Trial Outcomes & Findings for Study of Efficacy of Ranibizumab in Different Regimens in Patients With Diabetic Macula Edema (NCT NCT02366468)
NCT ID: NCT02366468
Last Updated: 2019-01-04
Results Overview
BCVA was assessed as letters read using Early Treatment Diabetic Retinopathy Study (ETDRS) charts. The mean average change from baseline was defined as the difference between the average level of BCVA (ETDRS letters) over all post-baseline assessments from Month 1 to Month 12. A positive change represents an improvement in visual acuity
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
135 participants
Primary outcome timeframe
Baseline, Month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12
Results posted on
2019-01-04
Participant Flow
a total of 135 patients were randomized and assigned in a 1:1 ratio to the treatment arms.
At Screening, the eligibility criteria were performed.
Participant milestones
| Measure |
Discretion of the Investigator (DI)
Investigational - ranibizumab 0.5 mg
|
Pro re Nata (PRN)
Standard of Care - ranibizumab 0.5 mg
|
|---|---|---|
|
Overall Study
STARTED
|
68
|
67
|
|
Overall Study
Full Analysis Set (FAS)
|
67
|
66
|
|
Overall Study
Per Protocol Set (PPS)
|
62
|
61
|
|
Overall Study
COMPLETED
|
62
|
58
|
|
Overall Study
NOT COMPLETED
|
6
|
9
|
Reasons for withdrawal
| Measure |
Discretion of the Investigator (DI)
Investigational - ranibizumab 0.5 mg
|
Pro re Nata (PRN)
Standard of Care - ranibizumab 0.5 mg
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
5
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
|
Overall Study
Death
|
1
|
2
|
|
Overall Study
Other
|
0
|
2
|
Baseline Characteristics
FAS
Baseline characteristics by cohort
| Measure |
Discretion of the Investigator (DI)
n=67 Participants
Investigational - ranibizumab 0.5 mg
|
Pro re Nata (PRN)
n=66 Participants
Standard of Care - ranibizumab 0.5 mg
|
Total
n=133 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.6 years
STANDARD_DEVIATION 13.73 • n=5 Participants • FAS
|
65.0 years
STANDARD_DEVIATION 10.37 • n=7 Participants • FAS
|
63.8 years
STANDARD_DEVIATION 12.19 • n=5 Participants • FAS
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants • FAS
|
25 Participants
n=7 Participants • FAS
|
47 Participants
n=5 Participants • FAS
|
|
Sex: Female, Male
Male
|
45 Participants
n=5 Participants • FAS
|
41 Participants
n=7 Participants • FAS
|
86 Participants
n=5 Participants • FAS
|
|
Race/Ethnicity, Customized
Caucasian
|
64 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
128 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12Population: FAS - Last Observation Carried Forward (LOCF)
BCVA was assessed as letters read using Early Treatment Diabetic Retinopathy Study (ETDRS) charts. The mean average change from baseline was defined as the difference between the average level of BCVA (ETDRS letters) over all post-baseline assessments from Month 1 to Month 12. A positive change represents an improvement in visual acuity
Outcome measures
| Measure |
Discretion of the Investigator (DI)
n=67 Participants
Investigational - ranibizumab 0.5 mg
|
Pro re Nata (PRN)
n=66 Participants
Standard of Care - ranibizumab 0.5 mg
|
|---|---|---|
|
Mean Average Change From Baseline in Best Corrected Visual Acuity (BCVA) of the Study Eye From Month 1 to Study Treatment Completion (Month 12)
Baseline (Day 1)
|
67.4 Letters
Standard Deviation 9.52
|
65.1 Letters
Standard Deviation 9.59
|
|
Mean Average Change From Baseline in Best Corrected Visual Acuity (BCVA) of the Study Eye From Month 1 to Study Treatment Completion (Month 12)
post baseline average over month 1 to month 12
|
73.5 Letters
Standard Deviation 9.50
|
73.8 Letters
Standard Deviation 7.75
|
|
Mean Average Change From Baseline in Best Corrected Visual Acuity (BCVA) of the Study Eye From Month 1 to Study Treatment Completion (Month 12)
Visit-averaged change from baseline
|
6.1 Letters
Standard Deviation 6.54
|
8.6 Letters
Standard Deviation 6.45
|
SECONDARY outcome
Timeframe: Baseline to Month 12Population: FAS
Mean number of visits during the study
Outcome measures
| Measure |
Discretion of the Investigator (DI)
n=67 Participants
Investigational - ranibizumab 0.5 mg
|
Pro re Nata (PRN)
n=66 Participants
Standard of Care - ranibizumab 0.5 mg
|
|---|---|---|
|
Number of Visits
|
12.7 Visits
Standard Deviation 1.92
|
12.9 Visits
Standard Deviation 2.25
|
SECONDARY outcome
Timeframe: Baseline to Month 12Population: FAS
mean number of injections in the study eye during the study
Outcome measures
| Measure |
Discretion of the Investigator (DI)
n=67 Participants
Investigational - ranibizumab 0.5 mg
|
Pro re Nata (PRN)
n=66 Participants
Standard of Care - ranibizumab 0.5 mg
|
|---|---|---|
|
Number of Injections
|
8.4 Injections
Standard Deviation 2.98
|
7.8 Injections
Standard Deviation 3.25
|
SECONDARY outcome
Timeframe: Baseline to Month 12Population: FAS - including only patients with at least one treatment-free interval
A treatment-free interval is the interval between the first NO treatment given when the reason for NO treatment given is one of the three stability criteria and the first subsequent YES treatment given after that.
Outcome measures
| Measure |
Discretion of the Investigator (DI)
n=67 Participants
Investigational - ranibizumab 0.5 mg
|
Pro re Nata (PRN)
n=66 Participants
Standard of Care - ranibizumab 0.5 mg
|
|---|---|---|
|
Number of Treatment Free Intervals
|
1.6 Intervals
Standard Deviation 0.76
|
1.7 Intervals
Standard Deviation 0.94
|
SECONDARY outcome
Timeframe: Baseline to Month 12Population: FAS - Last Observation Carried Forward (LOCF)
Evaluated by central reading center assessing OCT images
Outcome measures
| Measure |
Discretion of the Investigator (DI)
n=67 Participants
Investigational - ranibizumab 0.5 mg
|
Pro re Nata (PRN)
n=66 Participants
Standard of Care - ranibizumab 0.5 mg
|
|---|---|---|
|
Mean Change in Central Subfield Retinal Thickness (CSRT)
Baseline
|
420.0 μm
Standard Deviation 114.98
|
431.0 μm
Standard Deviation 128.13
|
|
Mean Change in Central Subfield Retinal Thickness (CSRT)
Month 12 (LOCF)
|
313.3 μm
Standard Deviation 61.21
|
320.6 μm
Standard Deviation 85.27
|
|
Mean Change in Central Subfield Retinal Thickness (CSRT)
Change from Baseline to Month 12 (LOCF)
|
-106.7 μm
Standard Deviation 109.58
|
-110.4 μm
Standard Deviation 101.97
|
SECONDARY outcome
Timeframe: Baseline to Month 12Population: FAS - LOCF - including only patients with assessments
Evaluated by central reading center assessing OCT images
Outcome measures
| Measure |
Discretion of the Investigator (DI)
n=67 Participants
Investigational - ranibizumab 0.5 mg
|
Pro re Nata (PRN)
n=66 Participants
Standard of Care - ranibizumab 0.5 mg
|
|---|---|---|
|
Mean Change of Foveal Center Point Thickness
Baseline
|
398.8 μm
Standard Deviation 144.10
|
405.0 μm
Standard Deviation 138.06
|
|
Mean Change of Foveal Center Point Thickness
Month 12 - LOCF
|
273.3 μm
Standard Deviation 84.85
|
280.6 μm
Standard Deviation 105.44
|
|
Mean Change of Foveal Center Point Thickness
Change from Baseline to Month 12 (LOCF)
|
-125.6 μm
Standard Deviation 142.69
|
-124.4 μm
Standard Deviation 113.29
|
SECONDARY outcome
Timeframe: Baseline to Month 12Population: FAS - LOCF - including only patients with assessments
Evaluated by central reading center scoring fundus photography
Outcome measures
| Measure |
Discretion of the Investigator (DI)
n=67 Participants
Investigational - ranibizumab 0.5 mg
|
Pro re Nata (PRN)
n=66 Participants
Standard of Care - ranibizumab 0.5 mg
|
|---|---|---|
|
Number of Participants With Change in Diabetic Retinopathy Study (DRS) Retinopathy Scale
2 steps improvement
|
3 Participants
|
4 Participants
|
|
Number of Participants With Change in Diabetic Retinopathy Study (DRS) Retinopathy Scale
1 step improvement
|
6 Participants
|
1 Participants
|
|
Number of Participants With Change in Diabetic Retinopathy Study (DRS) Retinopathy Scale
> 2 steps loss
|
1 Participants
|
5 Participants
|
|
Number of Participants With Change in Diabetic Retinopathy Study (DRS) Retinopathy Scale
Missing
|
6 Participants
|
10 Participants
|
|
Number of Participants With Change in Diabetic Retinopathy Study (DRS) Retinopathy Scale
> 2 steps improvement
|
7 Participants
|
7 Participants
|
|
Number of Participants With Change in Diabetic Retinopathy Study (DRS) Retinopathy Scale
0 steps
|
38 Participants
|
34 Participants
|
|
Number of Participants With Change in Diabetic Retinopathy Study (DRS) Retinopathy Scale
1 step loss
|
4 Participants
|
4 Participants
|
|
Number of Participants With Change in Diabetic Retinopathy Study (DRS) Retinopathy Scale
2 steps loss
|
2 Participants
|
1 Participants
|
Adverse Events
Discretion of the Investigator (DI)
Serious events: 13 serious events
Other events: 44 other events
Deaths: 1 deaths
Pro re Nata (PRN)
Serious events: 22 serious events
Other events: 43 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Discretion of the Investigator (DI)
n=68 participants at risk
Investigational - ranibizumab 0.5 mg
|
Pro re Nata (PRN)
n=67 participants at risk
Standard of Care - ranibizumab 0.5 mg
|
|---|---|---|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
1.5%
1/68 • From start of study treatment until month 12
|
0.00%
0/67 • From start of study treatment until month 12
|
|
Cardiac disorders
Acute coronary syndrome
|
1.5%
1/68 • From start of study treatment until month 12
|
0.00%
0/67 • From start of study treatment until month 12
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/68 • From start of study treatment until month 12
|
1.5%
1/67 • From start of study treatment until month 12
|
|
Cardiac disorders
Atrial fibrillation
|
1.5%
1/68 • From start of study treatment until month 12
|
0.00%
0/67 • From start of study treatment until month 12
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/68 • From start of study treatment until month 12
|
3.0%
2/67 • From start of study treatment until month 12
|
|
Cardiac disorders
Coronary artery disease
|
1.5%
1/68 • From start of study treatment until month 12
|
1.5%
1/67 • From start of study treatment until month 12
|
|
Cardiac disorders
Heart valve incompetence
|
0.00%
0/68 • From start of study treatment until month 12
|
1.5%
1/67 • From start of study treatment until month 12
|
|
Eye disorders
Cataract
|
0.00%
0/68 • From start of study treatment until month 12
|
1.5%
1/67 • From start of study treatment until month 12
|
|
Eye disorders
Eyelid function disorder
|
0.00%
0/68 • From start of study treatment until month 12
|
1.5%
1/67 • From start of study treatment until month 12
|
|
Eye disorders
Retinal detachment
|
1.5%
1/68 • From start of study treatment until month 12
|
1.5%
1/67 • From start of study treatment until month 12
|
|
Eye disorders
Vitreous haemorrhage
|
1.5%
1/68 • From start of study treatment until month 12
|
0.00%
0/67 • From start of study treatment until month 12
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/68 • From start of study treatment until month 12
|
1.5%
1/67 • From start of study treatment until month 12
|
|
Gastrointestinal disorders
Gastritis
|
1.5%
1/68 • From start of study treatment until month 12
|
3.0%
2/67 • From start of study treatment until month 12
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
1.5%
1/68 • From start of study treatment until month 12
|
0.00%
0/67 • From start of study treatment until month 12
|
|
General disorders
Oedema peripheral
|
0.00%
0/68 • From start of study treatment until month 12
|
1.5%
1/67 • From start of study treatment until month 12
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/68 • From start of study treatment until month 12
|
1.5%
1/67 • From start of study treatment until month 12
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/68 • From start of study treatment until month 12
|
1.5%
1/67 • From start of study treatment until month 12
|
|
Infections and infestations
Bronchitis
|
1.5%
1/68 • From start of study treatment until month 12
|
1.5%
1/67 • From start of study treatment until month 12
|
|
Infections and infestations
Endophthalmitis
|
0.00%
0/68 • From start of study treatment until month 12
|
1.5%
1/67 • From start of study treatment until month 12
|
|
Infections and infestations
Erysipelas
|
0.00%
0/68 • From start of study treatment until month 12
|
1.5%
1/67 • From start of study treatment until month 12
|
|
Infections and infestations
Pneumonia
|
0.00%
0/68 • From start of study treatment until month 12
|
1.5%
1/67 • From start of study treatment until month 12
|
|
Infections and infestations
Wound infection
|
0.00%
0/68 • From start of study treatment until month 12
|
1.5%
1/67 • From start of study treatment until month 12
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/68 • From start of study treatment until month 12
|
1.5%
1/67 • From start of study treatment until month 12
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.00%
0/68 • From start of study treatment until month 12
|
1.5%
1/67 • From start of study treatment until month 12
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/68 • From start of study treatment until month 12
|
1.5%
1/67 • From start of study treatment until month 12
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/68 • From start of study treatment until month 12
|
1.5%
1/67 • From start of study treatment until month 12
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
1.5%
1/68 • From start of study treatment until month 12
|
0.00%
0/67 • From start of study treatment until month 12
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/68 • From start of study treatment until month 12
|
1.5%
1/67 • From start of study treatment until month 12
|
|
Injury, poisoning and procedural complications
VIIth nerve injury
|
0.00%
0/68 • From start of study treatment until month 12
|
1.5%
1/67 • From start of study treatment until month 12
|
|
Investigations
Blood glucose increased
|
0.00%
0/68 • From start of study treatment until month 12
|
3.0%
2/67 • From start of study treatment until month 12
|
|
Investigations
Urinary nitrogen increased
|
0.00%
0/68 • From start of study treatment until month 12
|
1.5%
1/67 • From start of study treatment until month 12
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/68 • From start of study treatment until month 12
|
1.5%
1/67 • From start of study treatment until month 12
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.5%
1/68 • From start of study treatment until month 12
|
0.00%
0/67 • From start of study treatment until month 12
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.5%
1/68 • From start of study treatment until month 12
|
0.00%
0/67 • From start of study treatment until month 12
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/68 • From start of study treatment until month 12
|
1.5%
1/67 • From start of study treatment until month 12
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acoustic neuroma
|
0.00%
0/68 • From start of study treatment until month 12
|
1.5%
1/67 • From start of study treatment until month 12
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/68 • From start of study treatment until month 12
|
1.5%
1/67 • From start of study treatment until month 12
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/68 • From start of study treatment until month 12
|
1.5%
1/67 • From start of study treatment until month 12
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic myeloid leukaemia
|
0.00%
0/68 • From start of study treatment until month 12
|
1.5%
1/67 • From start of study treatment until month 12
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/68 • From start of study treatment until month 12
|
1.5%
1/67 • From start of study treatment until month 12
|
|
Nervous system disorders
Cerebrovascular accident
|
1.5%
1/68 • From start of study treatment until month 12
|
0.00%
0/67 • From start of study treatment until month 12
|
|
Nervous system disorders
Diabetic neuropathy
|
1.5%
1/68 • From start of study treatment until month 12
|
0.00%
0/67 • From start of study treatment until month 12
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/68 • From start of study treatment until month 12
|
1.5%
1/67 • From start of study treatment until month 12
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/68 • From start of study treatment until month 12
|
1.5%
1/67 • From start of study treatment until month 12
|
|
Nervous system disorders
Transient ischaemic attack
|
1.5%
1/68 • From start of study treatment until month 12
|
0.00%
0/67 • From start of study treatment until month 12
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/68 • From start of study treatment until month 12
|
1.5%
1/67 • From start of study treatment until month 12
|
|
Renal and urinary disorders
Acute kidney injury
|
2.9%
2/68 • From start of study treatment until month 12
|
0.00%
0/67 • From start of study treatment until month 12
|
|
Renal and urinary disorders
Nephrotic syndrome
|
1.5%
1/68 • From start of study treatment until month 12
|
0.00%
0/67 • From start of study treatment until month 12
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.5%
1/68 • From start of study treatment until month 12
|
1.5%
1/67 • From start of study treatment until month 12
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/68 • From start of study treatment until month 12
|
1.5%
1/67 • From start of study treatment until month 12
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
1.5%
1/68 • From start of study treatment until month 12
|
0.00%
0/67 • From start of study treatment until month 12
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
1.5%
1/68 • From start of study treatment until month 12
|
1.5%
1/67 • From start of study treatment until month 12
|
|
Vascular disorders
Behcet's syndrome
|
1.5%
1/68 • From start of study treatment until month 12
|
0.00%
0/67 • From start of study treatment until month 12
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/68 • From start of study treatment until month 12
|
1.5%
1/67 • From start of study treatment until month 12
|
|
Vascular disorders
Hypertension
|
1.5%
1/68 • From start of study treatment until month 12
|
1.5%
1/67 • From start of study treatment until month 12
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/68 • From start of study treatment until month 12
|
1.5%
1/67 • From start of study treatment until month 12
|
Other adverse events
| Measure |
Discretion of the Investigator (DI)
n=68 participants at risk
Investigational - ranibizumab 0.5 mg
|
Pro re Nata (PRN)
n=67 participants at risk
Standard of Care - ranibizumab 0.5 mg
|
|---|---|---|
|
Eye disorders
Cataract
|
2.9%
2/68 • From start of study treatment until month 12
|
7.5%
5/67 • From start of study treatment until month 12
|
|
Eye disorders
Conjunctival haemorrhage
|
19.1%
13/68 • From start of study treatment until month 12
|
20.9%
14/67 • From start of study treatment until month 12
|
|
Eye disorders
Corneal erosion
|
5.9%
4/68 • From start of study treatment until month 12
|
6.0%
4/67 • From start of study treatment until month 12
|
|
Eye disorders
Eye irritation
|
1.5%
1/68 • From start of study treatment until month 12
|
7.5%
5/67 • From start of study treatment until month 12
|
|
Eye disorders
Eye pain
|
10.3%
7/68 • From start of study treatment until month 12
|
6.0%
4/67 • From start of study treatment until month 12
|
|
Eye disorders
Foreign body sensation in eyes
|
8.8%
6/68 • From start of study treatment until month 12
|
1.5%
1/67 • From start of study treatment until month 12
|
|
Eye disorders
Macular oedema
|
7.4%
5/68 • From start of study treatment until month 12
|
7.5%
5/67 • From start of study treatment until month 12
|
|
Eye disorders
Ocular discomfort
|
5.9%
4/68 • From start of study treatment until month 12
|
6.0%
4/67 • From start of study treatment until month 12
|
|
Eye disorders
Visual acuity reduced
|
10.3%
7/68 • From start of study treatment until month 12
|
11.9%
8/67 • From start of study treatment until month 12
|
|
Eye disorders
Visual impairment
|
5.9%
4/68 • From start of study treatment until month 12
|
3.0%
2/67 • From start of study treatment until month 12
|
|
Eye disorders
Vitreous floaters
|
4.4%
3/68 • From start of study treatment until month 12
|
7.5%
5/67 • From start of study treatment until month 12
|
|
Eye disorders
Vitreous haemorrhage
|
8.8%
6/68 • From start of study treatment until month 12
|
3.0%
2/67 • From start of study treatment until month 12
|
|
Infections and infestations
Conjunctivitis
|
1.5%
1/68 • From start of study treatment until month 12
|
6.0%
4/67 • From start of study treatment until month 12
|
|
Infections and infestations
Viral upper respiratory tract infection
|
27.9%
19/68 • From start of study treatment until month 12
|
26.9%
18/67 • From start of study treatment until month 12
|
|
Investigations
Glycosylated haemoglobin increased
|
7.4%
5/68 • From start of study treatment until month 12
|
10.4%
7/67 • From start of study treatment until month 12
|
|
Investigations
Intraocular pressure increased
|
11.8%
8/68 • From start of study treatment until month 12
|
9.0%
6/67 • From start of study treatment until month 12
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.9%
4/68 • From start of study treatment until month 12
|
3.0%
2/67 • From start of study treatment until month 12
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.9%
4/68 • From start of study treatment until month 12
|
1.5%
1/67 • From start of study treatment until month 12
|
|
Nervous system disorders
Headache
|
5.9%
4/68 • From start of study treatment until month 12
|
1.5%
1/67 • From start of study treatment until month 12
|
|
Vascular disorders
Haematoma
|
5.9%
4/68 • From start of study treatment until month 12
|
0.00%
0/67 • From start of study treatment until month 12
|
|
Vascular disorders
Hypertension
|
4.4%
3/68 • From start of study treatment until month 12
|
10.4%
7/67 • From start of study treatment until month 12
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER