Trial Outcomes & Findings for Study to Show a Superior Benefit in Terms of Reduction of Ranibizumab Injections in Patients Receiving Ranibizumab Plus Laser Photocoagulation Combination Therapy Without Loss of Efficacy and Safety (NCT NCT02953938)
NCT ID: NCT02953938
Last Updated: 2020-02-25
Results Overview
Number of ranibizumab treatments from Day 1 to Month 11 using full analysis set (observed) based on a stratified Cochran-Mantel-Haenszel (CMH) test. Stratification was done based on categories of baseline decimal VA (\<0.3, or =\>0.3). Difference of mean number of injections, 95% confidence interval (CI) of difference and one-sided p-value of the CMH test was reported. Analysis was conducted within the FAS with observed data. Stratification was based on baseline visual acuity on logMAR scale (\<0.52, \>=0.52). Test was one-sided.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
59 participants
Primary outcome timeframe
Month 1 through Month 12
Results posted on
2020-02-25
Participant Flow
73 patients were screened and 59 were randomized on a 1:1 ratio to the ranibizumab group (29 patients) and ranibizumab with laser group (30 patients). Of the randomized patients, 56 (94.9%) completed the study and 11 months of treatment. 3 (5.1%) discontinued both study and study treatment: 2 (3.4%) withdrew consent and 1 (1.7%) had adverse event
Below is the participant flow of Randomized patients
Participant milestones
| Measure |
Ranibizumab 0.5 mg
0.5 mg ranibizumab applied one + PRN as intravitreal injection of 0.05 mL
|
Ranibizumab 0.5 mg and Laser
0.5 mg ranibizumab applied one + PRN as intravitreal injection of 0.05 mL with the laser treatment
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
30
|
|
Overall Study
COMPLETED
|
28
|
28
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Ranibizumab 0.5 mg
0.5 mg ranibizumab applied one + PRN as intravitreal injection of 0.05 mL
|
Ranibizumab 0.5 mg and Laser
0.5 mg ranibizumab applied one + PRN as intravitreal injection of 0.05 mL with the laser treatment
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Study to Show a Superior Benefit in Terms of Reduction of Ranibizumab Injections in Patients Receiving Ranibizumab Plus Laser Photocoagulation Combination Therapy Without Loss of Efficacy and Safety
Baseline characteristics by cohort
| Measure |
Ranibizumab 0.5 mg
n=29 Participants
0.5 mg ranibizumab applied one + PRN as intravitreal injection of 0.05 mL
|
Ranibizumab 0.5 mg and Laser
n=30 Participants
0.5 mg ranibizumab applied one + PRN as intravitreal injection of 0.05 mL with the laser treatment
|
Total
n=59 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.8 years
STANDARD_DEVIATION 9.91 • n=99 Participants
|
66.7 years
STANDARD_DEVIATION 9.83 • n=107 Participants
|
66.8 years
STANDARD_DEVIATION 9.78 • n=206 Participants
|
|
Age, Customized
<65 years
|
12 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Age, Customized
>=65 years
|
17 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
29 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
59 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Month 1 through Month 12Population: Randomized Set, i.e.; all randomized patients.
Number of ranibizumab treatments from Day 1 to Month 11 using full analysis set (observed) based on a stratified Cochran-Mantel-Haenszel (CMH) test. Stratification was done based on categories of baseline decimal VA (\<0.3, or =\>0.3). Difference of mean number of injections, 95% confidence interval (CI) of difference and one-sided p-value of the CMH test was reported. Analysis was conducted within the FAS with observed data. Stratification was based on baseline visual acuity on logMAR scale (\<0.52, \>=0.52). Test was one-sided.
Outcome measures
| Measure |
Ranibizumab 0.5 mg
n=29 Participants
0.5 mg ranibizumab applied one + PRN as intravitreal injection of 0.05 mL
|
Ranibizumab 0.5 mg Laser
n=30 Participants
0.5 mg ranibizumab applied one + PRN as intravitreal injection of 0.05 mL with the laser treatment.
|
|---|---|---|
|
Difference in Mean Number of Ranibizumab Injections
|
4.3 number of injections
Standard Deviation 2.51
|
4.1 number of injections
Standard Deviation 2.41
|
SECONDARY outcome
Timeframe: Month 1 through Month 12 (for ETDRS: Month 6 and Month 12)Population: The Full Analysis Set (FAS) consisted of all randomized patients who received at least one administration of ranibizumab injection.
