Reduction in the Occurrence of Center-Involved Diabetic Macular Edema
Study Details
Study Description
Brief Summary
The purpose of this study is to determine if ruboxistaurin can help slow the worsening of an eye disease called macular edema in patients with diabetes.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Ruboxistaurin 32 milligrams (mg) once daily (QD) oral for up to 36 months |
Drug: ruboxistaurin
32 mg once daily (QD) oral for up to 36 months
Other Names:
|
Placebo Comparator: Placebo QD oral for up to 36 months |
Drug: placebo
QD oral for up to 36 months
|
Outcome Measures
Primary Outcome Measures
- Mean Duration of Definite Center of Macula-involved Diabetic Macular Edema (DME) [6 Months through 36 Months]
Duration of center of macula involvement when primary study outcome (DME involvement in center of macula determined by central grading of stereoscopic fundus photographs) was identified at a visit, participant was considered to have had definite center involvement for a specified length of time between the adjacent visits. Total duration of center involvement was calculated. Mean duration was total duration of center involvement divided by total number of participants. Participant durations were summarized, total number of months of center involvement in both treatment groups were displayed.
- Occurrence of Sustained Moderate Visual Loss (SMVL) in a Diabetic Retinopathy (DR) Study Eye [Baseline, 36 Months]
The occurrence of SMVL was defined as ≥15 letter decrease from baseline in best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) in any DR study eye relative to baseline that is sustained for the last 6 months of participation. ETDRS VA: participant starts at the top of the chart containing 5 letters per row and reads down the chart until reaching a row where a minimum of 3 letters on a line cannot be read. Participant is scored by how many letters could be correctly identified. A higher number of letters correctly identified represents better visual acuity.
Secondary Outcome Measures
- Change From Baseline in Visual Acuity by Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) Chart at 36 Months [Baseline, 36 Months]
ETDRS VA: participant starts at the top of the chart containing 5 letters per row and reads down the chart until reaching a row where a minimum of 3 letters on a line cannot be read. Participant is scored by how many letters could be correctly identified. A higher number of letters correctly identified represents better visual acuity. Results are reported based on the number of diabetic retinopathy (DR) eyes.
- First Occurrence of Focal/Grid Photocoagulation [Baseline through 36 Months]
The first occurrence of focal/grid photocoagulation regardless of diabetic macular edema (DME) distance from the center of the macula.
- Change From Baseline in Contrast Sensitivity by Pelli-Robson [Baseline, 36 Months]
Pelli-Robson chart read from left to right + from top to bottom. Each line has 2 groups, each of 3 letters. Letters in each group have same contrast. Contrast in each successive group is less than the preceding group. Participant reads letters starting with highest contrast, continues until 2 or 3 letters in 1 group are incorrectly named. Scored on key showing all letters at full contrast, gives the log contrast sensitivity corresponding to each group. Score is determined by previous group (last group in which 2 or 3 letters were correctly named). Results reported based on number of DR eyes.
- Progression of Nonproliferative Diabetic Retinopathy (DR) by Seven-field Stereo Fundus Photography [Baseline through 36 Months]
Participants were classified as having experienced progression or no progression of DR by 36-month visit. Progression of DR=3 steps on ETDRS retinopathy severity person scale for participants with both eyes less than proliferative diabetic retinopathy (PDR) at baseline OR 2 steps on ETDRS retinopathy severity eye scale for participants with 1 eye less than PDR at baseline OR application of panretinal laser therapy. Participants were assigned at baseline to ETDRS retinopathy severity scale for persons or individual eyes; determination of no progression/progression was dependent on the scale.
- Change From Baseline in Estimated Glomerular Filtration Rate [Baseline, 36 Months]
The Modification of Diet in Renal Disease (MDRD) study formula used for the estimated glomerular filtration rate (eGFR) determination is: eGFR = 170 X (Serum creatinine concentration [mg/deciliter (dL)])-0.999 X (Age [years]) -0.176 X (0.762 if participant is female) X (1.180 if participant is black) X (Serum urea nitrogen concentration [mg/dL])-0.170 X (Serum albumin concentration [grams (g)/dL])+0.318.
- Change From Baseline at Endpoint in Albumin/Creatinine Ratio [36 Months]
- Change From Baseline at Endpoint in Visual Function by the National Eye Institute Visual Functioning Questionnaire (NEI VFQ-25) at 36 Months [36 Months]
25 vision-targeted questions representing 11 vision-related constructs and a 1-item general health rating question. Measures the influence of visual disability and visual symptoms on generic health domains such as emotional well-being and social functioning and task-oriented domains related to daily visual functioning. Each item is converted to a 0 to 100 scale such that a higher score represents better functioning.
- Number of Participants With Adverse Events [Baseline through 36 Months]
Summaries of serious adverse events (SAEs) and all other non-serious adverse events (AEs) are located in the Reported Adverse Event Module.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Type 1 or Type 2 diabetes
-
18 years or older
-
Non-clinically significant diabetic macular edema
-
Mild to moderate diabetic retinopathy in the study eye, vitreous hemorrhage in the study eye
-
Relatively good vision (20/30 or better)
Exclusion Criteria:
-
Surgery or laser treatment in the study eye
-
Glaucoma in the study eye
-
Glycosylated hemoglobin (HbA1c) greater than 11%, or systolic blood pressure greater than 170 millimeters of mercury (mmHg)
-
Liver disease, dialysis or renal transplant
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | 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. | Artesia | California | United States | 90701 |
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80 | 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. | Liverpool | Merseyside | United Kingdom | L7 8XP |
81 | 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. | Aberdeen | Scotland | United Kingdom | AB25 2ZN |
82 | 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. | Birmingham | West Midlands | United Kingdom | B9 5SS |
83 | 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. | Bristol | United Kingdom | BS1 2LX | |
84 | 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. | London | United Kingdom | EC1V 2PD |
Sponsors and Collaborators
- Chromaderm, Inc.
Investigators
- Study Director: Karl Beutner, Chromaderm, Inc.
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 8211
- B7A-MC-MBDL
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Ruboxistaurin | Placebo |
---|---|---|
Arm/Group Description | 32 mg once daily (QD) oral for up to 36 months | QD oral for up to 36 months |
Period Title: Overall Study | ||
STARTED | 371 | 360 |
COMPLETED | 298 | 285 |
NOT COMPLETED | 73 | 75 |
Baseline Characteristics
Arm/Group Title | Ruboxistaurin | Placebo | Total |
---|---|---|---|
Arm/Group Description | 32 mg once daily (QD) oral for up to 36 months | QD oral for up to 36 months | Total of all reporting groups |
Overall Participants | 371 | 360 | 731 |
Age (years) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [years] |
55.20
(10.85)
|
55.15
(11.18)
|
55.17
(11.01)
|
Sex: Female, Male (Count of Participants) | |||
Female |
138
37.2%
|
137
38.1%
|
275
37.6%
|
Male |
233
62.8%
|
223
61.9%
|
456
62.4%
|
Region of Enrollment (participants) [Number] | |||
United States |
93
25.1%
|
97
26.9%
|
190
26%
|
Portugal |
15
4%
|
16
4.4%
|
31
4.2%
|
Taiwan |
3
0.8%
|
1
0.3%
|
4
0.5%
|
Spain |
13
3.5%
|
11
3.1%
|
24
3.3%
|
Russian Federation |
28
7.5%
|
24
6.7%
|
52
7.1%
|
United Kingdom |
21
5.7%
|
18
5%
|
39
5.3%
|
Italy |
8
2.2%
|
6
1.7%
|
14
1.9%
|
India |
25
6.7%
|
26
7.2%
|
51
7%
|
France |
11
3%
|
10
2.8%
|
21
2.9%
|
Mexico |
22
5.9%
|
22
6.1%
|
44
6%
|
Canada |
22
5.9%
|
25
6.9%
|
47
6.4%
|
Brazil |
13
3.5%
|
16
4.4%
|
29
4%
|
Poland |
20
5.4%
|
16
4.4%
|
36
4.9%
|
Australia |
20
5.4%
|
17
4.7%
|
37
5.1%
|
Denmark |
26
7%
|
28
7.8%
|
54
7.4%
|
Netherlands |
9
2.4%
|
8
2.2%
|
17
2.3%
|
Germany |
22
5.9%
|
19
5.3%
|
41
5.6%
|
Body Mass Index (BMI) (kilograms/square meters (kg/m^2)) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [kilograms/square meters (kg/m^2)] |
29.90
(6.09)
|
29.82
(5.89)
|
29.86
(5.99)
|
Blood Pressure (millimeters of mercury (mmHg)) [Mean (Standard Deviation) ] | |||
Systolic Blood Pressure |
132.90
(15.25)
|
133.50
(15.58)
|
133.20
(5.99)
|
Diastolic Blood Pressure |
77.68
(8.68)
|
77.77
(9.05)
|
77.73
(8.86)
|
Glycosylated hemoglobin (HbA1c) (percent glycosylated hemoglobin) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [percent glycosylated hemoglobin] |
8.14
(1.31)
|
8.25
(1.31)
|
8.19
(1.31)
|
Diabetes Type (participants) [Number] | |||
Type 1 |
85
22.9%
|
76
21.1%
|
161
22%
|
Type 2 |
286
77.1%
|
284
78.9%
|
570
78%
|
Duration of diabetes (years) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [years] |
15.82
(8.00)
|
15.57
(7.48)
|
15.70
(7.75)
|
Insulin use (participants) [Number] | |||
Yes |
241
65%
|
228
63.3%
|
469
64.2%
|
No |
130
35%
|
132
36.7%
|
262
35.8%
|
Number of diabetic retinopathy (DR) study eyes per participant (participants) [Number] | |||
Two |
351
94.6%
|
336
93.3%
|
687
94%
|
One |
20
5.4%
|
24
6.7%
|
44
6%
|
Visual Acuity Score (Letters Correct) (Letters read correctly) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [Letters read correctly] |
84.12
(7.93)
|
84.27
(7.70)
|
84.19
(7.81)
|
Diabetic Retinopathy (DR) Level (DR study eyes for each level) [Number] | |||
<47 |
465
|
421
|
886
|
47 |
250
|
272
|
522
|
53 |
7
|
3
|
10
|
Outcome Measures
Title | Mean Duration of Definite Center of Macula-involved Diabetic Macular Edema (DME) |
---|---|
Description | Duration of center of macula involvement when primary study outcome (DME involvement in center of macula determined by central grading of stereoscopic fundus photographs) was identified at a visit, participant was considered to have had definite center involvement for a specified length of time between the adjacent visits. Total duration of center involvement was calculated. Mean duration was total duration of center involvement divided by total number of participants. Participant durations were summarized, total number of months of center involvement in both treatment groups were displayed. |
Time Frame | 6 Months through 36 Months |
Outcome Measure Data
Analysis Population Description |
---|
Intent-to-treat (ITT) population including all randomized participants analyzed according to the treatment group to which they were originally assigned by random allocation even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. |
Arm/Group Title | Ruboxistaurin | Placebo |
---|---|---|
Arm/Group Description | 32 mg once daily (QD) oral for up to 36 months | QD oral for up to 36 months |
Measure Participants | 349 | 346 |
Mean (Standard Deviation) [months per participant] |
1.72
(4.95)
|
1.69
