Effect of Ruboxistaurin on Clinically Significant Macular... | NCT00133952

ID	Type	Description	Link
B7A-MC-MBCU	Other Identifier	Eli Lilly and Company

Label	Type	Description	Intervention Names
Ruboxistaurin	Experimental	32 mg taken orally daily for up to 48 months	Drug: Ruboxistaurin
Placebo	Placebo Comparator	Taken orally daily for up to 48 months	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Ruboxistaurin	Drug	Administered orally	Ruboxistaurin	LY333531

Measure	Description	Time Frame
Percentage of Participants With Sustained Moderate Visual Loss (SMVL) Any Time Baseline Through Month 48	SMVL is defined as a 15 letter or more decrease from baseline in best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity that is sustained for the participant's last 6 months of study participation. ETDRS visual acuity uses an eye chart with 5 letters per line. The scores range from 0 (no letters read correctly) to 100 (all letters read correctly).	Baseline through 48 months

Measure	Description	Time Frame
Change From Baseline to Month 24 in Mean Retinal Thickness Within 500 Microns of the Center of the Macula	Least Squares (LS) Mean values were controlled for treatment, pooled center, and baseline value.	Baseline, 24 months
Number of Eyes With Significant Center-Involved Macular Edema at Any Time From Baseline Through Month 24

Name	Affiliation	Role
Karl Beutner	Chromaderm, Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.		Phoenix	Arizona	85020

PubMed Identifier	Type	Citation	Retractions
23404115	Derived	Sheetz MJ, Aiello LP, Davis MD, Danis R, Bek T, Cunha-Vaz J, Shahri N, Berg PH; MBDL and MBCU Study Groups. The effect of the oral PKC beta inhibitor ruboxistaurin on vision loss in two phase 3 studies. Invest Ophthalmol Vis Sci. 2013 Mar 11;54(3):1750-7. doi: 10.1167/iovs.12-11055.

ID	Title	Description
FG000	Placebo	Taken orally daily for up to 48 months
FG001	Ruboxistaurin	32 milligrams (mg) taken orally daily for up to 48 months

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

Percentage of Participants With Sustained Moderate Visual Loss (SMVL) Any Time Baseline Through Month 48

SMVL is defined as a 15 letter or more decrease from baseline in best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity that is sustained for the participant's last 6 months of study participation. ETDRS visual acuity uses an eye chart with 5 letters per line. The scores range from 0 (no letters read correctly) to 100 (all letters read correctly).

All randomized participants who took at least 1 dose of study drug and had post-baseline SMVL measurements.

Posted

Number

percent of participants

Baseline through 48 months

ID	Title	Description
OG000	Placebo	Taken orally daily for up to 48 months
OG001	Ruboxistaurin	32 milligrams (mg) taken orally daily for up to 48 months

Units	Counts
Participants	OG000146 OG001138

Title

Denominators

Categories

Title	Measurements
	OG0003.4 OG0012.2

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		Fisher Exact		0.724		Odds Ratio (OR)	0.63			2-Sided	95	0.15	2.67				No	Superiority or Other

Secondary

Change From Baseline to Month 24 in Mean Retinal Thickness Within 500 Microns of the Center of the Macula

Least Squares (LS) Mean values were controlled for treatment, pooled center, and baseline value.

All randomized participants who took at least 1 dose of study drug and had both baseline and post-baseline retinal thickness measurements.

Posted

Least Squares Mean

Standard Error

micrometer (µm)

Baseline, 24 months

ID	Title	Description
OG000	Placebo	Taken orally daily for up to 48 months
OG001	Ruboxistaurin	32 milligrams (mg) taken orally daily for up to 48 months

Units	Counts
Participants	OG000

Secondary

Number of Eyes With Significant Center-Involved Macular Edema at Any Time From Baseline Through Month 24

Significant center-involved macular edema is defined as an absolute retinal thickness at the center of the macula >2 standard deviations above the mean baseline value (where the mean and standard deviation are calculated at baseline from the randomized population of participants with retinal thickness values of ≤ 300 microns in depth).

All randomized participants who took at least 1 dose of study drug and had post-baseline macular edema measurements.

Posted

Number

Eyes

Baseline through 24 months

Eyes

Participants

ID	Title	Description
OG000	Placebo	Taken orally daily for up to 48 months
OG001	Ruboxistaurin	32 milligrams (mg) taken orally daily for up to 48 months

Units	Counts
Participants	OG000

Secondary

Time to Focal Photocoagulation

All randomized participants who took at least 1 dose of study drug and had post-baseline determination of focal photocoagulation treatment.

Posted

Median

95% Confidence Interval

months

Baseline through 48 months

ID	Title	Description
OG000	Placebo	Taken orally daily for up to 48 months
OG001	Ruboxistaurin	32 milligrams (mg) taken orally daily for up to 48 months

Units	Counts
Participants	OG000

Secondary

Change From Baseline to Month 24 in Contrast Sensitivity

Values are presented as changes in the number of letters read correctly on the Pelli-Robson contrast sensitivity chart which consists of 16 triplets (48 letters total) with letters of the same size but decreasing contrast. Least Squares (LS) Mean values were controlled for treatment, pooled center, and baseline value.

All randomized participants who took at least 1 dose of study drug and had both baseline and post-baseline contrast sensitivity measurements.

Posted

Least Squares Mean

Standard Error

letters read correctly

Baseline, 24 months

ID	Title	Description
OG000	Placebo	Taken orally daily for up to 48 months
OG001	Ruboxistaurin	32 milligrams (mg) taken orally daily for up to 48 months

Units	Counts
Participants	OG000

Secondary

Change From Baseline to Month 24 in Retinal Thickness at the Center of the Macula

All randomized participants who took at least 1 dose of study drug and had both baseline and post-baseline retinal thickness measurements, last observation carried forward (LOCF).

Posted

Mean

Standard Deviation

micrometer (µm)

Baseline, up to 24 months

ID	Title	Description
OG000	Placebo	Taken orally daily for up to 48 months
OG001	Ruboxistaurin	32 milligrams (mg) taken orally daily for up to 48 months

Units	Counts
Participants	OG000

Secondary

Number of Participants Requiring Focal Photocoagulation at Any Time From Baseline Through Month 24

All randomized participants who took at least 1 dose of study drug and had post-baseline determination of focal photocoagulation treatment.

Posted

Number

participants

Baseline through 24 months

ID	Title	Description
OG000	Placebo	Taken orally daily for up to 48 months
OG001	Ruboxistaurin	32 milligrams (mg) taken orally daily for up to 48 months

Units	Counts
Participants	OG000

Secondary

Number of Participants Not Requiring Focal Photocoagulation at Any Time From Baseline Through Month 24

All randomized participants who took at least 1 dose of study drug and had post-baseline determination of focal photocoagulation treatment.

Posted

Number

participants

Baseline through 24 months

ID	Title	Description
OG000	Placebo	Taken orally daily for up to 48 months
OG001	Ruboxistaurin	32 milligrams (mg) taken orally daily for up to 48 months

Units	Counts
Participants	OG000

Secondary

Number of Participants Requiring Repeat Focal Photocoagulation at Any Time From Baseline Though Month 24

Repeat focal photocoagulation is defined as 2 or more focal photocoagulation treatments needed during the study.

All randomized participants who took at least 1 dose of study drug and had post-baseline determination of focal photocoagulation treatment.

Posted

Number

participants

Baseline through 24 months

ID	Title	Description
OG000	Placebo	Taken orally daily for up to 48 months
OG001	Ruboxistaurin	32 milligrams (mg) taken orally daily for up to 48 months

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0013 events3 affected149 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected149 at risk
Angina pectoris	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0011 events1 affected149 at risk
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0014 events1 affected149 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected149 at risk
Cardiac failure	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0012 events1 affected149 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected149 at risk
Coronary artery disease	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0003 events3 affected153 at risk EG0011 events1 affected149 at risk
Myocardial infarction	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0002 events2 affected153 at risk EG0011 events1 affected149 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0011 events1 affected149 at risk
Nodal arrhythmia	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected149 at risk
Pericarditis	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected149 at risk
Deafness unilateral	Ear and labyrinth disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected149 at risk
Constipation	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected149 at risk
Erosive oesophagitis	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected149 at risk
Pyrexia	General disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected149 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected149 at risk
Hepatic function abnormal	Hepatobiliary disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected149 at risk
Hypersensitivity	Immune system disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected149 at risk
Abscess	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0012 events1 affected149 at risk
Abscess limb	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected149 at risk
Appendicitis	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0011 events1 affected149 at risk
Cellulitis	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected149 at risk
Erysipelas	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0011 events1 affected149 at risk
Gangrene	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected149 at risk
Gastroenteritis	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected149 at risk
Influenza	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected149 at risk
Localised infection	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0002 events2 affected153 at risk EG0010 events0 affected149 at risk
Omphalitis	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected149 at risk
Pilonidal cyst	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected149 at risk
Pneumonia	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0003 events3 affected153 at risk EG0015 events5 affected149 at risk
Pneumonia viral	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected149 at risk
Pulmonary tuberculosis	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected149 at risk
Pyelonephritis	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected149 at risk
Sepsis	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0011 events1 affected149 at risk
Soft tissue infection	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected149 at risk
Urinary tract infection	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0014 events1 affected149 at risk
Wound infection	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0003 events2 affected153 at risk EG0010 events0 affected149 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected149 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0012 events2 affected149 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected149 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected149 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected149 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected149 at risk
Muscle rupture	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected149 at risk
Patella fracture	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected149 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected149 at risk
Tendon rupture	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected149 at risk
Thoracic vertebral fracture	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected149 at risk
Vascular pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected149 at risk
Hiv test positive	Investigations	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected149 at risk
Weight decreased	Investigations	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected149 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0014 events3 affected149 at risk
Diabetic foot	Metabolism and nutrition disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0012 events1 affected149 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0013 events3 affected149 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected149 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected149 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected149 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected149 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected149 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0002 events1 affected153 at risk EG0010 events0 affected149 at risk
Pseudarthrosis	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected149 at risk
Bladder papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected149 at risk
Breast cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected149 at risk
Colon adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected149 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Systematic Assessment	EG0002 events2 affected153 at risk EG0011 events1 affected149 at risk
Haemangioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected149 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected149 at risk
Multiple myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected149 at risk
Cerebral infarction	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected149 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0011 events1 affected149 at risk
Viith nerve paralysis	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected149 at risk
Depression	Psychiatric disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected149 at risk
Diabetic nephropathy	Renal and urinary disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected149 at risk
Haematuria	Renal and urinary disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0016 events2 affected149 at risk
Renal failure	Renal and urinary disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0013 events3 affected149 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 13.0	Systematic Assessment	EG0002 events2 affected153 at risk EG0011 events1 affected149 at risk
Renal failure chronic	Renal and urinary disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected149 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected149 at risk
Prostatitis	Reproductive system and breast disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected149 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected149 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected149 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected149 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected149 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected149 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected149 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected149 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0011 events1 affected149 at risk
Haemorrhage	Vascular disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected149 at risk
Hypertension	Vascular disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected149 at risk
Hypotension	Vascular disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected149 at risk
Thrombosis	Vascular disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected149 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cataract	Eye disorders	MedDRA 13.0	Systematic Assessment	EG0007 events6 affected153 at risk EG00110 events5 affected149 at risk
Lacrimation increased	Eye disorders	MedDRA 13.0	Systematic Assessment	EG0006 events5 affected153 at risk EG0010 events0 affected149 at risk
Vision blurred	Eye disorders	MedDRA 13.0	Systematic Assessment	EG0006 events5 affected153 at risk EG0015 events5 affected149 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG00011 events8 affected153 at risk EG00115 events13 affected149 at risk
Nausea	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0007 events7 affected153 at risk EG0015 events5 affected149 at risk
Vomiting	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0006 events5 affected153 at risk EG0017 events6 affected149 at risk
Pyrexia	General disorders	MedDRA 13.0	Systematic Assessment	EG00010 events7 affected153 at risk EG0019 events6 affected149 at risk
Bronchitis	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0005 events5 affected153 at risk EG0014 events4 affected149 at risk
Influenza	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG00020 events14 affected153 at risk EG0017 events7 affected149 at risk
Localised infection	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0008 events7 affected153 at risk EG0010 events0 affected149 at risk
Nasopharyngitis	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG00010 events8 affected153 at risk EG00120 events13 affected149 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0003 events3 affected153 at risk EG0015 events5 affected149 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0005 events5 affected153 at risk EG0014 events3 affected149 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA 13.0	Systematic Assessment	EG00011 events11 affected153 at risk EG0015 events4 affected149 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 13.0	Systematic Assessment	EG0007 events5 affected153 at risk EG0010 events0 affected149 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0005 events5 affected153 at risk EG00110 events7 affected149 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0006 events5 affected153 at risk EG00111 events10 affected149 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0005 events5 affected153 at risk EG0014 events3 affected149 at risk
Dizziness	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0007 events5 affected153 at risk EG0013 events3 affected149 at risk
Headache	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG00017 events13 affected153 at risk EG00117 events14 affected149 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0005 events5 affected153 at risk EG0011 events1 affected149 at risk
Depression	Psychiatric disorders	MedDRA 13.0	Systematic Assessment	EG0002 events2 affected153 at risk EG0015 events5 affected149 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0003 events3 affected153 at risk EG0018 events8 affected149 at risk
Hypertension	Vascular disorders	MedDRA 13.0	Systematic Assessment	EG00015 events14 affected153 at risk EG00113 events13 affected149 at risk

ID	Title	Description
BG000	Placebo	Taken orally daily for up to 48 months
BG001	Ruboxistaurin	32 milligrams (mg) taken orally daily for up to 48 months
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Taken orally daily for up to 48 months			31	153	112	153
EG001	Ruboxistaurin	32 milligrams (mg) taken orally daily for up to 48 months			36	149	118	149