Trial Outcomes & Findings for Study of Ivacaftor in Cystic Fibrosis Subjects 2 Through 5 Years of Age With a CFTR Gating Mutation (NCT NCT01705145)
NCT ID: NCT01705145
Last Updated: 2016-04-05
Results Overview
AE: any adverse change from participant's baseline (pre-treatment) condition, including any adverse experience, abnormal recording/clinical laboratory assessment which occurs during course of study, whether it is considered related to study drug or not. SAE: medical event or condition, which falls into any of following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolonged hospitalization, persistent/significant disability/incapacity, congenital anomaly/birth defect, important medical event. Related AEs includes all AEs for which the causality was either related to study drug or possibly related to study drug. Data was reported as per the dose received and for overall participants.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
35 participants
Primary outcome timeframe
Part A: Up to 93 Days
Results posted on
2016-04-05
Participant Flow
Participant milestones
| Measure |
Ivacaftor
Part A: Ivacaftor 50 milligram (mg) (for participants weighing less than \[\<\] 14 kilograms \[kg\]) or 75 mg (for participants weighing greater than or equal to \[\>=\] 14 kg) every 12 hours (q12h) from Day 1 through Day 3 and 1 morning dose on Day 4 during Part A of the study.
Part B: Ivacaftor 50 mg (for participants weighing \<14 kg) or 75 mg (for participants weighing \>=14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants.
|
|---|---|
|
Part A
STARTED
|
9
|
|
Part A
COMPLETED
|
9
|
|
Part A
NOT COMPLETED
|
0
|
|
Part B
STARTED
|
34
|
|
Part B
COMPLETED
|
33
|
|
Part B
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Ivacaftor
Part A: Ivacaftor 50 milligram (mg) (for participants weighing less than \[\<\] 14 kilograms \[kg\]) or 75 mg (for participants weighing greater than or equal to \[\>=\] 14 kg) every 12 hours (q12h) from Day 1 through Day 3 and 1 morning dose on Day 4 during Part A of the study.
Part B: Ivacaftor 50 mg (for participants weighing \<14 kg) or 75 mg (for participants weighing \>=14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants.
|
|---|---|
|
Part B
Adverse Event
|
1
|
Baseline Characteristics
Study of Ivacaftor in Cystic Fibrosis Subjects 2 Through 5 Years of Age With a CFTR Gating Mutation
Baseline characteristics by cohort
| Measure |
Ivacaftor
n=35 Participants
Part A: Ivacaftor 50 mg (for participants weighing \<14 kg) or 75 mg (for participants weighing \>=14 kg) q12h from Day 1 through Day 3 and 1 morning dose on Day 4 during Part A of the study.
Part B: Ivacaftor 50 mg (for participants weighing \<14 kg) or 75 mg (for participants weighing \>=14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants.
|
|---|---|
|
Age, Continuous
Part A (n = 9)
|
3.1 years
STANDARD_DEVIATION 1.17 • n=5 Participants
|
|
Age, Continuous
Part B (n = 34)
|
3.2 years
STANDARD_DEVIATION 0.96 • n=5 Participants
|
|
Sex/Gender, Customized
Part A (n = 9): Female
|
3 participants
n=5 Participants
|
|
Sex/Gender, Customized
Part A (n = 9): Male
|
6 participants
n=5 Participants
|
|
Sex/Gender, Customized
Part B (n = 34): Female
|
6 participants
n=5 Participants
|
|
Sex/Gender, Customized
Part B (n = 34): Male
|
28 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Part A: Up to 93 DaysPopulation: Part A Safety set included all participants who received at least 1 dose of study drug in part A.
AE: any adverse change from participant's baseline (pre-treatment) condition, including any adverse experience, abnormal recording/clinical laboratory assessment which occurs during course of study, whether it is considered related to study drug or not. SAE: medical event or condition, which falls into any of following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolonged hospitalization, persistent/significant disability/incapacity, congenital anomaly/birth defect, important medical event. Related AEs includes all AEs for which the causality was either related to study drug or possibly related to study drug. Data was reported as per the dose received and for overall participants.
Outcome measures
| Measure |
Part A: Ivacaftor 50 mg
n=4 Participants
Ivacaftor 50 mg (for participants weighing \<14 kg) q12h from Day 1 through Day 3 and 1 morning dose on Day 4 during Part A of the study.
|
Part A: Ivacaftor 75 mg
n=5 Participants
Ivacaftor 75 mg (for participants weighing \>=14 kg) q12h from Day 1 through Day 3 and 1 morning dose on Day 4 during Part A of the study.
|
Part A: Overall Ivacaftor
n=9 Participants
Ivacaftor 50 mg (for participants weighing \<14 kg) or 75 mg (for participants weighing \>=14 kg) q12h from Day 1 through Day 3 and 1 morning dose on Day 4 during Part A of the study.
|
|---|---|---|---|
|
Part A: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Related AEs
AEs
|
3 participants
|
5 participants
|
8 participants
|
|
Part A: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Related AEs
SAEs
|
0 participants
|
0 participants
|
0 participants
|
|
Part A: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Related AEs
Related AEs
|
1 participants
|
3 participants
|
4 participants
|
PRIMARY outcome
Timeframe: Part B: Up to 28 WeeksPopulation: Part B Safety set included all participants who received at least 1 dose of study drug in part B.
AE: any adverse change from participant's baseline (pre-treatment) condition, including any adverse experience, abnormal recording/clinical laboratory assessment which occurs during course of study, whether it is considered related to study drug or not. AE includes both serious and non-serious AE. SAE: medical event or condition, which falls into any of following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolonged hospitalization, persistent/significant disability/incapacity, congenital anomaly/birth defect, important medical event. Related AEs includes all AEs for which the causality was either related to study drug or possibly related to study drug. Data was reported as per the dose received.
Outcome measures
| Measure |
Part A: Ivacaftor 50 mg
n=10 Participants
Ivacaftor 50 mg (for participants weighing \<14 kg) q12h from Day 1 through Day 3 and 1 morning dose on Day 4 during Part A of the study.
|
Part A: Ivacaftor 75 mg
n=24 Participants
Ivacaftor 75 mg (for participants weighing \>=14 kg) q12h from Day 1 through Day 3 and 1 morning dose on Day 4 during Part A of the study.
|
Part A: Overall Ivacaftor
n=34 Participants
Ivacaftor 50 mg (for participants weighing \<14 kg) or 75 mg (for participants weighing \>=14 kg) q12h from Day 1 through Day 3 and 1 morning dose on Day 4 during Part A of the study.
|
|---|---|---|---|
|
Part B: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Related AEs
AEs
|
10 participants
|
23 participants
|
33 participants
|
|
Part B: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Related AEs
SAEs
|
3 participants
|
3 participants
|
6 participants
|
|
Part B: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Related AEs
Related AEs
|
3 participants
|
8 participants
|
11 participants
|
PRIMARY outcome
Timeframe: Part A: up to 24 hours post-dose on Day 4Population: Part A Safety set included all participants who received at least 1 dose of study drug in part A.
Plasma concentration was reported for ivacaftor and its metabolites (hydroxymethyl ivacaftor \[M1\] and ivacaftor carboxylate \[M6\]) up to 24 hours post-dose on Day 4 (Hour 0 \[pre-dose\] on Day 1 and Day 4; 2, 3, 6, 24 hours post-dose on Day 4). Data was planned to be reported for overall participants in the period.
Outcome measures
| Measure |
Part A: Ivacaftor 50 mg
n=9 Participants
Ivacaftor 50 mg (for participants weighing \<14 kg) q12h from Day 1 through Day 3 and 1 morning dose on Day 4 during Part A of the study.
|
Part A: Ivacaftor 75 mg
Ivacaftor 75 mg (for participants weighing \>=14 kg) q12h from Day 1 through Day 3 and 1 morning dose on Day 4 during Part A of the study.
|
Part A: Overall Ivacaftor
Ivacaftor 50 mg (for participants weighing \<14 kg) or 75 mg (for participants weighing \>=14 kg) q12h from Day 1 through Day 3 and 1 morning dose on Day 4 during Part A of the study.