(4.41)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Ruboxistaurin, Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.969 |
Comments | ||
Method | ANOVA | |
Comments | ||
Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
Estimated Value | -0.01 | |
Confidence Interval |
(2-Sided) 95% -0.714 to 0.686 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Change From Baseline in Visual Acuity by Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) Chart at 36 Months |
---|---|
Description | ETDRS VA: participant starts at the top of the chart containing 5 letters per row and reads down the chart until reaching a row where a minimum of 3 letters on a line cannot be read. Participant is scored by how many letters could be correctly identified. A higher number of letters correctly identified represents better visual acuity. Results are reported based on the number of diabetic retinopathy (DR) eyes. |
Time Frame | Baseline, 36 Months |
Outcome Measure Data
Analysis Population Description |
---|
Intent-to-treat (ITT) population including all randomized participants analyzed according to the treatment group to which they were originally assigned by random allocation even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. |
Arm/Group Title | Ruboxistaurin | Placebo |
---|---|---|
Arm/Group Description | 32 mg once daily (QD) oral for up to 36 months | QD oral for up to 36 months |
Measure Participants | 371 | 360 |
Measure DR study eyes | 722 | 695 |
Baseline (letters correct) (n=722, 695) |
84.12
(7.93)
|
84.27
(7.70)
|
Change from baseline (n=687,670) |
-1.14
(7.38)
|
-2.30
(9.21)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Ruboxistaurin, Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.015 |
Comments | P-value is for change from baseline. | |
Method | ANCOVA | |
Comments | ||
Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
Estimated Value | 1.09 | |
Confidence Interval |
(2-Sided) 95% 0.21 to 1.97 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | First Occurrence of Focal/Grid Photocoagulation |
---|---|
Description | The first occurrence of focal/grid photocoagulation regardless of diabetic macular edema (DME) distance from the center of the macula. |
Time Frame | Baseline through 36 Months |
Outcome Measure Data
Analysis Population Description |
---|
Intent-to-treat (ITT) population including all randomized participants analyzed according to the treatment group to which they were originally assigned by random allocation even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. |
Arm/Group Title | Ruboxistaurin | Placebo |
---|---|---|
Arm/Group Description | 32 mg once daily (QD) oral for up to 36 months | QD oral for up to 36 months |
Measure Participants | 371 | 360 |
Yes |
32
8.6%
|
27
7.5%
|
No |
339
91.4%
|
333
92.5%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Ruboxistaurin, Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.577 |
Comments | P-value is for first occurrence of focal/grid photocoagulation yes versus no. | |
Method | Chi-squared | |
Comments |
Title | Change From Baseline in Contrast Sensitivity by Pelli-Robson |
---|---|
Description | Pelli-Robson chart read from left to right + from top to bottom. Each line has 2 groups, each of 3 letters. Letters in each group have same contrast. Contrast in each successive group is less than the preceding group. Participant reads letters starting with highest contrast, continues until 2 or 3 letters in 1 group are incorrectly named. Scored on key showing all letters at full contrast, gives the log contrast sensitivity corresponding to each group. Score is determined by previous group (last group in which 2 or 3 letters were correctly named). Results reported based on number of DR eyes. |
Time Frame | Baseline, 36 Months |
Outcome Measure Data
Analysis Population Description |
---|
Intent-to-treat (ITT) population: all randomized participants analyzed according to treatment group to which they were originally assigned by random allocation even if they did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. |
Arm/Group Title | Ruboxistaurin | Placebo |
---|---|---|
Arm/Group Description | 32 mg once daily (QD) oral for up to 36 months | QD oral for up to 36 months |
Measure Participants | 371 | 360 |
Measure DR Study Eyes | 718 | 689 |
Baseline (letters correct) (n=718,689) |
33.54
(3.33)
|
33.71
(3.54)
|
Change from baseline (n=685,664) |
-0.54
(3.84)
|
-1.06
(4.68)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Ruboxistaurin, Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.041 |
Comments | P-value is for change from baseline. | |
Method | ANCOVA | |
Comments | ||
Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
Estimated Value | 0.45 | |
Confidence Interval |
(2-Sided) 95% 0.02 to 0.87 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Progression of Nonproliferative Diabetic Retinopathy (DR) by Seven-field Stereo Fundus Photography |
---|---|
Description | Participants were classified as having experienced progression or no progression of DR by 36-month visit. Progression of DR=3 steps on ETDRS retinopathy severity person scale for participants with both eyes less than proliferative diabetic retinopathy (PDR) at baseline OR 2 steps on ETDRS retinopathy severity eye scale for participants with 1 eye less than PDR at baseline OR application of panretinal laser therapy. Participants were assigned at baseline to ETDRS retinopathy severity scale for persons or individual eyes; determination of no progression/progression was dependent on the scale. |
Time Frame | Baseline through 36 Months |
Outcome Measure Data
Analysis Population Description |
---|
Intent-to-treat (ITT) population including all randomized participants analyzed according to the treatment group to which they were originally assigned by random allocation even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. |
Arm/Group Title | Ruboxistaurin | Placebo |
---|---|---|
Arm/Group Description | 32 mg once daily (QD) oral for up to 36 months | QD oral for up to 36 months |
Measure Participants | 371 | 360 |
No progression |
328
88.4%
|
312
86.7%
|
Progression |
43
11.6%
|
48
13.3%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Ruboxistaurin, Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.475 |
Comments | P-value is for progression of nonproliferative diabetic retinopathy (DR) by seven-field stereo fundus photography progression versus no progression. | |
Method | Chi-squared | |
Comments |
Title | Change From Baseline in Estimated Glomerular Filtration Rate |
---|---|
Description | The Modification of Diet in Renal Disease (MDRD) study formula used for the estimated glomerular filtration rate (eGFR) determination is: eGFR = 170 X (Serum creatinine concentration [mg/deciliter (dL)])-0.999 X (Age [years]) -0.176 X (0.762 if participant is female) X (1.180 if participant is black) X (Serum urea nitrogen concentration [mg/dL])-0.170 X (Serum albumin concentration [grams (g)/dL])+0.318. |
Time Frame | Baseline, 36 Months |
Outcome Measure Data
Analysis Population Description |
---|
Intent-to-treat (ITT) population including all randomized participants analyzed according to the treatment group to which they were originally assigned by random allocation even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. |
Arm/Group Title | Ruboxistaurin | Placebo |
---|---|---|
Arm/Group Description | 32 mg once daily (QD) oral for up to 36 months | QD oral for up to 36 months |
Measure Participants | 368 | 358 |
Baseline (n=368,358) |
85.35
(22.24)
|
87.27
(23.44)
|
Change from baseline (n=340,328) |
-5.55
(15.70)
|
-7.92
(17.31)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Ruboxistaurin, Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.211 |
Comments | P-value is for change from baseline. | |
Method | ANCOVA | |
Comments | ||
Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
Estimated Value | 1.52 | |
Confidence Interval |
(2-Sided) 95% -0.87 to 3.92 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Change From Baseline at Endpoint in Albumin/Creatinine Ratio |
---|---|
Description | |
Time Frame | 36 Months |
Outcome Measure Data
Analysis Population Description |
---|
The completer population includes participants who completed all 36 months of the treatment phase. |
Arm/Group Title | Ruboxistaurin | Placebo |
---|---|---|
Arm/Group Description | 32 mg once daily (QD) oral for up to 36 months | QD oral for up to 36 months |
Measure Participants | 270 | 261 |
Baseline (n=270,261) |
123.53
(507.93)
|
152.61
(623.98)
|
Change from baseline (n=267,253) |
135.90
(865.34)
|
72.69
(720.35)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Ruboxistaurin, Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.365 |
Comments | P-value is for change from baseline. | |
Method | t-test, 2 sided | |
Comments | ||
Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
Estimated Value | 63.22 | |
Confidence Interval |
(2-Sided) 95% -73.68 to 200.12 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Change From Baseline at Endpoint in Visual Function by the National Eye Institute Visual Functioning Questionnaire (NEI VFQ-25) at 36 Months |
---|---|
Description | 25 vision-targeted questions representing 11 vision-related constructs and a 1-item general health rating question. Measures the influence of visual disability and visual symptoms on generic health domains such as emotional well-being and social functioning and task-oriented domains related to daily visual functioning. Each item is converted to a 0 to 100 scale such that a higher score represents better functioning. |
Time Frame | 36 Months |
Outcome Measure Data
Analysis Population Description |
---|
Intent-to-treat (ITT) population including all randomized participants analyzed according to the treatment group to which they were originally assigned by random allocation even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. |
Arm/Group Title | Ruboxistaurin | Placebo |
---|---|---|
Arm/Group Description | 32 mg once daily (QD) oral for up to 36 months | QD oral for up to 36 months |
Measure Participants | 351 | 342 |
Baseline (n=351,342) |
67.86
(8.25)
|
67.56
(7.85)
|
Change from baseline (n=314,309) |
0.17
(6.21)
|
-1.36
(8.56)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Ruboxistaurin, Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.009 |
Comments | P-value is for change from baseline. | |
Method | ANCOVA | |
Comments | ||
Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
Estimated Value | 1.52 | |
Confidence Interval |
(2-Sided) 95% 0.38 to 2.66 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Number of Participants With Adverse Events |
---|---|
Description | Summaries of serious adverse events (SAEs) and all other non-serious adverse events (AEs) are located in the Reported Adverse Event Module. |
Time Frame | Baseline through 36 Months |
Outcome Measure Data
Analysis Population Description |
---|
Safety population: all randomized participants who received at least one dose of study drug. |
Arm/Group Title | Ruboxistaurin | Placebo |
---|---|---|
Arm/Group Description | 32 mg once daily (QD) oral for up to 36 months | QD oral for up to 36 months |
Measure Participants | 371 | 360 |
Serious adverse events |
93
25.1%
|
82
22.8%
|
Adverse events |
298
80.3%
|
299
83.1%
|
Title | Occurrence of Sustained Moderate Visual Loss (SMVL) in a Diabetic Retinopathy (DR) Study Eye |
---|---|
Description | The occurrence of SMVL was defined as ≥15 letter decrease from baseline in best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) in any DR study eye relative to baseline that is sustained for the last 6 months of participation. ETDRS VA: participant starts at the top of the chart containing 5 letters per row and reads down the chart until reaching a row where a minimum of 3 letters on a line cannot be read. Participant is scored by how many letters could be correctly identified. A higher number of letters correctly identified represents better visual acuity. |
Time Frame | Baseline, 36 Months |
Outcome Measure Data
Analysis Population Description |
---|
Intent-to-treat (ITT) population: all randomized participants with at least 1 eligible study eye analyzed according to the treatment group to which they were originally assigned by random allocation even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. |
Arm/Group Title | Ruboxistaurin | Placebo |
---|---|---|
Arm/Group Description | 32 mg once daily (QD) oral for up to 36 months | QD oral for up to 36 months |
Measure Participants | 342 | 331 |
Yes |
8
2.2%
|
16
4.4%
|
No |
334
90%
|
315
87.5%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Ruboxistaurin, Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.081 |
Comments | P-value is for occurrence of sustained moderate visual loss (SMVL) in a diabetic retinopathy (DR) study eye yes versus no. | |
Method | Chi-squared | |
Comments | ||
Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
Estimated Value | 0.47 | |
Confidence Interval |
(2-Sided) 95% 0.20 to 1.12 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Adverse Events
Time Frame | ||||
---|---|---|---|---|
Adverse Event Reporting Description | ||||
Arm/Group Title | Ruboxistaurin | Placebo | ||
Arm/Group Description | 32 mg once daily (QD) oral for up to 36 months | QD oral for up to 36 months | ||
All Cause Mortality |
||||
Ruboxistaurin | Placebo | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
Ruboxistaurin | Placebo | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 93/371 (25.1%) | 82/360 (22.8%) | ||
Blood and lymphatic system disorders | ||||
Anaemia | 3/371 (0.8%) | 4 | 0/360 (0%) | 0 |
Thrombocytopenia | 1/371 (0.3%) | 1 | 0/360 (0%) | 0 |
Cardiac disorders | ||||
Acute myocardial infarction | 2/371 (0.5%) | 3 | 5/360 (1.4%) | 5 |
Angina pectoris | 4/371 (1.1%) | 14 | 1/360 (0.3%) | 1 |
Angina unstable | 3/371 (0.8%) | 4 | 2/360 (0.6%) | 2 |
Aortic valve stenosis | 1/371 (0.3%) | 1 | 0/360 (0%) | 0 |
Arteriosclerosis coronary artery | 1/371 (0.3%) | 10 | 0/360 (0%) | 0 |
Atrial fibrillation | 2/371 (0.5%) | 5 | 1/360 (0.3%) | 2 |
Atrial flutter | 1/371 (0.3%) | 4 | 1/360 (0.3%) | 1 |
Atrioventricular block | 1/371 (0.3%) | 1 | 0/360 (0%) | 0 |
Cardiac arrest | 2/371 (0.5%) | 2 | 0/360 (0%) | 0 |
Cardiac failure | 0/371 (0%) | 0 | 1/360 (0.3%) | 8 |
Cardiac failure congestive | 1/371 (0.3%) | 4 | 2/360 (0.6%) | 9 |
Cardiogenic shock | 0/371 (0%) | 0 | 1/360 (0.3%) | 1 |
Cardiovascular disorder | 1/371 (0.3%) | 1 | 0/360 (0%) | 0 |
Cor pulmonale | 1/371 (0.3%) | 4 | 0/360 (0%) | 0 |
Coronary artery disease | 3/371 (0.8%) | 9 | 5/360 (1.4%) | 16 |
Coronary artery occlusion | 0/371 (0%) | 0 | 2/360 (0.6%) | 2 |
Ischaemic cardiomyopathy | 1/371 (0.3%) | 2 | 0/360 (0%) | 0 |
Left ventricular failure | 1/371 (0.3%) | 1 | 0/360 (0%) | 0 |
Myocardial infarction | 6/371 (1.6%) | 6 | 4/360 (1.1%) | 4 |
Myocardial ischaemia | 0/371 (0%) | 0 | 1/360 (0.3%) | 1 |
Stress cardiomyopathy | 1/371 (0.3%) | 1 | 0/360 (0%) | 0 |
Tachycardia | 1/371 (0.3%) | 1 | 1/360 (0.3%) | 1 |
Ear and labyrinth disorders | ||||
Hearing impaired | 0/371 (0%) | 0 | 1/360 (0.3%) | 11 |
Vertigo | 1/371 (0.3%) | 1 | 1/360 (0.3%) | 1 |
Endocrine disorders | ||||
Goitre | 1/371 (0.3%) | 8 | 0/360 (0%) | 0 |
Eye disorders | ||||
Cataract | 0/371 (0%) | 0 | 2/360 (0.6%) | 7 |
Ocular myasthenia | 1/371 (0.3%) | 4 | 0/360 (0%) | 0 |
Retinal detachment | 1/371 (0.3%) | 1 | 0/360 (0%) | 0 |
Visual disturbance | 1/371 (0.3%) | 1 | 0/360 (0%) | 0 |
Gastrointestinal disorders | ||||
Colitis | 0/371 (0%) | 0 | 1/360 (0.3%) | 1 |
Diarrhoea | 1/371 (0.3%) | 2 | 1/360 (0.3%) | 1 |
Faecal incontinence | 1/371 (0.3%) | 2 | 1/360 (0.3%) | 1 |
Gastritis | 0/371 (0%) | 0 | 1/360 (0.3%) | 1 |
Gastrointestinal ulcer haemorrhage | 1/371 (0.3%) | 1 | 0/360 (0%) | 0 |
Lower gastrointestinal haemorrhage | 0/371 (0%) | 0 | 1/360 (0.3%) | 1 |
Mouth ulceration | 0/371 (0%) | 0 | 1/360 (0.3%) | 1 |
Oesophageal ulcer | 0/371 (0%) | 0 | 1/360 (0.3%) | 1 |
Pancreatitis | 0/371 (0%) | 0 | 1/360 (0.3%) | 1 |
Pancreatitis acute | 0/371 (0%) | 0 | 1/360 (0.3%) | 1 |
Umbilical hernia | 1/371 (0.3%) | 1 | 0/360 (0%) | 0 |
Vomiting | 0/371 (0%) | 0 | 1/360 (0.3%) | 1 |
General disorders | ||||
Calcinosis | 1/371 (0.3%) | 3 | 0/360 (0%) | 0 |
Chest discomfort | 1/371 (0.3%) | 1 | 1/360 (0.3%) | 2 |
Chest pain | 3/371 (0.8%) | 3 | 1/360 (0.3%) | 1 |
Death | 0/371 (0%) | 0 | 3/360 (0.8%) | 3 |
Impaired healing | 0/371 (0%) | 0 | 1/360 (0.3%) | 4 |
Pyrexia | 1/371 (0.3%) | 1 | 0/360 (0%) | 0 |
Hepatobiliary disorders | ||||
Cholecystitis | 1/371 (0.3%) | 1 | 1/360 (0.3%) | 1 |
Cholecystitis acute | 0/371 (0%) | 0 | 1/360 (0.3%) | 1 |
Cholelithiasis | 0/371 (0%) | 0 | 1/360 (0.3%) | 1 |
Immune system disorders | ||||
Anaphylactic reaction | 0/371 (0%) | 0 | 1/360 (0.3%) | 1 |
Infections and infestations | ||||
Appendicitis | 0/371 (0%) | 0 | 1/360 (0.3%) | 1 |
Bacteraemia | 0/371 (0%) | 0 | 1/360 (0.3%) | 1 |
Cystitis | 1/371 (0.3%) | 2 | 0/360 (0%) | 0 |
Dengue fever | 0/371 (0%) | 0 | 1/360 (0.3%) | 1 |
Diarrhoea infectious | 0/371 (0%) | 0 | 1/360 (0.3%) | 1 |
Endocarditis | 1/371 (0.3%) | 1 | 0/360 (0%) | 0 |
Gastroenteritis | 2/371 (0.5%) | 2 | 2/360 (0.6%) | 2 |
Gastroenteritis viral | 0/371 (0%) | 0 | 1/360 (0.3%) | 1 |
Herpes zoster | 1/371 (0.3%) | 1 | 0/360 (0%) | 0 |
Liver abscess | 1/371 (0.3%) | 2 | 0/360 (0%) | 0 |
Lobar pneumonia | 1/371 (0.3%) | 1 | 0/360 (0%) | 0 |
Localised infection | 2/371 (0.5%) | 2 | 0/360 (0%) | 0 |
Osteomyelitis | 1/371 (0.3%) | 1 | 0/360 (0%) | 0 |
Perirectal abscess | 0/371 (0%) | 0 | 1/360 (0.3%) | 1 |
Pneumonia | 3/371 (0.8%) | 3 | 1/360 (0.3%) | 1 |
Pyelonephritis | 0/371 (0%) | 0 | 2/360 (0.6%) | 2 |
Pyelonephritis acute | 1/371 (0.3%) | 1 | 0/360 (0%) | 0 |
Sepsis | 0/371 (0%) | 0 | 1/360 (0.3%) | 1 |
Subcutaneous abscess | 1/371 (0.3%) | 1 | 0/360 (0%) | 0 |
Urinary tract infection | 0/371 (0%) | 0 | 2/360 (0.6%) | 2 |
Urinary tract infection fungal | 1/371 (0.3%) | 1 | 0/360 (0%) | 0 |
Wound infection | 0/371 (0%) | 0 | 1/360 (0.3%) | 1 |
Injury, poisoning and procedural complications | ||||
Ankle fracture | 3/371 (0.8%) | 6 | 0/360 (0%) | 0 |
Cerebral haemorrhage traumatic | 1/371 (0.3%) | 1 | 0/360 (0%) | 0 |
Chest injury | 1/371 (0.3%) | 1 | 0/360 (0%) | 0 |
Concussion | 1/371 (0.3%) | 1 | 0/360 (0%) | 0 |
Device occlusion | 0/371 (0%) | 0 | 1/360 (0.3%) | 1 |
Fall | 3/371 (0.8%) | 5 | 0/360 (0%) | 0 |
Foot fracture | 1/371 (0.3%) | 1 | 0/360 (0%) | 0 |
Head injury | 1/371 (0.3%) | 1 | 0/360 (0%) | 0 |
Hip fracture | 2/371 (0.5%) | 2 | 0/360 (0%) | 0 |
Jaw fracture | 1/371 (0.3%) | 1 | 0/360 (0%) | 0 |
Pelvic fracture | 1/371 (0.3%) | 2 | 0/360 (0%) | 0 |
Road traffic accident | 1/371 (0.3%) | 1 | 0/360 (0%) | 0 |
Spinal fracture | 1/371 (0.3%) | 1 | 0/360 (0%) | 0 |
Subdural haemorrhage | 1/371 (0.3%) | 1 | 0/360 (0%) | 0 |
Therapeutic agent toxicity | 0/371 (0%) | 0 | 1/360 (0.3%) | 1 |
Wound | 1/371 (0.3%) | 1 | 0/360 (0%) | 0 |
Wrist fracture | 1/371 (0.3%) | 2 | 0/360 (0%) | 0 |
Investigations | ||||
Blood glucose increased | 1/371 (0.3%) | 1 | 0/360 (0%) | 0 |
Colonoscopy | 0/371 (0%) | 0 | 1/360 (0.3%) | 1 |
Electrocardiogram abnormal | 0/371 (0%) | 0 | 1/360 (0.3%) | 1 |
Metabolism and nutrition disorders | ||||
Dehydration | 1/371 (0.3%) | 1 | 2/360 (0.6%) | 2 |
Diabetes mellitus inadequate control | 5/371 (1.3%) | 9 | 6/360 (1.7%) | 6 |
Diabetic foot | 0/371 (0%) | 0 | 2/360 (0.6%) | 7 |
Diabetic ketoacidosis | 1/371 (0.3%) | 1 | 0/360 (0%) | 0 |
Fluid retention | 0/371 (0%) | 0 | 1/360 (0.3%) | 1 |
Hyperglycaemia | 1/371 (0.3%) | 1 | 1/360 (0.3%) | 1 |
Hypoglycaemia | 3/371 (0.8%) | 3 | 2/360 (0.6%) | 2 |
Hypokalaemia | 1/371 (0.3%) | 1 | 0/360 (0%) | 0 |
Hyponatraemia | 1/371 (0.3%) | 1 | 0/360 (0%) | 0 |
Obesity | 2/371 (0.5%) | 10 | 0/360 (0%) | 0 |
Musculoskeletal and connective tissue disorders | ||||
Arthritis | 0/371 (0%) | 0 | 1/360 (0.3%) | 1 |
Back pain | 1/371 (0.3%) | 1 | 1/360 (0.3%) | 2 |
Cervical spinal stenosis | 0/371 (0%) | 0 | 1/360 (0.3%) | 3 |
Dupuytren's contracture | 1/371 (0.3%) | 1 | 0/360 (0%) | 0 |
Foot deformity | 1/371 (0.3%) | 10 | 0/360 (0%) | 0 |
Intervertebral disc protrusion | 1/371 (0.3%) | 1 | 1/360 (0.3%) | 1 |
Lumbar spinal stenosis | 0/371 (0%) | 0 | 1/360 (0.3%) | 4 |
Osteitis | 0/371 (0%) | 0 | 1/360 (0.3%) | 1 |
Osteoarthritis | 0/371 (0%) | 0 | 2/360 (0.6%) | 11 |
Rhabdomyolysis | 1/371 (0.3%) | 1 | 0/360 (0%) | 0 |
Spinal osteoarthritis | 1/371 (0.3%) | 1 | 0/360 (0%) | 0 |
Spondylolisthesis | 0/371 (0%) | 0 | 1/360 (0.3%) | 1 |
Tendonitis | 1/371 (0.3%) | 14 | 0/360 (0%) | 0 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
Angioimmunoblastic t-cell lymphoma | 1/371 (0.3%) | 1 | 0/360 (0%) | 0 |
Bladder transitional cell carcinoma | 0/371 (0%) | 0 | 1/360 (0.3%) | 1 |
Breast cancer | 0/371 (0%) | 0 | 1/360 (0.3%) | 4 |
Colon adenoma | 0/371 (0%) | 0 | 1/360 (0.3%) | 1 |
Colon cancer | 0/371 (0%) | 0 | 1/360 (0.3%) | 1 |
Colorectal cancer | 1/371 (0.3%) | 1 | 0/360 (0%) | 0 |
Gastric cancer stage iii | 0/371 (0%) | 0 | 1/360 (0.3%) | 1 |
Meningioma | 0/371 (0%) | 0 | 1/360 (0.3%) | 5 |
Pancreatic carcinoma | 2/371 (0.5%) | 2 | 1/360 (0.3%) | 1 |
Prostatic adenoma | 1/371 (0.3%) | 1 | 0/360 (0%) | 0 |
Renal cancer metastatic | 0/371 (0%) | 0 | 1/360 (0.3%) | 1 |
Small intestine carcinoma | 0/371 (0%) | 0 | 1/360 (0.3%) | 1 |
Squamous cell carcinoma of skin | 0/371 (0%) | 0 | 1/360 (0.3%) | 1 |
Thyroid cancer | 1/371 (0.3%) | 3 | 0/360 (0%) | 0 |
Nervous system disorders | ||||
Balance disorder | 1/371 (0.3%) | 1 | 0/360 (0%) | 0 |
Carotid artery stenosis | 2/371 (0.5%) | 4 | 0/360 (0%) | 0 |
Carpal tunnel syndrome | 1/371 (0.3%) | 4 | 0/360 (0%) | 0 |
Cerebral ischaemia | 1/371 (0.3%) | 7 | 0/360 (0%) | 0 |
Cerebrovascular accident | 4/371 (1.1%) | 5 | 2/360 (0.6%) | 3 |
Coma hepatic | 1/371 (0.3%) | 1 | 0/360 (0%) | 0 |
Coordination abnormal | 0/371 (0%) | 0 | 1/360 (0.3%) | 1 |
Cubital tunnel syndrome | 1/371 (0.3%) | 1 | 0/360 (0%) | 0 |
Diabetic hyperglycaemic coma | 1/371 (0.3%) | 1 | 0/360 (0%) | 0 |
Dysarthria | 1/371 (0.3%) | 1 | 0/360 (0%) | 0 |
Facial palsy | 1/371 (0.3%) | 1 | 0/360 (0%) | 0 |
Grand mal convulsion | 1/371 (0.3%) | 9 | 0/360 (0%) | 0 |
Ischaemic stroke | 2/371 (0.5%) | 7 | 0/360 (0%) | 0 |
Loss of consciousness | 1/371 (0.3%) | 1 | 0/360 (0%) | 0 |
Peripheral sensory neuropathy | 0/371 (0%) | 0 | 1/360 (0.3%) | 1 |
Sciatica | 1/371 (0.3%) | 1 | 0/360 (0%) | 0 |
Simple partial seizures | 1/371 (0.3%) | 1 | 0/360 (0%) | 0 |
Syncope | 1/371 (0.3%) | 1 | 0/360 (0%) | 0 |
Transient ischaemic attack | 2/371 (0.5%) | 2 | 0/360 (0%) | 0 |
Psychiatric disorders | ||||
Anxiety | 0/371 (0%) | 0 | 1/360 (0.3%) | 5 |
