Trial Outcomes & Findings for Efficacy, Safety and Tolerability of Multiple Doses of Valsartan in Children With Hypertension With or Without CKD (NCT NCT01617681)
NCT ID: NCT01617681
Last Updated: 2017-09-27
Results Overview
Patient's blood pressure will be measured in the same position at every visit Systolic and diastolic blood pressures will be measured three times at 2-3 minute intervals. The arithmetic mean of these three blood pressure measurements will be used as the mean office blood pressure (MSBP and MDBP) at Baseline and Week 6 endpoint in Period 1 Double Blind Phase
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
127 participants
Primary outcome timeframe
Baseline, week 6
Results posted on
2017-09-27
Participant Flow
Overall, 156 patients were screened, of which 127 patients were enrolled in the double blind period 1 of the study. A total of 120 patients (94.5%) completed Period 1 and entered Open Label Period 2.
Parallel= Period 1 (Double Blind phase) Single= Period 2 (Open Label phase)
Participant milestones
| Measure |
CKD Patients Valsartan 0.25 mg/kg
CKD patients: Valsartan oral solution 0.25mg/kg once daily + matching placebo of valsartan oral solution 4 mg/kg once daily for 6 weeks (period 1)
|
CKD Patients Valsartan 4 mg/kg
CKD patients: Valsartan oral solution 4 mg/kg once daily + matching placebo of valsartan oral solution 0.25 mg/kg once daily for 6 weeks (period 1)
|
Non-CKD Patients Valsartan 0.25 mg/kg
Non-CKD patients: Valsartan oral solution 0.25mg/kg once daily + matching placebo of valsartan oral solution 4 mg/kg once daily for 6 weeks (period 1)
|
Non-CKD Patients Valsartan 4 mg/kg
Non-CKD patients: Valsartan oral solution 4 mg/kg once daily + matching placebo of valsartan oral solution 0.25 mg/kg once daily for 6 weeks (period 1)
|
Valsartan 1 mg/kg (Period 2)
Open-label (Period 2) valsartan will be optionally titrated from 1 mg/kg to 2 mg/kg. Valsartan will continue to be optionally up titrated in 1 mg/kg increments every 4 weeks until maximum dose of 4 mg/kg is achieved. Duration 20 weeks.
|
|---|---|---|---|---|---|
|
Period 1 Double Blind
STARTED
|
32
|
31
|
33
|
31
|
0
|
|
Period 1 Double Blind
Full Analysis Set (FAS)
|
31
|
31
|
33
|
31
|
0
|
|
Period 1 Double Blind
COMPLETED
|
29
|
30
|
32
|
29
|
0
|
|
Period 1 Double Blind
NOT COMPLETED
|
3
|
1
|
1
|
2
|
0
|
|
Period 2 Open Label
STARTED
|
0
|
0
|
0
|
0
|
120
|
|
Period 2 Open Label
COMPLETED
|
0
|
0
|
0
|
0
|
114
|
|
Period 2 Open Label
NOT COMPLETED
|
0
|
0
|
0
|
0
|
6
|
Reasons for withdrawal
| Measure |
CKD Patients Valsartan 0.25 mg/kg
CKD patients: Valsartan oral solution 0.25mg/kg once daily + matching placebo of valsartan oral solution 4 mg/kg once daily for 6 weeks (period 1)
|
CKD Patients Valsartan 4 mg/kg
CKD patients: Valsartan oral solution 4 mg/kg once daily + matching placebo of valsartan oral solution 0.25 mg/kg once daily for 6 weeks (period 1)
|
Non-CKD Patients Valsartan 0.25 mg/kg
Non-CKD patients: Valsartan oral solution 0.25mg/kg once daily + matching placebo of valsartan oral solution 4 mg/kg once daily for 6 weeks (period 1)
|
Non-CKD Patients Valsartan 4 mg/kg
Non-CKD patients: Valsartan oral solution 4 mg/kg once daily + matching placebo of valsartan oral solution 0.25 mg/kg once daily for 6 weeks (period 1)
|
Valsartan 1 mg/kg (Period 2)
Open-label (Period 2) valsartan will be optionally titrated from 1 mg/kg to 2 mg/kg. Valsartan will continue to be optionally up titrated in 1 mg/kg increments every 4 weeks until maximum dose of 4 mg/kg is achieved. Duration 20 weeks.