|
|---|---|---|---|
|
Part A: Plasma Concentration of Ivacaftor and Its Metabolites
Ivacaftor: Hour 0 on Day 1
|
0.00 nanogram per milliliter (ng/mL)
Standard Deviation 0.00
|
—
|
—
|
|
Part A: Plasma Concentration of Ivacaftor and Its Metabolites
Ivacaftor: Hour 0 on Day 4
|
396 nanogram per milliliter (ng/mL)
Standard Deviation 337
|
—
|
—
|
|
Part A: Plasma Concentration of Ivacaftor and Its Metabolites
Ivacaftor: 2 Hours Post-Dose on Day 4
|
726 nanogram per milliliter (ng/mL)
Standard Deviation 284
|
—
|
—
|
|
Part A: Plasma Concentration of Ivacaftor and Its Metabolites
Ivacaftor: 3 Hours Post-Dose on Day 4
|
957 nanogram per milliliter (ng/mL)
Standard Deviation 283
|
—
|
—
|
|
Part A: Plasma Concentration of Ivacaftor and Its Metabolites
Ivacaftor: 6 Hours Post-Dose on Day 4
|
542 nanogram per milliliter (ng/mL)
Standard Deviation 241
|
—
|
—
|
|
Part A: Plasma Concentration of Ivacaftor and Its Metabolites
Ivacaftor: 24 Hours Post-Dose on Day 4
|
124 nanogram per milliliter (ng/mL)
Standard Deviation 149
|
—
|
—
|
|
Part A: Plasma Concentration of Ivacaftor and Its Metabolites
M1: Hour 0 on Day 1
|
0.00 nanogram per milliliter (ng/mL)
Standard Deviation 0.00
|
—
|
—
|
|
Part A: Plasma Concentration of Ivacaftor and Its Metabolites
M1: Hour 0 on Day 4
|
1240 nanogram per milliliter (ng/mL)
Standard Deviation 723
|
—
|
—
|
|
Part A: Plasma Concentration of Ivacaftor and Its Metabolites
M1: 2 Hours Post-Dose on Day 4
|
1540 nanogram per milliliter (ng/mL)
Standard Deviation 578
|
—
|
—
|
|
Part A: Plasma Concentration of Ivacaftor and Its Metabolites
M1: 3 Hours Post-Dose on Day 4
|
2310 nanogram per milliliter (ng/mL)
Standard Deviation 820
|
—
|
—
|
|
Part A: Plasma Concentration of Ivacaftor and Its Metabolites
M1: 6 Hours Post-Dose on Day 4
|
1580 nanogram per milliliter (ng/mL)
Standard Deviation 622
|
—
|
—
|
|
Part A: Plasma Concentration of Ivacaftor and Its Metabolites
M1: 24 Hours Post-Dose on Day 4
|
389 nanogram per milliliter (ng/mL)
Standard Deviation 336
|
—
|
—
|
|
Part A: Plasma Concentration of Ivacaftor and Its Metabolites
M6: Hour 0 on Day 1
|
0.00 nanogram per milliliter (ng/mL)
Standard Deviation 0.00
|
—
|
—
|
|
Part A: Plasma Concentration of Ivacaftor and Its Metabolites
M6: Hour 0 on Day 4
|
1150 nanogram per milliliter (ng/mL)
Standard Deviation 709
|
—
|
—
|
|
Part A: Plasma Concentration of Ivacaftor and Its Metabolites
M6: 2 Hours Post-Dose on Day 4
|
1050 nanogram per milliliter (ng/mL)
Standard Deviation 606
|
—
|
—
|
|
Part A: Plasma Concentration of Ivacaftor and Its Metabolites
M6: 3 Hours Post-Dose on Day 4
|
1300 nanogram per milliliter (ng/mL)
Standard Deviation 614
|
—
|
—
|
|
Part A: Plasma Concentration of Ivacaftor and Its Metabolites
M6: 6 Hours Post-Dose on Day 4
|
1390 nanogram per milliliter (ng/mL)
Standard Deviation 532
|
—
|
—
|
|
Part A: Plasma Concentration of Ivacaftor and Its Metabolites
M6: 24 Hours Post-Dose on Day 4
|
439 nanogram per milliliter (ng/mL)
Standard Deviation 355
|
—
|
—
|
SECONDARY outcome
Timeframe: Part B: up to 24 hours post-dose on Day 168Population: Part B Safety set included all participants who received at least 1 dose of study drug in part B.
Plasma concentration was reported for ivacaftor and its metabolites (M1 and M6) up to 24 hours post-dose on Day 168 (Hour 0 \[predose\] on Day 1, 14, 56, 112, and 168; 2, 3, 6 hours post-dose on Day 14; 1 hour post-dose on Day 56; 4, 6 hours post-dose on Day 112; 24 hours post-dose on Day 168). Data was planned to be reported for overall participants in the period.
Outcome measures
| Measure |
Part A: Ivacaftor 50 mg
n=34 Participants
Ivacaftor 50 mg (for participants weighing \<14 kg) q12h from Day 1 through Day 3 and 1 morning dose on Day 4 during Part A of the study.
|
Part A: Ivacaftor 75 mg
Ivacaftor 75 mg (for participants weighing \>=14 kg) q12h from Day 1 through Day 3 and 1 morning dose on Day 4 during Part A of the study.
|
Part A: Overall Ivacaftor
Ivacaftor 50 mg (for participants weighing \<14 kg) or 75 mg (for participants weighing \>=14 kg) q12h from Day 1 through Day 3 and 1 morning dose on Day 4 during Part A of the study.
|
|---|---|---|---|
|
Part B: Plasma Concentration of Ivacaftor and Its Metabolites
Ivacaftor: Hour 0 on Day 1
|
0.00 ng/mL
Standard Deviation 0.00
|
—
|
—
|
|
Part B: Plasma Concentration of Ivacaftor and Its Metabolites
Ivacaftor: Hour 0 on Day 14
|
614 ng/mL
Standard Deviation 590
|
—
|
—
|
|
Part B: Plasma Concentration of Ivacaftor and Its Metabolites
Ivacaftor: 2 Hours Post-Dose on Day 14
|
932 ng/mL
Standard Deviation 541
|
—
|
—
|
|
Part B: Plasma Concentration of Ivacaftor and Its Metabolites
Ivacaftor: 3 Hours Post-Dose on Day 14
|
1080 ng/mL
Standard Deviation 587
|
—
|
—
|
|
Part B: Plasma Concentration of Ivacaftor and Its Metabolites
Ivacaftor: 6 Hours Post-Dose on Day 14
|
1140 ng/mL
Standard Deviation 627
|
—
|
—
|
|
Part B: Plasma Concentration of Ivacaftor and Its Metabolites
Ivacaftor: Hour 0 on Day 56
|
448 ng/mL
Standard Deviation 455
|
—
|
—
|
|
Part B: Plasma Concentration of Ivacaftor and Its Metabolites
Ivacaftor: 1 Hour Post-Dose on Day 56
|
514 ng/mL
Standard Deviation 421
|
—
|
—
|
|
Part B: Plasma Concentration of Ivacaftor and Its Metabolites
Ivacaftor: Hour 0 on Day 112
|
596 ng/mL
Standard Deviation 747
|
—
|
—
|
|
Part B: Plasma Concentration of Ivacaftor and Its Metabolites
Ivacaftor: 4 Hours Post-Dose on Day 112
|
1080 ng/mL
Standard Deviation 835
|
—
|
—
|
|
Part B: Plasma Concentration of Ivacaftor and Its Metabolites
Ivacaftor: 6 Hours Post-Dose on Day 112
|
1010 ng/mL
Standard Deviation 885
|
—
|
—
|
|
Part B: Plasma Concentration of Ivacaftor and Its Metabolites
Ivacaftor: Hour 0 on Day 168
|
500 ng/mL
Standard Deviation 545
|
—
|
—
|
|
Part B: Plasma Concentration of Ivacaftor and Its Metabolites
Ivacaftor: 24 Hours Post-Dose on Day 168
|
207 ng/mL
Standard Deviation 372
|
—
|
—
|
|
Part B: Plasma Concentration of Ivacaftor and Its Metabolites
M1: Hour 0 on Day 1
|
0.00 ng/mL
Standard Deviation 0.00
|
—
|
—
|
|
Part B: Plasma Concentration of Ivacaftor and Its Metabolites
M1: Hour 0 on Day 14
|
1580 ng/mL
Standard Deviation 1030
|
—
|
—
|
|
Part B: Plasma Concentration of Ivacaftor and Its Metabolites
M1: 2 Hours Post-Dose on Day 14
|
1870 ng/mL
Standard Deviation 924
|
—
|
—
|
|
Part B: Plasma Concentration of Ivacaftor and Its Metabolites
M1: 3 Hours Post-Dose on Day 14
|
2280 ng/mL
Standard Deviation 1140
|
—
|
—
|
|
Part B: Plasma Concentration of Ivacaftor and Its Metabolites
M1: 6 Hours Post-Dose on Day 14
|
2670 ng/mL
Standard Deviation 1080
|
—
|
—
|
|
Part B: Plasma Concentration of Ivacaftor and Its Metabolites
M1: Hour 0 on Day 56
|
1340 ng/mL
Standard Deviation 880
|
—
|
—
|
|
Part B: Plasma Concentration of Ivacaftor and Its Metabolites
M1: 1 Hour Post-Dose on Day 56
|
1170 ng/mL
Standard Deviation 698
|
—
|
—
|
|
Part B: Plasma Concentration of Ivacaftor and Its Metabolites
M1: Hour 0 on Day 112
|
1680 ng/mL
Standard Deviation 1360
|
—
|
—
|
|
Part B: Plasma Concentration of Ivacaftor and Its Metabolites
M1: 4 Hours Post-Dose on Day 112
|
2450 ng/mL
Standard Deviation 1510
|
—
|
—
|
|
Part B: Plasma Concentration of Ivacaftor and Its Metabolites
M1: 6 Hours Post-Dose on Day 112
|
2500 ng/mL
Standard Deviation 1520
|
—
|
—
|
|
Part B: Plasma Concentration of Ivacaftor and Its Metabolites
M1: Hour 0 on Day 168
|
1460 ng/mL
Standard Deviation 1200
|
—
|
—
|
|
Part B: Plasma Concentration of Ivacaftor and Its Metabolites
M1: 24 Hours Post-Dose on Day 168
|
602 ng/mL
Standard Deviation 647
|
—
|
—
|
|
Part B: Plasma Concentration of Ivacaftor and Its Metabolites
M6: Hour 0 on Day 1
|
0.00 ng/mL
Standard Deviation 0.00
|
—
|
—
|
|
Part B: Plasma Concentration of Ivacaftor and Its Metabolites
M6: Hour 0 on Day 14
|
1520 ng/mL
Standard Deviation 1130
|
—
|
—
|
|
Part B: Plasma Concentration of Ivacaftor and Its Metabolites
M6: 2 Hours Post-Dose on Day 14
|
1430 ng/mL
Standard Deviation 989
|
—
|
—
|
|
Part B: Plasma Concentration of Ivacaftor and Its Metabolites
M6: 3 Hours Post-Dose on Day 14
|
1630 ng/mL
Standard Deviation 1130
|
—
|
—
|
|
Part B: Plasma Concentration of Ivacaftor and Its Metabolites
M6: 6 Hours Post-Dose on Day 14
|
2090 ng/mL
Standard Deviation 1350
|
—
|
—
|
|
Part B: Plasma Concentration of Ivacaftor and Its Metabolites
M6: Hour 0 on Day 56
|
1510 ng/mL
Standard Deviation 1080
|
—
|
—
|
|
Part B: Plasma Concentration of Ivacaftor and Its Metabolites
M6: 1 Hour Post-Dose on Day 56
|
1310 ng/mL
Standard Deviation 974
|
—
|
—
|
|
Part B: Plasma Concentration of Ivacaftor and Its Metabolites
M6: Hour 0 on Day 112
|
1660 ng/mL
Standard Deviation 1130
|
—
|
—
|
|
Part B: Plasma Concentration of Ivacaftor and Its Metabolites
M6: 4 Hours Post-Dose on Day 112
|
1810 ng/mL
Standard Deviation 1230
|
—
|
—
|
|
Part B: Plasma Concentration of Ivacaftor and Its Metabolites
M6: 6 Hours Post-Dose on Day 112
|
2130 ng/mL
Standard Deviation 1380
|
—
|
—
|
|
Part B: Plasma Concentration of Ivacaftor and Its Metabolites
M6: Hour 0 on Day 168
|
1520 ng/mL
Standard Deviation 1130
|
—
|
—
|
|
Part B: Plasma Concentration of Ivacaftor and Its Metabolites
M6: 24 Hours Post-Dose on Day 168
|
632 ng/mL
Standard Deviation 465
|
—
|
—
|
SECONDARY outcome
Timeframe: Part B: Baseline, Week 24Population: Part B Safety set included all participants who received at least 1 dose of study drug in part B. Number of participants analyzed is for participants who were evaluable for this outcome measure.