Summary of BCVA (letters) absolute value and change from Baseline at Month 12 in the study eye - full analysis set (LOCF) was based on an analysis of variance (ANOVA) model with treatment group, and stratification factors. Stratification was done based on categories of baseline decimal VA (\<0.3, or =\>0.3). The analyses was conducted within the FAS using the LOCF approach Stratification was based on baseline visual acuity on logMAR scale (\<0.52, \>=0.52). Test was one-sided.
Outcome measures
| Measure |
Ranibizumab 0.5 mg
n=29 Participants
0.5 mg ranibizumab applied one + PRN as intravitreal injection of 0.05 mL
|
Ranibizumab 0.5 mg Laser
n=30 Participants
0.5 mg ranibizumab applied one + PRN as intravitreal injection of 0.05 mL with the laser treatment.
|
|---|---|---|
|
The Mean Change in Best Corrected Visual Acuity (BCVA) Using Decimal Chart and Early Treatment Diabetic Retinopathy Study (ETDRS) Compared to Baseline
baseline
|
52.86 letters read correctly
Standard Deviation 13.384
|
54.03 letters read correctly
Standard Deviation 9.828
|
|
The Mean Change in Best Corrected Visual Acuity (BCVA) Using Decimal Chart and Early Treatment Diabetic Retinopathy Study (ETDRS) Compared to Baseline
month 12
|
74.83 letters read correctly
Standard Deviation 9.740
|
69.59 letters read correctly
Standard Deviation 8.842
|
|
The Mean Change in Best Corrected Visual Acuity (BCVA) Using Decimal Chart and Early Treatment Diabetic Retinopathy Study (ETDRS) Compared to Baseline
change from baseline to month 12
|
21.97 letters read correctly
Standard Deviation 14.749
|
15.00 letters read correctly
Standard Deviation 10.296
|
SECONDARY outcome
Timeframe: Month 1 through Month 12Population: FAS
Summary of BCVA (logMAR) absolute value and change from Baseline at Month 12 in the study eye - full analysis set (LOCF) was based on an analysis of variance (ANOVA) model with treatment group, and stratification factors. Stratification was based on baseline visual acuity (\< 0.52, \>= 0.52). The analyses was conducted within the FAS using the LOCF approach
Outcome measures
| Measure |
Ranibizumab 0.5 mg
n=29 Participants
0.5 mg ranibizumab applied one + PRN as intravitreal injection of 0.05 mL
|
Ranibizumab 0.5 mg Laser
n=30 Participants
0.5 mg ranibizumab applied one + PRN as intravitreal injection of 0.05 mL with the laser treatment.
|
|---|---|---|
|
The Mean Change in BCVA From Month 1 Through Month 12 Compared to Baseline (Day 1) by the Treatment Arms
baseline
|
0.553 logMAR
Standard Deviation 0.2276
|
0.558 logMAR
Standard Deviation 0.1719
|
|
The Mean Change in BCVA From Month 1 Through Month 12 Compared to Baseline (Day 1) by the Treatment Arms
month12
|
0.075 logMAR
Standard Deviation 0.1909
|
0.143 logMAR
Standard Deviation 0.1682
|
|
The Mean Change in BCVA From Month 1 Through Month 12 Compared to Baseline (Day 1) by the Treatment Arms
change from baseline to month 12
|
-0.478 logMAR
Standard Deviation 0.2586
|
-0.413 logMAR
Standard Deviation 0.1969
|
SECONDARY outcome
Timeframe: Month 6 and Month 12Population: Full Analysis Set (FAS) consisted of all randomized patients who received at least one administration of ranibizumab injection
Endpoints related to the number and proportion of patients with BCVA letter gain or loss from Baseline (Day1) was analyzed via stratified CMH test with stratification factors as described in primary model. The mean (SD) average (per patient) BCVA (logMAR) change from Baseline through Month 12 Summary of BCVA (logMAR) mean average change from Baseline from Month 1 through Month 12 in the study eye
Outcome measures
| Measure |
Ranibizumab 0.5 mg
n=29 Participants
0.5 mg ranibizumab applied one + PRN as intravitreal injection of 0.05 mL
|
Ranibizumab 0.5 mg Laser
n=30 Participants
0.5 mg ranibizumab applied one + PRN as intravitreal injection of 0.05 mL with the laser treatment.
