Trial Outcomes & Findings for Reduction in the Occurrence of Center-Involved Diabetic Macular Edema (NCT NCT00090519)
NCT ID: NCT00090519
Last Updated: 2016-10-06
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
731 participants
Primary outcome timeframe
6 Months through 36 Months
Results posted on
2016-10-06
Participant Flow
Participant milestones
| Measure |
Ruboxistaurin
32 mg once daily (QD) oral for up to 36 months
|
Placebo
QD oral for up to 36 months
|
|---|---|---|
|
Overall Study
STARTED
|
371
|
360
|
|
Overall Study
COMPLETED
|
298
|
285
|
|
Overall Study
NOT COMPLETED
|
73
|
75
|
Reasons for withdrawal
| Measure |
Ruboxistaurin
32 mg once daily (QD) oral for up to 36 months
|
Placebo
QD oral for up to 36 months
|
|---|---|---|
|
Overall Study
Adverse Event
|
5
|
4
|
|
Overall Study
Death
|
9
|
9
|
|
Overall Study
Lost to Follow-up
|
26
|
29
|
|
Overall Study
Withdrawal by Subject
|
28
|
29
|
|
Overall Study
Physician Decision
|
2
|
3
|
|
Overall Study
Sponsor Decision
|
3
|
1
|
Baseline Characteristics
Reduction in the Occurrence of Center-Involved Diabetic Macular Edema
Baseline characteristics by cohort
| Measure |
Ruboxistaurin
n=371 Participants
32 mg once daily (QD) oral for up to 36 months
|
Placebo
n=360 Participants
QD oral for up to 36 months
|
Total
n=731 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.20 years
STANDARD_DEVIATION 10.85 • n=5 Participants
|
55.15 years
STANDARD_DEVIATION 11.18 • n=7 Participants
|
55.17 years
STANDARD_DEVIATION 11.01 • n=5 Participants
|
|
Sex: Female, Male
Female
|
138 Participants
n=5 Participants
|
137 Participants
n=7 Participants
|
275 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
233 Participants
n=5 Participants
|
223 Participants
n=7 Participants
|
456 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
93 participants
n=5 Participants
|
97 participants
n=7 Participants
|
190 participants
n=5 Participants
|
|
Region of Enrollment
Portugal
|
15 participants
n=5 Participants
|
16 participants
n=7 Participants
|
31 participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
13 participants
n=5 Participants
|
11 participants
n=7 Participants
|
24 participants
n=5 Participants
|
|
Region of Enrollment
Russian Federation
|
28 participants
n=5 Participants
|
24 participants
n=7 Participants
|
52 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
21 participants
n=5 Participants
|
18 participants
n=7 Participants
|
39 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
8 participants
n=5 Participants
|
6 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Region of Enrollment
India
|
25 participants
n=5 Participants
|
26 participants
n=7 Participants
|
51 participants
n=5 Participants
|
|
Region of Enrollment
France
|
11 participants
n=5 Participants
|
10 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
22 participants
n=5 Participants
|
22 participants
n=7 Participants
|
44 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
22 participants
n=5 Participants
|
25 participants
n=7 Participants
|
47 participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
13 participants
n=5 Participants
|
16 participants
n=7 Participants
|
29 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
20 participants
n=5 Participants
|
16 participants
n=7 Participants
|
36 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
20 participants
n=5 Participants
|
17 participants
n=7 Participants
|
37 participants
n=5 Participants
|
|
Region of Enrollment
Denmark
|
26 participants
n=5 Participants
|
28 participants
n=7 Participants
|
54 participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
9 participants
n=5 Participants
|
8 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
22 participants
n=5 Participants
|
19 participants
n=7 Participants
|
41 participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
29.90 kilograms/square meters (kg/m^2)
STANDARD_DEVIATION 6.09 • n=5 Participants
|
29.82 kilograms/square meters (kg/m^2)
STANDARD_DEVIATION 5.89 • n=7 Participants
|
29.86 kilograms/square meters (kg/m^2)
STANDARD_DEVIATION 5.99 • n=5 Participants
|
|
Blood Pressure
Systolic Blood Pressure
|
132.90 millimeters of mercury (mmHg)
STANDARD_DEVIATION 15.25 • n=5 Participants
|
133.50 millimeters of mercury (mmHg)
STANDARD_DEVIATION 15.58 • n=7 Participants
|
133.20 millimeters of mercury (mmHg)
STANDARD_DEVIATION 5.99 • n=5 Participants
|
|
Blood Pressure
Diastolic Blood Pressure
|
77.68 millimeters of mercury (mmHg)
STANDARD_DEVIATION 8.68 • n=5 Participants
|
77.77 millimeters of mercury (mmHg)
STANDARD_DEVIATION 9.05 • n=7 Participants
|
77.73 millimeters of mercury (mmHg)
STANDARD_DEVIATION 8.86 • n=5 Participants
|
|
Glycosylated hemoglobin (HbA1c)
|
8.14 percent glycosylated hemoglobin
STANDARD_DEVIATION 1.31 • n=5 Participants
|
8.25 percent glycosylated hemoglobin
STANDARD_DEVIATION 1.31 • n=7 Participants
|
8.19 percent glycosylated hemoglobin
STANDARD_DEVIATION 1.31 • n=5 Participants
|
|
Diabetes Type
Type 1
|
85 participants
n=5 Participants
|
76 participants
n=7 Participants
|
161 participants
n=5 Participants
|
|
Diabetes Type
Type 2
|
286 participants
n=5 Participants
|
284 participants
n=7 Participants
|
570 participants
n=5 Participants
|
|
Duration of diabetes
|
15.82 years
STANDARD_DEVIATION 8.00 • n=5 Participants
|
15.57 years
STANDARD_DEVIATION 7.48 • n=7 Participants
|
15.70 years
STANDARD_DEVIATION 7.75 • n=5 Participants
|
|
Insulin use
Yes
|
241 participants
n=5 Participants
|
228 participants
n=7 Participants
|
469 participants
n=5 Participants
|
|
Insulin use
No
|
130 participants
n=5 Participants
|
132 participants
n=7 Participants
|
262 participants
n=5 Participants
|
|
Number of diabetic retinopathy (DR) study eyes per participant
Two
|
351 participants
n=5 Participants
|
336 participants
n=7 Participants
|
687 participants
n=5 Participants
|
|
Number of diabetic retinopathy (DR) study eyes per participant
One
|
20 participants
n=5 Participants
|
24 participants
n=7 Participants
|
44 participants
n=5 Participants
|
|
Visual Acuity Score (Letters Correct)
|
84.12 Letters read correctly
STANDARD_DEVIATION 7.93 • n=5 Participants
|
84.27 Letters read correctly
STANDARD_DEVIATION 7.70 • n=7 Participants
|
84.19 Letters read correctly
STANDARD_DEVIATION 7.81 • n=5 Participants
|
|
Diabetic Retinopathy (DR) Level
<47
|
465 DR study eyes for each level
n=5 Participants
|
421 DR study eyes for each level
n=7 Participants
|
886 DR study eyes for each level
n=5 Participants
|
|
Diabetic Retinopathy (DR) Level
47
|
250 DR study eyes for each level
n=5 Participants
|
272 DR study eyes for each level
n=7 Participants
|
522 DR study eyes for each level
n=5 Participants
|
|
Diabetic Retinopathy (DR) Level
53
|
7 DR study eyes for each level
n=5 Participants
|
3 DR study eyes for each level
n=7 Participants
|
10 DR study eyes for each level
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 Months through 36 MonthsPopulation: 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.
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.
Outcome measures
| Measure |
Ruboxistaurin
n=349 Participants
32 mg once daily (QD) oral for up to 36 months
|
Placebo
n=346 Participants
QD oral for up to 36 months
|
|---|---|---|
|
Mean Duration of Definite Center of Macula-involved Diabetic Macular Edema (DME)
|
1.72 months per participant
Standard Deviation 4.95
|
1.69 months per participant
Standard Deviation 4.41
|
PRIMARY outcome
Timeframe: Baseline, 36 MonthsPopulation: 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.
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.
Outcome measures
| Measure |
Ruboxistaurin
n=342 Participants
32 mg once daily (QD) oral for up to 36 months
|
Placebo
n=331 Participants
QD oral for up to 36 months
|
|---|---|---|
|
Occurrence of Sustained Moderate Visual Loss (SMVL) in a Diabetic Retinopathy (DR) Study Eye
Yes
|
8 participants
|
16 participants
|
|
Occurrence of Sustained Moderate Visual Loss (SMVL) in a Diabetic Retinopathy (DR) Study Eye
No
|
334 participants
|
315 participants
|
SECONDARY outcome
Timeframe: Baseline, 36 MonthsPopulation: 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.
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.
Outcome measures
| Measure |
Ruboxistaurin
n=722 DR study eyes
32 mg once daily (QD) oral for up to 36 months
|
Placebo
n=695 DR study eyes
QD oral for up to 36 months
|
|---|---|---|
|
Change From Baseline in Visual Acuity by Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) Chart at 36 Months
Baseline (letters correct) (n=722, 695)
|
84.12 Letters read correctly
Standard Deviation 7.93
|
84.27 Letters read correctly
Standard Deviation 7.70
|
|
Change From Baseline in Visual Acuity by Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) Chart at 36 Months
Change from baseline (n=687,670)
|
-1.14 Letters read correctly
Standard Deviation 7.38
|
-2.30 Letters read correctly
Standard Deviation 9.21
|
SECONDARY outcome
Timeframe: Baseline through 36 MonthsPopulation: 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.
