Trial Outcomes & Findings for Efficacy and Safety of Ranibizumab Intravitreal Injections Versus Dexamethasone Intravitreal Implant in Patients With Branch Retinal Vein Occlusion (BRVO) (NCT NCT01396057)
NCT ID: NCT01396057
Last Updated: 2014-08-07
Results Overview
the average of the changes in BCVA (letters) from baseline to any post-baseline visit, i.e. the mean of six differences to baseline for the six post-baseline visits at month 1 to 6
COMPLETED
PHASE3
244 participants
Baseline, month 6
2014-08-07
Participant Flow
Participant milestones
| Measure |
Ranibizumab
Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
|
Dexamethasone
Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
|
|---|---|---|
|
Overall Study
STARTED
|
126
|
118
|
|
Overall Study
COMPLETED
|
115
|
100
|
|
Overall Study
NOT COMPLETED
|
11
|
18
|
Reasons for withdrawal
| Measure |
Ranibizumab
Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
|
Dexamethasone
Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
6
|
|
Overall Study
Unsatisfactory therapeutic effect
|
2
|
6
|
|
Overall Study
Protocol deviation
|
4
|
4
|
|
Overall Study
Consent withdrawn
|
3
|
2
|
Baseline Characteristics
Efficacy and Safety of Ranibizumab Intravitreal Injections Versus Dexamethasone Intravitreal Implant in Patients With Branch Retinal Vein Occlusion (BRVO)
Baseline characteristics by cohort
| Measure |
Ranibizumab
n=126 Participants
Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
|
Dexamethasone
n=118 Participants
Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
|
Total
n=244 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.7 Years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
65.6 Years
STANDARD_DEVIATION 10.0 • n=7 Participants
|
65.6 Years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
76 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
133 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
111 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, month 6Population: The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned
the average of the changes in BCVA (letters) from baseline to any post-baseline visit, i.e. the mean of six differences to baseline for the six post-baseline visits at month 1 to 6
Outcome measures
| Measure |
Ranibizumab
n=126 Participants
Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
|
Dexamethasone
n=118 Participants
Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
|
|---|---|---|
|
Mean Average Best Corrected Visual Acuity (BCVA) Change From Month 1 Through Month 6 to Baseline
|
14.9 Letters
Standard Deviation 9.9
|
10.1 Letters
Standard Deviation 9.5
|
SECONDARY outcome
Timeframe: Baseline, month 6Population: The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned
The analysis was performed by an analysis of covariance (ANCOVA) model with average change in BCVA (letters) from Visit 1 through Visit 6 as dependent variable, and with the factors center, treatment and covariate baseline BCVA as predictors
Outcome measures
| Measure |
Ranibizumab
n=126 Participants
Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
|
Dexamethasone
n=118 Participants
Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
|
|---|---|---|
|
Mean BCVA Change From Baseline to Endpoints Month 1 to Month 6
|
16.18 Letters (EDTRS)
Interval 14.04 to 18.32
|
8.10 Letters (EDTRS)
Interval 5.79 to 10.4
|
SECONDARY outcome
Timeframe: Baseline, 6 monthPopulation: The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned
BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increased score indicates improvement in acuity. This outcome assessed the percentage of participants who gained 15, 10 or 5 more letters of visual acuity at month 6 as compared with baseline
Outcome measures
| Measure |
Ranibizumab
n=126 Participants
Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
|
Dexamethasone
n=118 Participants
Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
|
|---|---|---|
|
Percentage of Patients Gaining / Losing ≥ 15 / 10 / 5 Letters After 6 Month Treatment
Gain≥15 letters
|
77 Participants
|
44 Participants
|
|
Percentage of Patients Gaining / Losing ≥ 15 / 10 / 5 Letters After 6 Month Treatment
Loss of ≥15 letters
|
0 Participants
|
6 Participants
|
|
Percentage of Patients Gaining / Losing ≥ 15 / 10 / 5 Letters After 6 Month Treatment
Gain ≥10 letters
|
97 Participants
|
63 Participants
|
|
Percentage of Patients Gaining / Losing ≥ 15 / 10 / 5 Letters After 6 Month Treatment
Loss of ≥10 letters
|
2 Participants
|
8 Participants
|
|
Percentage of Patients Gaining / Losing ≥ 15 / 10 / 5 Letters After 6 Month Treatment
Gain ≥5 letters
|
108 Participants
|
76 Participants
|
|
Percentage of Patients Gaining / Losing ≥ 15 / 10 / 5 Letters After 6 Month Treatment
Loss of ≥5 letters
|
4 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Baseline, month 6Population: The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned
The time was analyzed by the Kaplan-Maier-Method, adjusting the calculation for dropouts
Outcome measures
| Measure |
Ranibizumab
n=126 Participants
Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
|
Dexamethasone
n=118 Participants
Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
|
|---|---|---|
|
Time to Achieve a Significant Improvement ≥ 15 Letters
|
63 Time to event (Days)
Interval 56.0 to 84.0
|
64 Time to event (Days)
Interval 59.0 to 126.0
|
SECONDARY outcome
Timeframe: baseline, month 6Population: The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned
The analysis was performed by an analysis of covariance (ANCOVA) model with average change in BCVA (letters) from Visit 1 through Visit 6 as dependent variable, and with the factors center, treatment and covariate baseline BCVA as predictors
Outcome measures
| Measure |
Ranibizumab
n=126 Participants
Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
|
Dexamethasone
n=118 Participants
Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
|
|---|---|---|
|
Change Over Time in BCVA
Month 2
|
13.84 Letters
Interval 12.04 to 15.64
|
12.62 Letters
Interval 10.69 to 14.56
|
|
Change Over Time in BCVA
Month 3
|
15.52 Letters
Interval 13.44 to 17.59
|
9.16 Letters
Interval 6.92 to 11.39
|
|
Change Over Time in BCVA
Month 6
|
16.18 Letters
Interval 14.04 to 18.32
|
8.10 Letters
Interval 5.79 to 10.4
|
|
Change Over Time in BCVA
Month 1
|
10.35 Letters
Interval 8.53 to 12.17
|
10.44 Letters
Interval 8.48 to 12.4
|
|
Change Over Time in BCVA
Month 4
|
14.39 Letters
Interval 12.38 to 16.41
|
8.59 Letters
Interval 6.42 to 10.76
|
|
Change Over Time in BCVA
Month 5
|
14.65 Letters
Interval 12.52 to 16.78
|
9.08 Letters
Interval 6.79 to 11.37
|
SECONDARY outcome
Timeframe: Baseline, month 6Population: The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned
Retinal thickness was measured using Optical Coherence Tomography (OCT). The images were reviewed by a central reading center to ensure a standardized evaluation
Outcome measures
| Measure |
Ranibizumab
n=126 Participants
Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
|
Dexamethasone
n=118 Participants
Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
|
|---|---|---|
|
Change Over Time of the Central Retinal Thickness (CRT)
|
-230.6 µm
Standard Deviation 169.3
|
-112.3 µm
Standard Deviation 172.1
|
SECONDARY outcome
Timeframe: Baseline, month 6Population: The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned
The VFQ-25 composite and subscale scores range from 0 to 100, a higher score indicating better functioning. The 12 subscales in the VFQ-25 are general health, general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision, and peripheral vision. The scores on the subscales were added together for a total score, which ranged from 0 to 100. A higher score indicated improvement in quality of life due to vision function.
Outcome measures
| Measure |
Ranibizumab
n=126 Participants
Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
|
Dexamethasone
n=118 Participants
Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
|
|---|---|---|
|
Changes in the Quality of Life According to the National Eye Institute Visual Function Questionnaire (NEI-VFQ 25) Questionnaires
|
7.2 Score on a scale
Standard Deviation 10.2
|
2.8 Score on a scale
Standard Deviation 12.6
|
SECONDARY outcome
Timeframe: Baseline, month 6Population: The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. observed is only described in this analysis.
SF-36 summary measures are norm-based scores with mean = 50 and SD = 10. Higher scores indicate better health
Outcome measures
| Measure |
Ranibizumab
n=126 Participants
Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
|
Dexamethasone
n=118 Participants
Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
|
|---|---|---|
|
Changes in the Quality of Life According to the Short Form (36) Health Survey (SF-36)Questionnaires
SF-36 physical component (n=121,114)
|
-1.1 Units on a scale
Standard Deviation 5.7
|
-0.4 Units on a scale
Standard Deviation 5.7
|
|
Changes in the Quality of Life According to the Short Form (36) Health Survey (SF-36)Questionnaires
SF-36 mental component (n=121,114)
|
3.3 Units on a scale
Standard Deviation 9.2
|
0.2 Units on a scale
Standard Deviation 9.6
|
SECONDARY outcome
Timeframe: Baseline, month 6Population: The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Observed participants are only described in this analysis
The EQ-5D visual analog scale ranges from 0 to 100, 0 representing the worst and 100 the best imaginable health state.
Outcome measures
| Measure |
Ranibizumab
n=123 Participants
Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
|
Dexamethasone
n=118 Participants
Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
|
|---|---|---|
|
Changes in the Quality of Life According to Euro Quality of Life (EQ-5D) Questionnaires
|
0.7 Units on a scale
Standard Deviation 15.2
|
-2.4 Units on a scale
Standard Deviation 15.4
|
SECONDARY outcome
Timeframe: Baseline, month 6Population: The Safety Set consisted of all patients from the RS who had received at least one application of study treatment and had at least one post-baseline safety assessment. Patients were analyzed according to treatment received. The statement that a patient had no adverse events also constituted a safety assessment
The proportion of patients with ≥ 10% increase in IOP compared to baseline at any post-baseline visit.
Outcome measures
| Measure |
Ranibizumab
n=126 Participants
Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
|
Dexamethasone
n=118 Participants
Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
|
|---|---|---|
|
Rate of the Internal Ocular Pressure (IOP)
|
79 Participants
|
106 Participants
|
Adverse Events
Ranibizumab
Dexamethasone
Serious adverse events
| Measure |
Ranibizumab
n=126 participants at risk
Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
|
Dexamethasone
n=118 participants at risk
Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
|
|---|---|---|
|
Cardiac disorders
ATRIOVENTRICULAR BLOCK SECOND DEGREE
|
0.79%
1/126
|
0.00%
0/118
|
|
Cardiac disorders
BRADYARRHYTHMIA
|
0.79%
1/126
|
0.00%
0/118
|
|
Eye disorders
CONJUNCTIVITIS (Study eye)
|
0.00%
0/126
|
0.85%
1/118
|
|
Eye disorders
OCULAR HYPERTENSION (Study eye)
|
0.00%
0/126
|
0.85%
1/118
|
|
Gastrointestinal disorders
ABDOMINAL HERNIA
|
0.00%
0/126
|
0.85%
1/118
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.79%
1/126
|
0.00%
0/118
|
|
Gastrointestinal disorders
DYSPEPSIA
|
0.79%
1/126
|
0.00%
0/118
|
|
Gastrointestinal disorders
INGUINAL HERNIA
|
0.00%
0/126
|
0.85%
1/118
|
|
Gastrointestinal disorders
LARGE INTESTINE POLYP
|
0.79%
1/126
|
0.00%
0/118
|
|
Gastrointestinal disorders
RECTAL HAEMORRHAGE
|
0.00%
0/126
|
0.85%
1/118
|
|
Gastrointestinal disorders
UMBILICAL HERNIA
|
0.00%
0/126
|
0.85%
1/118
|
|
General disorders
FATIGUE
|
0.79%
1/126
|
0.00%
0/118
|
|
Infections and infestations
APPENDICITIS
|
0.00%
0/126
|
0.85%
1/118
|
|
Infections and infestations
BRONCHITIS
|
0.00%
0/126
|
0.85%
1/118
|
|
Infections and infestations
CELLULITIS (Study eye)
|
0.00%
0/126
|
0.85%
1/118
|
|
Injury, poisoning and procedural complications
FOOT FRACTURE
|
0.00%
0/126
|
0.85%
1/118
|
|
Injury, poisoning and procedural complications
KIDNEY RUPTURE
|
0.00%
0/126
|
0.85%
1/118
|
|
Injury, poisoning and procedural complications
PERIRENAL HAEMATOMA
|
0.00%
0/126
|
0.85%
1/118
|
|
Injury, poisoning and procedural complications
ROAD TRAFFIC ACCIDENT
|
0.00%
0/126
|
0.85%
1/118
|
|
Injury, poisoning and procedural complications
SPLENIC INJURY
|
0.00%
0/126
|
0.85%
1/118
|
|
Metabolism and nutrition disorders
TYPE 2 DIABETES MELLITUS
|
0.79%
1/126
|
0.00%
0/118
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC PROTRUSION
|
0.79%
1/126
|
0.00%
0/118
|
|
Musculoskeletal and connective tissue disorders
RHEUMATIC DISORDER
|
0.79%
1/126
|
0.00%
0/118
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PROSTATE CANCER
|
0.79%
1/126
|
0.00%
0/118
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
RENAL CANCER
|
0.79%
1/126
|
0.00%
0/118
|
|
Renal and urinary disorders
DIABETIC NEPHROPATHY
|
0.79%
1/126
|
0.00%
0/118
|
|
Renal and urinary disorders
NEPHROLITHIASIS
|
0.00%
0/126
|
0.85%
1/118
|
|
Renal and urinary disorders
RENAL FAILURE
|
0.79%
1/126
|
0.00%
0/118
|
|
Renal and urinary disorders
URETHRAL PROLAPSE
|
0.00%
0/126
|
0.85%
1/118
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.79%
1/126
|
0.00%
0/118
|
|
Respiratory, thoracic and mediastinal disorders
SLEEP APNOEA SYNDROME
|
0.00%
0/126
|
0.85%
1/118
|
|
Vascular disorders
CIRCULATORY COLLAPSE
|
0.00%
0/126
|
0.85%
1/118
|
|
Vascular disorders
HYPERTENSION
|
0.00%
0/126
|
0.85%
1/118
|
Other adverse events
| Measure |
Ranibizumab
n=126 participants at risk
Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
|
Dexamethasone
n=118 participants at risk
Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
|
|---|---|---|
|
Eye disorders
ABNORMAL SENSATION IN EYE (Study eye)
|
4.0%
5/126
|
2.5%
3/118
|
|
Eye disorders
BLEPHARITIS (Fellow eye)
|
0.79%
1/126
|
2.5%
3/118
|
|
Eye disorders
BLEPHARITIS (Study eye)
|
1.6%
2/126
|
4.2%
5/118
|
|
Eye disorders
CATARACT (Study eye)
|
0.79%
1/126
|
3.4%
4/118
|
|
Eye disorders
CONJUNCTIVAL HAEMORRHAGE (Study eye)
|
9.5%
12/126
|
11.9%
14/118
|
|
Eye disorders
CONJUNCTIVAL IRRITATION (Study eye)
|
3.2%
4/126
|
3.4%
4/118
|
|
Eye disorders
CONJUNCTIVITIS (Study eye)
|
3.2%
4/126
|
1.7%
2/118
|
|
Eye disorders
EYE DISCHARGE (Study eye)
|
4.0%
5/126
|
4.2%
5/118
|
|
Eye disorders
EYE IRRITATION (Fellow eye)
|
0.79%
1/126
|
2.5%
3/118
|
|
Eye disorders
EYE IRRITATION (Study eye)
|
2.4%
3/126
|
5.1%
6/118
|
|
Eye disorders
EYE PAIN (Study eye)
|
7.1%
9/126
|
11.0%
13/118
|
|
Eye disorders
EYELID OEDEMA (Study eye)
|
0.00%
0/126
|
2.5%
3/118
|
|
Eye disorders
FOREIGN BODY SENSATION IN EYES (Study eye)
|
6.3%
8/126
|
3.4%
4/118
|
|
Eye disorders
GLAUCOMA (Study eye)
|
0.79%
1/126
|
2.5%
3/118
|
|
Eye disorders
LACRIMATION INCREASED (Fellow eye)
|
1.6%
2/126
|
3.4%
4/118
|
|
Eye disorders
LACRIMATION INCREASED (Study eye)
|
5.6%
7/126
|
3.4%
4/118
|
|
Eye disorders
MACULAR OEDEMA (Study eye)
|
3.2%
4/126
|
5.9%
7/118
|
|
Eye disorders
OCULAR DISCOMFORT (Study eye)
|
1.6%
2/126
|
6.8%
8/118
|
|
Eye disorders
OCULAR HYPERAEMIA (Study eye)
|
12.7%
16/126
|
17.8%
21/118
|
|
Eye disorders
OCULAR HYPERTENSION (Study eye)
|
0.00%
0/126
|
5.1%
6/118
|
|
Eye disorders
RETINAL EXUDATES (Study eye)
|
5.6%
7/126
|
2.5%
3/118
|
|
Eye disorders
VISION BLURRED (Study eye)
|
4.8%
6/126
|
1.7%
2/118
|
|
Eye disorders
VISUAL ACUITY REDUCED (Study eye)
|
3.2%
4/126
|
5.1%
6/118
|
|
Eye disorders
VITREOUS DETACHMENT (Study eye)
|
2.4%
3/126
|
5.9%
7/118
|
|
Eye disorders
VITREOUS FLOATERS (Study eye)
|
2.4%
3/126
|
2.5%
3/118
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/126
|
2.5%
3/118
|
|
Infections and infestations
CYSTITIS
|
3.2%
4/126
|
0.85%
1/118
|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION
|
2.4%
3/126
|
3.4%
4/118
|
|
Infections and infestations
NASOPHARYNGITIS
|
15.9%
20/126
|
17.8%
21/118
|
|
Injury, poisoning and procedural complications
FALL
|
4.8%
6/126
|
2.5%
3/118
|
|
Investigations
BLOOD GLUCOSE INCREASED
|
0.79%
1/126
|
3.4%
4/118
|
|
Investigations
INTRAOCULAR PRESSURE INCREASED
|
2.4%
3/126
|
16.1%
19/118
|
|
Investigations
INTRAOCULAR PRESSURE INCREASED (Study eye)
|
1.6%
2/126
|
14.4%
17/118
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
4.0%
5/126
|
5.1%
6/118
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
4.0%
5/126
|
0.85%
1/118
|
|
Nervous system disorders
HEADACHE
|
10.3%
13/126
|
9.3%
11/118
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
4.8%
6/126
|
2.5%
3/118
|
|
Vascular disorders
HYPERTENSION
|
5.6%
7/126
|
4.2%
5/118
|
|
Vascular disorders
VASCULAR SHUNT (Study eye)
|
3.2%
4/126
|
0.00%
0/118
|
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 (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety
- Publication restrictions are in place
Restriction type: OTHER