Trial Outcomes & Findings for ORIENT: Olmesartan Reducing Incidence of End Stage Renal Disease in Diabetic Nephropathy Trial (NCT NCT00141453)
NCT ID: NCT00141453
Last Updated: 2011-05-10
Results Overview
first occurrence of any of the following events: Doubling of serum creatinine level; Death; End stage renal disease
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
577 participants
Primary outcome timeframe
Randomization to 5 years
Results posted on
2011-05-10
Participant Flow
The study population was defined by the inclusion criteria. This study was carried out at 74 centers in Japan and 3 centers in Hong Kong. After the screening visit, the patients that met inclusion and exclusion criteria were selected to participate in the study. First Patient in: 19 May 2003.
During 6-week screening, patients were treated with placebo and assessed for eligibility. Eligible patients were assigned to 10mg of olmesartan or placebo. 857 were screened; 577 were randomized; 566=the full analysis set (11 who completed were excluded for protocol violations). Data are based on the participants in the full analysis set.
Participant milestones
| Measure |
Olmesartan Medoxomil
Experimental: Olmesartan medoxomil tablets 10mg to 40 mg
|
Placebo Comparator
Matching placebo tablets
|
|---|---|---|
|
Overall Study
STARTED
|
288
|
289
|
|
Overall Study
COMPLETED
|
282
|
284
|
|
Overall Study
NOT COMPLETED
|
6
|
5
|
Reasons for withdrawal
| Measure |
Olmesartan Medoxomil
Experimental: Olmesartan medoxomil tablets 10mg to 40 mg
|
Placebo Comparator
Matching placebo tablets
|
|---|---|---|
|
Overall Study
Protocol Violation
|
6
|
5
|
Baseline Characteristics
ORIENT: Olmesartan Reducing Incidence of End Stage Renal Disease in Diabetic Nephropathy Trial
Baseline characteristics by cohort
| Measure |
Olmesartan Medoxomil
n=282 Participants
Experimental: Olmesartan medoxomil tablets 10mg to 40 mg
|
Placebo Comparator
n=284 Participants
Matching placebo tablets
|
Total
n=566 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
59.1 years
STANDARD_DEVIATION 8.1 • n=5 Participants
|
59.2 years
STANDARD_DEVIATION 8.1 • n=7 Participants
|
59.2 years
STANDARD_DEVIATION 8.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
83 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
175 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
199 Participants
n=5 Participants
|
192 Participants
n=7 Participants
|
391 Participants
n=5 Participants
|
|
Region of Enrollment
East Asia
|
282 participants
n=5 Participants
|
284 participants
n=7 Participants
|
566 participants
n=5 Participants
|
|
Use of ACE inhibitors
Used ACE Inhibitors
|
205 participants
n=5 Participants
|
209 participants
n=7 Participants
|
414 participants
n=5 Participants
|
|
Use of ACE inhibitors
Did not use ACE Inhibitors
|
77 participants
n=5 Participants
|
75 participants
n=7 Participants
|
152 participants
n=5 Participants
|
|
Diastolic blood pressure
|
77.8 mmHg
STANDARD_DEVIATION 10.4 • n=5 Participants
|
77.2 mmHg
STANDARD_DEVIATION 10.6 • n=7 Participants
|
77.5 mmHg
STANDARD_DEVIATION 10.5 • n=5 Participants
|
|
HbA1c
|
7.11 Percentage of HbA1c
STANDARD_DEVIATION 1.20 • n=5 Participants
|
7.05 Percentage of HbA1c
STANDARD_DEVIATION 1.24 • n=7 Participants
|
7.08 Percentage of HbA1c
STANDARD_DEVIATION 1.22 • n=5 Participants
|
|
Serum creatinine
|
1.62 mg/dL
STANDARD_DEVIATION 0.32 • n=5 Participants
|
1.62 mg/dL
STANDARD_DEVIATION 0.35 • n=7 Participants
|
1.62 mg/dL
STANDARD_DEVIATION 0.34 • n=5 Participants
|
|
Systolic Blood Pressure
|
141.7 mmHg
STANDARD_DEVIATION 17.0 • n=5 Participants
|
140.8 mmHg
STANDARD_DEVIATION 18.0 • n=7 Participants
|
141.3 mmHg
STANDARD_DEVIATION 17.5 • n=5 Participants
|
|
Urinary albumin:creatinine ratio
|
1.70 g/g
n=5 Participants
|
1.69 g/g
n=7 Participants
|
1.69 g/g
n=5 Participants
|
|
Urinary protein: creatinine ratio
|
2.19 g/g
n=5 Participants
|
2.05 g/g
n=7 Participants
|
2.12 g/g
n=5 Participants
|
PRIMARY outcome
Timeframe: Randomization to 5 yearsPopulation: Full analysis set=566
first occurrence of any of the following events: Doubling of serum creatinine level; Death; End stage renal disease
Outcome measures
| Measure |
Olmesartan Medoxomil
n=282 Participants
Experimental: Olmesartan medoxomil tablets 10mg to 40 mg
|
Placebo Comparator
n=284 Participants
Matching placebo tablets
|
|---|---|---|
|
Renal Composite Outcomes
|
116 participants
|
129 participants
|
SECONDARY outcome
Timeframe: Within 5 yearsPopulation: Full analysis set=566
Number of participants experiencing the first occurence of any of the following: Cardiovascular death; non-fatal stroke; non-fatal myocardial infarction; hospitalization for unstable angina; lower extremity amputation; coronary/carotid/peripheral revascularization.