|
|---|---|---|
|
BCVA (Letters) Number and Proportion of Patients With a BCVA Improvement vs. Baseline, Loss Less Than 15 Letters, or Attainment of Greater Than or Equal to 85 Letters at Month 6 and at Month 12 in the Study Eye
month 12 Score >=80
|
8 Participants
|
13 Participants
|
|
BCVA (Letters) Number and Proportion of Patients With a BCVA Improvement vs. Baseline, Loss Less Than 15 Letters, or Attainment of Greater Than or Equal to 85 Letters at Month 6 and at Month 12 in the Study Eye
Month 6 - BCVA improvement of >=1
|
27 Participants
|
24 Participants
|
|
BCVA (Letters) Number and Proportion of Patients With a BCVA Improvement vs. Baseline, Loss Less Than 15 Letters, or Attainment of Greater Than or Equal to 85 Letters at Month 6 and at Month 12 in the Study Eye
month 6 - BCVA improvement of >=5
|
26 Participants
|
21 Participants
|
|
BCVA (Letters) Number and Proportion of Patients With a BCVA Improvement vs. Baseline, Loss Less Than 15 Letters, or Attainment of Greater Than or Equal to 85 Letters at Month 6 and at Month 12 in the Study Eye
month 6 - BCVA improvement of >=10
|
22 Participants
|
16 Participants
|
|
BCVA (Letters) Number and Proportion of Patients With a BCVA Improvement vs. Baseline, Loss Less Than 15 Letters, or Attainment of Greater Than or Equal to 85 Letters at Month 6 and at Month 12 in the Study Eye
Month 6 - BCVA improvement of >=15
|
17 Participants
|
12 Participants
|
|
BCVA (Letters) Number and Proportion of Patients With a BCVA Improvement vs. Baseline, Loss Less Than 15 Letters, or Attainment of Greater Than or Equal to 85 Letters at Month 6 and at Month 12 in the Study Eye
Month 6 - BCVA improvement of >=30
|
4 Participants
|
1 Participants
|
|
BCVA (Letters) Number and Proportion of Patients With a BCVA Improvement vs. Baseline, Loss Less Than 15 Letters, or Attainment of Greater Than or Equal to 85 Letters at Month 6 and at Month 12 in the Study Eye
month 6 Score >=73
|
12 Participants
|
10 Participants
|
|
BCVA (Letters) Number and Proportion of Patients With a BCVA Improvement vs. Baseline, Loss Less Than 15 Letters, or Attainment of Greater Than or Equal to 85 Letters at Month 6 and at Month 12 in the Study Eye
month 6 Score >=80
|
8 Participants
|
2 Participants
|
|
BCVA (Letters) Number and Proportion of Patients With a BCVA Improvement vs. Baseline, Loss Less Than 15 Letters, or Attainment of Greater Than or Equal to 85 Letters at Month 6 and at Month 12 in the Study Eye
month 6 Score >=85
|
3 Participants
|
1 Participants
|
|
BCVA (Letters) Number and Proportion of Patients With a BCVA Improvement vs. Baseline, Loss Less Than 15 Letters, or Attainment of Greater Than or Equal to 85 Letters at Month 6 and at Month 12 in the Study Eye
month 6 loss of <15
|
28 Participants
|
29 Participants
|
|
BCVA (Letters) Number and Proportion of Patients With a BCVA Improvement vs. Baseline, Loss Less Than 15 Letters, or Attainment of Greater Than or Equal to 85 Letters at Month 6 and at Month 12 in the Study Eye
Month 12 - BCVA improvement of >=1
|
27 Participants
|
28 Participants
|
|
BCVA (Letters) Number and Proportion of Patients With a BCVA Improvement vs. Baseline, Loss Less Than 15 Letters, or Attainment of Greater Than or Equal to 85 Letters at Month 6 and at Month 12 in the Study Eye
Month 12 - BCVA improvement of >=5
|
27 Participants
|
25 Participants
|
|
BCVA (Letters) Number and Proportion of Patients With a BCVA Improvement vs. Baseline, Loss Less Than 15 Letters, or Attainment of Greater Than or Equal to 85 Letters at Month 6 and at Month 12 in the Study Eye
Month 12 - BCVA improvement of >=10
|
24 Participants
|
18 Participants
|
|
BCVA (Letters) Number and Proportion of Patients With a BCVA Improvement vs. Baseline, Loss Less Than 15 Letters, or Attainment of Greater Than or Equal to 85 Letters at Month 6 and at Month 12 in the Study Eye
Month 12 - BCVA improvement of >=15
|
21 Participants
|
15 Participants
|
|
BCVA (Letters) Number and Proportion of Patients With a BCVA Improvement vs. Baseline, Loss Less Than 15 Letters, or Attainment of Greater Than or Equal to 85 Letters at Month 6 and at Month 12 in the Study Eye
Month 12 - BCVA improvement of >=30
|
9 Participants
|
3 Participants
|
|
BCVA (Letters) Number and Proportion of Patients With a BCVA Improvement vs. Baseline, Loss Less Than 15 Letters, or Attainment of Greater Than or Equal to 85 Letters at Month 6 and at Month 12 in the Study Eye
month 12 Score >=73
|
20 Participants
|
10 Participants
|
|
BCVA (Letters) Number and Proportion of Patients With a BCVA Improvement vs. Baseline, Loss Less Than 15 Letters, or Attainment of Greater Than or Equal to 85 Letters at Month 6 and at Month 12 in the Study Eye
month 12 Score >=85
|
4 Participants
|
0 Participants
|
|
BCVA (Letters) Number and Proportion of Patients With a BCVA Improvement vs. Baseline, Loss Less Than 15 Letters, or Attainment of Greater Than or Equal to 85 Letters at Month 6 and at Month 12 in the Study Eye
month 12 Loss of <15
|
29 Participants
|
29 Participants
|
SECONDARY outcome
Timeframe: Month 1 through Month 12Population: Full Analysis Set (FAS)
The mean change in investigator-assessed CSFT from Month 1 through Month 12 was compared to Baseline (Day1) by the treatment arms. The analyses at each visit was based on an analysis of variance (ANOVA) model as analogous to BCVA. The analyses was conducted within the FAS using the Last-Observation-Carried-Forward (LOCF) approach
Outcome measures
| Measure |
Ranibizumab 0.5 mg
n=29 Participants
0.5 mg ranibizumab applied one + PRN as intravitreal injection of 0.05 mL
|
Ranibizumab 0.5 mg Laser
n=30 Participants
0.5 mg ranibizumab applied one + PRN as intravitreal injection of 0.05 mL with the laser treatment.
|
|---|---|---|
|
The Mean Change in Change in Central Subfield Foveal Thickness (CSFT) From Month 1 Through Month 12 Compared to Baseline (Day1) by the Treatment Arms
month 12
|
257.0 mm
Standard Deviation 43.44
|
285.1 mm
Standard Deviation 82.80
|
|
The Mean Change in Change in Central Subfield Foveal Thickness (CSFT) From Month 1 Through Month 12 Compared to Baseline (Day1) by the Treatment Arms
baseline
|
563.3 mm
Standard Deviation 146.92
|
553.3 mm
Standard Deviation 182.39
|
|
The Mean Change in Change in Central Subfield Foveal Thickness (CSFT) From Month 1 Through Month 12 Compared to Baseline (Day1) by the Treatment Arms
change in baseline from month 12
|
-306.3 mm
Standard Deviation 164.35
|
-261.3 mm
Standard Deviation 180.23
|
Adverse Events
Ranibizumab 0.5 mg
Serious events: 1 serious events
Other events: 16 other events
Deaths: 0 deaths
Ranibizumab 0.5 mg+ Laser
Serious events: 2 serious events
Other events: 15 other events
Deaths: 0 deaths
Total
Serious events: 3 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ranibizumab 0.5 mg
n=29 participants at risk
0.5 mg ranibizumab applied one + PRN as intravitreal injection of 0.05 mL
|
Ranibizumab 0.5 mg+ Laser
n=30 participants at risk
0.5 mg ranibizumab applied one + PRN as intravitreal injection of 0.05 mL with the laser treatment.
