Trial Outcomes & Findings for Protein Kinase C (PKC) Inhibitor-Diabetic Retinopathy Phase 3 Study (NCT NCT00604383)
NCT ID: NCT00604383
Last Updated: 2016-10-06
Results Overview
SMVL is defined as a ≥15-letter decrease from baseline in best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) that the participant sustained during the last 6 months of study participation (Months 30-36). Participants who discontinued the study early may have had SMVL if there was a 6-month period of ≥15 letters lost in VA ending with the last visit at which VA was assessed. 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). Percentage of participants = (number of participants who had SMVL) / (number of participants who were randomized) \* 100.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
685 participants
Primary outcome timeframe
Baseline through 36 months
Results posted on
2016-10-06
Participant Flow
This study consisted of a 36-month treatment phase and a 0 to 6-month extended treatment phase. Completers are those who completed the 36-month treatment phase.
Participant milestones
| Measure |
Ruboxistaurin
One 32-milligram (mg) tablet, orally, daily, for up to 42 months
|
Placebo
1 tablet, orally, daily, for up to 42 months
|
|---|---|---|
|
Overall Study
STARTED
|
345
|
340
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
345
|
340
|
|
Overall Study
Received Extended Treatment
|
136
|
141
|
|
Overall Study
COMPLETED
|
258
|
256
|
|
Overall Study
NOT COMPLETED
|
87
|
84
|
Reasons for withdrawal
| Measure |
Ruboxistaurin
One 32-milligram (mg) tablet, orally, daily, for up to 42 months
|
Placebo
1 tablet, orally, daily, for up to 42 months
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
33
|
31
|
|
Overall Study
Lost to Follow-up
|
24
|
19
|
|
Overall Study
Death
|
14
|
22
|
|
Overall Study
Adverse Event
|
16
|
9
|
|
Overall Study
Physician Decision
|
0
|
3
|
Baseline Characteristics
Protein Kinase C (PKC) Inhibitor-Diabetic Retinopathy Phase 3 Study
Baseline characteristics by cohort
| Measure |
Ruboxistaurin
n=345 Participants
One 32-mg tablet, orally, daily, for up to 42 months
|
Placebo
n=340 Participants
1 tablet, orally, daily, for up to 42 months
|
Total
n=685 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.48 years
STANDARD_DEVIATION 10.91 • n=5 Participants
|
59.18 years
STANDARD_DEVIATION 10.61 • n=7 Participants
|
59.33 years
STANDARD_DEVIATION 10.76 • n=5 Participants
|
|
Sex: Female, Male
Female
|
130 Participants
n=5 Participants
|
122 Participants
n=7 Participants
|
252 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
215 Participants
n=5 Participants
|
218 Participants
n=7 Participants
|
433 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African Descent
|
43 participants
n=5 Participants
|
27 participants
n=7 Participants
|
70 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
259 participants
n=5 Participants
|
273 participants
n=7 Participants
|
532 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
East/Southeast Asian
|
15 participants
n=5 Participants
|
12 participants
n=7 Participants
|
27 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
18 participants
n=5 Participants
|
20 participants
n=7 Participants
|
38 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
9 participants
n=5 Participants
|
8 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Western Asian
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
345 participants
n=5 Participants
|
340 participants
n=7 Participants
|
685 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline through 36 monthsPopulation: All randomized participants.
SMVL is defined as a ≥15-letter decrease from baseline in best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) that the participant sustained during the last 6 months of study participation (Months 30-36). Participants who discontinued the study early may have had SMVL if there was a 6-month period of ≥15 letters lost in VA ending with the last visit at which VA was assessed. 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). Percentage of participants = (number of participants who had SMVL) / (number of participants who were randomized) \* 100.
Outcome measures
| Measure |
Ruboxistaurin
n=345 Participants
One 32-mg tablet, orally, daily, for 36 months
|
Placebo
n=340 Participants
1 tablet, orally, daily, for 36 months
|
|---|---|---|
|
Percentage of Participants Who Had Sustained Moderate Visual Loss (SMVL) as Defined as a Visual Acuity Loss of ≥15 Letters Measured Twice During a 6-month Period
|
5.5 percentage of participants
|
9.1 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline through 36 monthsPopulation: All randomized participants who had no center involved or imminently threatened DME at baseline.
DME is the accumulation of extracellular fluid in the retinal tissue of the macular area, which can reduce the ability for fine visual discrimination. Percentage of participants = (number of participants who developed center involved or imminently threatened DME) / (number of participants who had no center involved or imminently threatened DME at baseline) \* 100.
Outcome measures
| Measure |
Ruboxistaurin
n=248 Participants
One 32-mg tablet, orally, daily, for 36 months
|
Placebo
n=249 Participants
1 tablet, orally, daily, for 36 months
|
|---|---|---|
|
Percentage of Participants Who Developed Center Involved or Imminently Threatened Diabetic Macular Edema (DME)
|
44.4 percentage of participants
|
49.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline through 36 monthsPopulation: All randomized participants.
Percentage of participants = (number of participants who experienced the development of PDR) / (number of participants who were randomized) \* 100.
Outcome measures
| Measure |
Ruboxistaurin
n=345 Participants
One 32-mg tablet, orally, daily, for 36 months
|
Placebo
n=340 Participants
1 tablet, orally, daily, for 36 months
|
|---|---|---|
|
Percentage of Participants Who Experienced the Development of Proliferative Diabetic Retinopathy (PDR)
|
35.9 percentage of participants
|
36.5 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, up to 36 monthsPopulation: All randomized participants with evaluable NEI-VFQ-25 total score. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.
NEI-VFQ-25 consisted of 25 questions and was used to measure the influence of visual disability and symptoms on general health of participants. The possible total score range for the NEI-VFQ-25 was from 0 (worst possible outcome) to 100 (best possible outcome).
Outcome measures
| Measure |
Ruboxistaurin
n=290 Participants
One 32-mg tablet, orally, daily, for 36 months
|
Placebo
n=289 Participants
1 tablet, orally, daily, for 36 months
|
|---|---|---|
|
Change From Baseline up to 36 Months in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25)
|
-3.82 units on a scale
Standard Deviation 14.75
|
-4.10 units on a scale
Standard Deviation 13.45
|
SECONDARY outcome
Timeframe: Baseline, up to 36 monthsPopulation: All randomized participants with evaluable SF-36 MCS and PCS. LOCF was used to impute missing post-baseline values
SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions. There are 2 component scores, mental component score (MCS) and physical component score (PCS). MCS score consisted of social functioning, vitality, mental health, and role-emotional scales. PCS score consisted of physical functioning, bodily pain, role-physical, and general health scales. Both MCS and PCS have scores ranging from 0 to 100 with higher scores indicating better mental or physical health.
Outcome measures
| Measure |
Ruboxistaurin
n=290 Participants
One 32-mg tablet, orally, daily, for 36 months
|
Placebo
n=289 Participants
1 tablet, orally, daily, for 36 months
|
|---|---|---|
|
Change From Baseline up to 36 Months in Mental and Physical Components of the Medical Outcomes Study 36-Item Short Form (SF-36) Health Status Questionnaire
MCS
|
-12.21 units on a scale
Standard Deviation 70.91
|
-19.85 units on a scale
Standard Deviation 70.05
|
|
Change From Baseline up to 36 Months in Mental and Physical Components of the Medical Outcomes Study 36-Item Short Form (SF-36) Health Status Questionnaire
PCS
|
-30.63 units on a scale
Standard Deviation 84.92
|
-29.15 units on a scale
Standard Deviation 79.41
|
Adverse Events
Ruboxistaurin
Serious events: 145 serious events
Other events: 314 other events
Deaths: 0 deaths
Placebo
Serious events: 157 serious events
Other events: 322 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ruboxistaurin
n=345 participants at risk
One 32-mg tablet, orally, daily, for up to 42 months
|
Placebo
n=340 participants at risk
1 tablet, orally, daily, for up to 42 months
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.6%
9/345 • Number of events 10
|
3.8%
13/340 • Number of events 13
|
|
Blood and lymphatic system disorders
Hypersplenism
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Blood and lymphatic system disorders
Idiopathic thrombocytopenic purpura
|
0.00%
0/345
|
0.29%
1/340 • Number of events 1
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/345
|
0.29%
1/340 • Number of events 1
|
|
Blood and lymphatic system disorders
Normochromic normocytic anaemia
|
0.00%
0/345
|
0.29%
1/340 • Number of events 2
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.29%
1/345 • Number of events 1
|
0.29%
1/340 • Number of events 1
|
|
Cardiac disorders
Acute coronary syndrome
|
0.58%
2/345 • Number of events 2
|
0.59%
2/340 • Number of events 2
|
|
Cardiac disorders
Acute myocardial infarction
|
1.4%
5/345 • Number of events 5
|
1.8%
6/340 • Number of events 6
|
|
Cardiac disorders
Angina pectoris
|
0.58%
2/345 • Number of events 2
|
0.00%
0/340
|
|
Cardiac disorders
Angina unstable
|
1.4%
5/345 • Number of events 6
|
1.2%
4/340 • Number of events 4
|
|
Cardiac disorders
Aortic valve disease mixed
|
0.00%
0/345
|
0.29%
1/340 • Number of events 1
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.00%
0/345
|
0.29%
1/340 • Number of events 1
|
|
Cardiac disorders
Atrial fibrillation
|
1.4%
5/345 • Number of events 5
|
3.2%
11/340 • Number of events 11
|
|
Cardiac disorders
Atrial flutter
|
0.29%
1/345 • Number of events 1
|
0.29%
1/340 • Number of events 1
|
|
Cardiac disorders
Atrioventricular block complete
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.58%
2/345 • Number of events 2
|
0.29%
1/340 • Number of events 1
|
|
Cardiac disorders
Bradycardia
|
0.87%
3/345 • Number of events 3
|
0.29%
1/340 • Number of events 1
|
|
Cardiac disorders
Cardiac arrest
|
0.58%
2/345 • Number of events 2
|
1.5%
5/340 • Number of events 5
|
|
Cardiac disorders
Cardiac failure chronic
|
0.00%
0/345
|
0.29%
1/340 • Number of events 1
|
|
Cardiac disorders
Cardiac failure congestive
|
7.2%
25/345 • Number of events 38
|
5.6%
19/340 • Number of events 26
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.58%
2/345 • Number of events 2
|
0.29%
1/340 • Number of events 1
|
|
Cardiac disorders
Cardiomyopathy
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Cardiac disorders
Cor pulmonale chronic
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Cardiac disorders
Coronary artery atherosclerosis
|
0.29%
1/345 • Number of events 1
|
0.29%
1/340 • Number of events 2
|
|
Cardiac disorders
Coronary artery disease
|
8.7%
30/345 • Number of events 38
|
8.8%
30/340 • Number of events 33
|
|
Cardiac disorders
Coronary artery insufficiency
|
0.00%
0/345
|
0.29%
1/340 • Number of events 1
|
|
Cardiac disorders
Coronary artery occlusion
|
0.29%
1/345 • Number of events 1
|
0.88%
3/340 • Number of events 3
|
|
Cardiac disorders
Hypertensive cardiomyopathy
|
0.00%
0/345
|
0.29%
1/340 • Number of events 1
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.29%
1/345 • Number of events 1
|
0.59%
2/340 • Number of events 2
|
|
Cardiac disorders
Mitral valve incompetence
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Cardiac disorders
Myocardial infarction
|
1.2%
4/345 • Number of events 4
|
3.8%
13/340 • Number of events 16
|
|
Cardiac disorders
Pericardial effusion
|
0.58%
2/345 • Number of events 2
|
0.00%
0/340
|
|
Cardiac disorders
Pericarditis
|
0.58%
2/345 • Number of events 2
|
0.00%
0/340
|
|
Cardiac disorders
Right ventricular failure
|
0.00%
0/345
|
0.29%
1/340 • Number of events 1
|
|
Cardiac disorders
Sick sinus syndrome
|
0.00%
0/345
|
0.59%
2/340 • Number of events 2
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/345
|
0.29%
1/340 • Number of events 1
|
|
Cardiac disorders
Tachycardia
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Cardiac disorders
Torsade de pointes
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Cardiac disorders
Ventricular tachycardia
|
0.58%
2/345 • Number of events 3
|
0.59%
2/340 • Number of events 2
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.00%
0/345
|
0.29%
1/340 • Number of events 1
|
|
Ear and labyrinth disorders
Inner ear disorder
|
0.00%
0/345
|
0.29%
1/340 • Number of events 1
|
|
Ear and labyrinth disorders
Vestibular neuronitis
|
0.00%
0/345
|
0.29%
1/340 • Number of events 1
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/345
|
0.29%
1/340 • Number of events 1
|
|
Eye disorders
Cataract
|
0.00%
0/345
|
0.29%
1/340 • Number of events 2
|
|
Eye disorders
Endophthalmitis
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Eye disorders
Maculopathy
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Eye disorders
Retinal artery occlusion
|
0.00%
0/345
|
0.29%
1/340 • Number of events 3
|
|
Eye disorders
Retinal detachment
|
0.00%
0/345
|
1.2%
4/340 • Number of events 4
|
|
Eye disorders
Retinal neovascularisation
|
0.00%
0/345
|
0.29%
1/340 • Number of events 1
|
|
Eye disorders
Retinal tear
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Eye disorders
Retinal vein occlusion
|
0.00%
0/345
|
0.29%
1/340 • Number of events 1
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/345
|
0.29%
1/340 • Number of events 3
|
|
Eye disorders
Vitreous haemorrhage
|
0.29%
1/345 • Number of events 1
|
0.88%
3/340 • Number of events 5
|
|
Gastrointestinal disorders
Abdominal pain
|
0.29%
1/345 • Number of events 1
|
0.29%
1/340 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Gastrointestinal disorders
Abdominal strangulated hernia
|
0.00%
0/345
|
0.29%
1/340 • Number of events 1
|
|
Gastrointestinal disorders
Ascites
|
0.58%
2/345 • Number of events 2
|
0.00%
0/340
|
|
Gastrointestinal disorders
Coeliac disease
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.00%
0/345
|
0.59%
2/340 • Number of events 3
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.29%
1/345 • Number of events 1
|
0.29%
1/340 • Number of events 2
|
|
Gastrointestinal disorders
Colonic haemorrhage
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Gastrointestinal disorders
Diabetic gastroparesis
|
0.58%
2/345 • Number of events 2
|
0.00%
0/340
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/345
|
1.2%
4/340 • Number of events 4
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.00%
0/345
|
0.29%
1/340 • Number of events 1
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/345
|
0.29%
1/340 • Number of events 1
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/345
|
0.29%
1/340 • Number of events 1
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.00%
0/345
|
0.29%
1/340 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis
|
0.29%
1/345 • Number of events 1
|
0.29%
1/340 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/345
|
0.88%
3/340 • Number of events 4
|
|
Gastrointestinal disorders
Gastrointestinal inflammation
|
0.00%
0/345
|
0.29%
1/340 • Number of events 1
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/345
|
0.59%
2/340 • Number of events 2
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Gastrointestinal disorders
Ileus
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/345
|
0.59%
2/340 • Number of events 2
|
|
Gastrointestinal disorders
Mallory-weiss syndrome
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Gastrointestinal disorders
Nausea
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Gastrointestinal disorders
Oesophagitis
|
0.29%
1/345 • Number of events 1
|
0.59%
2/340 • Number of events 2
|
|
Gastrointestinal disorders
Pancreatitis
|
0.87%
3/345 • Number of events 3
|
0.59%
2/340 • Number of events 2
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.00%
0/345
|
0.29%
1/340 • Number of events 1
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/345
|
0.59%
2/340 • Number of events 2
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Gastrointestinal disorders
Uvulitis
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Gastrointestinal disorders
Vomiting
|
0.29%
1/345 • Number of events 1
|
0.29%
1/340 • Number of events 1
|
|
General disorders
Asthenia
|
0.29%
1/345 • Number of events 1
|
0.29%
1/340 • Number of events 1
|
|
General disorders
Chest pain
|
2.9%
10/345 • Number of events 12
|
1.2%
4/340 • Number of events 4
|
|
General disorders
Death
|
0.00%
0/345
|
0.59%
2/340 • Number of events 2
|
|
General disorders
Generalised oedema
|
0.00%
0/345
|
0.29%
1/340 • Number of events 1
|
|
General disorders
Impaired healing
|
0.00%
0/345
|
0.29%
1/340 • Number of events 1
|
|
General disorders
Multi-organ failure
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
General disorders
Non-cardiac chest pain
|
1.2%
4/345 • Number of events 4
|
1.5%
5/340 • Number of events 6
|
|
General disorders
Pyrexia
|
0.29%
1/345 • Number of events 1
|
0.29%
1/340 • Number of events 1
|
|
General disorders
Sudden death
|
0.00%
0/345
|
0.29%
1/340 • Number of events 1
|
|
Hepatobiliary disorders
Cholecystitis
|
0.29%
1/345 • Number of events 1
|
0.29%
1/340 • Number of events 1
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/345
|
0.29%
1/340 • Number of events 1
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.00%
0/345
|
0.59%
2/340 • Number of events 2
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.87%
3/345 • Number of events 3
|
1.5%
5/340 • Number of events 5
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.58%
2/345 • Number of events 2
|
0.00%
0/340
|
|
Hepatobiliary disorders
Hepatic failure
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Hepatobiliary disorders
Portal hypertensive gastropathy
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Immune system disorders
Allergy to arthropod sting
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/345
|
0.29%
1/340 • Number of events 1
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/345
|
0.29%
1/340 • Number of events 1
|
|
Infections and infestations
Abscess
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Infections and infestations
Abscess limb
|
0.58%
2/345 • Number of events 2
|
0.88%
3/340 • Number of events 3
|
|
Infections and infestations
Abscess neck
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Infections and infestations
Acute tonsillitis
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Infections and infestations
Appendicitis
|
0.58%
2/345 • Number of events 2
|
0.29%
1/340 • Number of events 1
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/345
|
0.59%
2/340 • Number of events 2
|
|
Infections and infestations
Bronchitis
|
0.29%
1/345 • Number of events 1
|
0.59%
2/340 • Number of events 2
|
|
Infections and infestations
Bronchitis acute
|
0.29%
1/345 • Number of events 1
|
0.29%
1/340 • Number of events 1
|
|
Infections and infestations
Cellulitis
|
3.5%
12/345 • Number of events 16
|
3.5%
12/340 • Number of events 13
|
|
Infections and infestations
Clostridium colitis
|
1.2%
4/345 • Number of events 4
|
0.59%
2/340 • Number of events 2
|
|
Infections and infestations
Cystitis
|
0.00%
0/345
|
0.29%
1/340 • Number of events 1
|
|
Infections and infestations
Diabetic foot infection
|
0.00%
0/345
|
0.29%
1/340 • Number of events 1
|
|
Infections and infestations
Diarrhoea infectious
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Infections and infestations
Diverticulitis
|
0.87%
3/345 • Number of events 3
|
0.00%
0/340
|
|
Infections and infestations
Endocarditis
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Infections and infestations
Enterococcal infection
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Infections and infestations
Fungal cystitis
|
0.00%
0/345
|
0.29%
1/340 • Number of events 1
|
|
Infections and infestations
Gangrene
|
0.58%
2/345 • Number of events 2
|
0.88%
3/340 • Number of events 4
|
|
Infections and infestations
Gastroenteritis
|
0.29%
1/345 • Number of events 1
|
0.29%
1/340 • Number of events 1
|
|
Infections and infestations
Gastroenteritis viral
|
0.58%
2/345 • Number of events 2
|
0.00%
0/340
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/345
|
0.29%
1/340 • Number of events 1
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/345
|
0.29%
1/340 • Number of events 1
|
|
Infections and infestations
Influenza
|
0.00%
0/345
|
0.29%
1/340 • Number of events 1
|
|
Infections and infestations
Localised infection
|
0.58%
2/345 • Number of events 2
|
0.59%
2/340 • Number of events 2
|
|
Infections and infestations
Mastoiditis
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Infections and infestations
Meningitis viral
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Infections and infestations
Necrotising fasciitis
|
0.58%
2/345 • Number of events 2
|
0.00%
0/340
|
|
Infections and infestations
Oesophageal candidiasis
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Infections and infestations
Osteomyelitis
|
2.3%
8/345 • Number of events 9
|
1.8%
6/340 • Number of events 9
|
|
Infections and infestations
Otitis externa
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Infections and infestations
Paronychia
|
0.00%
0/345
|
0.29%
1/340 • Number of events 1
|
|
Infections and infestations
Parotitis
|
0.29%
1/345 • Number of events 1
|
0.29%
1/340 • Number of events 1
|
|
Infections and infestations
Perirectal abscess
|
0.00%
0/345
|
0.29%
1/340 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
4.1%
14/345 • Number of events 15
|
3.8%
13/340 • Number of events 15
|
|
Infections and infestations
Post procedural cellulitis
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Infections and infestations
Postoperative infection
|
0.29%
1/345 • Number of events 1
|
0.88%
3/340 • Number of events 3
|
|
Infections and infestations
Pseudomonas infection
|
0.00%
0/345
|
0.29%
1/340 • Number of events 1
|
|
Infections and infestations
Pyelonephritis
|
0.87%
3/345 • Number of events 3
|
0.59%
2/340 • Number of events 2
|
|
Infections and infestations
Sepsis
|
1.2%
4/345 • Number of events 4
|
1.2%
4/340 • Number of events 4
|
|
Infections and infestations
Septic embolus
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Infections and infestations
Sinusitis
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/345
|
0.29%
1/340 • Number of events 1
|
|
Infections and infestations
Staphylococcal infection
|
0.58%
2/345 • Number of events 2
|
0.59%
2/340 • Number of events 3
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/345
|
0.29%
1/340 • Number of events 1
|
|
Infections and infestations
Streptococcal bacteraemia
|
0.00%
0/345
|
0.29%
1/340 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
0.58%
2/345 • Number of events 2
|
1.5%
5/340 • Number of events 5
|
|
Infections and infestations
Urinary tract infection enterococcal
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Infections and infestations
Urosepsis
|
0.29%
1/345 • Number of events 1
|
1.2%
4/340 • Number of events 5
|
|
Infections and infestations
Wound infection
|
0.58%
2/345 • Number of events 2
|
0.29%
1/340 • Number of events 1
|
|
Infections and infestations
Wound infection staphylococcal
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Injury, poisoning and procedural complications
Brain contusion
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Injury, poisoning and procedural complications
Chemical burn of skin
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Injury, poisoning and procedural complications
Closed head injury
|
0.00%
0/345
|
0.29%
1/340 • Number of events 1
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/345
|
0.29%
1/340 • Number of events 1
|
|
Injury, poisoning and procedural complications
Dislocation of joint prosthesis
|
0.00%
0/345
|
0.29%
1/340 • Number of events 1
|
|
Injury, poisoning and procedural complications
Drug toxicity
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Injury, poisoning and procedural complications
Fall
|
1.7%
6/345 • Number of events 6
|
1.5%
5/340 • Number of events 5
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/345
|
0.29%
1/340 • Number of events 1
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/345
|
0.29%
1/340 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/345
|
0.29%
1/340 • Number of events 1
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/345
|
0.29%
1/340 • Number of events 1
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Injury, poisoning and procedural complications
Haemothorax
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/345
|
0.29%
1/340 • Number of events 1
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.29%
1/345 • Number of events 1
|
1.2%
4/340 • Number of events 4
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.29%
1/345 • Number of events 1
|
0.29%
1/340 • Number of events 1
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/345
|
0.29%
1/340 • Number of events 1
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/345
|
0.29%
1/340 • Number of events 1
|
|
Injury, poisoning and procedural complications
Lung injury
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/345
|
0.29%
1/340 • Number of events 1
|
|
Injury, poisoning and procedural complications
Procedural hypertension
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.29%
1/345 • Number of events 1
|
1.2%
4/340 • Number of events 4
|
|
Injury, poisoning and procedural complications
Scapula fracture
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Injury, poisoning and procedural complications
Shunt occlusion
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Injury, poisoning and procedural complications
Therapeutic agent toxicity
|
0.00%
0/345
|
0.29%
1/340 • Number of events 1
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Injury, poisoning and procedural complications
Vascular graft occlusion
|
0.00%
0/345
|
0.29%
1/340 • Number of events 1
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Investigations
Blood glucose fluctuation
|
0.00%
0/345
|
0.29%
1/340 • Number of events 1
|
|
Investigations
Blood glucose increased
|
0.29%
1/345 • Number of events 1
|
0.29%
1/340 • Number of events 1
|
|
Investigations
Blood potassium increased
|
0.00%
0/345
|
0.29%
1/340 • Number of events 1
|
|
Investigations
Coagulation time abnormal
|
0.00%
0/345
|
0.29%
1/340 • Number of events 1
|
|
Investigations
Electrocardiogram qt prolonged
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Investigations
Weight decreased
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Metabolism and nutrition disorders
Anorexia
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Metabolism and nutrition disorders
Dehydration
|
0.58%
2/345 • Number of events 3
|
2.1%
7/340 • Number of events 9
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.58%
2/345 • Number of events 4
|
0.29%
1/340 • Number of events 1
|
|
Metabolism and nutrition disorders
Diabetic foot
|
0.29%
1/345 • Number of events 1
|
0.29%
1/340 • Number of events 1
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.58%
2/345 • Number of events 2
|
0.88%
3/340 • Number of events 4
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/345
|
0.29%
1/340 • Number of events 1
|
|
Metabolism and nutrition disorders
Gout
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.58%
2/345 • Number of events 3
|
0.29%
1/340 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.29%
1/345 • Number of events 1
|
0.29%
1/340 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.2%
4/345 • Number of events 4
|
0.88%
3/340 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/345
|
0.29%
1/340 • Number of events 1
|
|
Metabolism and nutrition disorders
Ketoacidosis
|
0.29%
1/345 • Number of events 3
|
0.00%
0/340
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.00%
0/345
|
0.29%
1/340 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.58%
2/345 • Number of events 2
|
0.59%
2/340 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Lower limb deformity
|
0.00%
0/345
|
0.29%
1/340 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.29%
1/345 • Number of events 1
|
0.29%
1/340 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Monarthritis
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Musculoskeletal and connective tissue disorders
Neuropathic arthropathy
|
0.58%
2/345 • Number of events 3
|
0.59%
2/340 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.87%
3/345 • Number of events 3
|
0.88%
3/340 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/345
|
0.29%
1/340 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/345
|
0.29%
1/340 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.00%
0/345
|
0.29%
1/340 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer recurrent
|
0.00%
0/345
|
0.29%
1/340 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer in situ
|
0.00%
0/345
|
0.29%
1/340 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.29%
1/345 • Number of events 1
|
0.29%
1/340 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.00%
0/130
|
0.82%
1/122 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/345
|
0.29%
1/340 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/345
|
0.29%
1/340 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.00%
0/345
|
0.29%
1/340 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lymph nodes
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to pleura
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic malignant melanoma
|
0.58%
2/345 • Number of events 4
|
0.00%
0/340
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.00%
0/345
|
0.29%
1/340 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal adenocarcinoma metastatic
|
0.00%
0/345
|
0.29%
1/340 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.00%
0/345
|
0.59%
2/340 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/215
|
0.46%
1/218 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma stage unspecified
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Spinal meningioma benign
|
0.00%
0/345
|
0.29%
1/340 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous endometrial carcinoma
|
0.00%
0/345
|
0.29%
1/340 • Number of events 1
|
|
Nervous system disorders
Anoxic encephalopathy
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Nervous system disorders
Carotid artery occlusion
|
0.00%
0/345
|
0.29%
1/340 • Number of events 1
|
|
Nervous system disorders
Carotid artery stenosis
|
0.87%
3/345 • Number of events 3
|
0.59%
2/340 • Number of events 2
|
|
Nervous system disorders
Cerebellar haemorrhage
|
0.00%
0/345
|
0.29%
1/340 • Number of events 1
|
|
Nervous system disorders
Cerebral artery occlusion
|
0.00%
0/345
|
0.59%
2/340 • Number of events 2
|
|
Nervous system disorders
Cerebrovascular accident
|
1.4%
5/345 • Number of events 5
|
2.4%
8/340 • Number of events 9
|
|
Nervous system disorders
Cognitive disorder
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Nervous system disorders
Convulsion
|
0.29%
1/345 • Number of events 1
|
0.59%
2/340 • Number of events 2
|
|
Nervous system disorders
Dementia
|
0.00%
0/345
|
0.59%
2/340 • Number of events 2
|
|
Nervous system disorders
Demyelinating polyneuropathy
|
0.00%
0/345
|
0.29%
1/340 • Number of events 1
|
|
Nervous system disorders
Diabetic neuropathy
|
0.29%
1/345 • Number of events 1
|
0.29%
1/340 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
0.29%
1/345 • Number of events 1
|
1.2%
4/340 • Number of events 5
|
|
Nervous system disorders
Embolic stroke
|
0.29%
1/345 • Number of events 1
|
0.29%
1/340 • Number of events 1
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/345
|
0.59%
2/340 • Number of events 2
|
|
Nervous system disorders
Facial palsy
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Nervous system disorders
Hemiparesis
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.00%
0/345
|
0.29%
1/340 • Number of events 1
|
|
Nervous system disorders
Intracranial aneurysm
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Nervous system disorders
Intraventricular haemorrhage
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/345
|
0.29%
1/340 • Number of events 1
|
|
Nervous system disorders
Migraine
|
0.00%
0/345
|
0.29%
1/340 • Number of events 1
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/345
|
0.29%
1/340 • Number of events 1
|
|
Nervous system disorders
Paraesthesia
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Nervous system disorders
Radiculopathy
|
0.00%
0/345
|
0.29%
1/340 • Number of events 1
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.87%
3/345 • Number of events 3
|
0.00%
0/340
|
|
Nervous system disorders
Syncope
|
1.2%
4/345 • Number of events 5
|
2.1%
7/340 • Number of events 8
|
|
Nervous system disorders
Syncope vasovagal
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Nervous system disorders
Transient ischaemic attack
|
0.58%
2/345 • Number of events 2
|
0.29%
1/340 • Number of events 1
|
|
Nervous system disorders
Tremor
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Psychiatric disorders
Confusional state
|
0.29%
1/345 • Number of events 1
|
0.29%
1/340 • Number of events 1
|
|
Psychiatric disorders
Conversion disorder
|
0.00%
0/345
|
0.29%
1/340 • Number of events 1
|
|
Psychiatric disorders
Delirium
|
0.29%
1/345 • Number of events 2
|
0.29%
1/340 • Number of events 1
|
|
Psychiatric disorders
Hallucination
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Psychiatric disorders
Major depression
|
0.00%
0/345
|
0.29%
1/340 • Number of events 1
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/345
|
0.29%
1/340 • Number of events 1
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/345
|
0.29%
1/340 • Number of events 1
|
|
Renal and urinary disorders
Azotaemia
|
0.00%
0/345
|
0.29%
1/340 • Number of events 1
|
|
Renal and urinary disorders
Bladder neck obstruction
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/345
|
0.59%
2/340 • Number of events 2
|
|
Renal and urinary disorders
Obstructive uropathy
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.58%
2/345 • Number of events 2
|
0.00%
0/340
|
|
Renal and urinary disorders
Renal failure
|
0.87%
3/345 • Number of events 3
|
1.8%
6/340 • Number of events 6
|
|
Renal and urinary disorders
Renal failure acute
|
4.1%
14/345 • Number of events 18
|
3.5%
12/340 • Number of events 12
|
|
Renal and urinary disorders
Renal failure chronic
|
2.6%
9/345 • Number of events 12
|
1.5%
5/340 • Number of events 6
|
|
Renal and urinary disorders
Renal tubular necrosis
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Renal and urinary disorders
Urinary retention
|
0.58%
2/345 • Number of events 2
|
0.29%
1/340 • Number of events 1
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.47%
1/215 • Number of events 1
|
0.00%
0/218
|
|
Reproductive system and breast disorders
Priapism
|
0.00%
0/215
|
0.46%
1/218 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.00%
0/345
|
0.29%
1/340 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/345
|
0.29%
1/340 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.58%
2/345 • Number of events 3
|
0.29%
1/340 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive airways disease exacerbated
|
0.00%
0/345
|
0.59%
2/340 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.87%
3/345 • Number of events 3
|
0.59%
2/340 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.87%
3/345 • Number of events 3
|
0.59%
2/340 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Hydrothorax
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnia
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.58%
2/345 • Number of events 2
|
0.00%
0/340
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.87%
3/345 • Number of events 5
|
0.88%
3/340 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/345
|
0.59%
2/340 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/345
|
0.29%
1/340 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/345
|
0.29%
1/340 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.58%
2/345 • Number of events 2
|
1.2%
4/340 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.29%
1/345 • Number of events 1
|
0.59%
2/340 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.58%
2/345 • Number of events 2
|
0.29%
1/340 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.29%
1/345 • Number of events 1
|
0.29%
1/340 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.87%
3/345 • Number of events 3
|
0.88%
3/340 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Restrictive pulmonary disease
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/345
|
0.29%
1/340 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/345
|
0.59%
2/340 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Diabetic ulcer
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.58%
2/345 • Number of events 3
|
2.1%
7/340 • Number of events 7
|
|
Surgical and medical procedures
Cardiac pacemaker insertion
|
0.00%
0/345
|
0.29%
1/340 • Number of events 1
|
|
Surgical and medical procedures
Carotid endarterectomy
|
0.00%
0/345
|
0.29%
1/340 • Number of events 1
|
|
Surgical and medical procedures
Mastectomy
|
0.00%
0/345
|
0.29%
1/340 • Number of events 1
|
|
Vascular disorders
Aortic stenosis
|
0.29%
1/345 • Number of events 1
|
0.29%
1/340 • Number of events 1
|
|
Vascular disorders
Blood pressure inadequately controlled
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Vascular disorders
Deep vein thrombosis
|
0.87%
3/345 • Number of events 3
|
0.88%
3/340 • Number of events 4
|
|
Vascular disorders
Femoral artery occlusion
|
0.00%
0/345
|
0.29%
1/340 • Number of events 1
|
|
Vascular disorders
Haematoma
|
0.58%
2/345 • Number of events 2
|
0.29%
1/340 • Number of events 1
|
|
Vascular disorders
Hypertension
|
2.0%
7/345 • Number of events 8
|
2.4%
8/340 • Number of events 9
|
|
Vascular disorders
Hypertensive emergency
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Vascular disorders
Hypoperfusion
|
0.00%
0/345
|
0.29%
1/340 • Number of events 1
|
|
Vascular disorders
Hypotension
|
1.2%
4/345 • Number of events 4
|
0.59%
2/340 • Number of events 2
|
|
Vascular disorders
Orthostatic hypotension
|
0.87%
3/345 • Number of events 4
|
0.88%
3/340 • Number of events 4
|
|
Vascular disorders
Peripheral embolism
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Vascular disorders
Peripheral occlusive disease
|
0.29%
1/345 • Number of events 1
|
0.00%
0/340
|
|
Vascular disorders
Peripheral vascular disorder
|
0.87%
3/345 • Number of events 3
|
0.88%
3/340 • Number of events 3
|
|
Vascular disorders
Shock
|
0.00%
0/345
|
0.29%
1/340 • Number of events 1
|
|
Vascular disorders
Subclavian vein thrombosis
|
0.00%
0/345
|
0.29%
1/340 • Number of events 1
|
Other adverse events
| Measure |
Ruboxistaurin
n=345 participants at risk
One 32-mg tablet, orally, daily, for up to 42 months
|
Placebo
n=340 participants at risk
1 tablet, orally, daily, for up to 42 months
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
8.7%
30/345 • Number of events 33
|
10.6%
36/340 • Number of events 37
|
|
Eye disorders
Dry eye
|
4.9%
17/345 • Number of events 19
|
5.6%
19/340 • Number of events 21
|
|
Eye disorders
Eye pain
|
6.4%
22/345 • Number of events 30
|
5.3%
18/340 • Number of events 28
|
|
Eye disorders
Maculopathy
|
4.1%
14/345 • Number of events 19
|
5.0%
17/340 • Number of events 17
|
|
Eye disorders
Vision blurred
|
5.2%
18/345 • Number of events 22
|
5.6%
19/340 • Number of events 26
|
|
Eye disorders
Visual disturbance
|
5.5%
19/345 • Number of events 26
|
5.9%
20/340 • Number of events 26
|
|
Eye disorders
Vitreous floaters
|
5.5%
19/345 • Number of events 26
|
4.4%
15/340 • Number of events 17
|
|
Eye disorders
Vitreous haemorrhage
|
4.9%
17/345 • Number of events 20
|
5.9%
20/340 • Number of events 24
|
|
Gastrointestinal disorders
Constipation
|
6.1%
21/345 • Number of events 24
|
6.2%
21/340 • Number of events 22
|
|
Gastrointestinal disorders
Diarrhoea
|
9.3%
32/345 • Number of events 37
|
11.8%
40/340 • Number of events 104
|
|
Gastrointestinal disorders
Dyspepsia
|
5.5%
19/345 • Number of events 22
|
3.5%
12/340 • Number of events 13
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
7.8%
27/345 • Number of events 27
|
6.2%
21/340 • Number of events 21
|
|
Gastrointestinal disorders
Nausea
|
7.5%
26/345 • Number of events 33
|
10.9%
37/340 • Number of events 46
|
|
Gastrointestinal disorders
Vomiting
|
5.8%
20/345 • Number of events 24
|
9.7%
33/340 • Number of events 56
|
|
General disorders
Asthenia
|
5.2%
18/345 • Number of events 30
|
5.0%
17/340 • Number of events 19
|
|
General disorders
Chest pain
|
4.9%
17/345 • Number of events 24
|
6.5%
22/340 • Number of events 32
|
|
General disorders
Fatigue
|
5.5%
19/345 • Number of events 23
|
5.6%
19/340 • Number of events 21
|
|
General disorders
Oedema peripheral
|
17.7%
61/345 • Number of events 73
|
19.7%
67/340 • Number of events 99
|
|
General disorders
Pyrexia
|
5.5%
19/345 • Number of events 26
|
4.7%
16/340 • Number of events 20
|
|
Infections and infestations
Bronchitis
|
7.0%
24/345 • Number of events 30
|
8.5%
29/340 • Number of events 38
|
|
Infections and infestations
Influenza
|
12.8%
44/345 • Number of events 55
|
13.2%
45/340 • Number of events 49
|
|
Infections and infestations
Localised infection
|
6.1%
21/345 • Number of events 29
|
6.5%
22/340 • Number of events 29
|
|
Infections and infestations
Nasopharyngitis
|
17.1%
59/345 • Number of events 91
|
19.7%
67/340 • Number of events 112
|
|
Infections and infestations
Onychomycosis
|
5.2%
18/345 • Number of events 19
|
5.3%
18/340 • Number of events 19
|
|
Infections and infestations
Pneumonia
|
3.2%
11/345 • Number of events 12
|
5.0%
17/340 • Number of events 19
|
|
Infections and infestations
Sinusitis
|
7.2%
25/345 • Number of events 38
|
9.4%
32/340 • Number of events 43
|
|
Infections and infestations
Upper respiratory tract infection
|
6.7%
23/345 • Number of events 29
|
10.3%
35/340 • Number of events 51
|
|
Infections and infestations
Urinary tract infection
|
7.2%
25/345 • Number of events 33
|
9.1%
31/340 • Number of events 44
|
|
Injury, poisoning and procedural complications
Contusion
|
3.5%
12/345 • Number of events 19
|
6.8%
23/340 • Number of events 26
|
|
Injury, poisoning and procedural complications
Fall
|
5.2%
18/345 • Number of events 19
|
5.0%
17/340 • Number of events 23
|
|
Investigations
Blood cholesterol increased
|
7.2%
25/345 • Number of events 25
|
4.7%
16/340 • Number of events 16
|
|
Investigations
Cardiac murmur
|
7.5%
26/345 • Number of events 26
|
6.2%
21/340 • Number of events 22
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
8.7%
30/345 • Number of events 30
|
8.2%
28/340 • Number of events 28
|
|
Metabolism and nutrition disorders
Obesity
|
4.1%
14/345 • Number of events 14
|
5.3%
18/340 • Number of events 18
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.0%
24/345 • Number of events 29
|
10.6%
36/340 • Number of events 44
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
2.3%
8/345 • Number of events 8
|
5.9%
20/340 • Number of events 23
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.3%
32/345 • Number of events 36
|
7.9%
27/340 • Number of events 34
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
7.8%
27/345 • Number of events 32
|
8.5%
29/340 • Number of events 39
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
3.2%
11/345 • Number of events 16
|
5.3%
18/340 • Number of events 19
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
11.0%
38/345 • Number of events 44
|
10.3%
35/340 • Number of events 50
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
5.2%
18/345 • Number of events 23
|
3.8%
13/340 • Number of events 15
|
|
Nervous system disorders
Dizziness
|
8.4%
29/345 • Number of events 40
|
7.9%
27/340 • Number of events 30
|
|
Nervous system disorders
Headache
|
9.6%
33/345 • Number of events 39
|
13.2%
45/340 • Number of events 59
|
|
Nervous system disorders
Hypoaesthesia
|
6.1%
21/345 • Number of events 23
|
9.7%
33/340 • Number of events 36
|
|
Nervous system disorders
Neuropathy peripheral
|
5.5%
19/345 • Number of events 21
|
4.4%
15/340 • Number of events 15
|
|
Psychiatric disorders
Anxiety
|
3.8%
13/345 • Number of events 13
|
5.3%
18/340 • Number of events 22
|
|
Psychiatric disorders
Depression
|
8.1%
28/345 • Number of events 28
|
9.1%
31/340 • Number of events 33
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.5%
57/345 • Number of events 78
|
12.4%
42/340 • Number of events 60
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.4%
29/345 • Number of events 35
|
8.8%
30/340 • Number of events 33
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
5.2%
18/345 • Number of events 28
|
8.5%
29/340 • Number of events 35
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
6.1%
21/345 • Number of events 25
|
6.2%
21/340 • Number of events 28
|
|
Vascular disorders
Hypertension
|
16.8%
58/345 • Number of events 58
|
14.7%
50/340 • Number of events 50
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60