|
|---|---|---|---|---|---|
|
Period 1 Double Blind
Adverse Event
|
2
|
0
|
0
|
2
|
0
|
|
Period 1 Double Blind
Withdrawal by Subject
|
1
|
1
|
1
|
0
|
0
|
|
Period 2 Open Label
Adverse Event
|
0
|
0
|
0
|
0
|
3
|
|
Period 2 Open Label
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
3
|
Baseline Characteristics
Efficacy, Safety and Tolerability of Multiple Doses of Valsartan in Children With Hypertension With or Without CKD
Baseline characteristics by cohort
| Measure |
CKD Patients Valsartan 0.25 mg/kg
n=32 Participants
CKD patients: Valsartan oral solution 0.25mg/kg once daily + matching placebo of valsartan oral solution 4 mg/kg once daily for 6 weeks (period 1)
|
CKD Patients Valsartan 4 mg/kg
n=31 Participants
CKD patients: Valsartan oral solution 4 mg/kg once daily + matching placebo of valsartan oral solution 0.25 mg/kg once daily for 6 weeks (period 1)
|
Non-CKD Patients Valsartan 0.25 mg/kg
n=33 Participants
Non-CKD patients: Valsartan oral solution 0.25mg/kg once daily + matching placebo of valsartan oral solution 4 mg/kg once daily for 6 weeks (period 1)
|
Non-CKD Patients Valsartan 4 mg/kg
n=31 Participants
Non-CKD patients: Valsartan oral solution 4 mg/kg once daily + matching placebo of valsartan oral solution 0.25 mg/kg once daily for 6 weeks (period 1)
|
Total
n=127 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
2.99 years
STANDARD_DEVIATION 1.47 • n=5 Participants
|
2.72 years
STANDARD_DEVIATION 1.33 • n=7 Participants
|
3.7 years
STANDARD_DEVIATION 1.51 • n=5 Participants
|
3.62 years
STANDARD_DEVIATION 1.36 • n=4 Participants
|
3.26 years
STANDARD_DEVIATION 1.466 • n=21 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
47 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
80 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
57 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
70 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline, week 6Population: Full analysis set (FAS) included all randomized patient except for 1 patient that guardian did not sign informed consent
Patient's blood pressure will be measured in the same position at every visit Systolic and diastolic blood pressures will be measured three times at 2-3 minute intervals. The arithmetic mean of these three blood pressure measurements will be used as the mean office blood pressure (MSBP and MDBP) at Baseline and Week 6 endpoint in Period 1 Double Blind Phase
Outcome measures
| Measure |
CKD Patients Valsartan 0.25 mg/kg
n=31 Participants
CKD patients: Valsartan oral solution 0.25mg/kg once daily + matching placebo of valsartan oral solution 4 mg/kg once daily for 6 weeks (period 1)
|
CKD Patients Valsartan 4 mg/kg
n=31 Participants
CKD patients: Valsartan oral solution 4 mg/kg once daily + matching placebo of valsartan oral solution 0.25 mg/kg once daily for 6 weeks (period 1)
|
Non-CKD Patients Valsartan 0.25 mg/kg
n=33 Participants
Non-CKD patients: Valsartan oral solution 0.25mg/kg once daily + matching placebo of valsartan oral solution 4 mg/kg once daily for 6 weeks (period 1)
|
Non-CKD Patients Valsartan 4 mg/kg
n=31 Participants
Non-CKD patients: Valsartan oral solution 4 mg/kg once daily + matching placebo of valsartan oral solution 0.25 mg/kg once daily for 6 weeks (period 1)
|
|---|---|---|---|---|
|
Change From Baseline in Mean Systolic Blood Pressure (MSBP) at Week 6 Endpoint
|
-1.2 mmHg
Standard Error 2.05
|
-9.2 mmHg
Standard Error 2.05
|
-6.9 mmHg
Standard Error 1.44
|
-7.8 mmHg
Standard Error 1.48
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: Full analysis set (FAS) included all randomized patient except for 1 patient that guardian did not sign informed consent
Patient's blood pressure will be measured in the same position at every visit Systolic and diastolic blood pressures will be measured three times at 2-3 minute intervals. The arithmetic mean of these three blood pressure measurements will be used as the mean office blood pressure (MSBP and MDBP) Baseline and Week 6 endpoint in Period 1 Double Blind Phase
Outcome measures
| Measure |
CKD Patients Valsartan 0.25 mg/kg
n=31 Participants
CKD patients: Valsartan oral solution 0.25mg/kg once daily + matching placebo of valsartan oral solution 4 mg/kg once daily for 6 weeks (period 1)
|
CKD Patients Valsartan 4 mg/kg
n=31 Participants
CKD patients: Valsartan oral solution 4 mg/kg once daily + matching placebo of valsartan oral solution 0.25 mg/kg once daily for 6 weeks (period 1)
|
Non-CKD Patients Valsartan 0.25 mg/kg
n=33 Participants
Non-CKD patients: Valsartan oral solution 0.25mg/kg once daily + matching placebo of valsartan oral solution 4 mg/kg once daily for 6 weeks (period 1)
|
Non-CKD Patients Valsartan 4 mg/kg
n=31 Participants
Non-CKD patients: Valsartan oral solution 4 mg/kg once daily + matching placebo of valsartan oral solution 0.25 mg/kg once daily for 6 weeks (period 1)
|
|---|---|---|---|---|
|
Change From Baseline in Mean Diastolic Blood Pressure (MDBP) at Week 6
|
1.3 mmHg
Standard Error 1.79
|
-6.5 mmHg
Standard Error 1.79
|
-1.9 mmHg
Standard Error 1.26
|
-7.2 mmHg
Standard Error 1.30
|
SECONDARY outcome
Timeframe: Week 6Population: Full analysis set (FAS) included all randomized patient except for 1 patient that guardian did not sign informed consent
Patient's blood pressure will be measured in the same position at every visit Systolic and diastolic blood pressures will be measured three times at 2-3 minute intervals. The arithmetic mean of these three blood pressure measurements will be used as the mean office blood pressure (MSBP and MDBP) Week 6
Outcome measures
| Measure |
CKD Patients Valsartan 0.25 mg/kg
n=31 Participants
CKD patients: Valsartan oral solution 0.25mg/kg once daily + matching placebo of valsartan oral solution 4 mg/kg once daily for 6 weeks (period 1)
|
CKD Patients Valsartan 4 mg/kg
n=31 Participants
CKD patients: Valsartan oral solution 4 mg/kg once daily + matching placebo of valsartan oral solution 0.25 mg/kg once daily for 6 weeks (period 1)
|
Non-CKD Patients Valsartan 0.25 mg/kg
n=33 Participants
Non-CKD patients: Valsartan oral solution 0.25mg/kg once daily + matching placebo of valsartan oral solution 4 mg/kg once daily for 6 weeks (period 1)
|
Non-CKD Patients Valsartan 4 mg/kg
n=31 Participants
Non-CKD patients: Valsartan oral solution 4 mg/kg once daily + matching placebo of valsartan oral solution 0.25 mg/kg once daily for 6 weeks (period 1)
|
|---|---|---|---|---|
|
Patients Achieving <90th Percentile for Age, Gender and Height at Week 6 Endpoint in Both MSBP and MDBP
|
6 participants
|
9 participants
|
7 participants
|
8 participants
|
SECONDARY outcome
Timeframe: Week 6 weeksPopulation: Full analysis set (FAS) included all randomized patient except for 1 patient that guardian did not sign informed consent - CKD patients only The number of patients with an UACR at baseline and week 6 endpoint (included in the analysis).
UACR response is defined as percentage change from baseline in UACR≤ 25%. UACR \[mg/mmol\] = urine albumin \[mg/L\] / urine creatinine \[mmol/L\] UACR was collected for CKD patients only. The UACR value at a given visit for a patient was to be derived by the median of the three lab values collected for that visit Week 6.