|
Total
n=59 participants at risk
Total
|
|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.00%
0/29 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
3.3%
1/30 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
1.7%
1/59 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
|
Nervous system disorders
Putamen haemorrhage
|
0.00%
0/29 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
3.3%
1/30 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
1.7%
1/59 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
|
Renal and urinary disorders
Haematuria
|
3.4%
1/29 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
0.00%
0/30 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
1.7%
1/59 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
Other adverse events
| Measure |
Ranibizumab 0.5 mg
n=29 participants at risk
0.5 mg ranibizumab applied one + PRN as intravitreal injection of 0.05 mL
|
Ranibizumab 0.5 mg+ Laser
n=30 participants at risk
0.5 mg ranibizumab applied one + PRN as intravitreal injection of 0.05 mL with the laser treatment.
|
Total
n=59 participants at risk
Total
|
|---|---|---|---|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/29 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
3.3%
1/30 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
1.7%
1/59 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/29 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
3.3%
1/30 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
1.7%
1/59 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
|
Eye disorders
Corneal erosion
|
0.00%
0/29 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
3.3%
1/30 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
1.7%
1/59 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
|
Eye disorders
Dry eye
|
3.4%
1/29 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
3.3%
1/30 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
3.4%
2/59 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
|
Eye disorders
Keratitis
|
3.4%
1/29 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
0.00%
0/30 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
1.7%
1/59 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
|
Eye disorders
Macular fibrosis
|
0.00%
0/29 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
3.3%
1/30 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
1.7%
1/59 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
|
Eye disorders
Photopsia
|
0.00%
0/29 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
3.3%
1/30 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
1.7%
1/59 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
|
Gastrointestinal disorders
Nausea
|
6.9%
2/29 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
3.3%
1/30 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
5.1%
3/59 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
|
General disorders
Feeling abnormal
|
0.00%
0/29 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
3.3%
1/30 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
1.7%
1/59 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
3.4%
1/29 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
0.00%
0/30 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
1.7%
1/59 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
|
Immune system disorders
Seasonal allergy
|
3.4%
1/29 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
3.3%
1/30 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
3.4%
2/59 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
|
Infections and infestations
Influenza
|
3.4%
1/29 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
3.3%
1/30 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
3.4%
2/59 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
|
Infections and infestations
Nasopharyngitis
|
20.7%
6/29 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
16.7%
5/30 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
18.6%
11/59 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
|
Infections and infestations
Periodontitis
|
3.4%
1/29 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
0.00%
0/30 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
1.7%
1/59 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
|
Infections and infestations
Urinary tract infection
|
3.4%
1/29 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
0.00%
0/30 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
1.7%
1/59 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
|
Injury, poisoning and procedural complications
Foot fracture
|
3.4%
1/29 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
0.00%
0/30 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
1.7%
1/59 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
3.4%
1/29 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
0.00%
0/30 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
1.7%
1/59 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
|
Investigations
Intraocular pressure increased
|
0.00%
0/29 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
10.0%
3/30 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
5.1%
3/59 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
3.4%
1/29 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
0.00%
0/30 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
1.7%
1/59 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/29 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
3.3%
1/30 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
1.7%
1/59 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/29 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
3.3%
1/30 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
1.7%
1/59 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
|
Nervous system disorders
Dizziness
|
3.4%
1/29 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
3.3%
1/30 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
3.4%
2/59 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/29 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
3.3%
1/30 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
1.7%
1/59 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
|
Nervous system disorders
Headache
|
10.3%
3/29 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
0.00%
0/30 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
5.1%
3/59 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
|
Nervous system disorders
Hemiplegia
|
0.00%
0/29 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
3.3%
1/30 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
1.7%
1/59 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
|
Nervous system disorders
Migraine
|
0.00%
0/29 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
3.3%
1/30 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
1.7%
1/59 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
|
Reproductive system and breast disorders
Atrophic vulvovaginitis
|
0.00%
0/29 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
3.3%
1/30 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
1.7%
1/59 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
3.4%
1/29 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
0.00%
0/30 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
1.7%
1/59 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/29 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
3.3%
1/30 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
1.7%
1/59 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
|
Vascular disorders
Hypertension
|
6.9%
2/29 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
3.3%
1/30 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
5.1%
3/59 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreement with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publications of the pooled data (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER