participants
OG000931
OG001982
OG002882
OG003940
Title
Denominators
Categories
Insulin, Adjusted Change from Baseline
Title
Measurements
OG000-18.6± 1.01
OG0013.7± 1.77
OG002-16.9± 1.65
OG003-12.1± 1.91
Pro-insulin, Adjusted Change from Baseline
Title
Measurements
OG000-2.4± 0.26
OG0014.2± 0.43
OG002-3.2± 0.48
OG003
Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
OG003
MET in Addition to Background SU
Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Units
Counts
Participants
OG0001117
OG0011105
OG0021103
OG0031122
Title
Denominators
Categories
HbA1c Responders
Title
Measurements
OG000265
OG001208
OG002235
OG003180
FPG Responders
Title
Measurements
OG000300
OG001180
OG002257
OG003
OG002
RSG in Addition to Background SU
Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
OG003
MET in Addition to Background SU
Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Units
Counts
Participants
OG000926
OG001977
OG002878
OG003933
Title
Denominators
Categories
Beta cell function
Title
Measurements
OG00020.54(16.52 to 24.70)
OG00119.28(14.66 to 24.09)
OG00232.35(26.55 to 38.41)
OG00312.43(7.42 to 17.67)
Insulin sensitivity
Title
Measurements
OG00042.57(37.57 to 47.76)
OG001-3.45(-7.21 to 0.47)
OG00242.07(36.39 to 47.98)
OG003
Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
OG002
RSG in Addition to Background SU
Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
OG003
MET in Addition to Background SU
Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Units
Counts
Participants
OG0001117
OG0011105
OG0021103
OG0031122
Title
Denominators
Categories
Total cholesterol
Title
Measurements
OG000-5.49(-6.99 to -3.96)
OG001-9.09(-10.33 to -7.84)
OG002-2.91(-4.62 to -1.17)
OG003-9.68(-11.03 to -8.31)
HDL-cholesterol
Title
Measurements
OG0009.95(8.44 to 11.49)
OG0012.57(1.46 to 3.68)
OG0027.73(6.18 to 9.30)
OG003
LDL-cholesterol
Title
Measurements
OG000-12.70(-15.03 to -10.30)
OG001-17.68(-19.70 to -15.61)
OG002-8.99(-11.42 to -6.49)
OG003
Triglycerides
Title
Measurements
OG000-7.97(-10.72 to -5.15)
OG001-1.95(-4.73 to 0.91)
OG002-2.68(-5.69 to 0.43)
OG003
Free fatty acids
Title
Measurements
OG000-16.46(-19.13 to -13.71)
OG0012.79(-0.23 to 5.91)
OG002-11.58(-14.65 to -8.41)
OG003
Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
OG002
RSG in Addition to Background SU
Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
OG003
MET in Addition to Background SU
Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Units
Counts
Participants
OG0001117
OG0011105
OG0021103
OG0031122
Title
Denominators
Categories
Total Cholesterol: HDL Cholesterol Ratio
Title
Measurements
OG000-14.20(-15.98 to -12.39)
OG001-11.33(-12.82 to -9.81)
OG002-9.93(-11.83 to -7.98)
OG003-15.01(-16.44 to -13.55)
LDL Cholesterol: HDL-Cholesterol Ratio
Title
Measurements
OG000-20.89(-23.24 to -18.46)
OG001-20.04(-22.16 to -17.87)
OG002-15.85(-18.26 to -13.37)
OG003
OG002
RSG in Addition to Background SU
Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
OG003
MET in Addition to Background SU
Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Units
Counts
Participants
OG000949
OG0011007
OG002906
OG003970
Title
Denominators
Categories
Title
Measurements
OG000-13.77(-15.45 to -12.05)
OG001-11.63(-13.10 to -10.14)
OG002-9.68(-11.55 to -7.77)
OG003-12.09(-13.67 to -10.47)
OG002
RSG in Addition to Background SU
Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
OG003
MET in Addition to Background SU
Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Units
Counts
Participants
OG000899
OG001921
OG002891
OG003901
Title
Denominators
Categories
Title
Measurements
OG0008.31(-0.70 to 18.14)
OG00115.17(6.73 to 24.28)
OG002-3.43(-11.91 to 5.87)
OG00311.91(3.10 to 21.46)
RSG in Addition to Background SU
Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
OG003
MET in Addition to Background SU
Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Units
Counts
Participants
OG0001096
OG0011079
OG0021073
OG0031079
Title
Denominators
Categories
Title
Measurements
OG0003.93± 0.263
OG001-0.54± 0.192
OG0024.72± 0.235
OG003-2.16± 0.179
RSG in Addition to Background SU
Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
OG003
MET in Addition to Background SU
Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Units
Counts
Participants
OG0001094
OG0011077
OG0021073
OG0031078
Title
Denominators
Categories
Title
Measurements
OG000-37.43(-39.22 to -35.59)
OG001-21.73(-23.90 to -19.50)
OG002-30.17(-31.98 to -28.31)
OG003-24.00(-26.21 to -21.73)
RSG in Addition to Background SU
Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4mg once daily dose and was increased to a maximum dose of 8mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
OG003
MET in Addition to Background SU
Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Units
Counts
Participants
OG000972
OG0011032
OG002926
OG003994
Title
Denominators
Categories
Title
Measurements
OG0002.70± 0.266
OG0010.65± 0.214
OG0023.00± 0.263
OG003-0.60± 0.215
OG002
RSG in Addition to Background SU
Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4mg once daily dose and was increased to a maximum dose of 8mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
OG003
MET in Addition to Background SU
Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Units
Counts
Participants
OG0001096
OG0011079
OG0021074
OG0031079
Title
Denominators
Categories
SBP
Title
Measurements
OG000-1.9± 0.54
OG001-2.2± 0.52
OG002-2.3± 0.52
OG003-0.6± 0.53
DBP
Title
Measurements
OG000-3.6± 0.34
OG001-3.4± 0.29
OG002-3.6± 0.31
OG003
OG002
RSG in Addition to Background SU
Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4mg once daily dose and was increased to a maximum dose of 8mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
OG003
MET in Addition to Background SU
Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Units
Counts
Participants
OG000942
OG001987
OG002887
OG003952
Title
Denominators
Categories
Title
Measurements
OG000-57.40(-60.41 to -54.15)
OG001-28.92(-33.71 to -23.79)
OG002-56.50(-61.56 to -55.21)
OG003-36.29(-41.03 to -31.17)
OG002
RSG in Addition to Background SU
Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4mg once daily dose and was increased to a maximum dose of 8mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
OG003
MET in Addition to Background SU
Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Units
Counts
Participants
OG000918
OG001987
OG002875
OG003941
Title
Denominators
Categories
Title
Measurements
OG0002.12(0.54 to 3.72)
OG0015.74(4.22 to 7.28)
OG002-0.23(-1.79 to 1.35)
OG0033.14(1.38 to 4.93)
OG002
RSG in Addition to Background SU
Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4mg once daily dose and was increased to a maximum dose of 8mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
OG003
MET in Addition to Background SU
Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Units
Counts
Participants
OG000931
OG001991
OG002882
OG003939
Title
Denominators
Categories
Title
Measurements
OG000-9.85(-14.42 to -5.02)
OG00115.01(9.77 to 20.50)
OG002-7.79(-12.61 to -2.71)
OG003-0.64(-5.82 to 4.83)
Units
Counts
Participants
OG0002220
OG0012227
Title
Denominators
Categories
Title
Measurements
OG000139
OG001160
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Hazard Ratio (HR)
0.86
95
0.68
1.08
Superiority or Other
Units
Counts
Participants
OG0002220
OG0012227
Title
Denominators
Categories
Title
Measurements
OG000181
OG001188
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Hazard Ratio (HR)
0.95
95
0.78
1.17
Superiority or Other
Units
Counts
Participants
OG0002220
OG0012227
Title
Denominators
Categories
Title
Measurements
OG000186
OG001191
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Hazard Ratio (HR)
0.97
95
0.79
1.18
Superiority or Other
Units
Counts
Participants
OG0002220
OG0012227
Title
Denominators
Categories
Title
Measurements
OG00088
OG00196
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Hazard Ratio (HR)
0.90
95
0.68
1.21
Superiority or Other
Units
Counts
Participants
OG0002220
OG0012227
Title
Denominators
Categories
Title
Measurements
OG00088
OG00196
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Hazard Ratio (HR)
0.90
95
0.68
1.21
Superiority or Other
Units
Counts
Participants
OG0002220
OG0012227
Title
Denominators
Categories
Title
Measurements
OG00068
OG00160
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Hazard Ratio (HR)
1.13
95
0.80
1.59
Superiority or Other
Units
Counts
Participants
OG0002220
OG0012227
Title
Denominators
Categories
Title
Measurements
OG00072
OG00162
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Hazard Ratio (HR)
1.15
95
0.82
1.62
Superiority or Other
Units
Counts
Participants
OG0002220
OG0012227
Title
Denominators
Categories
Title
Measurements
OG00050
OG00163
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Hazard Ratio (HR)
0.79
95
0.54
1.14
Superiority or Other
Units
Counts
Participants
OG0002220
OG0012227
Title
Denominators
Categories
Title
Measurements
OG00053
OG00164
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Hazard Ratio (HR)
0.82
95
0.57
1.18
Superiority or Other
OG001
Combined MET/SU: Main Study and Observational Follow-up
Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
Units
Counts
Participants
OG0002220
OG0012227
Title
Denominators
Categories
All neoplasms/cancer (N/C) (benign/malignant)
Title
Measurements
OG000196
OG001215
Malignant (Mal.) N/C
Title
Measurements
OG000179
OG001195
Mal. N/C; excluding non-melanomatous skin cancers
Title
Measurements
OG000164
OG001186
OG001
Combined MET/SU: Observational Follow-up
Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
Units
Counts
Participants
OG0001280
OG0011250
Title
Denominators
Categories
All neoplasms/cancer (N/C) (benign/malignant)
Title
Measurements
OG00060
OG00151
Malignant (Mal.) N/C
Title
Measurements
OG00059
OG00151
Mal. N/C; excluding non-melanomatous skin cancers
Title
Measurements
OG00055
OG00146
OG001
Combined MET/SU: Main Study and Observational Follow-up
Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
Units
Counts
Participants
OG0002220
OG0012227
Title
Denominators
Categories
Any genitourinary
Title
Measurements
OG00057
OG00157
Prostate
Title
Measurements
OG00022
OG00122
Renal
Title
Measurements
OG00012
OG0019
Uterine
Title
Measurements
OG00011
OG00116
Bladder
Title
Measurements
OG0008
OG0015
Vaginal/vulvar
Title
Measurements
OG0001
OG0011
Ovarian
Title
Measurements
OG0005
OG0014
Any gastrointestinal
Title
Measurements
OG00048
OG00162
Colon/rectal cancer
Title
Measurements
OG00022
OG00130
Colon
Title
Measurements
OG00014
OG00121
Gastric
Title
Measurements
OG00013
OG0015
Pancreatic
Title
Measurements
OG0005
OG00116
Liver
Title
Measurements
OG0004
OG0015
Gall bladder/biliary
Title
Measurements
OG0004
OG0015
Gastrointestinal; not specified
Title
Measurements
OG0000
OG0011
Any hematologic
Title
Measurements
OG00012
OG0016
Lung
Title
Measurements
OG00019
OG00115
Skin (non-melanomatous)
Title
Measurements
OG00019
OG00113
Skin (melanomatous)
Title
Measurements
OG0006
OG0014
Metastases
Title
Measurements
OG00012
OG00118
Breast
Title
Measurements
OG00012
OG00123
Head and neck
Title
Measurements
OG0004
OG0017
Neurologic
Title
Measurements
OG0003
OG0013
Endocrine
Title
Measurements
OG0003
OG0016
Not specified
Title
Measurements
OG0000
OG0011
Other
Title
Measurements
OG0000
OG0013
OG001
Combined MET/SU: Observational Follow-up
Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
Units
Counts
Participants
OG0001280
OG0011250
Title
Denominators
Categories
Any genitourinary
Title
Measurements
OG00018
OG0018
Prostate
Title
Measurements
OG0007
OG0011
Renal
Title
Measurements
OG0005
OG0012
Uterine
Title
Measurements
OG0004
OG0014
Bladder
Title
Measurements
OG0002
OG0010
Vaginal/vulvar
Title
Measurements
OG0000
OG0011
Ovarian
Title
Measurements
OG0000
OG0010
Any gastrointestinal
Title
Measurements
OG00017
OG00119
Colon/rectal cancer
Title
Measurements
OG0005
OG00111
Colon
Title
Measurements
OG0002
OG0017
Gastric
Title
Measurements
OG0005
OG0011
Pancreatic
Title
Measurements
OG0004
OG0013
Liver
Title
Measurements
OG0002
OG0012
Gall bladder/biliary
Title
Measurements
OG0001
OG0011
Gastrointestinal; not specified
Title
Measurements
OG0000
OG0011
Any hematologic
Title
Measurements
OG0006
OG0011
Lung
Title
Measurements
OG0006
OG0016
Skin (non-melanomatous)
Title
Measurements
OG0006
OG0015
Skin (melanomatous)
Title
Measurements
OG0003
OG0012
Metastases
Title
Measurements
OG0003
OG0016
Breast
Title
Measurements
OG0002
OG0017
Head and neck
Title
Measurements
OG0002
OG0011
Neurologic
Title
Measurements
OG0001
OG0011
Endocrine
Title
Measurements
OG0000
OG0011
Not specified
Title
Measurements
OG0000
OG0010
Other
Title
Measurements
OG0000
OG0010
OG001
Combined MET/SU: Main Study and Observational Follow-up
Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
Units
Counts
Participants
OG0002220
OG0012227
Title
Denominators
Categories
Any cancer-related death
Title
Measurements
OG00059
OG00172
Any gastrointestinal event
Title
Measurements
OG00025
OG00134
Pancreatic
Title
Measurements
OG0004
OG00112
Colon/rectal
Title
Measurements
OG0006
OG00111
Gastric
Title
Measurements
OG0007
OG0013
Liver
Title
Measurements
OG0004
OG0014
Gall bladder/biliary
Title
Measurements
OG0004
OG0013
Gastrointestinal event; not specified
Title
Measurements
OG0000
OG0011
Any genitourinary event
Title
Measurements
OG0006
OG00115
Renal
Title
Measurements
OG0002
OG0013
Uterine
Title
Measurements
OG0001
OG0015
Prostate
Title
Measurements
OG0001
OG0012
Bladder
Title
Measurements
OG0001
OG0013
Ovarian
Title
Measurements
OG0001
OG0012
Lung
Title
Measurements
OG00013
OG00111
Any hematologic event
Title
Measurements
OG0004
OG0010
Skin (melanoma)
Title
Measurements
OG0003
OG0010
Skin (non-melanomatous)
Title
Measurements
OG0001
OG0010
Metastases
Title
Measurements
OG0002
OG0014
Breast
Title
Measurements
OG0002
OG0013
Head and neck
Title
Measurements
OG0001
OG0012
Any neurologic event
Title
Measurements
OG0002
OG0012
Endocrine
Title
Measurements
OG0001
OG0010
Not specified
Title
Measurements
OG0000
OG0011
OG001
Combined MET/SU: Observational Follow-up
Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
Units
Counts
Participants
OG0001280
OG0011250
Title
Denominators
Categories
Any cancer-related death
Title
Measurements
OG00025
OG00124
Any gastrointestinal event
Title
Measurements
OG00010
OG00114
Pancreatic
Title
Measurements
OG0003
OG0013
Colon/rectal
Title
Measurements
OG0002
OG0016
Gastric
Title
Measurements
OG0002
OG0011
Liver
Title
Measurements
OG0002
OG0012
Gall bladder/biliary
Title
Measurements
OG0001
OG0011
Gastrointestinal event; not specified
Title
Measurements
OG0000
OG0011
Any genitourinary event
Title
Measurements
OG0002
OG0010
Renal
Title
Measurements
OG0001
OG0010
Uterine
Title
Measurements
OG0001
OG0010
Prostate
Title
Measurements
OG0000
OG0010
Bladder
Title
Measurements
OG0000
OG0010
Ovarian
Title
Measurements
OG0000
OG0010
Lung
Title
Measurements
OG0004
OG0015
Any hematologic event
Title
Measurements
OG0004
OG0010
Skin (melanoma)
Title
Measurements
OG0001
OG0010
Skin (non-melanomatous)
Title
Measurements
OG0001
OG0010
Metastases
Title
Measurements
OG0001
OG0011
Breast
Title
Measurements
OG0001
OG0013
Head and neck
Title
Measurements
OG0001
OG0010
Any neurologic event
Title
Measurements
OG0001
OG0011
Endocrine
Title
Measurements
OG0000
OG0010
Not specified
Title
Measurements
OG0000
OG0010
Units
Counts
Participants
OG0002220
OG0012227
Title
Denominators
Categories
Overall, n=2220, 2227
Title
Measurements
OG000238
OG001151
Male, n=1142, 1152
Title
Measurements
OG00082
OG00160
Female, n=1078, 1075
Title
Measurements
OG000156
OG00191
Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
Units
Counts
Participants
OG0001280
OG0011250
Title
Denominators
Categories
Overall, n=1280, 1250
Title
Measurements
OG00064
OG00137
Male, n=665, 635
Title
Measurements
OG00025
OG00111
Female, n=615, 615
Title
Measurements
OG00039
OG00126
OG001
Combined MET/SU: Main Study and Observational Follow-up
Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
Units
Counts
Participants
OG0002220
OG0012227
Title
Denominators
Categories
Any event
Title
Measurements
OG00081
OG00157
Upper limb
Title
Measurements
OG00041
OG00117
Distal lower limb
Title
Measurements
OG00024
OG00116
Femur/hip
Title
Measurements
OG00015
OG00111
Spinal
Title
Measurements
OG0007
OG0019
Pelvic
Title
Measurements
OG0000
OG0013
Other
Title
Measurements
OG0007
OG0014
OG001
Combined MET/SU: Observational Follow-up
Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
Units
Counts
Participants
OG0001280
OG0011250
Title
Denominators
Categories
Any event
Title
Measurements
OG00035
OG00121
Upper limb
Title
Measurements
OG00017
OG0015
Distal lower limb
Title
Measurements
OG0009
OG0018
Femur/hip
Title
Measurements
OG0006
OG0014
Spinal
Title
Measurements
OG0002
OG0013
Pelvic
Title
Measurements
OG0000
OG0011
Other
Title
Measurements
OG0002
OG0011
Units
Counts
Participants
OG0002220
OG0012227
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
Units
Counts
Participants
OG0002220
OG0012227
Title
Denominators
Categories
Any event, overall; n=2220, 2227
Title
Measurements
OG000238
OG001151
Any event, male; n=1142, 1152
Title
Measurements
OG00082
OG00160
Any event, female; n=1078, 1075
Title
Measurements
OG000156
OG00191
Upper limb, any event, overall; n=2220, 2227
Title
Measurements
OG000116
OG00170
Upper limb, any event, male; n=1142, 1152
Title
Measurements
OG00032
OG00122
Upper limb, any event, female; n=1078, 1075
Title
Measurements
OG00084
OG00148
Distal lower limb, any event, overall; n=2220, 222
Title
Measurements
OG00088
OG00140
Distal lower limb, any event, male; n=1142, 1152
Title
Measurements
OG00031
OG00114
Distal lower limb, any event, female; n=1078, 1075
Title
Measurements
OG00057
OG00126
Femur/hip, any event, overall; n=2220, 2227
Title
Measurements
OG00016
OG00113
Femur/hip, any event, male; n=1142, 1152
Title
Measurements
OG0004
OG0011
Femur/hip, any event, female; n=1078, 1075
Title
Measurements
OG00012
OG00112
Spinal, any event, overall; n=2220, 2227
Title
Measurements
OG00018
OG00114
Spinal, any event, male; n=1142, 1152
Title
Measurements
OG0007
OG0019
Spinal, any event, female; n=1078, 1075
Title
Measurements
OG00011
OG0015
Pelvic, any event, overall; n=2220, 2227
Title
Measurements
OG0000
OG0015
Pelvic, any event, male; n=1142, 1152
Title
Measurements
OG0000
OG0014
Pelvic, any event, female; n=1078, 1075
Title
Measurements
OG0000
OG0011
Unclassified, any event, overall; n=2220, 2227
Title
Measurements
OG0001
OG0010
Unclassified, any event, male; n=1142, 1152
Title
Measurements
OG0001
OG0010
Unclassified, any event, female; n=1078, 1075
Title
Measurements
OG0000
OG0010
Other, any event, overall; n=2220, 2227
Title
Measurements
OG00031
OG00126
Other, any event, male; n=1142, 1152
Title
Measurements
OG00018
OG00116
Other, any event, female; n=1078, 1075
Title
Measurements
OG00013
OG00110
Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
Units
Counts
Participants
OG0001280
OG0011250
Title
Denominators
Categories
Any event, overall; n=1280, 1250
Title
Measurements
OG00064
OG00137
Any event, male; n=665, 635
Title
Measurements
OG00025
OG00111
Any event, female; n=615, 615
Title
Measurements
OG00039
OG00126
Upper limb, any event, overall; n=1280, 1250
Title
Measurements
OG00033
OG00115
Upper limb, any event, male; n=665, 635
Title
Measurements
OG00010
OG0013
Upper limb, any event, female; n=615, 615
Title
Measurements
OG00023
OG00112
Distal lower limb, any event, overall; n=1280,1250
Title
Measurements
OG00018
OG00113
Distal lower limb, any event, male; n=665, 635
Title
Measurements
OG0009
OG0014
Distal lower limb, any event, female; n=615, 615
Title
Measurements
OG0009
OG0019
Femur/hip, any event, overall; n=1280, 1250
Title
Measurements
OG0006
OG0015
Femur/hip, any event, male; n=665, 635
Title
Measurements
OG0001
OG0010
Femur/hip, any event, female; n=615, 615
Title
Measurements
OG0005
OG0015
Spinal, any event, overall; n=1280, 1250
Title
Measurements
OG0004
OG0015
Spinal, any event, male; n=665, 635
Title
Measurements
OG0001
OG0014
Spinal, any event, female; n=615, 615
Title
Measurements
OG0003
OG0011
Pelvic, any event, overall; n=1280, 1250
Title
Measurements
OG0000
OG0011
Pelvic, any event, male; n=665, 635
Title
Measurements
OG0000
OG0011
Pelvic, any event, female; n=615, 615
Title
Measurements
OG0000
OG0010
Unclassified, any event, overall; n=1280, 1250
Title
Measurements
OG0001
OG0010
Unclassified, any event, male; n=665, 635
Title
Measurements
OG0001
OG0010
Unclassified, any event, female; n=615, 615
Title
Measurements
OG0000
OG0010
Other, any event, overall; n=1280, 1250
Title
Measurements
OG0006
OG0011
Other, any event, male; n=665, 635
Title
Measurements
OG0004
OG0011
Other, any event, female; n=615, 615
Title
Measurements
OG0002
OG0010
Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
Units
Counts
Participants
OG0002220
OG0012227
Title
Denominators
Categories
Any event, overall, n=2220, 2227
Title
Measurements
OG00031
OG00131
Any event, male, n=1142, 1152
Title
Measurements
OG00010
OG00113
Any event, female, n=1078, 1075
Title
Measurements
OG00021
OG00118
Hip, overall, n=2220, 2227
Title
Measurements
OG0009
OG0017
Hip, male, n=1142, 1152
Title
Measurements
OG0000
OG0011
Hip, female, n=1078, 1075
Title
Measurements
OG0009
OG0016
Pelvis, overall, n=2220, 2227
Title
Measurements
OG0000
OG0015
Pelvis, male, n=1142, 1152
Title
Measurements
OG0000
OG0014
Pelvis, female, n=1078, 1075
Title
Measurements
OG0000
OG0011
Upper leg, overall, n=2220, 2227
Title
Measurements
OG0007
OG0016
Upper leg, male, n=1142, 1152
Title
Measurements
OG0004
OG0010
Upper leg, female, n=1078, 1075
Title
Measurements
OG0003
OG0016
Any vertebral event, overall, n=2220, 2227
Title
Measurements
OG00016
OG00113
Any vertebral event, male, n=1142, 1152
Title
Measurements
OG0006
OG0018
Any vertebral event, female, n=1078, 1075
Title
Measurements
OG00010
OG0015
Lumbar spine, overall, n=2220, 2227
Title
Measurements
OG00010
OG0014
Lumbar spine, male, n=1142, 1152
Title
Measurements
OG0005
OG0013
Lumbar spine, female, n=1078, 1075
Title
Measurements
OG0005
OG0011
Thoracic spine, overall, n=2220, 2227
Title
Measurements
OG0005
OG0018
Thoracic spine, male, n=1142, 1152
Title
Measurements
OG0001
OG0014
Thoracic spine, female, n=1078, 1075
Title
Measurements
OG0004
OG0014
Cervical spine, overall, n=2220, 2227
Title
Measurements
OG0001
OG0011
Cervical spine, male, n=1142, 1152
Title
Measurements
OG0000
OG0011
Cervical spine, female, n=1078, 1075
Title
Measurements
OG0001
OG0010
OG001
Combined MET/SU: Main Study and Observational Follow-up
Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
Units
Counts
Participants
OG0001280
OG0011250
Title
Denominators
Categories
Any event
Title
Measurements
OG00064
OG00137
Non-traumatic event,
Title
Measurements
OG00036
OG00114
Traumatic event
Title
Measurements
OG00024
OG00117
Pathologic
Title
Measurements
OG0001
OG0012
Unknown
Title
Measurements
OG0001
OG0014
Data unavailable
Title
Measurements
OG0003
OG0011
Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
Units
Counts
Participants
OG0002220
OG0012227
Title
Denominators
Categories
Number of bone fracture events
Title
Measurements
OG000299
OG001174
Unknown
Title
Measurements
OG0007
OG0015
Normal healing with standard management
Title
Measurements
OG000250
OG001142
Complication
Title
Measurements
OG00014
OG00113
Additional therapeutic measures required
Title
Measurements
OG00016
OG0019
Data unavailable
Title
Measurements
OG00012
OG0015
Combined MET/SU: Observational Follow-up
Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
Units
Counts
Participants
OG0001280
OG0011250
Title
Denominators
Categories
Number of bone fracture events
Title
Measurements
OG00070
OG00141
Unknown
Title
Measurements
OG0001
OG0011
Normal healing with standard management
Title
Measurements
OG00051
OG00133
Complication
Title
Measurements
OG0007
OG0014
Additional therapeutic measures required
Title
Measurements
OG0003
OG0012
Data unavailable
Title
Measurements
OG0008
OG0011
OG001
Combined MET/SU: Observational Follow-up
Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.