Outcome measures
| Measure |
CKD Patients Valsartan 0.25 mg/kg
n=27 Participants
CKD patients: Valsartan oral solution 0.25mg/kg once daily + matching placebo of valsartan oral solution 4 mg/kg once daily for 6 weeks (period 1)
|
CKD Patients Valsartan 4 mg/kg
n=27 Participants
CKD patients: Valsartan oral solution 4 mg/kg once daily + matching placebo of valsartan oral solution 0.25 mg/kg once daily for 6 weeks (period 1)
|
Non-CKD Patients Valsartan 0.25 mg/kg
Non-CKD patients: Valsartan oral solution 0.25mg/kg once daily + matching placebo of valsartan oral solution 4 mg/kg once daily for 6 weeks (period 1)
|
Non-CKD Patients Valsartan 4 mg/kg
Non-CKD patients: Valsartan oral solution 4 mg/kg once daily + matching placebo of valsartan oral solution 0.25 mg/kg once daily for 6 weeks (period 1)
|
|---|---|---|---|---|
|
CKD Patients Achieving Urine Albumin Creatinine Ratio Percentage Reduction (UACR) >=25% at Week 6
|
12 participants
|
9 participants
|
—
|
—
|
Adverse Events
Valsartan 0.25 mg/kg
Serious events: 2 serious events
Other events: 19 other events
Deaths: 0 deaths
Valsartan 4.0 mg/kg
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
All Open Label Patients
Serious events: 6 serious events
Other events: 62 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Valsartan 0.25 mg/kg
n=64 participants at risk
All Patients CKD \& Non-CKD: Valsartan oral solution 0.25mg/kg once daily + matching placebo of valsartan oral solution 4 mg/kg once daily for 6 weeks (period 1)
|
Valsartan 4.0 mg/kg
n=62 participants at risk
All Patients CKD \& Non-CKD patients: Valsartan oral solution 4 mg/kg once daily + matching placebo of valsartan oral solution 0.25 mg/kg once daily for 6 weeks (period 1)
|
All Open Label Patients
n=120 participants at risk
Open-label (Period 2) valsartan will be optionally titrated from 1 mg/kg to 2 mg/kg. Valsartan will continue to be optionally up titrated in 1 mg/kg increments every 4 weeks until maximum dose of 4 mg/kg is achieved. Duration 20 weeks.
|
|---|---|---|---|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/64 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
|
1.6%
1/62 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
|
0.00%
0/120 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
|
|
General disorders
Oedema peripheral
|
0.00%
0/64 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
|
0.00%
0/62 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
|
0.83%
1/120 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
|
|
Infections and infestations
Bronchitis
|
1.6%
1/64 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
|
1.6%
1/62 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
|
0.00%
0/120 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/64 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
|
0.00%
0/62 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
|
1.7%
2/120 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
|
|
Infections and infestations
Mastoiditis
|
0.00%
0/64 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
|
0.00%
0/62 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
|
0.83%
1/120 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/64 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
|
0.00%
0/62 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
|
0.83%
1/120 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/64 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
|
0.00%
0/62 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
|
0.83%
1/120 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
|
|
Psychiatric disorders
Aggression
|
1.6%
1/64 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
|
0.00%
0/62 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
|
0.00%
0/120 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.00%
0/64 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
|
0.00%
0/62 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
|
0.83%
1/120 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
|
Other adverse events
| Measure |
Valsartan 0.25 mg/kg
n=64 participants at risk
All Patients CKD \& Non-CKD: Valsartan oral solution 0.25mg/kg once daily + matching placebo of valsartan oral solution 4 mg/kg once daily for 6 weeks (period 1)
|
Valsartan 4.0 mg/kg
n=62 participants at risk
All Patients CKD \& Non-CKD patients: Valsartan oral solution 4 mg/kg once daily + matching placebo of valsartan oral solution 0.25 mg/kg once daily for 6 weeks (period 1)
|
All Open Label Patients
n=120 participants at risk
Open-label (Period 2) valsartan will be optionally titrated from 1 mg/kg to 2 mg/kg. Valsartan will continue to be optionally up titrated in 1 mg/kg increments every 4 weeks until maximum dose of 4 mg/kg is achieved. Duration 20 weeks.
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
6.2%
4/64 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
|
3.2%
2/62 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
|
8.3%
10/120 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
|
|
Gastrointestinal disorders
Vomiting
|
4.7%
3/64 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
|
1.6%
1/62 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
|
7.5%
9/120 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
|
|
General disorders
Pyrexia
|
3.1%
2/64 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
|
4.8%
3/62 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
|
16.7%
20/120 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
|
|
Infections and infestations
Bronchitis
|
4.7%
3/64 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
|
0.00%
0/62 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
|
5.8%
7/120 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
|
|
Infections and infestations
Ear infection
|
0.00%
0/64 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
|
0.00%
0/62 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
|
5.8%
7/120 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
|
|
Infections and infestations
Nasopharyngitis
|
4.7%
3/64 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
|
3.2%
2/62 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
|
7.5%
9/120 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
|
|
Infections and infestations
Respiratory tract infection
|
6.2%
4/64 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
|
4.8%
3/62 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
|
5.0%
6/120 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/64 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
|
3.2%
2/62 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
|
6.7%
8/120 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.6%
1/64 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
|
0.00%
0/62 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
|
8.3%
10/120 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.8%
5/64 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
|
1.6%
1/62 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
|
9.2%
11/120 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single- site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER