Trial Outcomes & Findings for Effect of Ruboxistaurin on Clinically Significant Macular Edema (NCT NCT00133952)
NCT ID: NCT00133952
Last Updated: 2016-10-06
Results Overview
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).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
309 participants
Primary outcome timeframe
Baseline through 48 months
Results posted on
2016-10-06
Participant Flow
Participant milestones
| Measure |
Placebo
Taken orally daily for up to 48 months
|
Ruboxistaurin
32 milligrams (mg) taken orally daily for up to 48 months
|
|---|---|---|
|
Overall Study
STARTED
|
157
|
152
|
|
Overall Study
Received at Least One Dose of Study Drug
|
153
|
149
|
|
Overall Study
COMPLETED
|
115
|
124
|
|
Overall Study
NOT COMPLETED
|
42
|
28
|
Reasons for withdrawal
| Measure |
Placebo
Taken orally daily for up to 48 months
|
Ruboxistaurin
32 milligrams (mg) taken orally daily for up to 48 months
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
2
|
|
Overall Study
Death
|
3
|
2
|
|
Overall Study
Lost to Follow-up
|
9
|
14
|
|
Overall Study
Protocol Entry Criteria Exclusion
|
4
|
1
|
|
Overall Study
Protocol Violation
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
20
|
4
|
|
Overall Study
Physician Decision
|
4
|
3
|
|
Overall Study
Sponsor Decision
|
0
|
1
|
Baseline Characteristics
Effect of Ruboxistaurin on Clinically Significant Macular Edema
Baseline characteristics by cohort
| Measure |
Placebo
n=157 Participants
Taken orally daily for up to 48 months
|
Ruboxistaurin
n=152 Participants
32 milligrams (mg) taken orally daily for up to 48 months
|
Total
n=309 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.5 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
55.4 years
STANDARD_DEVIATION 9.9 • n=7 Participants
|
55.5 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
67 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
133 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
90 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
176 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
117 participants
n=5 Participants
|
111 participants
n=7 Participants
|
228 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African Descent
|
18 participants
n=5 Participants
|
15 participants
n=7 Participants
|
33 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
East Asian
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
West Asian
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
20 participants
n=5 Participants
|
21 participants
n=7 Participants
|
41 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
52 participants
n=5 Participants
|
46 participants
n=7 Participants
|
98 participants
n=5 Participants
|
|
Region of Enrollment
Portugal
|
16 participants
n=5 Participants
|
17 participants
n=7 Participants
|
33 participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
7 participants
n=5 Participants
|
10 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
11 participants
n=5 Participants
|
11 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
9 participants
n=5 Participants
|
9 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Region of Enrollment
Lithuania
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
Romania
|
13 participants
n=5 Participants
|
12 participants
n=7 Participants
|
25 participants
n=5 Participants
|
|
Region of Enrollment
Denmark
|
26 participants
n=5 Participants
|
26 participants
n=7 Participants
|
52 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
13 participants
n=5 Participants
|
10 participants
n=7 Participants
|
23 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Region of Enrollment
France
|
4 participants
n=5 Participants
|
6 participants
n=7 Participants
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline through 48 monthsPopulation: All randomized participants who took at least 1 dose of study drug and had post-baseline SMVL measurements.
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).
Outcome measures
| Measure |
Placebo
n=146 Participants
Taken orally daily for up to 48 months
|
Ruboxistaurin
n=138 Participants
32 milligrams (mg) taken orally daily for up to 48 months
|
|---|---|---|
|
Percentage of Participants With Sustained Moderate Visual Loss (SMVL) Any Time Baseline Through Month 48
|
3.4 percent of participants
|
2.2 percent of participants
|
SECONDARY outcome
Timeframe: Baseline, 24 monthsPopulation: All randomized participants who took at least 1 dose of study drug and had both baseline and post-baseline retinal thickness measurements.
Least Squares (LS) Mean values were controlled for treatment, pooled center, and baseline value.
Outcome measures
| Measure |
Placebo
n=148 Participants
Taken orally daily for up to 48 months
|
Ruboxistaurin
n=149 Participants
32 milligrams (mg) taken orally daily for up to 48 months
|
|---|---|---|
|
Change From Baseline to Month 24 in Mean Retinal Thickness Within 500 Microns of the Center of the Macula
|
12.8 micrometer (µm)
Standard Error 5.5
|
9.4 micrometer (µm)
Standard Error 5.3
|
SECONDARY outcome
Timeframe: Baseline through 24 monthsPopulation: All randomized participants who took at least 1 dose of study drug and had post-baseline macular edema measurements.
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).
Outcome measures
| Measure |
Placebo
n=286 Eyes
Taken orally daily for up to 48 months
|
Ruboxistaurin
n=286 Eyes
32 milligrams (mg) taken orally daily for up to 48 months
|
|---|---|---|
|
Number of Eyes With Significant Center-Involved Macular Edema at Any Time From Baseline Through Month 24
|
77 Eyes
|
76 Eyes
|
SECONDARY outcome
Timeframe: Baseline through 48 monthsPopulation: All randomized participants who took at least 1 dose of study drug and had post-baseline determination of focal photocoagulation treatment.
Outcome measures
| Measure |
Placebo
n=148 Participants
Taken orally daily for up to 48 months
|
Ruboxistaurin
n=149 Participants
32 milligrams (mg) taken orally daily for up to 48 months
|
|---|---|---|
|
Time to Focal Photocoagulation
|
NA months
Median value was not calculable due to low number of participants requiring focal photocoagulation during the study.
|
NA months
Median value was not calculable due to low number of participants requiring focal photocoagulation during the study.
|
SECONDARY outcome
Timeframe: Baseline, 24 monthsPopulation: All randomized participants who took at least 1 dose of study drug and had both baseline and post-baseline contrast sensitivity measurements.
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.
Outcome measures
| Measure |
Placebo
n=148 Participants
Taken orally daily for up to 48 months
|
Ruboxistaurin
n=149 Participants
32 milligrams (mg) taken orally daily for up to 48 months
|
|---|---|---|
|
Change From Baseline to Month 24 in Contrast Sensitivity
|
-1.1 letters read correctly
Standard Error 0.4
|
-0.6 letters read correctly
Standard Error 0.4
|
SECONDARY outcome
Timeframe: Baseline, up to 24 monthsPopulation: 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).
Outcome measures
| Measure |
Placebo
n=148 Participants
Taken orally daily for up to 48 months
|
Ruboxistaurin
n=149 Participants
32 milligrams (mg) taken orally daily for up to 48 months
|
|---|---|---|
|
Change From Baseline to Month 24 in Retinal Thickness at the Center of the Macula
|
10.5 micrometer (µm)
Standard Deviation 65.4
|
13.1 micrometer (µm)
Standard Deviation 74.9
|
SECONDARY outcome
Timeframe: Baseline through 24 monthsPopulation: All randomized participants who took at least 1 dose of study drug and had post-baseline determination of focal photocoagulation treatment.
Outcome measures
| Measure |
Placebo
n=148 Participants
Taken orally daily for up to 48 months
|
Ruboxistaurin
n=149 Participants
32 milligrams (mg) taken orally daily for up to 48 months
|
|---|---|---|
|
Number of Participants Requiring Focal Photocoagulation at Any Time From Baseline Through Month 24
|
35 participants
|
26 participants
|
SECONDARY outcome
Timeframe: Baseline through 24 monthsPopulation: All randomized participants who took at least 1 dose of study drug and had post-baseline determination of focal photocoagulation treatment.
Outcome measures
| Measure |
Placebo
n=148 Participants
Taken orally daily for up to 48 months
|
Ruboxistaurin
n=149 Participants
32 milligrams (mg) taken orally daily for up to 48 months
|
|---|---|---|
|
Number of Participants Not Requiring Focal Photocoagulation at Any Time From Baseline Through Month 24
|
113 participants
|
123 participants
|
SECONDARY outcome
Timeframe: Baseline through 24 monthsPopulation: All randomized participants who took at least 1 dose of study drug and had post-baseline determination of focal photocoagulation treatment.
Repeat focal photocoagulation is defined as 2 or more focal photocoagulation treatments needed during the study.
Outcome measures
| Measure |
Placebo
n=148 Participants
Taken orally daily for up to 48 months
|
Ruboxistaurin
n=149 Participants
32 milligrams (mg) taken orally daily for up to 48 months
|
|---|---|---|
|
Number of Participants Requiring Repeat Focal Photocoagulation at Any Time From Baseline Though Month 24
|
11 participants
|
12 participants
|
Adverse Events
Placebo
Serious events: 31 serious events
Other events: 112 other events
Deaths: 0 deaths
Ruboxistaurin
Serious events: 36 serious events
Other events: 118 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=153 participants at risk
Taken orally daily for up to 48 months
|
Ruboxistaurin
n=149 participants at risk
32 milligrams (mg) taken orally daily for up to 48 months
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/153
|
2.0%
3/149 • Number of events 3
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.65%
1/153 • Number of events 1
|
0.00%
0/149
|
|
Cardiac disorders
Angina pectoris
|
0.65%
1/153 • Number of events 1
|
0.67%
1/149 • Number of events 1
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.00%
0/153
|
0.67%
1/149 • Number of events 4
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/153
|
0.67%
1/149 • Number of events 1
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/153
|
0.67%
1/149 • Number of events 2
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.65%
1/153 • Number of events 1
|
0.00%
0/149
|
|
Cardiac disorders
Coronary artery disease
|
2.0%
3/153 • Number of events 3
|
0.67%
1/149 • Number of events 1
|
|
Cardiac disorders
Myocardial infarction
|
1.3%
2/153 • Number of events 2
|
0.67%
1/149 • Number of events 1
|
|
Cardiac disorders
Myocardial ischaemia
|
0.65%
1/153 • Number of events 1
|
0.67%
1/149 • Number of events 1
|
|
Cardiac disorders
Nodal arrhythmia
|
0.00%
0/153
|
0.67%
1/149 • Number of events 1
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/153
|
0.67%
1/149 • Number of events 1
|
|
Ear and labyrinth disorders
Deafness unilateral
|
0.00%
0/153
|
0.67%
1/149 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/153
|
0.67%
1/149 • Number of events 1
|
|
Gastrointestinal disorders
Erosive oesophagitis
|
0.00%
0/153
|
0.67%
1/149 • Number of events 1
|
|
General disorders
Pyrexia
|
0.65%
1/153 • Number of events 1
|
0.00%
0/149
|
|
Hepatobiliary disorders
Cholecystitis
|
0.65%
1/153 • Number of events 1
|
0.00%
0/149
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.65%
1/153 • Number of events 1
|
0.00%
0/149
|
|
Immune system disorders
Hypersensitivity
|
0.65%
1/153 • Number of events 1
|
0.00%
0/149
|
|
Infections and infestations
Abscess
|
0.00%
0/153
|
0.67%
1/149 • Number of events 2
|
|
Infections and infestations
Abscess limb
|
0.65%
1/153 • Number of events 1
|
0.00%
0/149
|
|
Infections and infestations
Appendicitis
|
0.65%
1/153 • Number of events 1
|
0.67%
1/149 • Number of events 1
|
|
Infections and infestations
Cellulitis
|
0.65%
1/153 • Number of events 1
|
0.00%
0/149
|
|
Infections and infestations
Erysipelas
|
0.65%
1/153 • Number of events 1
|
0.67%
1/149 • Number of events 1
|
|
Infections and infestations
Gangrene
|
0.65%
1/153 • Number of events 1
|
0.00%
0/149
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/153
|
0.67%
1/149 • Number of events 1
|
|
Infections and infestations
Influenza
|
0.00%
0/153
|
0.67%
1/149 • Number of events 1
|
|
Infections and infestations
Localised infection
|
1.3%
2/153 • Number of events 2
|
0.00%
0/149
|
|
Infections and infestations
Omphalitis
|
0.00%
0/153
|
0.67%
1/149 • Number of events 1
|
|
Infections and infestations
Pilonidal cyst
|
0.65%
1/153 • Number of events 1
|
0.00%
0/149
|
|
Infections and infestations
Pneumonia
|
2.0%
3/153 • Number of events 3
|
3.4%
5/149 • Number of events 5
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/153
|
0.67%
1/149 • Number of events 1
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.65%
1/153 • Number of events 1
|
0.00%
0/149
|
|
Infections and infestations
Pyelonephritis
|
0.65%
1/153 • Number of events 1
|
0.00%
0/149
|
|
Infections and infestations
Sepsis
|
0.65%
1/153 • Number of events 1
|
0.67%
1/149 • Number of events 1
|
|
Infections and infestations
Soft tissue infection
|
0.65%
1/153 • Number of events 1
|
0.00%
0/149
|
|
Infections and infestations
Urinary tract infection
|
0.65%
1/153 • Number of events 1
|
0.67%
1/149 • Number of events 4
|
|
Infections and infestations
Wound infection
|
1.3%
2/153 • Number of events 3
|
0.00%
0/149
|
|
Injury, poisoning and procedural complications
Concussion
|
0.65%
1/153 • Number of events 1
|
0.00%
0/149
|
|
Injury, poisoning and procedural complications
Fall
|
0.65%
1/153 • Number of events 1
|
1.3%
2/149 • Number of events 2
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/153
|
0.67%
1/149 • Number of events 1
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/153
|
0.67%
1/149 • Number of events 1
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/153
|
0.67%
1/149 • Number of events 1
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.65%
1/153 • Number of events 1
|
0.00%
0/149
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.65%
1/153 • Number of events 1
|
0.00%
0/149
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.65%
1/153 • Number of events 1
|
0.00%
0/149
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.65%
1/153 • Number of events 1
|
0.00%
0/149
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.65%
1/153 • Number of events 1
|
0.00%
0/149
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/153
|
0.67%
1/149 • Number of events 1
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.65%
1/153 • Number of events 1
|
0.00%
0/149
|
|
Investigations
Hiv test positive
|
0.00%
0/153
|
0.67%
1/149 • Number of events 1
|
|
Investigations
Weight decreased
|
0.65%
1/153 • Number of events 1
|
0.00%
0/149
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/153
|
2.0%
3/149 • Number of events 4
|
|
Metabolism and nutrition disorders
Diabetic foot
|
0.00%
0/153
|
0.67%
1/149 • Number of events 2
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/153
|
2.0%
3/149 • Number of events 3
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/153
|
0.67%
1/149 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/153
|
0.67%
1/149 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/153
|
0.67%
1/149 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.65%
1/153 • Number of events 1
|
0.00%
0/149
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/153
|
0.67%
1/149 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.65%
1/153 • Number of events 2
|
0.00%
0/149
|
|
Musculoskeletal and connective tissue disorders
Pseudarthrosis
|
0.00%
0/153
|
0.67%
1/149 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder papilloma
|
0.00%
0/153
|
0.67%
1/149 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.65%
1/153 • Number of events 1
|
0.00%
0/149
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.00%
0/153
|
0.67%
1/149 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
1.3%
2/153 • Number of events 2
|
0.67%
1/149 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma
|
0.00%
0/153
|
0.67%
1/149 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/153
|
0.67%
1/149 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple myeloma
|
0.00%
0/153
|
0.67%
1/149 • Number of events 1
|
|
Nervous system disorders
Cerebral infarction
|
0.65%
1/153 • Number of events 1
|
0.00%
0/149
|
|
Nervous system disorders
Cerebrovascular accident
|
0.65%
1/153 • Number of events 1
|
0.67%
1/149 • Number of events 1
|
|
Nervous system disorders
Viith nerve paralysis
|
0.00%
0/153
|
0.67%
1/149 • Number of events 1
|
|
Psychiatric disorders
Depression
|
0.65%
1/153 • Number of events 1
|
0.00%
0/149
|
|
Renal and urinary disorders
Diabetic nephropathy
|
0.65%
1/153 • Number of events 1
|
0.00%
0/149
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/153
|
1.3%
2/149 • Number of events 6
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/153
|
2.0%
3/149 • Number of events 3
|
|
Renal and urinary disorders
Renal failure acute
|
1.3%
2/153 • Number of events 2
|
0.67%
1/149 • Number of events 1
|
|
Renal and urinary disorders
Renal failure chronic
|
0.00%
0/153
|
0.67%
1/149 • Number of events 1
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/153
|
0.67%
1/149 • Number of events 1
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/153
|
0.67%
1/149 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/153
|
0.67%
1/149 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.65%
1/153 • Number of events 1
|
0.00%
0/149
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.65%
1/153 • Number of events 1
|
0.00%
0/149
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/153
|
0.67%
1/149 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/153
|
0.67%
1/149 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/153
|
0.67%
1/149 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/153
|
0.67%
1/149 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.65%
1/153 • Number of events 1
|
0.67%
1/149 • Number of events 1
|
|
Vascular disorders
Haemorrhage
|
0.65%
1/153 • Number of events 1
|
0.00%
0/149
|
|
Vascular disorders
Hypertension
|
0.00%
0/153
|
0.67%
1/149 • Number of events 1
|
|
Vascular disorders
Hypotension
|
0.00%
0/153
|
0.67%
1/149 • Number of events 1
|
|
Vascular disorders
Thrombosis
|
0.65%
1/153 • Number of events 1
|
0.00%
0/149
|
Other adverse events
| Measure |
Placebo
n=153 participants at risk
Taken orally daily for up to 48 months
|
Ruboxistaurin
n=149 participants at risk
32 milligrams (mg) taken orally daily for up to 48 months
|
|---|---|---|
|
Eye disorders
Cataract
|
3.9%
6/153 • Number of events 7
|
3.4%
5/149 • Number of events 10
|
|
Eye disorders
Lacrimation increased
|
3.3%
5/153 • Number of events 6
|
0.00%
0/149
|
|
Eye disorders
Vision blurred
|
3.3%
5/153 • Number of events 6
|
3.4%
5/149 • Number of events 5
|
|
Gastrointestinal disorders
Diarrhoea
|
5.2%
8/153 • Number of events 11
|
8.7%
13/149 • Number of events 15
|
|
Gastrointestinal disorders
Nausea
|
4.6%
7/153 • Number of events 7
|
3.4%
5/149 • Number of events 5
|
|
Gastrointestinal disorders
Vomiting
|
3.3%
5/153 • Number of events 6
|
4.0%
6/149 • Number of events 7
|
|
General disorders
Pyrexia
|
4.6%
7/153 • Number of events 10
|
4.0%
6/149 • Number of events 9
|
|
Infections and infestations
Bronchitis
|
3.3%
5/153 • Number of events 5
|
2.7%
4/149 • Number of events 4
|
|
Infections and infestations
Influenza
|
9.2%
14/153 • Number of events 20
|
4.7%
7/149 • Number of events 7
|
|
Infections and infestations
Localised infection
|
4.6%
7/153 • Number of events 8
|
0.00%
0/149
|
|
Infections and infestations
Nasopharyngitis
|
5.2%
8/153 • Number of events 10
|
8.7%
13/149 • Number of events 20
|
|
Infections and infestations
Upper respiratory tract infection
|
2.0%
3/153 • Number of events 3
|
3.4%
5/149 • Number of events 5
|
|
Injury, poisoning and procedural complications
Fall
|
3.3%
5/153 • Number of events 5
|
2.0%
3/149 • Number of events 4
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
7.2%
11/153 • Number of events 11
|
2.7%
4/149 • Number of events 5
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
3.3%
5/153 • Number of events 7
|
0.00%
0/149
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.3%
5/153 • Number of events 5
|
4.7%
7/149 • Number of events 10
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.3%
5/153 • Number of events 6
|
6.7%
10/149 • Number of events 11
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.3%
5/153 • Number of events 5
|
2.0%
3/149 • Number of events 4
|
|
Nervous system disorders
Dizziness
|
3.3%
5/153 • Number of events 7
|
2.0%
3/149 • Number of events 3
|
|
Nervous system disorders
Headache
|
8.5%
13/153 • Number of events 17
|
9.4%
14/149 • Number of events 17
|
|
Nervous system disorders
Neuropathy peripheral
|
3.3%
5/153 • Number of events 5
|
0.67%
1/149 • Number of events 1
|
|
Psychiatric disorders
Depression
|
1.3%
2/153 • Number of events 2
|
3.4%
5/149 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.0%
3/153 • Number of events 3
|
5.4%
8/149 • Number of events 8
|
|
Vascular disorders
Hypertension
|
9.2%
14/153 • Number of events 15
|
8.7%
13/149 • Number of events 13
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60