Trial Outcomes & Findings for Compare Safety/Efficacy of Labeled vs Wait-Extend Regimen of Lucentis in Turkish Patients With VI Due to DME (NCT NCT02262260)
NCT ID: NCT02262260
Last Updated: 2019-06-24
Results Overview
Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. A positive average change from baseline of BCVA indicates improvement
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
87 participants
Primary outcome timeframe
12 months
Results posted on
2019-06-24
Participant Flow
Participant milestones
| Measure |
Labeled Regime Arm
Treatment will be given monthly and will be continued until maximum visual acuity is achieved (the patient's visual acuity is stable for three consecutive monthly assessments performed while on ranibizumab treatment). Thereafter patients should be monitored monthly for visual acuity. Treatment will be resumed when monitoring indicates loss of visual acuity due to DME. Monthly injections should then be administered until stable visual acuity is reached again for three consecutive monthly assessments (implying a minimum of two injections). The interval between two doses should not be shorter than 1 month
|
Wait and Extend Regime Arm
Lucentis (ranibizumab) 0.5 mg will be injected subsequently at baseline, month 1 and 2. After the three initial loading doses, patients will be called for the control visits 1 month later. If the visual acuity has reached a stable level and there is no sign of edema on OCT, patients will not receive intravitreal injection and will be called to come back 6 weeks later. The interval is increased by 2 weeks until a maximum of 8 weeks as long as the patient presents as stable regarding visual acuity, central retinal thickness and clinical findings. If there is a negative change, the interval is shortened back to 4 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
45
|
42
|
|
Overall Study
COMPLETED
|
34
|
32
|
|
Overall Study
NOT COMPLETED
|
11
|
10
|
Reasons for withdrawal
| Measure |
Labeled Regime Arm
Treatment will be given monthly and will be continued until maximum visual acuity is achieved (the patient's visual acuity is stable for three consecutive monthly assessments performed while on ranibizumab treatment). Thereafter patients should be monitored monthly for visual acuity. Treatment will be resumed when monitoring indicates loss of visual acuity due to DME. Monthly injections should then be administered until stable visual acuity is reached again for three consecutive monthly assessments (implying a minimum of two injections). The interval between two doses should not be shorter than 1 month
|
Wait and Extend Regime Arm
Lucentis (ranibizumab) 0.5 mg will be injected subsequently at baseline, month 1 and 2. After the three initial loading doses, patients will be called for the control visits 1 month later. If the visual acuity has reached a stable level and there is no sign of edema on OCT, patients will not receive intravitreal injection and will be called to come back 6 weeks later. The interval is increased by 2 weeks until a maximum of 8 weeks as long as the patient presents as stable regarding visual acuity, central retinal thickness and clinical findings. If there is a negative change, the interval is shortened back to 4 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
1
|
|
Overall Study
Withdrawal of consent
|
4
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
|
Overall Study
Protocol deviation
|
2
|
5
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Labeled Regime Arm
n=45 Participants
Treatment will be given monthly and will be continued until maximum visual acuity is achieved (the patient's visual acuity is stable for three consecutive monthly assessments performed while on ranibizumab treatment). Thereafter patients should be monitored monthly for visual acuity. Treatment will be resumed when monitoring indicates loss of visual acuity due to DME. Monthly injections should then be administered until stable visual acuity is reached again for three consecutive monthly assessments (implying a minimum of two injections). The interval between two doses should not be shorter than 1 month
|
Wait and Extend Regime Arm
n=42 Participants
Lucentis (ranibizumab) 0.5 mg will be injected subsequently at baseline, month 1 and 2. After the three initial loading doses, patients will be called for the control visits 1 month later. If the visual acuity has reached a stable level and there is no sign of edema on OCT, patients will not receive intravitreal injection and will be called to come back 6 weeks later. The interval is increased by 2 weeks until a maximum of 8 weeks as long as the patient presents as stable regarding visual acuity, central retinal thickness and clinical findings. If there is a negative change, the interval is shortened back to 4 weeks.
|
Total
n=87 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61 Years
STANDARD_DEVIATION 9.93 • n=45 Participants
|
59.5 Years
STANDARD_DEVIATION 9.68 • n=42 Participants
|
60.3 Years
STANDARD_DEVIATION 9.78 • n=87 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=45 Participants
|
15 Participants
n=42 Participants
|
31 Participants
n=87 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=45 Participants
|
27 Participants
n=42 Participants
|
56 Participants
n=87 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Study completers- The patients who have completed 12 months of treatment and follow-up are defined as Study Completers.
Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. A positive average change from baseline of BCVA indicates improvement
Outcome measures
| Measure |
Labeled Regime Arm
n=34 Participants
Treatment will be given monthly and will be continued until maximum visual acuity is achieved (the patient's visual acuity is stable for three consecutive monthly assessments performed while on ranibizumab treatment). Thereafter patients should be monitored monthly for visual acuity. Treatment will be resumed when monitoring indicates loss of visual acuity due to DME. Monthly injections should then be administered until stable visual acuity is reached again for three consecutive monthly assessments (implying a minimum of two injections). The interval between two doses should not be shorter than 1 month
|
Wait and Extend Regime Arm
n=32 Participants
Lucentis (ranibizumab) 0.5 mg will be injected subsequently at baseline, month 1 and 2. After the three initial loading doses, patients will be called for the control visits 1 month later. If the visual acuity has reached a stable level and there is no sign of edema on OCT, patients will not receive intravitreal injection and will be called to come back 6 weeks later. The interval is increased by 2 weeks until a maximum of 8 weeks as long as the patient presents as stable regarding visual acuity, central retinal thickness and clinical findings. If there is a negative change, the interval is shortened back to 4 weeks.
|
|---|---|---|
|
Mean Change in "Best-corrected Visual Acuity" at Month 12
|
76.44 Letters
Standard Error 1.78
|
73.09 Letters
Standard Error 1.68
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Study completers- The patients who have completed 12 months of treatment and follow-up are defined as Study Completers.
CRT was assessed by Optical Coherence Tomography (OCT).
Outcome measures
| Measure |
Labeled Regime Arm
n=34 Participants
Treatment will be given monthly and will be continued until maximum visual acuity is achieved (the patient's visual acuity is stable for three consecutive monthly assessments performed while on ranibizumab treatment). Thereafter patients should be monitored monthly for visual acuity. Treatment will be resumed when monitoring indicates loss of visual acuity due to DME. Monthly injections should then be administered until stable visual acuity is reached again for three consecutive monthly assessments (implying a minimum of two injections). The interval between two doses should not be shorter than 1 month
|
Wait and Extend Regime Arm
n=32 Participants
Lucentis (ranibizumab) 0.5 mg will be injected subsequently at baseline, month 1 and 2. After the three initial loading doses, patients will be called for the control visits 1 month later. If the visual acuity has reached a stable level and there is no sign of edema on OCT, patients will not receive intravitreal injection and will be called to come back 6 weeks later. The interval is increased by 2 weeks until a maximum of 8 weeks as long as the patient presents as stable regarding visual acuity, central retinal thickness and clinical findings. If there is a negative change, the interval is shortened back to 4 weeks.
|
|---|---|---|
|
Mean Change in Central Retinal Thickness (CRT)
|
315.7 Micrometers
Standard Error 15.07
|
348.9 Micrometers
Standard Error 16.54
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Study completers- The patients who have completed 12 months of treatment and follow-up are defined as Study Completers. Statistical analysis not performed for the injection numbers
Mean number of injections over a 12-month treatment period
Outcome measures
| Measure |
Labeled Regime Arm
n=34 Participants
Treatment will be given monthly and will be continued until maximum visual acuity is achieved (the patient's visual acuity is stable for three consecutive monthly assessments performed while on ranibizumab treatment). Thereafter patients should be monitored monthly for visual acuity. Treatment will be resumed when monitoring indicates loss of visual acuity due to DME. Monthly injections should then be administered until stable visual acuity is reached again for three consecutive monthly assessments (implying a minimum of two injections). The interval between two doses should not be shorter than 1 month
|
Wait and Extend Regime Arm
n=32 Participants
Lucentis (ranibizumab) 0.5 mg will be injected subsequently at baseline, month 1 and 2. After the three initial loading doses, patients will be called for the control visits 1 month later. If the visual acuity has reached a stable level and there is no sign of edema on OCT, patients will not receive intravitreal injection and will be called to come back 6 weeks later. The interval is increased by 2 weeks until a maximum of 8 weeks as long as the patient presents as stable regarding visual acuity, central retinal thickness and clinical findings. If there is a negative change, the interval is shortened back to 4 weeks.
|
|---|---|---|
|
Mean Number of Injections
|
7.4 Injections
Standard Error 0.44
|
7.5 Injections
Standard Error 0.44
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Study completers- The patients who have completed 12 months of treatment and follow-up are defined as Study Completers. Statistical analysis not performed to compare visits
Mean number of visits over a 12-month treatment period
Outcome measures
| Measure |
Labeled Regime Arm
n=34 Participants
Treatment will be given monthly and will be continued until maximum visual acuity is achieved (the patient's visual acuity is stable for three consecutive monthly assessments performed while on ranibizumab treatment). Thereafter patients should be monitored monthly for visual acuity. Treatment will be resumed when monitoring indicates loss of visual acuity due to DME. Monthly injections should then be administered until stable visual acuity is reached again for three consecutive monthly assessments (implying a minimum of two injections). The interval between two doses should not be shorter than 1 month
|
Wait and Extend Regime Arm
n=32 Participants
Lucentis (ranibizumab) 0.5 mg will be injected subsequently at baseline, month 1 and 2. After the three initial loading doses, patients will be called for the control visits 1 month later. If the visual acuity has reached a stable level and there is no sign of edema on OCT, patients will not receive intravitreal injection and will be called to come back 6 weeks later. The interval is increased by 2 weeks until a maximum of 8 weeks as long as the patient presents as stable regarding visual acuity, central retinal thickness and clinical findings. If there is a negative change, the interval is shortened back to 4 weeks.
|
|---|---|---|
|
Mean Number of Visits
|
11.2 Number of visits
Standard Error 0.19
|
10.2 Number of visits
Standard Error 0.24
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Study completers- The patients who have completed 12 months of treatment and follow-up are defined as Study Completers
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 increased score indicates improvement in acuity. This outcome assessed the number of participants who had improvement of ≥5 letters of visual acuity at month 12 as compared with baseline
Outcome measures
| Measure |
Labeled Regime Arm
n=34 Participants
Treatment will be given monthly and will be continued until maximum visual acuity is achieved (the patient's visual acuity is stable for three consecutive monthly assessments performed while on ranibizumab treatment). Thereafter patients should be monitored monthly for visual acuity. Treatment will be resumed when monitoring indicates loss of visual acuity due to DME. Monthly injections should then be administered until stable visual acuity is reached again for three consecutive monthly assessments (implying a minimum of two injections). The interval between two doses should not be shorter than 1 month
|
Wait and Extend Regime Arm
n=32 Participants
Lucentis (ranibizumab) 0.5 mg will be injected subsequently at baseline, month 1 and 2. After the three initial loading doses, patients will be called for the control visits 1 month later. If the visual acuity has reached a stable level and there is no sign of edema on OCT, patients will not receive intravitreal injection and will be called to come back 6 weeks later. The interval is increased by 2 weeks until a maximum of 8 weeks as long as the patient presents as stable regarding visual acuity, central retinal thickness and clinical findings. If there is a negative change, the interval is shortened back to 4 weeks.
|
|---|---|---|
|
Proportion of Patients Who Gained ≥5 Letters
|
29 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Study completers- The patients who have completed 12 months of treatment and follow-up are defined as Study Completers
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 increased score indicates improvement in acuity. This outcome assessed the number of participants who had improvement of ≥10 letters of visual acuity at month 12 as compared with baseline
Outcome measures
| Measure |
Labeled Regime Arm
n=34 Participants
Treatment will be given monthly and will be continued until maximum visual acuity is achieved (the patient's visual acuity is stable for three consecutive monthly assessments performed while on ranibizumab treatment). Thereafter patients should be monitored monthly for visual acuity. Treatment will be resumed when monitoring indicates loss of visual acuity due to DME. Monthly injections should then be administered until stable visual acuity is reached again for three consecutive monthly assessments (implying a minimum of two injections). The interval between two doses should not be shorter than 1 month
|
Wait and Extend Regime Arm
n=32 Participants
Lucentis (ranibizumab) 0.5 mg will be injected subsequently at baseline, month 1 and 2. After the three initial loading doses, patients will be called for the control visits 1 month later. If the visual acuity has reached a stable level and there is no sign of edema on OCT, patients will not receive intravitreal injection and will be called to come back 6 weeks later. The interval is increased by 2 weeks until a maximum of 8 weeks as long as the patient presents as stable regarding visual acuity, central retinal thickness and clinical findings. If there is a negative change, the interval is shortened back to 4 weeks.
|
|---|---|---|
|
Proportion of Patients Who Gained ≥10 Letters
|
23 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Study completers- The patients who have completed 12 months of treatment and follow-up are defined as Study Completers
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 increased score indicates improvement in acuity. This outcome assessed the number of participants who had improvement of ≥15 letters of visual acuity at month 12 as compared with baseline
Outcome measures
| Measure |
Labeled Regime Arm
n=34 Participants
Treatment will be given monthly and will be continued until maximum visual acuity is achieved (the patient's visual acuity is stable for three consecutive monthly assessments performed while on ranibizumab treatment). Thereafter patients should be monitored monthly for visual acuity. Treatment will be resumed when monitoring indicates loss of visual acuity due to DME. Monthly injections should then be administered until stable visual acuity is reached again for three consecutive monthly assessments (implying a minimum of two injections). The interval between two doses should not be shorter than 1 month
|
Wait and Extend Regime Arm
n=32 Participants
Lucentis (ranibizumab) 0.5 mg will be injected subsequently at baseline, month 1 and 2. After the three initial loading doses, patients will be called for the control visits 1 month later. If the visual acuity has reached a stable level and there is no sign of edema on OCT, patients will not receive intravitreal injection and will be called to come back 6 weeks later. The interval is increased by 2 weeks until a maximum of 8 weeks as long as the patient presents as stable regarding visual acuity, central retinal thickness and clinical findings. If there is a negative change, the interval is shortened back to 4 weeks.
|
|---|---|---|
|
Proportion of Patients Who Gained ≥15 Letters
|
12 Participants
|
10 Participants
|
Adverse Events
Labeled Treatment Arm
Serious events: 10 serious events
Other events: 12 other events
Deaths: 1 deaths
Wait and Extend Regimen Arm
Serious events: 7 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Labeled Treatment Arm
n=45 participants at risk
Treatment will be given monthly and will be continued until maximum visual acuity is achieved (the patient's visual acuity is stable for three consecutive monthly assessments performed while on ranibizumab treatment). Thereafter patients should be monitored monthly for visual acuity. Treatment will be resumed when monitoring indicates loss of visual acuity due to DME. Monthly injections should then be administered until stable visual acuity is reached again for three consecutive monthly assessments (implying a minimum of two injections). The interval between two doses should not be shorter than 1 month
|
Wait and Extend Regimen Arm
n=42 participants at risk
Lucentis (ranibizumab) 0.5 mg will be injected subsequently at baseline, month 1 and 2. After the three initial loading doses, patients will be called for the control visits 1 month later. If the visual acuity has reached a stable level and there is no sign of edema on OCT, patients will not receive intravitreal injection and will be called to come back 6 weeks later. The interval is increased by 2 weeks until a maximum of 8 weeks as long as the patient presents as stable regarding visual acuity, central retinal thickness and clinical findings. If there is a negative change, the interval is shortened back to 4 weeks.
|
|---|---|---|
|
Cardiac disorders
Angina pectoris
|
2.2%
1/45 • 12 month study
|
0.00%
0/42 • 12 month study
|
|
Cardiac disorders
Coronary artery disease
|
2.2%
1/45 • 12 month study
|
2.4%
1/42 • 12 month study
|
|
Cardiac disorders
Myocardial infarction
|
4.4%
2/45 • 12 month study
|
2.4%
1/42 • 12 month study
|
|
Eye disorders
Vitreous hemorrhage
|
0.00%
0/45 • 12 month study
|
2.4%
1/42 • 12 month study
|
|
General disorders
Fatigue
|
2.2%
1/45 • 12 month study
|
0.00%
0/42 • 12 month study
|
|
Hepatobiliary disorders
Cholecystitis
|
2.2%
1/45 • 12 month study
|
0.00%
0/42 • 12 month study
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/45 • 12 month study
|
2.4%
1/42 • 12 month study
|
|
Infections and infestations
Pneumonia
|
0.00%
0/45 • 12 month study
|
2.4%
1/42 • 12 month study
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/45 • 12 month study
|
2.4%
1/42 • 12 month study
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
2.2%
1/45 • 12 month study
|
0.00%
0/42 • 12 month study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
2.2%
1/45 • 12 month study
|
0.00%
0/42 • 12 month study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder neoplasm
|
2.2%
1/45 • 12 month study
|
0.00%
0/42 • 12 month study
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/45 • 12 month study
|
2.4%
1/42 • 12 month study
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/45 • 12 month study
|
2.4%
1/42 • 12 month study
|
|
Renal and urinary disorders
Renal failure
|
2.2%
1/45 • 12 month study
|
0.00%
0/42 • 12 month study
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
4.4%
2/45 • 12 month study
|
0.00%
0/42 • 12 month study
|
Other adverse events
| Measure |
Labeled Treatment Arm
n=45 participants at risk
Treatment will be given monthly and will be continued until maximum visual acuity is achieved (the patient's visual acuity is stable for three consecutive monthly assessments performed while on ranibizumab treatment). Thereafter patients should be monitored monthly for visual acuity. Treatment will be resumed when monitoring indicates loss of visual acuity due to DME. Monthly injections should then be administered until stable visual acuity is reached again for three consecutive monthly assessments (implying a minimum of two injections). The interval between two doses should not be shorter than 1 month
|
Wait and Extend Regimen Arm
n=42 participants at risk
Lucentis (ranibizumab) 0.5 mg will be injected subsequently at baseline, month 1 and 2. After the three initial loading doses, patients will be called for the control visits 1 month later. If the visual acuity has reached a stable level and there is no sign of edema on OCT, patients will not receive intravitreal injection and will be called to come back 6 weeks later. The interval is increased by 2 weeks until a maximum of 8 weeks as long as the patient presents as stable regarding visual acuity, central retinal thickness and clinical findings. If there is a negative change, the interval is shortened back to 4 weeks.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/45 • 12 month study
|
2.4%
1/42 • 12 month study
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
2.2%
1/45 • 12 month study
|
0.00%
0/42 • 12 month study
|
|
Cardiac disorders
Angina pectoris
|
2.2%
1/45 • 12 month study
|
0.00%
0/42 • 12 month study
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/45 • 12 month study
|
2.4%
1/42 • 12 month study
|
|
Eye disorders
Dry eye
|
2.2%
1/45 • 12 month study
|
0.00%
0/42 • 12 month study
|
|
Eye disorders
Eye haemorrhage
|
2.2%
1/45 • 12 month study
|
2.4%
1/42 • 12 month study
|
|
Eye disorders
Itchy eyes
|
2.2%
1/45 • 12 month study
|
0.00%
0/42 • 12 month study
|
|
Eye disorders
Ocular hyperemia
|
4.4%
2/45 • 12 month study
|
2.4%
1/42 • 12 month study
|
|
Eye disorders
Vitreoretinal traction syndrome
|
2.2%
1/45 • 12 month study
|
2.4%
1/42 • 12 month study
|
|
Eye disorders
Vitreous hemorrhage
|
0.00%
0/45 • 12 month study
|
2.4%
1/42 • 12 month study
|
|
Eye disorders
Vitreous opacity
|
2.2%
1/45 • 12 month study
|
0.00%
0/42 • 12 month study
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/45 • 12 month study
|
4.8%
2/42 • 12 month study
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/45 • 12 month study
|
2.4%
1/42 • 12 month study
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/45 • 12 month study
|
4.8%
2/42 • 12 month study
|
|
Gastrointestinal disorders
Gastric spasm
|
2.2%
1/45 • 12 month study
|
0.00%
0/42 • 12 month study
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/45 • 12 month study
|
2.4%
1/42 • 12 month study
|
|
Gastrointestinal disorders
Nausea
|
2.2%
1/45 • 12 month study
|
0.00%
0/42 • 12 month study
|
|
Gastrointestinal disorders
Ocular hyperemia
|
2.2%
1/45 • 12 month study
|
0.00%
0/42 • 12 month study
|
|
Hepatobiliary disorders
Gall bladder stone
|
0.00%
0/45 • 12 month study
|
2.4%
1/42 • 12 month study
|
|
Hepatobiliary disorders
Gallbladder inflammation
|
2.2%
1/45 • 12 month study
|
0.00%
0/42 • 12 month study
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/45 • 12 month study
|
2.4%
1/42 • 12 month study
|
|
Infections and infestations
Adenovirus infection
|
2.2%
1/45 • 12 month study
|
0.00%
0/42 • 12 month study
|
|
Infections and infestations
Eye infection
|
0.00%
0/45 • 12 month study
|
2.4%
1/42 • 12 month study
|
|
Infections and infestations
Foot infection
|
0.00%
0/45 • 12 month study
|
2.4%
1/42 • 12 month study
|
|
Infections and infestations
Influenza
|
2.2%
1/45 • 12 month study
|
0.00%
0/42 • 12 month study
|
|
Infections and infestations
Pneumonia
|
0.00%
0/45 • 12 month study
|
2.4%
1/42 • 12 month study
|
|
Infections and infestations
Upper respiratory tract infection
|
2.2%
1/45 • 12 month study
|
0.00%
0/42 • 12 month study
|
|
Infections and infestations
Urinary tract infection
|
2.2%
1/45 • 12 month study
|
0.00%
0/42 • 12 month study
|
|
Investigations
Increased intraocular pressure
|
2.2%
1/45 • 12 month study
|
0.00%
0/42 • 12 month study
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/45 • 12 month study
|
2.4%
1/42 • 12 month study
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/45 • 12 month study
|
2.4%
1/42 • 12 month study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder papillary adenocarcinoma
|
2.2%
1/45 • 12 month study
|
0.00%
0/42 • 12 month study
|
|
Nervous system disorders
Tinnitus
|
2.2%
1/45 • 12 month study
|
0.00%
0/42 • 12 month study
|
|
Renal and urinary disorders
Impaired renal function
|
2.2%
1/45 • 12 month study
|
0.00%
0/42 • 12 month study
|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/45 • 12 month study
|
2.4%
1/42 • 12 month study
|
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