The first occurrence of focal/grid photocoagulation regardless of diabetic macular edema (DME) distance from the center of the macula.
Outcome measures
| Measure |
Ruboxistaurin
n=371 Participants
32 mg once daily (QD) oral for up to 36 months
|
Placebo
n=360 Participants
QD oral for up to 36 months
|
|---|---|---|
|
First Occurrence of Focal/Grid Photocoagulation
Yes
|
32 participants
|
27 participants
|
|
First Occurrence of Focal/Grid Photocoagulation
No
|
339 participants
|
333 participants
|
SECONDARY outcome
Timeframe: Baseline, 36 MonthsPopulation: 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.
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.
Outcome measures
| Measure |
Ruboxistaurin
n=718 DR Study Eyes
32 mg once daily (QD) oral for up to 36 months
|
Placebo
n=689 DR Study Eyes
QD oral for up to 36 months
|
|---|---|---|
|
Change From Baseline in Contrast Sensitivity by Pelli-Robson
Baseline (letters correct) (n=718,689)
|
33.54 Letters read correctly
Standard Deviation 3.33
|
33.71 Letters read correctly
Standard Deviation 3.54
|
|
Change From Baseline in Contrast Sensitivity by Pelli-Robson
Change from baseline (n=685,664)
|
-0.54 Letters read correctly
Standard Deviation 3.84
|
-1.06 Letters read correctly
Standard Deviation 4.68
|
SECONDARY outcome
Timeframe: Baseline through 36 MonthsPopulation: 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.
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.
Outcome measures
| Measure |
Ruboxistaurin
n=371 Participants
32 mg once daily (QD) oral for up to 36 months
|
Placebo
n=360 Participants
QD oral for up to 36 months
|
|---|---|---|
|
Progression of Nonproliferative Diabetic Retinopathy (DR) by Seven-field Stereo Fundus Photography
No progression
|
328 participants
|
312 participants
|
|
Progression of Nonproliferative Diabetic Retinopathy (DR) by Seven-field Stereo Fundus Photography
Progression
|
43 participants
|
48 participants
|
SECONDARY outcome
Timeframe: Baseline, 36 MonthsPopulation: 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.
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.
Outcome measures
| Measure |
Ruboxistaurin
n=368 Participants
32 mg once daily (QD) oral for up to 36 months
|
Placebo
n=358 Participants
QD oral for up to 36 months
|
|---|---|---|
|
Change From Baseline in Estimated Glomerular Filtration Rate
Baseline (n=368,358)
|
85.35 milliliter/minute/1.73 square meter
Standard Deviation 22.24
|
87.27 milliliter/minute/1.73 square meter
Standard Deviation 23.44
|
|
Change From Baseline in Estimated Glomerular Filtration Rate
Change from baseline (n=340,328)
|
-5.55 milliliter/minute/1.73 square meter
Standard Deviation 15.70
|
-7.92 milliliter/minute/1.73 square meter
Standard Deviation 17.31
|
SECONDARY outcome
Timeframe: 36 MonthsPopulation: The completer population includes participants who completed all 36 months of the treatment phase.
Outcome measures
| Measure |
Ruboxistaurin
n=270 Participants
32 mg once daily (QD) oral for up to 36 months
|
Placebo
n=261 Participants
QD oral for up to 36 months
|
|---|---|---|
|
Change From Baseline at Endpoint in Albumin/Creatinine Ratio
Baseline (n=270,261)
|
123.53 micrograms/millimole (ug/mmol)
Standard Deviation 507.93
|
152.61 micrograms/millimole (ug/mmol)
Standard Deviation 623.98
|
|
Change From Baseline at Endpoint in Albumin/Creatinine Ratio
Change from baseline (n=267,253)
|
135.90 micrograms/millimole (ug/mmol)
Standard Deviation 865.34
|
72.69 micrograms/millimole (ug/mmol)
Standard Deviation 720.35
|
SECONDARY outcome
Timeframe: 36 MonthsPopulation: 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.
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.
Outcome measures
| Measure |
Ruboxistaurin
n=351 Participants
32 mg once daily (QD) oral for up to 36 months
|
Placebo
n=342 Participants
QD oral for up to 36 months
|
|---|---|---|
|
Change From Baseline at Endpoint in Visual Function by the National Eye Institute Visual Functioning Questionnaire (NEI VFQ-25) at 36 Months
Baseline (n=351,342)
|
67.86 units on a scale
Standard Deviation 8.25
|
67.56 units on a scale
Standard Deviation 7.85
|
|
Change From Baseline at Endpoint in Visual Function by the National Eye Institute Visual Functioning Questionnaire (NEI VFQ-25) at 36 Months
Change from baseline (n=314,309)
|
0.17 units on a scale
Standard Deviation 6.21
|
-1.36 units on a scale
Standard Deviation 8.56
|
SECONDARY outcome
Timeframe: Baseline through 36 MonthsPopulation: Safety population: all randomized participants who received at least one dose of study drug.
Summaries of serious adverse events (SAEs) and all other non-serious adverse events (AEs) are located in the Reported Adverse Event Module.
Outcome measures
| Measure |
Ruboxistaurin
n=371 Participants
32 mg once daily (QD) oral for up to 36 months
|
Placebo
n=360 Participants
QD oral for up to 36 months
|
|---|---|---|
|
Number of Participants With Adverse Events
Serious adverse events
|
93 participants
|
82 participants
|
|
Number of Participants With Adverse Events
Adverse events
|
298 participants
|
299 participants
|
Adverse Events
Ruboxistaurin
Serious events: 93 serious events
Other events: 298 other events
Deaths: 0 deaths
Placebo
Serious events: 82 serious events
Other events: 299 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ruboxistaurin
n=371 participants at risk
32 mg once daily (QD) oral for up to 36 months
|
Placebo
n=360 participants at risk
QD oral for up to 36 months
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.81%
3/371 • Number of events 4
|
0.00%
0/360
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.27%
1/371 • Number of events 1
|
0.00%
0/360
|
|
Cardiac disorders
Acute myocardial infarction
|
0.54%
2/371 • Number of events 3
|
1.4%
5/360 • Number of events 5
|
|
Cardiac disorders
Angina pectoris
|
1.1%
4/371 • Number of events 14
|
0.28%
1/360 • Number of events 1
|
|
Cardiac disorders
Angina unstable
|
0.81%
3/371 • Number of events 4
|
0.56%
2/360 • Number of events 2
|
|
Cardiac disorders
Aortic valve stenosis
|
0.27%
1/371 • Number of events 1
|
0.00%
0/360
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.27%
1/371 • Number of events 10
|
0.00%
0/360
|
|
Cardiac disorders
Atrial fibrillation
|
0.54%
2/371 • Number of events 5
|
0.28%
1/360 • Number of events 2
|
|
Cardiac disorders
Atrial flutter
|
0.27%
1/371 • Number of events 4
|
0.28%
1/360 • Number of events 1
|
|
Cardiac disorders
Atrioventricular block
|
0.27%
1/371 • Number of events 1
|
0.00%
0/360
|
|
Cardiac disorders
Cardiac arrest
|
0.54%
2/371 • Number of events 2
|
0.00%
0/360
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/371
|
0.28%
1/360 • Number of events 8
|
|
Cardiac disorders
Cardiac failure congestive
|
0.27%
1/371 • Number of events 4
|
0.56%
2/360 • Number of events 9
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/371
|
0.28%
1/360 • Number of events 1
|
|
Cardiac disorders
Cardiovascular disorder
|
0.27%
1/371 • Number of events 1
|
0.00%
0/360
|
|
Cardiac disorders
Cor pulmonale
|
0.27%
1/371 • Number of events 4
|
0.00%
0/360
|
|
Cardiac disorders
Coronary artery disease
|
0.81%
3/371 • Number of events 9
|
1.4%
5/360 • Number of events 16
|
|
Cardiac disorders
Coronary artery occlusion
|
0.00%
0/371
|
0.56%
2/360 • Number of events 2
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.27%
1/371 • Number of events 2
|
0.00%
0/360
|
|
Cardiac disorders
Left ventricular failure
|
0.27%
1/371 • Number of events 1
|
0.00%
0/360
|
|
Cardiac disorders
Myocardial infarction
|
1.6%
6/371 • Number of events 6
|
1.1%
4/360 • Number of events 4
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/371
|
0.28%
1/360 • Number of events 1
|
|
Cardiac disorders
Stress cardiomyopathy
|
0.27%
1/371 • Number of events 1
|
0.00%
0/360
|
|
Cardiac disorders
Tachycardia
|
0.27%
1/371 • Number of events 1
|
0.28%
1/360 • Number of events 1
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.00%
0/371
|
0.28%
1/360 • Number of events 11
|
|
Ear and labyrinth disorders
Vertigo
|
0.27%
1/371 • Number of events 1
|
0.28%
1/360 • Number of events 1
|
|
Endocrine disorders
Goitre
|
0.27%
1/371 • Number of events 8
|
0.00%
0/360
|
|
Eye disorders
Cataract
|
0.00%
0/371
|
0.56%
2/360 • Number of events 7
|
|
Eye disorders
Ocular myasthenia
|
0.27%
1/371 • Number of events 4
|
0.00%
0/360
|
|
Eye disorders
Retinal detachment
|
0.27%
1/371 • Number of events 1
|
0.00%
0/360
|
|
Eye disorders
Visual disturbance
|
0.27%
1/371 • Number of events 1
|
0.00%
0/360
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/371
|
0.28%
1/360 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
0.27%
1/371 • Number of events 2
|
0.28%
1/360 • Number of events 1
|
|
Gastrointestinal disorders
Faecal incontinence
|
0.27%
1/371 • Number of events 2
|
0.28%
1/360 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/371
|
0.28%
1/360 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal ulcer haemorrhage
|
0.27%
1/371 • Number of events 1
|
0.00%
0/360
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/371
|
0.28%
1/360 • Number of events 1
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/371
|
0.28%
1/360 • Number of events 1
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.00%
0/371
|
0.28%
1/360 • Number of events 1
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/371
|
0.28%
1/360 • Number of events 1
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/371
|
0.28%
1/360 • Number of events 1
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.27%
1/371 • Number of events 1
|
0.00%
0/360
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/371
|
0.28%
1/360 • Number of events 1
|
|
General disorders
Calcinosis
|
0.27%
1/371 • Number of events 3
|
0.00%
0/360
|
|
General disorders
Chest discomfort
|
0.27%
1/371 • Number of events 1
|
0.28%
1/360 • Number of events 2
|
|
General disorders
Chest pain
|
0.81%
3/371 • Number of events 3
|
0.28%
1/360 • Number of events 1
|
|
General disorders
Death
|
0.00%
0/371
|
0.83%
3/360 • Number of events 3
|
|
General disorders
Impaired healing
|
0.00%
0/371
|
0.28%
1/360 • Number of events 4
|
|
General disorders
Pyrexia
|
0.27%
1/371 • Number of events 1
|
0.00%
0/360
|
|
Hepatobiliary disorders
Cholecystitis
|
0.27%
1/371 • Number of events 1
|
0.28%
1/360 • Number of events 1
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/371
|
0.28%
1/360 • Number of events 1
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/371
|
0.28%
1/360 • Number of events 1
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/371
|
0.28%
1/360 • Number of events 1
|
|
Infections and infestations
Appendicitis
|
0.00%
0/371
|
0.28%
1/360 • Number of events 1
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/371
|
0.28%
1/360 • Number of events 1
|
|
Infections and infestations
Cystitis
|
0.27%
1/371 • Number of events 2
|
0.00%
0/360
|
|
Infections and infestations
Dengue fever
|
0.00%
0/371
|
0.28%
1/360 • Number of events 1
|
|
Infections and infestations
Diarrhoea infectious
|
0.00%
0/371
|
0.28%
1/360 • Number of events 1
|
|
Infections and infestations
Endocarditis
|
0.27%
1/371 • Number of events 1
|
0.00%
0/360
|
|
Infections and infestations
Gastroenteritis
|
0.54%
2/371 • Number of events 2
|
0.56%
2/360 • Number of events 2
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/371
|
0.28%
1/360 • Number of events 1
|
|
Infections and infestations
Herpes zoster
|
0.27%
1/371 • Number of events 1
|
0.00%
0/360
|
|
Infections and infestations
Liver abscess
|
0.27%
1/371 • Number of events 2
|
0.00%
0/360
|
|
Infections and infestations
Lobar pneumonia
|
0.27%
1/371 • Number of events 1
|
0.00%
0/360
|
|
Infections and infestations
Localised infection
|
0.54%
2/371 • Number of events 2
|
0.00%
0/360
|
|
Infections and infestations
Osteomyelitis
|
0.27%
1/371 • Number of events 1
|
0.00%
0/360
|
|
Infections and infestations
Perirectal abscess
|
0.00%
0/371
|
0.28%
1/360 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
0.81%
3/371 • Number of events 3
|
0.28%
1/360 • Number of events 1
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/371
|
0.56%
2/360 • Number of events 2
|
|
Infections and infestations
Pyelonephritis acute
|
0.27%
1/371 • Number of events 1
|
0.00%
0/360
|
|
Infections and infestations
Sepsis
|
0.00%
0/371
|
0.28%
1/360 • Number of events 1
|
|
Infections and infestations
Subcutaneous abscess
|
0.27%
1/371 • Number of events 1
|
0.00%
0/360
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/371
|
0.56%
2/360 • Number of events 2
|
|
Infections and infestations
Urinary tract infection fungal
|
0.27%
1/371 • Number of events 1
|
0.00%
0/360
|
|
Infections and infestations
Wound infection
|
0.00%
0/371
|
0.28%
1/360 • Number of events 1
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.81%
3/371 • Number of events 6
|
0.00%
0/360
|
|
Injury, poisoning and procedural complications
Cerebral haemorrhage traumatic
|
0.27%
1/371 • Number of events 1
|
0.00%
0/360
|
|
Injury, poisoning and procedural complications
Chest injury
|
0.27%
1/371 • Number of events 1
|
0.00%
0/360
|
|
Injury, poisoning and procedural complications
Concussion
|
0.27%
1/371 • Number of events 1
|
0.00%
0/360
|
|
Injury, poisoning and procedural complications
Device occlusion
|
0.00%
0/371
|
0.28%
1/360 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fall
|
0.81%
3/371 • Number of events 5
|
0.00%
0/360
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.27%
1/371 • Number of events 1
|
0.00%
0/360
|
|
Injury, poisoning and procedural complications
Head injury
|
0.27%
1/371 • Number of events 1
|
0.00%
0/360
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.54%
2/371 • Number of events 2
|
0.00%
0/360
|
|
Injury, poisoning and procedural complications
Jaw fracture
|
0.27%
1/371 • Number of events 1
|
0.00%
0/360
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.27%
1/371 • Number of events 2
|
0.00%
0/360
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.27%
1/371 • Number of events 1
|
0.00%
0/360
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.27%
1/371 • Number of events 1
|
0.00%
0/360
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.27%
1/371 • Number of events 1
|
0.00%
0/360
|
|
Injury, poisoning and procedural complications
Therapeutic agent toxicity
|
0.00%
0/371
|
0.28%
1/360 • Number of events 1
|
|
Injury, poisoning and procedural complications
Wound
|
0.27%
1/371 • Number of events 1
|
0.00%
0/360
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.27%
1/371 • Number of events 2
|
0.00%
0/360
|
|
Investigations
Blood glucose increased
|
0.27%
1/371 • Number of events 1
|
0.00%
0/360
|
|
Investigations
Colonoscopy
|
0.00%
0/371
|
0.28%
1/360 • Number of events 1
|
|
Investigations
Electrocardiogram abnormal
|
0.00%
0/371
|
0.28%
1/360 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
0.27%
1/371 • Number of events 1
|
0.56%
2/360 • Number of events 2
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
1.3%
5/371 • Number of events 9
|
1.7%
6/360 • Number of events 6
|
|
Metabolism and nutrition disorders
Diabetic foot
|
0.00%
0/371
|
0.56%
2/360 • Number of events 7
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.27%
1/371 • Number of events 1
|
0.00%
0/360
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/371
|
0.28%
1/360 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.27%
1/371 • Number of events 1
|
0.28%
1/360 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.81%
3/371 • Number of events 3
|
0.56%
2/360 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.27%
1/371 • Number of events 1
|
0.00%
0/360
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.27%
1/371 • Number of events 1
|
0.00%
0/360
|
|
Metabolism and nutrition disorders
Obesity
|
0.54%
2/371 • Number of events 10
|
0.00%
0/360
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/371
|
0.28%
1/360 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.27%
1/371 • Number of events 1
|
0.28%
1/360 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.00%
0/371
|
0.28%
1/360 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Dupuytren's contracture
|
0.27%
1/371 • Number of events 1
|
0.00%
0/360
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.27%
1/371 • Number of events 10
|
0.00%
0/360
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.27%
1/371 • Number of events 1
|
0.28%
1/360 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/371
|
0.28%
1/360 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Osteitis
|
0.00%
0/371
|
0.28%
1/360 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/371
|
0.56%
2/360 • Number of events 11
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.27%
1/371 • Number of events 1
|
0.00%
0/360
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.27%
1/371 • Number of events 1
|
0.00%
0/360
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.00%
0/371
|
0.28%
1/360 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.27%
1/371 • Number of events 14
|
0.00%
0/360
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Angioimmunoblastic t-cell lymphoma
|
0.27%
1/371 • Number of events 1
|
0.00%
0/360
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.00%
0/371
|
0.28%
1/360 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/371
|
0.28%
1/360 • Number of events 4
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.00%
0/371
|
0.28%
1/360 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/371
|
0.28%
1/360 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer
|
0.27%
1/371 • Number of events 1
|
0.00%
0/360
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer stage iii
|
0.00%
0/371
|
0.28%
1/360 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.00%
0/371
|
0.28%
1/360 • Number of events 5
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.54%
2/371 • Number of events 2
|
0.28%
1/360 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostatic adenoma
|
0.27%
1/371 • Number of events 1
|
0.00%
0/360
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer metastatic
|
0.00%
0/371
|
0.28%
1/360 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small intestine carcinoma
|
0.00%
0/371
|
0.28%
1/360 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/371
|
0.28%
1/360 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.27%
1/371 • Number of events 3
|
0.00%
0/360
|
|
Nervous system disorders
Balance disorder
|
0.27%
1/371 • Number of events 1
|
0.00%
0/360
|
|
Nervous system disorders
Carotid artery stenosis
|
0.54%
2/371 • Number of events 4
|
0.00%
0/360
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.27%
1/371 • Number of events 4
|
0.00%
0/360
|
|
Nervous system disorders
Cerebral ischaemia
|
0.27%
1/371 • Number of events 7
|
0.00%
0/360
|
|
Nervous system disorders
Cerebrovascular accident
|
1.1%
4/371 • Number of events 5
|
0.56%
2/360 • Number of events 3
|
|
Nervous system disorders
Coma hepatic
|
0.27%
1/371 • Number of events 1
|
0.00%
0/360
|
|
Nervous system disorders
Coordination abnormal
|
0.00%
0/371
|
0.28%
1/360 • Number of events 1
|
|
Nervous system disorders
Cubital tunnel syndrome
|
0.27%
1/371 • Number of events 1
|
0.00%
0/360
|
|
Nervous system disorders
Diabetic hyperglycaemic coma
|
0.27%
1/371 • Number of events 1
|
0.00%
0/360
|
|
Nervous system disorders
Dysarthria
|
0.27%
1/371 • Number of events 1
|
0.00%
0/360
|
|
Nervous system disorders
Facial palsy
|
0.27%
1/371 • Number of events 1
|
0.00%
0/360
|
|
Nervous system disorders
Grand mal convulsion
|
0.27%
1/371 • Number of events 9
|
0.00%
0/360
|
|
Nervous system disorders
Ischaemic stroke
|
0.54%
2/371 • Number of events 7
|
0.00%
0/360
|
|
Nervous system disorders
Loss of consciousness
|
0.27%
1/371 • Number of events 1
|
0.00%
0/360
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/371
|
0.28%
1/360 • Number of events 1
|
|
Nervous system disorders
Sciatica
|
0.27%
1/371 • Number of events 1
|
0.00%
0/360
|
|
Nervous system disorders
Simple partial seizures
|
0.27%
1/371 • Number of events 1
|
0.00%
0/360
|
|
Nervous system disorders
Syncope
|
0.27%
1/371 • Number of events 1
|
0.00%
0/360
|
|
Nervous system disorders
Transient ischaemic attack
|
0.54%
2/371 • Number of events 2
|
0.00%
0/360
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/371
|
0.28%
1/360 • Number of events 5
|
|
Psychiatric disorders
Confusional state
|
0.27%
1/371 • Number of events 1
|
0.00%
0/360
|
|
Psychiatric disorders
Conversion disorder
|
0.27%
1/371 • Number of events 1
|
0.00%
0/360
|
|
Psychiatric disorders
Depression
|
0.27%
1/371 • Number of events 12
|
0.00%
0/360
|
|
Psychiatric disorders
Suicidal ideation
|
0.27%
1/371 • Number of events 4
|
0.00%
0/360
|
|
Renal and urinary disorders
Diabetic nephropathy
|
0.54%
2/371 • Number of events 7
|
0.00%
0/360
|
|
Renal and urinary disorders
Dysuria
|
0.27%
1/371 • Number of events 1
|
0.00%
0/360
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.27%
1/371 • Number of events 1
|
0.00%
0/360
|
|
Renal and urinary disorders
Pelvi-ureteric obstruction
|
0.00%
0/371
|
0.28%
1/360 • Number of events 9
|
|
Renal and urinary disorders
Renal artery arteriosclerosis
|
0.27%
1/371 • Number of events 1
|
0.00%
0/360
|
|
Renal and urinary disorders
Renal failure
|
0.81%
3/371 • Number of events 11
|
0.00%
0/360
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/371
|
0.28%
1/360 • Number of events 1
|
|
Renal and urinary disorders
Renal failure chronic
|
0.27%
1/371 • Number of events 4
|
0.00%
0/360
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/371
|
0.28%
1/360 • Number of events 1
|
|
Renal and urinary disorders
Urge incontinence
|
0.00%
0/371
|
0.28%
1/360 • Number of events 1
|
|
Renal and urinary disorders
Urinary retention
|
0.27%
1/371 • Number of events 4
|
0.00%
0/360
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.27%
1/371 • Number of events 4
|
0.56%
2/360 • Number of events 15
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/371
|
0.28%
1/360 • Number of events 1
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/371
|
0.28%
1/360 • Number of events 1
|
|
Reproductive system and breast disorders
Priapism
|
0.00%
0/371
|
0.28%
1/360 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/371
|
0.28%
1/360 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/371
|
0.83%
3/360 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.27%
1/371 • Number of events 1
|
0.00%
0/360
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.27%
1/371 • Number of events 1
|
0.00%
0/360
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.00%
0/371
|
0.28%
1/360 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/371
|
0.28%
1/360 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.27%
1/371 • Number of events 4
|
0.28%
1/360 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Diabetic neuropathic ulcer
|
0.27%
1/371 • Number of events 1
|
0.00%
0/360
|
|
Skin and subcutaneous tissue disorders
Idiopathic urticaria
|
0.00%
0/371
|
0.28%
1/360 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin necrosis
|
0.27%
1/371 • Number of events 1
|
0.00%
0/360
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.27%
1/371 • Number of events 1
|
0.00%
0/360
|
|
Surgical and medical procedures
Cholecystectomy
|
0.00%
0/371
|
0.28%
1/360 • Number of events 1
|
|
Surgical and medical procedures
Splenectomy
|
0.00%
0/371
|
0.28%
1/360 • Number of events 1
|
|
Surgical and medical procedures
Thyroidectomy
|
0.27%
1/371 • Number of events 1
|
0.00%
0/360
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/371
|
0.28%
1/360 • Number of events 1
|
|
Vascular disorders
Aortic stenosis
|
0.27%
1/371 • Number of events 13
|
0.00%
0/360
|
|
Vascular disorders
Arteriosclerosis
|
0.27%
1/371 • Number of events 1
|
0.00%
0/360
|
|
Vascular disorders
Circulatory collapse
|
0.27%
1/371 • Number of events 1
|
0.00%
0/360
|
|
Vascular disorders
Deep vein thrombosis
|
0.27%
1/371 • Number of events 4
|
0.00%
0/360
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/371
|
0.28%
1/360 • Number of events 3
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.27%
1/371 • Number of events 1
|
0.00%
0/360
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/371
|
0.28%
1/360 • Number of events 1
|
|
Vascular disorders
Peripheral vascular disorder
|
0.54%
2/371 • Number of events 11
|
0.56%
2/360 • Number of events 5
|
|
Vascular disorders
Subclavian artery stenosis
|
0.27%
1/371 • Number of events 1
|
0.00%
0/360
|
|
Vascular disorders
Vasculitis
|
0.00%
0/371
|
0.28%
1/360 • Number of events 1
|
Other adverse events
| Measure |
Ruboxistaurin
n=371 participants at risk
32 mg once daily (QD) oral for up to 36 months
|
Placebo
n=360 participants at risk
QD oral for up to 36 months
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
10.2%
38/371 • Number of events 90
|
8.9%
32/360 • Number of events 108
|
|
Gastrointestinal disorders
Nausea
|
4.6%
17/371 • Number of events 23
|
5.8%
21/360 • Number of events 60
|
|
Gastrointestinal disorders
Vomiting
|
5.1%
19/371 • Number of events 22
|
4.7%
17/360 • Number of events 25
|
|
General disorders
Oedema peripheral
|
4.3%
16/371 • Number of events 60
|
6.7%
24/360 • Number of events 86
|
|
General disorders
Pyrexia
|
4.0%
15/371 • Number of events 18
|
5.3%
19/360 • Number of events 19
|
|
Infections and infestations
Bronchitis
|
5.1%
19/371 • Number of events 28
|
4.4%
16/360 • Number of events 23
|
|
Infections and infestations
Influenza
|
12.7%
47/371 • Number of events 67
|
10.0%
36/360 • Number of events 58
|
|
Infections and infestations
Nasopharyngitis
|
17.5%
65/371 • Number of events 135
|
16.4%
59/360 • Number of events 121
|
|
Infections and infestations
Sinusitis
|
6.5%
24/371 • Number of events 54
|
3.6%
13/360 • Number of events 20
|
|
Infections and infestations
Upper respiratory tract infection
|
4.6%
17/371 • Number of events 25
|
5.6%
20/360 • Number of events 34
|
|
Infections and infestations
Urinary tract infection
|
5.4%
20/371 • Number of events 42
|
5.0%
18/360 • Number of events 40
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
7.5%
28/371 • Number of events 129
|
8.1%
29/360 • Number of events 131
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.3%
27/371 • Number of events 89
|
9.7%
35/360 • Number of events 144
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.8%
29/371 • Number of events 93
|
10.0%
36/360 • Number of events 105
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
4.3%
16/371 • Number of events 56
|
6.7%
24/360 • Number of events 83
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.6%
32/371 • Number of events 82
|
6.1%
22/360 • Number of events 99
|
|
Nervous system disorders
Headache
|
10.0%
37/371 • Number of events 102
|
12.2%
44/360 • Number of events 129
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.2%
38/371 • Number of events 73
|
12.8%
46/360 • Number of events 85
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
5.7%
21/371 • Number of events 36
|
6.7%
24/360 • Number of events 36
|
|
Vascular disorders
Hypertension
|
11.6%
43/371 • Number of events 229
|
13.6%
49/360 • Number of events 282
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60