Outcome measures
| Measure |
Olmesartan Medoxomil
n=282 Participants
Experimental: Olmesartan medoxomil tablets 10mg to 40 mg
|
Placebo Comparator
n=284 Participants
Matching placebo tablets
|
|---|---|---|
|
Number of Participants Experiencing Cardiovascular Composite Outcomes
|
40 participants
|
53 participants
|
SECONDARY outcome
Timeframe: Randomization to 5 yearsPopulation: Full analysis set=566
The median percentage change from baseline value in urinary protein:creatinine ratio
Outcome measures
| Measure |
Olmesartan Medoxomil
n=282 Participants
Experimental: Olmesartan medoxomil tablets 10mg to 40 mg
|
Placebo Comparator
n=284 Participants
Matching placebo tablets
|
|---|---|---|
|
The Change in Proteinuria
12-week value
|
-19.5 Median percentage change in ratio
|
12.6 Median percentage change in ratio
|
|
The Change in Proteinuria
48-week value
|
-20.0 Median percentage change in ratio
|
6.9 Median percentage change in ratio
|
|
The Change in Proteinuria
144 -week value
|
-24.9 Median percentage change in ratio
|
3.1 Median percentage change in ratio
|
SECONDARY outcome
Timeframe: Randomization to 5 yearsPopulation: Full analysis set=566
The amount of serum creatinine was determined by blood tests periodically during the study. The amount of creatinine is an indication of kidney function. The reciprocal of serum creatinine is used in an equation to determine the change in kidney function from baseline. The reciprocal of the serum creatinine was monitored to detect kidney function changes over duration of the study.
Outcome measures
| Measure |
Olmesartan Medoxomil
n=282 Participants
Experimental: Olmesartan medoxomil tablets 10mg to 40 mg
|
Placebo Comparator
n=284 Participants
Matching placebo tablets
|
|---|---|---|
|
Reciprocal (1/Serum Creatinine) of Serum Creatinine
|
-0.071 dL/mg/year
Interval -0.148 to -0.032
|
-0.089 dL/mg/year
Interval -0.151 to -0.044
|
Adverse Events
Olmesartan Medoxomil
Serious events: 147 serious events
Other events: 264 other events
Deaths: 0 deaths
Placebo Comparator
Serious events: 171 serious events
Other events: 265 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Olmesartan Medoxomil
n=287 participants at risk
Experimental: Olmesartan medoxomil tablets 10mg to 40 mg
|
Placebo Comparator
n=288 participants at risk
Matching placebo tablets
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.35%
1/287 • From baseline to up to 226 weeks
|
2.1%
6/288 • From baseline to up to 226 weeks
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/287 • From baseline to up to 226 weeks
|
1.4%
4/288 • From baseline to up to 226 weeks
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.00%
0/288 • From baseline to up to 226 weeks
|
|
Blood and lymphatic system disorders
Neprogenic anaemia
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Cardiac disorders
Acute myocardial infarction
|
8.7%
25/287 • From baseline to up to 226 weeks
|
12.2%
35/288 • From baseline to up to 226 weeks
|
|
Cardiac disorders
Angina pectoris
|
0.70%
2/287 • From baseline to up to 226 weeks
|
0.69%
2/288 • From baseline to up to 226 weeks
|
|
Cardiac disorders
Angina unstable
|
0.70%
2/287 • From baseline to up to 226 weeks
|
0.69%
2/288 • From baseline to up to 226 weeks
|
|
Cardiac disorders
Aortic valve stenosis
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Cardiac disorders
Atrial fibrillation
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.69%
2/288 • From baseline to up to 226 weeks
|
|
Cardiac disorders
Antrioventricular block complete
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Cardiac disorders
Cardiac failure
|
1.0%
3/287 • From baseline to up to 226 weeks
|
2.1%
6/288 • From baseline to up to 226 weeks
|
|
Cardiac disorders
Cardiac failure acute
|
0.70%
2/287 • From baseline to up to 226 weeks
|
2.4%
7/288 • From baseline to up to 226 weeks
|
|
Cardiac disorders
Cardiac failure chronic
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.00%
0/288 • From baseline to up to 226 weeks
|
|
Cardiac disorders
Cardiac failure congestive
|
4.2%
12/287 • From baseline to up to 226 weeks
|
4.2%
12/288 • From baseline to up to 226 weeks
|
|
Cardiac disorders
Coronary artery disease
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.00%
0/288 • From baseline to up to 226 weeks
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Cardiac disorders
Myocardial ischaemia
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.69%
2/288 • From baseline to up to 226 weeks
|
|
Cardiac disorders
Nodal arrhythmia
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.00%
0/288 • From baseline to up to 226 weeks
|
|
Cardiac disorders
Palpitations
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Cardiac disorders
sick sinus syndrome
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Cardiac disorders
supraventricular tachycardia
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Cardiac disorders
tachycardia paroxysmal
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Cardiac disorders
silent myocardial infarction
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Cardiac disorders
Acute coronary syndrome
|
1.0%
3/287 • From baseline to up to 226 weeks
|
1.4%
4/288 • From baseline to up to 226 weeks
|
|
Ear and labyrinth disorders
Deafness neurosensory
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.00%
0/288 • From baseline to up to 226 weeks
|
|
Ear and labyrinth disorders
Vertigo
|
0.70%
2/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Ear and labyrinth disorders
vertigo positional
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Ear and labyrinth disorders
sudden hearing loss
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.00%
0/288 • From baseline to up to 226 weeks
|
|
Eye disorders
angle closure glaucoma
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.00%
0/288 • From baseline to up to 226 weeks
|
|
Eye disorders
aphakia
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.00%
0/288 • From baseline to up to 226 weeks
|
|
Eye disorders
boardline glaucoma
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.00%
0/288 • From baseline to up to 226 weeks
|
|
Eye disorders
Cataract
|
4.2%
12/287 • From baseline to up to 226 weeks
|
3.8%
11/288 • From baseline to up to 226 weeks
|
|
Eye disorders
Cataract diabetic
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Eye disorders
Diabetic retinal oedema
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.00%
0/288 • From baseline to up to 226 weeks
|
|
Eye disorders
Glaucoma
|
0.70%
2/287 • From baseline to up to 226 weeks
|
0.00%
0/288 • From baseline to up to 226 weeks
|
|
Eye disorders
macular oedema
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Eye disorders
maculopathy
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Eye disorders
retinal detachment
|
0.70%
2/287 • From baseline to up to 226 weeks
|
1.0%
3/288 • From baseline to up to 226 weeks
|
|
Eye disorders
retinal hemorrhage
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Eye disorders
retinal tear
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Eye disorders
retinopathy proliferative
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.00%
0/288 • From baseline to up to 226 weeks
|
|
Eye disorders
vitreous haemorrhage
|
2.4%
7/287 • From baseline to up to 226 weeks
|
2.8%
8/288 • From baseline to up to 226 weeks
|
|
Eye disorders
macular hole
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Gastrointestinal disorders
Adominal distension
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Gastrointestinal disorders
abdominal pain
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.00%
0/288 • From baseline to up to 226 weeks
|
|
Gastrointestinal disorders
abdominal pain lower
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Gastrointestinal disorders
anal fistula
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.00%
0/288 • From baseline to up to 226 weeks
|
|
Gastrointestinal disorders
appendicitis perforated
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.00%
0/288 • From baseline to up to 226 weeks
|
|
Gastrointestinal disorders
ascites
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Gastrointestinal disorders
colitis
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.00%
0/288 • From baseline to up to 226 weeks
|
|
Gastrointestinal disorders
colonic polyp
|
1.7%
5/287 • From baseline to up to 226 weeks
|
3.8%
11/288 • From baseline to up to 226 weeks
|
|
Gastrointestinal disorders
constipation
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Gastrointestinal disorders
diarroea
|
0.00%
0/287 • From baseline to up to 226 weeks
|
1.0%
3/288 • From baseline to up to 226 weeks
|
|
Gastrointestinal disorders
duodenal polyp
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.00%
0/288 • From baseline to up to 226 weeks
|
|
Gastrointestinal disorders
duodenal ulcer
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.00%
0/288 • From baseline to up to 226 weeks
|
|
Gastrointestinal disorders
duodenal ulcer haemorrhage
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.00%
0/288 • From baseline to up to 226 weeks
|
|
Gastrointestinal disorders
entrocolitis
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.00%
0/288 • From baseline to up to 226 weeks
|
|
Gastrointestinal disorders
gastric ulcer
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Gastrointestinal disorders
gastric ulcer haemorrhage
|
0.70%
2/287 • From baseline to up to 226 weeks
|
0.00%
0/288 • From baseline to up to 226 weeks
|
|
Gastrointestinal disorders
gastritis
|
0.70%
2/287 • From baseline to up to 226 weeks
|
0.69%
2/288 • From baseline to up to 226 weeks
|
|
Gastrointestinal disorders
gastritis erosive
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Gastrointestinal disorders
gastritis haemorrhagic
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Gastrointestinal disorders
haemorrhoids
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Gastrointestinal disorders
inguinal hernia
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Gastrointestinal disorders
intestinal obstruction
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.69%
2/288 • From baseline to up to 226 weeks
|
|
Gastrointestinal disorders
Mallory-Weiss syndrome
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.69%
2/288 • From baseline to up to 226 weeks
|
|
Gastrointestinal disorders
Melaena
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.00%
0/288 • From baseline to up to 226 weeks
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.69%
2/288 • From baseline to up to 226 weeks
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Gastrointestinal disorders
Salivary gland calculus
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Gastrointestinal disorders
Stomach discomfort
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.00%
0/288 • From baseline to up to 226 weeks
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.00%
0/288 • From baseline to up to 226 weeks
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Gastrointestinal disorders
Varices oesophageal
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.69%
2/288 • From baseline to up to 226 weeks
|
|
General disorders
Chest discomfort
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.00%
0/288 • From baseline to up to 226 weeks
|
|
General disorders
Chest pain
|
1.4%
4/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
General disorders
Chills
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.00%
0/288 • From baseline to up to 226 weeks
|
|
General disorders
Generalised oedema
|
0.35%
1/287 • From baseline to up to 226 weeks
|
1.0%
3/288 • From baseline to up to 226 weeks
|
|
General disorders
Hernia
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
General disorders
Malaise
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
General disorders
Oedema
|
0.70%
2/287 • From baseline to up to 226 weeks
|
0.69%
2/288 • From baseline to up to 226 weeks
|
|
General disorders
Oedema peripheral
|
0.00%
0/287 • From baseline to up to 226 weeks
|
1.0%
3/288 • From baseline to up to 226 weeks
|
|
General disorders
Sudden death
|
1.0%
3/287 • From baseline to up to 226 weeks
|
1.0%
3/288 • From baseline to up to 226 weeks
|
|
Hepatobiliary disorders
Bile duct stone
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.00%
0/288 • From baseline to up to 226 weeks
|
|
Hepatobiliary disorders
Cirrhosis alcoholic
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.69%
2/288 • From baseline to up to 226 weeks
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Immune system disorders
Anaphylactic shock
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.00%
0/288 • From baseline to up to 226 weeks
|
|
Infections and infestations
Appendicitis
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.69%
2/288 • From baseline to up to 226 weeks
|
|
Infections and infestations
Arthritis viral
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Infections and infestations
Bartholin's abscess
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Infections and infestations
Bronchitis
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.69%
2/288 • From baseline to up to 226 weeks
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Infections and infestations
Cellulitis
|
1.7%
5/287 • From baseline to up to 226 weeks
|
1.4%
4/288 • From baseline to up to 226 weeks
|
|
Infections and infestations
Diabetic gangrene
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.00%
0/288 • From baseline to up to 226 weeks
|
|
Infections and infestations
Gangrene
|
0.70%
2/287 • From baseline to up to 226 weeks
|
0.00%
0/288 • From baseline to up to 226 weeks
|
|
Infections and infestations
Gastroenteritis
|
2.4%
7/287 • From baseline to up to 226 weeks
|
1.0%
3/288 • From baseline to up to 226 weeks
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Infections and infestations
Hepatitis C
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Infections and infestations
Herpes zoster
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Infections and infestations
HIV infection
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Infections and infestations
Infected sebaceous cyst
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.00%
0/288 • From baseline to up to 226 weeks
|
|
Infections and infestations
Influenza
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.00%
0/288 • From baseline to up to 226 weeks
|
|
Infections and infestations
Lobar pneumonia
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.00%
0/288 • From baseline to up to 226 weeks
|
|
Infections and infestations
Lower respiratory tract infection
|
1.7%
5/287 • From baseline to up to 226 weeks
|
2.1%
6/288 • From baseline to up to 226 weeks
|
|
Infections and infestations
Nasopharyngitis
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Infections and infestations
Otitis media
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Infections and infestations
Perianal abscess
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Infections and infestations
Pneumonia
|
1.7%
5/287 • From baseline to up to 226 weeks
|
2.8%
8/288 • From baseline to up to 226 weeks
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Infections and infestations
Pyothorax
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Infections and infestations
Sepsis
|
0.00%
0/287 • From baseline to up to 226 weeks
|
1.4%
4/288 • From baseline to up to 226 weeks
|
|
Infections and infestations
Sialoadenitis
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Infections and infestations
Subcutaneous abscess
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.00%
0/288 • From baseline to up to 226 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/287 • From baseline to up to 226 weeks
|
1.4%
4/288 • From baseline to up to 226 weeks
|
|
Infections and infestations
Urinary tract infection
|
2.4%
7/287 • From baseline to up to 226 weeks
|
2.1%
6/288 • From baseline to up to 226 weeks
|
|
Infections and infestations
Urosepsis
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Infections and infestations
Abscess limb
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Infections and infestations
Enteritis infectious
|
0.70%
2/287 • From baseline to up to 226 weeks
|
0.00%
0/288 • From baseline to up to 226 weeks
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.00%
0/288 • From baseline to up to 226 weeks
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.00%
0/288 • From baseline to up to 226 weeks
|
|
Injury, poisoning and procedural complications
Fracture
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Injury, poisoning and procedural complications
Overdose
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.00%
0/288 • From baseline to up to 226 weeks
|
|
Injury, poisoning and procedural complications
Skull fractured base
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.00%
0/288 • From baseline to up to 226 weeks
|
|
Injury, poisoning and procedural complications
Spinal cord injury cervical
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.00%
0/288 • From baseline to up to 226 weeks
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.00%
0/288 • From baseline to up to 226 weeks
|
|
Injury, poisoning and procedural complications
Traumatic fracture
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Injury, poisoning and procedural complications
Contusion
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.00%
0/288 • From baseline to up to 226 weeks
|
|
Injury, poisoning and procedural complications
Intraocular lens dislocation
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Injury, poisoning and procedural complications
Brain contusion
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Injury, poisoning and procedural complications
Eye injury
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Injury, poisoning and procedural complications
Neck injury
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Injury, poisoning and procedural complications
Medical device site reaction
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Investigations
Alanine aminotransferase increased
|
0.35%
1/287 • From baseline to up to 226 weeks
|
1.0%
3/288 • From baseline to up to 226 weeks
|
|
Investigations
Arteriogram coronary
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Investigations
Aspartate aminotransferase increased
|
0.35%
1/287 • From baseline to up to 226 weeks
|
1.0%
3/288 • From baseline to up to 226 weeks
|
|
Investigations
Bilirubin conjugated increased
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Investigations
Blood bilirubin increased
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Investigations
Blood calcium decreased
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Investigations
Blood chloride decreased
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Investigations
Blood creatine phosphokinase increased
|
0.70%
2/287 • From baseline to up to 226 weeks
|
1.7%
5/288 • From baseline to up to 226 weeks
|
|
Investigations
Blood creatinine increased
|
4.2%
12/287 • From baseline to up to 226 weeks
|
5.2%
15/288 • From baseline to up to 226 weeks
|
|
Investigations
Blood glucose decreased
|
0.70%
2/287 • From baseline to up to 226 weeks
|
1.7%
5/288 • From baseline to up to 226 weeks
|
|
Investigations
Blood glucose increased
|
0.70%
2/287 • From baseline to up to 226 weeks
|
0.69%
2/288 • From baseline to up to 226 weeks
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Investigations
Blood potassium decreased
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.00%
0/288 • From baseline to up to 226 weeks
|
|
Investigations
Blood potassium increased
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.69%
2/288 • From baseline to up to 226 weeks
|
|
Investigations
Blood pressure increased
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.00%
0/288 • From baseline to up to 226 weeks
|
|
Investigations
Blood urea increased
|
2.1%
6/287 • From baseline to up to 226 weeks
|
2.4%
7/288 • From baseline to up to 226 weeks
|
|
Investigations
C-reactive protein increased
|
1.0%
3/287 • From baseline to up to 226 weeks
|
1.0%
3/288 • From baseline to up to 226 weeks
|
|
Investigations
Colonoscopy
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.69%
2/288 • From baseline to up to 226 weeks
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.69%
2/288 • From baseline to up to 226 weeks
|
|
Investigations
Glycosylated haemoglobin increased
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Investigations
Haematocrit decreased
|
0.70%
2/287 • From baseline to up to 226 weeks
|
1.4%
4/288 • From baseline to up to 226 weeks
|
|
Investigations
Haemoglobin decreased
|
1.0%
3/287 • From baseline to up to 226 weeks
|
1.7%
5/288 • From baseline to up to 226 weeks
|
|
Investigations
International normalised ratio increased
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Investigations
Myoglobin blood increased
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Investigations
Neutrophil count increased
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Investigations
Nuclear magnetic resonance imaging brain abnormal
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.00%
0/288 • From baseline to up to 226 weeks
|
|
Investigations
Red blood cell count decreased
|
0.70%
2/287 • From baseline to up to 226 weeks
|
1.4%
4/288 • From baseline to up to 226 weeks
|
|
Investigations
Serum ferritin decreased
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Investigations
Weight increased
|
0.70%
2/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Investigations
White blood cell count increased
|
1.0%
3/287 • From baseline to up to 226 weeks
|
0.69%
2/288 • From baseline to up to 226 weeks
|
|
Investigations
Blood phosphorus increased
|
0.00%
0/287 • From baseline to up to 226 weeks
|
1.0%
3/288 • From baseline to up to 226 weeks
|
|
Investigations
Creatinine urine increased
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.00%
0/288 • From baseline to up to 226 weeks
|
|
Investigations
Sleep study
|
1.7%
5/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Investigations
Brain natriuretic peptide increased
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Investigations
Urine protein/creatinine ratio decreased
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.00%
0/288 • From baseline to up to 226 weeks
|
|
Investigations
Urine protein/creatinine ratio increased
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Investigations
Cardiac function test
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Investigations
Blood alkaline phosphatase increased
|
0.35%
1/287 • From baseline to up to 226 weeks
|
1.0%
3/288 • From baseline to up to 226 weeks
|
|
Investigations
Dexamethasone suppression test positive
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.69%
2/288 • From baseline to up to 226 weeks
|
|
Investigations
Dexamethasone suppression test
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Investigations
Renal function test
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.00%
0/288 • From baseline to up to 226 weeks
|
|
Investigations
Pulmonary function test abnormal
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.00%
0/288 • From baseline to up to 226 weeks
|
|
Investigations
Endoscopy large bowel
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.00%
0/288 • From baseline to up to 226 weeks
|
|
Investigations
Investigation
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Investigations
Nephrological examination
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.00%
0/288 • From baseline to up to 226 weeks
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Metabolism and nutrition disorders
Dehydration
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.69%
2/288 • From baseline to up to 226 weeks
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
2.4%
7/287 • From baseline to up to 226 weeks
|
2.8%
8/288 • From baseline to up to 226 weeks
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Metabolism and nutrition disorders
Fluid overload
|
1.7%
5/287 • From baseline to up to 226 weeks
|
3.5%
10/288 • From baseline to up to 226 weeks
|
|
Metabolism and nutrition disorders
Fluid retention
|
1.0%
3/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Metabolism and nutrition disorders
Gout
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.4%
4/287 • From baseline to up to 226 weeks
|
1.4%
4/288 • From baseline to up to 226 weeks
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
3.5%
10/287 • From baseline to up to 226 weeks
|
2.1%
6/288 • From baseline to up to 226 weeks
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
2.8%
8/287 • From baseline to up to 226 weeks
|
5.2%
15/288 • From baseline to up to 226 weeks
|
|
Metabolism and nutrition disorders
Hypoglycaemia unawareness
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.00%
0/288 • From baseline to up to 226 weeks
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.00%
0/288 • From baseline to up to 226 weeks
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.69%
2/288 • From baseline to up to 226 weeks
|
|
Metabolism and nutrition disorders
Diabetic foot
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Musculoskeletal and connective tissue disorders
Amyotrophy
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.00%
0/288 • From baseline to up to 226 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.70%
2/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Musculoskeletal and connective tissue disorders
Joint contracture
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.00%
0/288 • From baseline to up to 226 weeks
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Musculoskeletal and connective tissue disorders
Neuropathic arthropathy
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.00%
0/288 • From baseline to up to 226 weeks
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.69%
2/288 • From baseline to up to 226 weeks
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.70%
2/287 • From baseline to up to 226 weeks
|
0.00%
0/288 • From baseline to up to 226 weeks
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.00%
0/288 • From baseline to up to 226 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid tumour of the gastrointestinal tract
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.00%
0/288 • From baseline to up to 226 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.69%
2/288 • From baseline to up to 226 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.69%
2/288 • From baseline to up to 226 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm malignant
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.00%
0/288 • From baseline to up to 226 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer stage unspecified
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Large intestine carcinoma
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.69%
2/288 • From baseline to up to 226 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour benign
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.00%
0/288 • From baseline to up to 226 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Nervous system disorders
Altered state of consciousness
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Nervous system disorders
Cerebellar infarction
|
0.70%
2/287 • From baseline to up to 226 weeks
|
0.69%
2/288 • From baseline to up to 226 weeks
|
|
Nervous system disorders
Cerebrovascular accident
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Nervous system disorders
Convulsion
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Nervous system disorders
Diabetic autonomic neuropathy
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.00%
0/288 • From baseline to up to 226 weeks
|
|
Nervous system disorders
Dizziness
|
1.0%
3/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Nervous system disorders
Epilepsy
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.00%
0/288 • From baseline to up to 226 weeks
|
|
Nervous system disorders
Intracranial aneurysm
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Nervous system disorders
Loss of consciousness
|
0.70%
2/287 • From baseline to up to 226 weeks
|
0.00%
0/288 • From baseline to up to 226 weeks
|
|
Nervous system disorders
Thrombotic cerebral infarction
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Nervous system disorders
Syncope
|
0.00%
0/287 • From baseline to up to 226 weeks
|
1.0%
3/288 • From baseline to up to 226 weeks
|
|
Nervous system disorders
Mononeuropathy multiplex
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Nervous system disorders
Syncope vasovagal
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.00%
0/288 • From baseline to up to 226 weeks
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.00%
0/288 • From baseline to up to 226 weeks
|
|
Nervous system disorders
VIth nerve paralysis
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.00%
0/288 • From baseline to up to 226 weeks
|
|
Nervous system disorders
Cubital tunnel syndrome
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Nervous system disorders
Cranial nerve paralysis
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Psychiatric disorders
Completed suicide
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Psychiatric disorders
Depression
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.00%
0/288 • From baseline to up to 226 weeks
|
|
Psychiatric disorders
Dysthymic disorder
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Psychiatric disorders
Psychosomatic disease
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.00%
0/288 • From baseline to up to 226 weeks
|
|
Renal and urinary disorders
Azotaemia
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Renal and urinary disorders
Nephropathy toxic
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.00%
0/288 • From baseline to up to 226 weeks
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.00%
0/288 • From baseline to up to 226 weeks
|
|
Renal and urinary disorders
Neurogenic bladder
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Renal and urinary disorders
Renal failure
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.00%
0/288 • From baseline to up to 226 weeks
|
|
Renal and urinary disorders
Renal failure acute
|
2.4%
7/287 • From baseline to up to 226 weeks
|
1.0%
3/288 • From baseline to up to 226 weeks
|
|
Renal and urinary disorders
Renal failure chronic
|
1.4%
4/287 • From baseline to up to 226 weeks
|
0.69%
2/288 • From baseline to up to 226 weeks
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Renal and urinary disorders
Diabetic nephropathy
|
0.70%
2/287 • From baseline to up to 226 weeks
|
0.69%
2/288 • From baseline to up to 226 weeks
|
|
Renal and urinary disorders
Renal impairment
|
1.4%
4/287 • From baseline to up to 226 weeks
|
0.69%
2/288 • From baseline to up to 226 weeks
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.70%
2/287 • From baseline to up to 226 weeks
|
0.00%
0/288 • From baseline to up to 226 weeks
|
|
Reproductive system and breast disorders
Epididymitis
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.70%
2/287 • From baseline to up to 226 weeks
|
0.00%
0/288 • From baseline to up to 226 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.00%
0/288 • From baseline to up to 226 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Asthma late onset
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.00%
0/288 • From baseline to up to 226 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.00%
0/288 • From baseline to up to 226 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal oedema
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.0%
3/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pleural fibrosis
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.00%
0/288 • From baseline to up to 226 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.70%
2/287 • From baseline to up to 226 weeks
|
0.00%
0/288 • From baseline to up to 226 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
1.0%
3/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.70%
2/287 • From baseline to up to 226 weeks
|
0.00%
0/288 • From baseline to up to 226 weeks
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.00%
0/288 • From baseline to up to 226 weeks
|
|
Surgical and medical procedures
Catheterisation cardiac
|
0.35%
1/287 • From baseline to up to 226 weeks
|
1.4%
4/288 • From baseline to up to 226 weeks
|
|
Surgical and medical procedures
Uterine prolapse repair
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.00%
0/288 • From baseline to up to 226 weeks
|
|
Surgical and medical procedures
Vitrectomy
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.00%
0/288 • From baseline to up to 226 weeks
|
|
Surgical and medical procedures
Glaucoma surgery
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.00%
0/288 • From baseline to up to 226 weeks
|
|
Surgical and medical procedures
Coronary angioplasty
|
0.70%
2/287 • From baseline to up to 226 weeks
|
0.69%
2/288 • From baseline to up to 226 weeks
|
|
Surgical and medical procedures
Continuous positive airway pressure
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Surgical and medical procedures
Hospitalisation
|
1.0%
3/287 • From baseline to up to 226 weeks
|
1.0%
3/288 • From baseline to up to 226 weeks
|
|
Surgical and medical procedures
Surgical vascular shunt
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Surgical and medical procedures
Elective surgery
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Surgical and medical procedures
Arteriovenous shunt operation
|
0.70%
2/287 • From baseline to up to 226 weeks
|
0.69%
2/288 • From baseline to up to 226 weeks
|
|
Surgical and medical procedures
Tooth extraction
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.00%
0/288 • From baseline to up to 226 weeks
|
|
Surgical and medical procedures
Cataract operation
|
3.1%
9/287 • From baseline to up to 226 weeks
|
4.5%
13/288 • From baseline to up to 226 weeks
|
|
Surgical and medical procedures
Blood pressure management
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.00%
0/288 • From baseline to up to 226 weeks
|
|
Surgical and medical procedures
Percutaneous coronary intervention
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Vascular disorders
Arteriosclerosis
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.00%
0/288 • From baseline to up to 226 weeks
|
|
Vascular disorders
Hypertension
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Vascular disorders
Hypotension
|
1.4%
4/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.69%
2/288 • From baseline to up to 226 weeks
|
|
Vascular disorders
Peripheral vascular disorder
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
|
Vascular disorders
Deep vein thrombosis
|
0.35%
1/287 • From baseline to up to 226 weeks
|
0.00%
0/288 • From baseline to up to 226 weeks
|
|
Vascular disorders
Blood pressure inadequately controlled
|
0.70%
2/287 • From baseline to up to 226 weeks
|
0.00%
0/288 • From baseline to up to 226 weeks
|
|
Vascular disorders
Arteriosclerosis obliterans
|
0.00%
0/287 • From baseline to up to 226 weeks
|
0.35%
1/288 • From baseline to up to 226 weeks
|
Other adverse events
| Measure |
Olmesartan Medoxomil
n=287 participants at risk
Experimental: Olmesartan medoxomil tablets 10mg to 40 mg
|
Placebo Comparator
n=288 participants at risk
Matching placebo tablets
|
|---|---|---|
|
Eye disorders
Cataract
|
15.3%
44/287 • From baseline to up to 226 weeks
|
15.6%
45/288 • From baseline to up to 226 weeks
|
|
Eye disorders
Diabetic retinopathy
|
9.1%
26/287 • From baseline to up to 226 weeks
|
8.3%
24/288 • From baseline to up to 226 weeks
|
|
Eye disorders
Vitreous haemorrhage
|
4.2%
12/287 • From baseline to up to 226 weeks
|
5.6%
16/288 • From baseline to up to 226 weeks
|
|
Gastrointestinal disorders
Colonic polyp
|
3.1%
9/287 • From baseline to up to 226 weeks
|
5.9%
17/288 • From baseline to up to 226 weeks
|
|
Gastrointestinal disorders
Constipation
|
17.1%
49/287 • From baseline to up to 226 weeks
|
14.2%
41/288 • From baseline to up to 226 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
9.8%
28/287 • From baseline to up to 226 weeks
|
13.9%
40/288 • From baseline to up to 226 weeks
|
|
Gastrointestinal disorders
Gastritis
|
5.6%
16/287 • From baseline to up to 226 weeks
|
6.6%
19/288 • From baseline to up to 226 weeks
|
|
Gastrointestinal disorders
Nausea
|
5.2%
15/287 • From baseline to up to 226 weeks
|
4.2%
12/288 • From baseline to up to 226 weeks
|
|
Gastrointestinal disorders
Toothache
|
5.6%
16/287 • From baseline to up to 226 weeks
|
5.6%
16/288 • From baseline to up to 226 weeks
|
|
General disorders
Chest discomfort
|
5.6%
16/287 • From baseline to up to 226 weeks
|
6.2%
18/288 • From baseline to up to 226 weeks
|
|
General disorders
Chest pain
|
6.6%
19/287 • From baseline to up to 226 weeks
|
3.1%
9/288 • From baseline to up to 226 weeks
|
|
General disorders
Malaise
|
2.4%
7/287 • From baseline to up to 226 weeks
|
5.6%
16/288 • From baseline to up to 226 weeks
|
|
General disorders
Oedema
|
5.9%
17/287 • From baseline to up to 226 weeks
|
6.9%
20/288 • From baseline to up to 226 weeks
|
|
General disorders
Oedema peripheral
|
22.6%
65/287 • From baseline to up to 226 weeks
|
26.4%
76/288 • From baseline to up to 226 weeks
|
|
Infections and infestations
Bronchitis
|
7.3%
21/287 • From baseline to up to 226 weeks
|
7.6%
22/288 • From baseline to up to 226 weeks
|
|
Infections and infestations
Gastroenteritis
|
9.1%
26/287 • From baseline to up to 226 weeks
|
4.9%
14/288 • From baseline to up to 226 weeks
|
|
Infections and infestations
Infuenza
|
5.2%
15/287 • From baseline to up to 226 weeks
|
3.8%
11/288 • From baseline to up to 226 weeks
|
|
Infections and infestations
Nasopharyngitis
|
36.6%
105/287 • From baseline to up to 226 weeks
|
36.8%
106/288 • From baseline to up to 226 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
20.6%
59/287 • From baseline to up to 226 weeks
|
19.8%
57/288 • From baseline to up to 226 weeks
|
|
Infections and infestations
Urinary tract infection
|
6.6%
19/287 • From baseline to up to 226 weeks
|
5.9%
17/288 • From baseline to up to 226 weeks
|
|
Injury, poisoning and procedural complications
Contusion
|
8.7%
25/287 • From baseline to up to 226 weeks
|
5.6%
16/288 • From baseline to up to 226 weeks
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
4.5%
13/287 • From baseline to up to 226 weeks
|
5.2%
15/288 • From baseline to up to 226 weeks
|
|
Metabolism and nutrition disorders
Gout
|
6.3%
18/287 • From baseline to up to 226 weeks
|
5.6%
16/288 • From baseline to up to 226 weeks
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
23.7%
68/287 • From baseline to up to 226 weeks
|
21.2%
61/288 • From baseline to up to 226 weeks
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
24.0%
69/287 • From baseline to up to 226 weeks
|
24.0%
69/288 • From baseline to up to 226 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.9%
40/287 • From baseline to up to 226 weeks
|
11.5%
33/288 • From baseline to up to 226 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.4%
47/287 • From baseline to up to 226 weeks
|
14.6%
42/288 • From baseline to up to 226 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
7.3%
21/287 • From baseline to up to 226 weeks
|
12.8%
37/288 • From baseline to up to 226 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
6.6%
19/287 • From baseline to up to 226 weeks
|
7.6%
22/288 • From baseline to up to 226 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.8%
28/287 • From baseline to up to 226 weeks
|
11.8%
34/288 • From baseline to up to 226 weeks
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
6.6%
19/287 • From baseline to up to 226 weeks
|
5.9%
17/288 • From baseline to up to 226 weeks
|
|
Nervous system disorders
Dizziness
|
14.3%
41/287 • From baseline to up to 226 weeks
|
17.4%
50/288 • From baseline to up to 226 weeks
|
|
Nervous system disorders
Dizziness postural
|
4.9%
14/287 • From baseline to up to 226 weeks
|
5.9%
17/288 • From baseline to up to 226 weeks
|
|
Nervous system disorders
Headache
|
9.1%
26/287 • From baseline to up to 226 weeks
|
8.3%
24/288 • From baseline to up to 226 weeks
|
|
Nervous system disorders
Hypoaesthesia
|
6.3%
18/287 • From baseline to up to 226 weeks
|
6.6%
19/288 • From baseline to up to 226 weeks
|
|
Psychiatric disorders
Insomnia
|
7.0%
20/287 • From baseline to up to 226 weeks
|
5.9%
17/288 • From baseline to up to 226 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.9%
60/287 • From baseline to up to 226 weeks
|
19.8%
57/288 • From baseline to up to 226 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.1%
9/287 • From baseline to up to 226 weeks
|
5.9%
17/288 • From baseline to up to 226 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
5.2%
15/287 • From baseline to up to 226 weeks
|
5.2%
15/288 • From baseline to up to 226 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
12.9%
37/287 • From baseline to up to 226 weeks
|
8.0%
23/288 • From baseline to up to 226 weeks
|
|
Skin and subcutaneous tissue disorders
Eczema
|
9.4%
27/287 • From baseline to up to 226 weeks
|
9.4%
27/288 • From baseline to up to 226 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.3%
21/287 • From baseline to up to 226 weeks
|
8.7%
25/288 • From baseline to up to 226 weeks
|
|
Vascular disorders
Hypotension
|
5.2%
15/287 • From baseline to up to 226 weeks
|
2.1%
6/288 • From baseline to up to 226 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Results of Study shall not be published without prior express written consent and approval of Sponsor. Sponsor has right to change proposed publication and/or prohibit publication and Contractor must comply with requirements of Sponsor.
- Publication restrictions are in place
Restriction type: OTHER