Hyperglycemia and Cardiovascular Outcomes With Type 2 Dia... | NCT00191282

ID	Type	Description	Link
F3Z-MC-IONM	Other Identifier	Eli Lilly and Company

Label	Type	Description	Intervention Names
1	Experimental	Postprandial: Premeal insulin lispro +/- bedtime NPH	Drug: Insulin lispro Drug: Human insulin isophane suspension (NPH)
2	Active Comparator	Fasting: NPH/insulin glargine or human insulin 30/70	Drug: Insulin glargine Drug: Human insulin isophane suspension Drug: Human insulin 30/70

Name	Type	Description	Arm Group Labels	Other Names
Insulin lispro	Drug	Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study	1

Measure	Description	Time Frame
Number of Participants Who Experienced a Primary Combined Outcome	The combined study outcomes consisted of cardiovascular (CV) death, nonfatal myocardial infarction (MI), nonfatal stroke, hospitalization for acute coronary syndromes (HACS), and coronary revascularization procedures planned after randomization.	Randomization (Day 0) until first occurrence of primary combined outcome (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)

Measure	Description	Time Frame
Number of Participants Who Experienced Death From Any Cause or Any One of the Primary Outcomes	Primary outcomes in this study consisted of: cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, hospitalization for acute coronary syndromes (HACS), and coronary revascularization procedure planned after randomization.	Randomization (Day 0) until death from any cause or one of the primary outcomes (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)

Measure	Description	Time Frame
Summary of Reasons for Deaths		Randomization (Day 0) to death (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)

Name	Affiliation	Role
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9am-5pm Eastern time (UTC/GMT - 5 hours, EST)	Eli Lilly and Company	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
For additional information regarding investigative sites for this trial, please call 1-877-CTLILLY (1-877-285-4559, 1-317-651-4559), Monday-Friday, 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician		Toronto	Ontario

PubMed Identifier	Type	Citation	Retractions
19246588	Result	Raz I, Wilson PW, Strojek K, Kowalska I, Bozikov V, Gitt AK, Jermendy G, Campaigne BN, Kerr L, Milicevic Z, Jacober SJ. Effects of prandial versus fasting glycemia on cardiovascular outcomes in type 2 diabetes: the HEART2D trial. Diabetes Care. 2009 Mar;32(3):381-6. doi: 10.2337/dc08-1671.
18227478	Result	Milicevic Z, Raz I, Beattie SD, Campaigne BN, Sarwat S, Gromniak E, Kowalska I, Galic E, Tan M, Hanefeld M. Natural history of cardiovascular disease in patients with diabetes: role of hyperglycemia. Diabetes Care. 2008 Feb;31 Suppl 2:S155-60. doi: 10.2337/dc08-s240.

ID	Title	Description
FG000	Postprandial	Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.

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 Who Experienced a Primary Combined Outcome

The combined study outcomes consisted of cardiovascular (CV) death, nonfatal myocardial infarction (MI), nonfatal stroke, hospitalization for acute coronary syndromes (HACS), and coronary revascularization procedures planned after randomization.

All randomized patients who took at least one dose of study drug

Posted

Number

participants

Randomization (Day 0) until first occurrence of primary combined outcome (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)

ID	Title	Description
OG000	Postprandial	Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
OG001	Fasting	Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.

Units	Counts
Participants	OG000557 OG001558

Title

Denominators

Categories

Title	Measurements
	OG000174 OG001181

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	To achieve 80% power, 490 pts need to experience primary combined CV outcome to detect diff. between treatments, assuming: >=18.5% reduction in incidence of outcomes, 18 mo. pt recruitment, 18 mo. pt follow-up, 10% annual drop-out rate, 2-yr outcome incidence rate of >=40% (pts in least efficacious treatment), and nominal 2-sided signif. of 0.045.	Log Rank		0.866		Hazard Ratio (HR)	0.98				95						No	Superiority or Other

Secondary

Number of Participants Who Experienced Death From Any Cause or Any One of the Primary Outcomes

Primary outcomes in this study consisted of: cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, hospitalization for acute coronary syndromes (HACS), and coronary revascularization procedure planned after randomization.

All randomized patients who took at least one dose of study drug.

Posted

Number

participants

Randomization (Day 0) until death from any cause or one of the primary outcomes (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)

ID	Title	Description
OG000	Postprandial	Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
OG001	Fasting	Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.

Secondary

Number of Participants Who Experienced Any One of the Primary Outcomes Adjusted for Indicators of Metabolic Control

Indicators of metabolic control included glycosylated hemoglobin (HbA1c) and fasting blood glucose concentrations.

All randomized patients who took at least one dose of study drug.

Posted

Number

participants

Randomization (Day 0) until occurrence of primary outcome (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)

ID	Title	Description
OG000	Postprandial	Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
OG001	Fasting	Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.

Secondary

Number of Participants Who Experienced Primary Outcomes Adjusted for Metabolic Control and Major Cardiovascular (CV) Risk Factors

Primary outcomes adjusted for major cardiovascular (CV) risk factors (blood pressure, cholesterol [total, high density lipoprotein (HDL), and low density lipoprotein (LDL)], triglycerides, smoking, albuminuria, age, gender, and body mass index (BMI).

All randomized patients who took at least one dose of study drug.

Posted

Number

participants

Randomization (Day 0) until occurrence of primary outcome (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)

ID	Title	Description
OG000	Postprandial	Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
OG001	Fasting	Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.

Secondary

Number of Participants Who Experienced Death From Any Cause

All randomized patients who took at least one dose of study drug.

Posted

Number

participants

Randomization (Day 0) until death from any cause (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)

ID	Title	Description
OG000	Postprandial	Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
OG001	Fasting	Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.

Units	Counts

Secondary

Number of Participants Who Experienced Cardiovascular (CV) Death

All randomized patients who took at least one dose of study drug.

Posted

Number

participants

Randomization (Day 0) until cardiovascular death (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)

ID	Title	Description
OG000	Postprandial	Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
OG001	Fasting	Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.

Units	Counts

Secondary

Number of Participants Who Experienced Myocardial Infarction (MI)

Occurrence of myocardial infarction (MI) (fatal, nonfatal, any).

All randomized patients who took at least one dose of study drug.

Posted

Number

participants

Randomization (Day 0) until myocardial infarction (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)

ID	Title	Description
OG000	Postprandial	Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
OG001	Fasting	Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.

Secondary

Number of Participants Who Experienced Stroke

Occurrence of stroke (fatal, nonfatal, any).

All randomized patients who took at least one dose of study drug.

Posted

Number

participants

Randomization (Day 0) until stroke (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)

ID	Title	Description
OG000	Postprandial	Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
OG001	Fasting	Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.

Secondary

Number of Participants Who Experienced Hospitalization for Acute Coronary Syndromes (HACS)

All randomized patients who took at least one dose of study drug.

Posted

Number

participants

Randomization (Day 0) until HACS (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)

ID	Title	Description
OG000	Postprandial	Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
OG001	Fasting	Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.

Units	Counts

Secondary

Number of Participants Who Experienced Coronary Revascularization Procedures

Occurrence of all coronary revascularization procedures (angioplasty or coronary artery by-pass surgery) planned after randomization.

All randomized patients who took at least one dose of study drug.

Posted

Number

participants

Randomization (Day 0) until coronary revascularization procedures (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)

ID	Title	Description
OG000	Postprandial	Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
OG001	Fasting	Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.

Secondary

Number of Participants Who Experienced Amputation for Peripheral Vascular Disease Planned After Randomization

All randomized patients who took at least one dose of study drug.

Posted

Number

participants

Randomization (Day 0) until amputation (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)

ID	Title	Description
OG000	Postprandial	Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
OG001	Fasting	Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.

Units

Secondary

Number of Participants Who Experienced Congestive Heart Failure

Occurrence of congestive heart failure (newly diagnosed after Visit 2).

All randomized patients who took at least one dose of study drug.

Posted

Number

participants

Randomization (Day 0) until congestive heart failure (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)

ID	Title	Description
OG000	Postprandial	Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
OG001	Fasting	Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.

Secondary

Number of Participants Who Experienced Revascularization Procedure for Peripheral Vascular Disease Planned After Randomization

All randomized patients who took at least one dose of study drug.

Posted

Number

participants

Randomization (Day 0) until revascularization procedure (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)

ID	Title	Description
OG000	Postprandial	Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
OG001	Fasting	Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.

Secondary

Number of Participants Who Experienced Coronary Angiography Planned After Randomization

All randomized patients who took at least one dose of study drug.

Posted

Number

participants

Randomization (Day 0) until coronary angiography (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)

ID	Title	Description
OG000	Postprandial	Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
OG001	Fasting	Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.

Units	Counts

Secondary

Number of Participants With Self-Reported Hypoglycemia During Month 1

Hypoglycemia was defined as any time a patient feels, or another person observes, that the patient is experiencing a sign/symptom which he/she would associate with hypoglycemia (for example, tremors, headache, sweating, disorientation, weakness, etc) or a blood glucose measurement less than 3.5 mmol/L (63 mg/dL).

All randomized patients who took at least one dose of study drug.

Posted

Number

participants

Visit 3 (Month 1)

ID	Title	Description
OG000	Postprandial	Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
OG001	Fasting	Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.

Secondary

Number of Episodes of Self-Reported Hypoglycemia Reported by Participants With Self-Reported Hypoglycemia During Month 1

All randomized participants who self-reported hypoglycemia during Month 1.

Posted

Number

episodes of hypoglycemia

Visit 3 (Month 1)

ID	Title	Description
OG000	Postprandial	Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
OG001	Fasting	Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.

Secondary

Number of Participants With Self-Reported Hypoglycemia During Month 3

All randomized patients who took at least one dose of study drug and who were still in the study.

Posted

Number

participants

Visit 4 (Month 3)

ID	Title	Description
OG000	Postprandial	Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
OG001	Fasting	Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.

Secondary

Number of Episodes of Self-Reported Hypoglycemia Reported by Participants With Self-Reported Hypoglycemia During Month 3

All randomized participants who self-reported hypoglycemia during Month 3.

Posted

Number

episodes of hypoglycemia

Visit 4 (Month 3)

ID	Title	Description
OG000	Postprandial	Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
OG001	Fasting	Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.

Secondary

Number of Participants With Self-Reported Hypoglycemia During Month 6

All randomized patients who took at least one dose of study drug and who were still in the study.

Posted

Number

participants

Visit 5 (Month 6)

ID	Title	Description
OG000	Postprandial	Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
OG001	Fasting	Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.

Other Pre-specified

Summary of Reasons for Deaths

All randomized patients who took at least one dose of study drug.

Posted

Number

participants

Randomization (Day 0) to death (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)

ID	Title	Description
OG000	Postprandial	Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
OG001	Fasting	Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.

Units	Counts
Participants

Secondary

Number of Episodes of Self-Reported Hypoglycemia Reported by Participants With Self-Reported Hypoglycemia During Month 6

All randomized participants with self-reported hypoglycemia during Month 6.

Posted

Number

episodes of hypoglycemia

Visit 5 (Month 6)

ID	Title	Description
OG000	Postprandial	Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
OG001	Fasting	Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.

Secondary

Number of Participants With Self-Reported Hypoglycemia During Month 9

All randomized patients who took at least one dose of study drug and who were still in the study.

Posted

Number

participants

Visit 6 (Month 9)

ID	Title	Description
OG000	Postprandial	Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
OG001	Fasting	Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.

Secondary

Number of Episodes of Self-Reported Hypoglycemia Reported by Participants With Self-Reported Hypoglycemia During Month 9

All randomized participants with self-reported hypoglycemia during Month 9.

Posted

Number

episodes of hypoglycemia

Visit 6 (Month 9)

ID	Title	Description
OG000	Postprandial	Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
OG001	Fasting	Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.

Secondary

Number of Participants With Self-Reported Hypoglycemia During Month 12

All randomized patients who took at least one dose of study drug and who were still in the study.

Posted

Number

participants

Visit 7 (Month 12)

ID	Title	Description
OG000	Postprandial	Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
OG001	Fasting	Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.

Secondary

Number of Episodes of Self-Reported Hypoglycemia Reported by Participants With Self-Reported Hypoglycemia During Month 12

All randomized participants with self-reported hypoglycemia during Month 12.

Posted

Number

episodes of hypoglycemia

Visit 7 (Month 12)

ID	Title	Description
OG000	Postprandial	Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
OG001	Fasting	Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.

Secondary

Number of Participants With Self-Reported Hypoglycemia During Month 18

All randomized patients who took at least one dose of study drug and who were still in the study.

Posted

Number

participants

Visit 8 (Month 18)

ID	Title	Description
OG000	Postprandial	Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
OG001	Fasting	Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.

Secondary

Number of Episodes of Self-Reported Hypoglycemia Reported by Participants With Self-Reported Hypoglycemia During Month 18

All randomized participants with self-reported hypoglycemia during Month 18.

Posted

Number

episodes of hypoglycemia

Visit 8 (Month 18)

ID	Title	Description
OG000	Postprandial	Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
OG001	Fasting	Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0011 events1 affected558 at risk
Hypochromic anaemia	Blood and lymphatic system disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0010 events0 affected558 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0011 events1 affected558 at risk
Normochromic normocytic anaemia	Blood and lymphatic system disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0010 events0 affected558 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0011 events1 affected558 at risk
Acute left ventricular failure	Cardiac disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0010 events0 affected558 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0012 events2 affected558 at risk
Angina pectoris	Cardiac disorders	MedDRA 10.1	Systematic Assessment	EG0003 events3 affected557 at risk EG0013 events3 affected558 at risk
Angina unstable	Cardiac disorders	MedDRA 10.1	Systematic Assessment	EG0002 events2 affected557 at risk EG0011 events1 affected558 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 10.1	Systematic Assessment	EG0002 events2 affected557 at risk EG0017 events7 affected558 at risk
Atrial flutter	Cardiac disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0010 events0 affected558 at risk
Atrioventricular block	Cardiac disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0011 events1 affected558 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0011 events1 affected558 at risk
Atrioventricular block second degree	Cardiac disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0010 events0 affected558 at risk
Cardiac failure	Cardiac disorders	MedDRA 10.1	Systematic Assessment	EG0002 events2 affected557 at risk EG0011 events1 affected558 at risk
Cardiac failure chronic	Cardiac disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0012 events2 affected558 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 10.1	Systematic Assessment	EG0008 events8 affected557 at risk EG0018 events8 affected558 at risk
Conduction disorder	Cardiac disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0010 events0 affected558 at risk
Coronary artery insufficiency	Cardiac disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0011 events1 affected558 at risk
Coronary artery restenosis	Cardiac disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0010 events0 affected558 at risk
Dressler's syndrome	Cardiac disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0011 events1 affected558 at risk
Intracardiac thrombus	Cardiac disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0011 events1 affected558 at risk
Left ventricular dysfunction	Cardiac disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0011 events1 affected558 at risk
Left ventricular failure	Cardiac disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0011 events1 affected558 at risk
Mitral valve incompetence	Cardiac disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0010 events0 affected558 at risk
Myocardial infarction	Cardiac disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0012 events2 affected558 at risk
Sick sinus syndrome	Cardiac disorders	MedDRA 10.1	Systematic Assessment	EG0002 events2 affected557 at risk EG0012 events2 affected558 at risk
Sinus bradycardia	Cardiac disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0010 events0 affected558 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0011 events1 affected558 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0010 events0 affected558 at risk
Ventricular tachyarrhythmia	Cardiac disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0011 events1 affected558 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 10.1	Systematic Assessment	EG0002 events2 affected557 at risk EG0011 events1 affected558 at risk
Hearing impaired	Ear and labyrinth disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0011 events1 affected558 at risk
Sudden hearing loss	Ear and labyrinth disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0011 events1 affected558 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 10.1	Systematic Assessment	EG0002 events2 affected557 at risk EG0010 events0 affected558 at risk
Vestibular neuronitis	Ear and labyrinth disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0010 events0 affected558 at risk
Hyperthyroidism	Endocrine disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0010 events0 affected558 at risk
Cataract	Eye disorders	MedDRA 10.1	Systematic Assessment	EG0003 events3 affected557 at risk EG0011 events1 affected558 at risk
Conjunctivitis	Eye disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0011 events1 affected558 at risk
Diabetic retinopathy	Eye disorders	MedDRA 10.1	Systematic Assessment	EG0002 events2 affected557 at risk EG0011 events1 affected558 at risk
Glaucoma	Eye disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0011 events1 affected558 at risk
Retinal detachment	Eye disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0010 events0 affected558 at risk
Vitreous haemorrhage	Eye disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0010 events0 affected558 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0002 events2 affected557 at risk EG0012 events2 affected558 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0012 events2 affected558 at risk
Anal haemorrhage	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0010 events0 affected558 at risk
Colonic polyp	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0011 events1 affected558 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0011 events1 affected558 at risk
Duodenitis	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0010 events0 affected558 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0011 events1 affected558 at risk
Enteritis	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0010 events0 affected558 at risk
Enterocolitis	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0011 events1 affected558 at risk
Gastric polyps	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0011 events1 affected558 at risk
Gastric ulcer haemorrhage	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0010 events0 affected558 at risk
Gastritis	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0003 events3 affected557 at risk EG0012 events2 affected558 at risk
Gastritis erosive	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0011 events1 affected558 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0002 events2 affected557 at risk EG0010 events0 affected558 at risk
Gastrointestinal telangiectasia	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0010 events0 affected558 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0012 events2 affected558 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0011 events1 affected558 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0012 events2 affected558 at risk
Ileus	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0010 events0 affected558 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0002 events2 affected557 at risk EG0010 events0 affected558 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0011 events1 affected558 at risk
Melaena	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0012 events2 affected558 at risk
Mouth cyst	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0011 events1 affected558 at risk
Nausea	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0011 events1 affected558 at risk
Peptic ulcer	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0010 events0 affected558 at risk
Peritonitis	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0010 events0 affected558 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0011 events1 affected558 at risk
Vomiting	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0012 events2 affected558 at risk
Asthenia	General disorders	MedDRA 10.1	Systematic Assessment	EG0002 events2 affected557 at risk EG0011 events1 affected558 at risk
Chest discomfort	General disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0011 events1 affected558 at risk
Chest pain	General disorders	MedDRA 10.1	Systematic Assessment	EG0004 events4 affected557 at risk EG0016 events6 affected558 at risk
Cyst	General disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0011 events1 affected558 at risk
Hernia obstructive	General disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0011 events1 affected558 at risk
Multi-organ failure	General disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0012 events2 affected558 at risk
Non-cardiac chest pain	General disorders	MedDRA 10.1	Systematic Assessment	EG0002 events2 affected557 at risk EG0012 events2 affected558 at risk
Oedema peripheral	General disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0010 events0 affected558 at risk
Pyrexia	General disorders	MedDRA 10.1	Systematic Assessment	EG0003 events3 affected557 at risk EG0011 events1 affected558 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0012 events2 affected558 at risk
Biliary colic	Hepatobiliary disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0011 events1 affected558 at risk
Cholangitis	Hepatobiliary disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0011 events1 affected558 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0011 events1 affected558 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0011 events1 affected558 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0013 events3 affected558 at risk
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0010 events0 affected558 at risk
Hypersensitivity	Immune system disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0010 events0 affected558 at risk
Sarcoidosis	Immune system disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0011 events1 affected558 at risk
Abscess limb	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0011 events1 affected558 at risk
Abscess neck	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0011 events1 affected558 at risk
Appendicitis	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0002 events2 affected557 at risk EG0012 events2 affected558 at risk
Arthritis bacterial	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0011 events1 affected558 at risk
Bronchitis	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0003 events3 affected557 at risk EG0013 events3 affected558 at risk
Bronchopneumonia	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0013 events3 affected558 at risk
Campylobacter gastroenteritis	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0011 events1 affected558 at risk
Cellulitis	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0003 events3 affected557 at risk EG0013 events3 affected558 at risk
Chronic tonsillitis	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0011 events1 affected558 at risk
Diverticulitis	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0011 events1 affected558 at risk
Erysipelas	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0011 events1 affected558 at risk
Gangrene	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0010 events0 affected558 at risk
Gastroenteritis	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0012 events2 affected558 at risk
Intervertebral discitis	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0010 events0 affected558 at risk
Localised infection	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0010 events0 affected558 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0012 events2 affected558 at risk
Mediastinitis	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0010 events0 affected558 at risk
Meningitis	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0010 events0 affected558 at risk
Meningitis aseptic	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0010 events0 affected558 at risk
Nasopharyngitis	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0010 events0 affected558 at risk
Osteomyelitis	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0010 events0 affected558 at risk
Paronychia	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0011 events1 affected558 at risk
Perianal abscess	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0011 events1 affected558 at risk
Pneumonia	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0007 events7 affected557 at risk EG0014 events4 affected558 at risk
Postoperative wound infection	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0011 events1 affected558 at risk
Purulent pericarditis	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0011 events1 affected558 at risk
Pyelonephritis	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0011 events1 affected558 at risk
Pyelonephritis chronic	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0011 events1 affected558 at risk
Pyometra	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0011 events1 affected558 at risk
Respiratory tract infection viral	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0011 events1 affected558 at risk
Sepsis	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0005 events5 affected557 at risk EG0010 events0 affected558 at risk
Septic arthritis staphylococcal	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0011 events1 affected558 at risk
Septic shock	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0002 events2 affected557 at risk EG0012 events2 affected558 at risk
Streptococcal bacteraemia	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0010 events0 affected558 at risk
Subcutaneous abscess	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0011 events1 affected558 at risk
Urinary tract infection	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0005 events5 affected557 at risk EG0014 events4 affected558 at risk
Wound infection	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0010 events0 affected558 at risk
Wound sepsis	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0003 events3 affected557 at risk EG0010 events0 affected558 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0011 events1 affected558 at risk
Excoriation	Injury, poisoning and procedural complications	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0010 events0 affected558 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 10.1	Systematic Assessment	EG0002 events2 affected557 at risk EG0010 events0 affected558 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0010 events0 affected558 at risk
Glaucoma traumatic	Injury, poisoning and procedural complications	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0010 events0 affected558 at risk
Hand fracture	Injury, poisoning and procedural complications	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0010 events0 affected558 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0011 events1 affected558 at risk
Soft tissue injury	Injury, poisoning and procedural complications	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0011 events1 affected558 at risk
Subdural haemorrhage	Injury, poisoning and procedural complications	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0010 events0 affected558 at risk
Thermal burn	Injury, poisoning and procedural complications	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0010 events0 affected558 at risk
Traumatic intracranial haemorrhage	Injury, poisoning and procedural complications	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0011 events1 affected558 at risk
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0011 events1 affected558 at risk
Blood pressure increased	Investigations	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0010 events0 affected558 at risk
Hepatic enzyme increased	Investigations	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0010 events0 affected558 at risk
International normalised ratio increased	Investigations	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0011 events1 affected558 at risk
Troponin increased	Investigations	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0010 events0 affected558 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0010 events0 affected558 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA 10.1	Systematic Assessment	EG0004 events4 affected557 at risk EG0011 events1 affected558 at risk
Diabetic foot	Metabolism and nutrition disorders	MedDRA 10.1	Systematic Assessment	EG0003 events3 affected557 at risk EG0011 events1 affected558 at risk
Gout	Metabolism and nutrition disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0010 events0 affected558 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 10.1	Systematic Assessment	EG0004 events4 affected557 at risk EG0011 events1 affected558 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0010 events0 affected558 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 10.1	Systematic Assessment	EG0006 events6 affected557 at risk EG0017 events7 affected558 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0011 events1 affected558 at risk
Insulin resistance	Metabolism and nutrition disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0010 events0 affected558 at risk
Fistula	Musculoskeletal and connective tissue disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0010 events0 affected558 at risk
Intervertebral disc disorder	Musculoskeletal and connective tissue disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0010 events0 affected558 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0011 events1 affected558 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0011 events1 affected558 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 10.1	Systematic Assessment	EG0002 events2 affected557 at risk EG0010 events0 affected558 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 10.1	Systematic Assessment	EG0002 events2 affected557 at risk EG0010 events0 affected558 at risk
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0010 events0 affected558 at risk
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0010 events0 affected558 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0011 events1 affected558 at risk
Adenocarcinoma pancreas	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0011 events1 affected558 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0010 events0 affected558 at risk
Bile duct cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0010 events0 affected558 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0010 events0 affected558 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0010 events0 affected558 at risk
Choroid melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0010 events0 affected558 at risk
Chronic lymphocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0011 events1 affected558 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0011 events1 affected558 at risk
Endometrial cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0011 events1 affected558 at risk
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0010 events0 affected558 at risk
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0011 events1 affected558 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.1	Systematic Assessment	EG0002 events2 affected557 at risk EG0010 events0 affected558 at risk
Meningioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0011 events1 affected558 at risk
Pancreatic carcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0011 events1 affected558 at risk
Prostatic adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0011 events1 affected558 at risk
Renal cell carcinoma stage II	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0011 events1 affected558 at risk
Renal cell carcinoma stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0010 events0 affected558 at risk
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0011 events1 affected558 at risk
Amnesia	Nervous system disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0011 events1 affected558 at risk
Carotid artery occlusion	Nervous system disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0010 events0 affected558 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA 10.1	Systematic Assessment	EG0002 events2 affected557 at risk EG0011 events1 affected558 at risk
Cervicobrachial syndrome	Nervous system disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0011 events1 affected558 at risk
Cluster headache	Nervous system disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0011 events1 affected558 at risk
Diabetic neuropathy	Nervous system disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0011 events1 affected558 at risk
Dizziness	Nervous system disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0011 events1 affected558 at risk
Epilepsy	Nervous system disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0011 events1 affected558 at risk
Headache	Nervous system disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0010 events0 affected558 at risk
Hemiparesis	Nervous system disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0011 events1 affected558 at risk
Hypotonia	Nervous system disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0011 events1 affected558 at risk
Intercostal neuralgia	Nervous system disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0010 events0 affected558 at risk
Mononeuropathy multiplex	Nervous system disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0010 events0 affected558 at risk
Parkinson's disease	Nervous system disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0010 events0 affected558 at risk
Presyncope	Nervous system disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0010 events0 affected558 at risk
Psychomotor hyperactivity	Nervous system disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0010 events0 affected558 at risk
Radiculopathy	Nervous system disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0011 events1 affected558 at risk
Subarachnoid haemorrhage	Nervous system disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0011 events1 affected558 at risk
Syncope	Nervous system disorders	MedDRA 10.1	Systematic Assessment	EG0002 events2 affected557 at risk EG0017 events7 affected558 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 10.1	Systematic Assessment	EG0004 events4 affected557 at risk EG0010 events0 affected558 at risk
Vertebrobasilar insufficiency	Nervous system disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0011 events1 affected558 at risk
Mood disorder due to a general medical condition	Psychiatric disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0010 events0 affected558 at risk
Post-traumatic stress disorder	Psychiatric disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0011 events1 affected558 at risk
Psychotic disorder due to a general medical condition	Psychiatric disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0010 events0 affected558 at risk
Calculus ureteric	Renal and urinary disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0011 events1 affected558 at risk
Diabetic nephropathy	Renal and urinary disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0010 events0 affected558 at risk
Haematuria	Renal and urinary disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0011 events1 affected558 at risk
Renal artery stenosis	Renal and urinary disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0010 events0 affected558 at risk
Renal colic	Renal and urinary disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0011 events1 affected558 at risk
Renal failure	Renal and urinary disorders	MedDRA 10.1	Systematic Assessment	EG0002 events2 affected557 at risk EG0012 events2 affected558 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0013 events3 affected558 at risk
Renal failure chronic	Renal and urinary disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0012 events2 affected558 at risk
Urethral obstruction	Renal and urinary disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0011 events1 affected558 at risk
Urinary retention	Renal and urinary disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0011 events1 affected558 at risk
Endometrial hyperplasia	Reproductive system and breast disorders	MedDRA 10.1	Systematic Assessment	EG0002 events2 affected557 at risk EG0010 events0 affected558 at risk
Polycystic ovaries	Reproductive system and breast disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0011 events1 affected558 at risk
Postmenopausal haemorrhage	Reproductive system and breast disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0011 events1 affected558 at risk
Uterine polyp	Reproductive system and breast disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0010 events0 affected558 at risk
Uterine prolapse	Reproductive system and breast disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0010 events0 affected558 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0010 events0 affected558 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0010 events0 affected558 at risk
Bronchitis chronic	Respiratory, thoracic and mediastinal disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0011 events1 affected558 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0013 events3 affected558 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0011 events1 affected558 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0010 events0 affected558 at risk
Hydrothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0011 events1 affected558 at risk
Pharyngeal oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0010 events0 affected558 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0013 events3 affected558 at risk
Pulmonary congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0011 events1 affected558 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0011 events1 affected558 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 10.1	Systematic Assessment	EG0003 events3 affected557 at risk EG0012 events2 affected558 at risk
Vocal cord polyp	Respiratory, thoracic and mediastinal disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0011 events1 affected558 at risk
Angioedema	Skin and subcutaneous tissue disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0011 events1 affected558 at risk
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0011 events1 affected558 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0010 events0 affected558 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0010 events0 affected558 at risk
Idiopathic urticaria	Skin and subcutaneous tissue disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0011 events1 affected558 at risk
Photodermatosis	Skin and subcutaneous tissue disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0011 events1 affected558 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0011 events1 affected558 at risk
Implantable defibrillator insertion	Surgical and medical procedures	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0011 events1 affected558 at risk
Toe amputation	Surgical and medical procedures	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0010 events0 affected558 at risk
Accelerated hypertension	Vascular disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0010 events0 affected558 at risk
Aortic aneurysm	Vascular disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0012 events2 affected558 at risk
Arterial stenosis limb	Vascular disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0011 events1 affected558 at risk
Arteriosclerosis obliterans	Vascular disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0010 events0 affected558 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0010 events0 affected558 at risk
Embolism	Vascular disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0010 events0 affected558 at risk
Extremity necrosis	Vascular disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0011 events1 affected558 at risk
Hypertension	Vascular disorders	MedDRA 10.1	Systematic Assessment	EG0002 events2 affected557 at risk EG0011 events1 affected558 at risk
Hypertensive crisis	Vascular disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0010 events0 affected558 at risk
Hypotension	Vascular disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0010 events0 affected558 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 10.1	Systematic Assessment	EG0002 events2 affected557 at risk EG0011 events1 affected558 at risk
Peripheral embolism	Vascular disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0011 events1 affected558 at risk
Peripheral ischaemia	Vascular disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0010 events0 affected558 at risk
Post thrombotic syndrome	Vascular disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0010 events0 affected558 at risk
Shock	Vascular disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0010 events0 affected558 at risk
Thrombosis	Vascular disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0011 events1 affected558 at risk
Varicose vein	Vascular disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected557 at risk EG0011 events1 affected558 at risk
Venous thrombosis	Vascular disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected557 at risk EG0010 events0 affected558 at risk

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Postprandial	Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.			145		356
EG001	Fasting	Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.			142		346

ID	Term
D003924	Diabetes Mellitus, Type 2
D003920	Diabetes Mellitus
D009203	Myocardial Infarction

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases
D007238	Infarction
D007511	Ischemia
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D009336	Necrosis

ID	Term
D061268	Insulin Lispro
D000069036	Insulin Glargine

ID	Term
D061266	Insulin, Short-Acting
D061385	Insulins
D010187	Pancreatic Hormones
D036361	Peptide Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D049528	Insulin, Long-Acting

ID	Title	Description
BG000	Postprandial	Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
BG001	Fasting	Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
BG002	Total	Total of all reporting groups