Confusional state | 1/371 (0.3%) | 1 | 0/360 (0%) | 0 |
Conversion disorder | 1/371 (0.3%) | 1 | 0/360 (0%) | 0 |
Depression | 1/371 (0.3%) | 12 | 0/360 (0%) | 0 |
Suicidal ideation | 1/371 (0.3%) | 4 | 0/360 (0%) | 0 |
Renal and urinary disorders | ||||
Diabetic nephropathy | 2/371 (0.5%) | 7 | 0/360 (0%) | 0 |
Dysuria | 1/371 (0.3%) | 1 | 0/360 (0%) | 0 |
Nephrolithiasis | 1/371 (0.3%) | 1 | 0/360 (0%) | 0 |
Pelvi-ureteric obstruction | 0/371 (0%) | 0 | 1/360 (0.3%) | 9 |
Renal artery arteriosclerosis | 1/371 (0.3%) | 1 | 0/360 (0%) | 0 |
Renal failure | 3/371 (0.8%) | 11 | 0/360 (0%) | 0 |
Renal failure acute | 0/371 (0%) | 0 | 1/360 (0.3%) | 1 |
Renal failure chronic | 1/371 (0.3%) | 4 | 0/360 (0%) | 0 |
Renal impairment | 0/371 (0%) | 0 | 1/360 (0.3%) | 1 |
Urge incontinence | 0/371 (0%) | 0 | 1/360 (0.3%) | 1 |
Urinary retention | 1/371 (0.3%) | 4 | 0/360 (0%) | 0 |
Reproductive system and breast disorders | ||||
Benign prostatic hyperplasia | 1/371 (0.3%) | 4 | 2/360 (0.6%) | 15 |
Ovarian cyst | 0/371 (0%) | 0 | 1/360 (0.3%) | 1 |
Pelvic pain | 0/371 (0%) | 0 | 1/360 (0.3%) | 1 |
Priapism | 0/371 (0%) | 0 | 1/360 (0.3%) | 1 |
Respiratory, thoracic and mediastinal disorders | ||||
Asthma | 0/371 (0%) | 0 | 1/360 (0.3%) | 8 |
Dyspnoea | 0/371 (0%) | 0 | 3/360 (0.8%) | 3 |
Epistaxis | 1/371 (0.3%) | 1 | 0/360 (0%) | 0 |
Hypoxia | 1/371 (0.3%) | 1 | 0/360 (0%) | 0 |
Obstructive airways disorder | 0/371 (0%) | 0 | 1/360 (0.3%) | 2 |
Pulmonary embolism | 0/371 (0%) | 0 | 1/360 (0.3%) | 1 |
Sleep apnoea syndrome | 1/371 (0.3%) | 4 | 1/360 (0.3%) | 4 |
Skin and subcutaneous tissue disorders | ||||
Diabetic neuropathic ulcer | 1/371 (0.3%) | 1 | 0/360 (0%) | 0 |
Idiopathic urticaria | 0/371 (0%) | 0 | 1/360 (0.3%) | 1 |
Skin necrosis | 1/371 (0.3%) | 1 | 0/360 (0%) | 0 |
Skin ulcer | 1/371 (0.3%) | 1 | 0/360 (0%) | 0 |
Surgical and medical procedures | ||||
Cholecystectomy | 0/371 (0%) | 0 | 1/360 (0.3%) | 1 |
Splenectomy | 0/371 (0%) | 0 | 1/360 (0.3%) | 1 |
Thyroidectomy | 1/371 (0.3%) | 1 | 0/360 (0%) | 0 |
Tooth extraction | 0/371 (0%) | 0 | 1/360 (0.3%) | 1 |
Vascular disorders | ||||
Aortic stenosis | 1/371 (0.3%) | 13 | 0/360 (0%) | 0 |
Arteriosclerosis | 1/371 (0.3%) | 1 | 0/360 (0%) | 0 |
Circulatory collapse | 1/371 (0.3%) | 1 | 0/360 (0%) | 0 |
Deep vein thrombosis | 1/371 (0.3%) | 4 | 0/360 (0%) | 0 |
Haemorrhage | 0/371 (0%) | 0 | 1/360 (0.3%) | 3 |
Peripheral arterial occlusive disease | 1/371 (0.3%) | 1 | 0/360 (0%) | 0 |
Peripheral ischaemia | 0/371 (0%) | 0 | 1/360 (0.3%) | 1 |
Peripheral vascular disorder | 2/371 (0.5%) | 11 | 2/360 (0.6%) | 5 |
Subclavian artery stenosis | 1/371 (0.3%) | 1 | 0/360 (0%) | 0 |
Vasculitis | 0/371 (0%) | 0 | 1/360 (0.3%) | 1 |
Other (Not Including Serious) Adverse Events |
||||
Ruboxistaurin | Placebo | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 298/371 (80.3%) | 299/360 (83.1%) | ||
Gastrointestinal disorders | ||||
Diarrhoea | 38/371 (10.2%) | 90 | 32/360 (8.9%) | 108 |
Nausea | 17/371 (4.6%) | 23 | 21/360 (5.8%) | 60 |
Vomiting | 19/371 (5.1%) | 22 | 17/360 (4.7%) | 25 |
General disorders | ||||
Oedema peripheral | 16/371 (4.3%) | 60 | 24/360 (6.7%) | 86 |
Pyrexia | 15/371 (4%) | 18 | 19/360 (5.3%) | 19 |
Infections and infestations | ||||
Bronchitis | 19/371 (5.1%) | 28 | 16/360 (4.4%) | 23 |
Influenza | 47/371 (12.7%) | 67 | 36/360 (10%) | 58 |
Nasopharyngitis | 65/371 (17.5%) | 135 | 59/360 (16.4%) | 121 |
Sinusitis | 24/371 (6.5%) | 54 | 13/360 (3.6%) | 20 |
Upper respiratory tract infection | 17/371 (4.6%) | 25 | 20/360 (5.6%) | 34 |
Urinary tract infection | 20/371 (5.4%) | 42 | 18/360 (5%) | 40 |
Metabolism and nutrition disorders | ||||
Hypercholesterolaemia | 28/371 (7.5%) | 129 | 29/360 (8.1%) | 131 |
Musculoskeletal and connective tissue disorders | ||||
Arthralgia | 27/371 (7.3%) | 89 | 35/360 (9.7%) | 144 |
Back pain | 29/371 (7.8%) | 93 | 36/360 (10%) | 105 |
Musculoskeletal pain | 16/371 (4.3%) | 56 | 24/360 (6.7%) | 83 |
Pain in extremity | 32/371 (8.6%) | 82 | 22/360 (6.1%) | 99 |
Nervous system disorders | ||||
Headache | 37/371 (10%) | 102 | 44/360 (12.2%) | 129 |
Respiratory, thoracic and mediastinal disorders | ||||
Cough | 38/371 (10.2%) | 73 | 46/360 (12.8%) | 85 |
Pharyngolaryngeal pain | 21/371 (5.7%) | 36 | 24/360 (6.7%) | 36 |
Vascular disorders | ||||
Hypertension | 43/371 (11.6%) | 229 | 49/360 (13.6%) | 282 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
Name/Title | info@chroma-derm.com |
---|---|
Organization | Chromaderm |
Phone | |
info@chroma-derm.com |
- 8211
- B7A-MC-MBDL