Sweat samples were collected using an approved Macroduct (Wescor, Logan, Utah) collection device. A volume of greater than or equal to (\>=) 15 microliter was required for determination of sweat chloride. Data was reported as per the dose received and for overall participants.
Outcome measures
| Measure |
Part A: Ivacaftor 50 mg
n=7 Participants
Ivacaftor 50 mg (for participants weighing \<14 kg) q12h from Day 1 through Day 3 and 1 morning dose on Day 4 during Part A of the study.
|
Part A: Ivacaftor 75 mg
n=18 Participants
Ivacaftor 75 mg (for participants weighing \>=14 kg) q12h from Day 1 through Day 3 and 1 morning dose on Day 4 during Part A of the study.
|
Part A: Overall Ivacaftor
n=25 Participants
Ivacaftor 50 mg (for participants weighing \<14 kg) or 75 mg (for participants weighing \>=14 kg) q12h from Day 1 through Day 3 and 1 morning dose on Day 4 during Part A of the study.
|
|---|---|---|---|
|
Part B: Absolute Change From Baseline in Sweat Chloride at Week 24
|
-47.07 millimole per liter (mmol/L)
Standard Deviation 24.256
|
-46.78 millimole per liter (mmol/L)
Standard Deviation 27.584
|
-46.86 millimole per liter (mmol/L)
Standard Deviation 26.193
|
SECONDARY outcome
Timeframe: Part B: Baseline, Week 24Population: Part B Safety set included all participants who received at least 1 dose of study drug in part B. Number of participants analyzed is for participants who were evaluable for this outcome measure.
Data was reported as per the dose received and for overall participants.
Outcome measures
| Measure |
Part A: Ivacaftor 50 mg
n=9 Participants
Ivacaftor 50 mg (for participants weighing \<14 kg) q12h from Day 1 through Day 3 and 1 morning dose on Day 4 during Part A of the study.
|
Part A: Ivacaftor 75 mg
n=24 Participants
Ivacaftor 75 mg (for participants weighing \>=14 kg) q12h from Day 1 through Day 3 and 1 morning dose on Day 4 during Part A of the study.
|
Part A: Overall Ivacaftor
n=33 Participants
Ivacaftor 50 mg (for participants weighing \<14 kg) or 75 mg (for participants weighing \>=14 kg) q12h from Day 1 through Day 3 and 1 morning dose on Day 4 during Part A of the study.
|
|---|---|---|---|
|
Part B: Absolute Change From Baseline in Weight at Week 24
|
1.00 kilograms (kg)
Standard Deviation 0.418
|
1.50 kilograms (kg)
Standard Deviation 0.552
|
1.36 kilograms (kg)
Standard Deviation 0.561
|
SECONDARY outcome
Timeframe: Part B: Baseline, Week 24Population: Part B Safety set included all participants who received at least 1 dose of study drug in part B. Number of participants analyzed is for participants who were evaluable for this outcome measure.
Stature was measured as height if children could stand unassisted and follow directions; otherwise, stature was measured as length. Data was reported as per the dose received and for overall participants.
Outcome measures
| Measure |
Part A: Ivacaftor 50 mg
n=9 Participants
Ivacaftor 50 mg (for participants weighing \<14 kg) q12h from Day 1 through Day 3 and 1 morning dose on Day 4 during Part A of the study.
|
Part A: Ivacaftor 75 mg
n=23 Participants
Ivacaftor 75 mg (for participants weighing \>=14 kg) q12h from Day 1 through Day 3 and 1 morning dose on Day 4 during Part A of the study.
|
Part A: Overall Ivacaftor
n=32 Participants
Ivacaftor 50 mg (for participants weighing \<14 kg) or 75 mg (for participants weighing \>=14 kg) q12h from Day 1 through Day 3 and 1 morning dose on Day 4 during Part A of the study.
|
|---|---|---|---|
|
Part B: Absolute Change From Baseline in Stature at Week 24
|
2.5 centimeters (cm)
Standard Deviation 1.45
|
3.5 centimeters (cm)
Standard Deviation 0.93
|
3.3 centimeters (cm)
Standard Deviation 1.17
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Part B Safety set included all participants who received at least 1 dose of study drug in part B. Number of participants analyzed is for participants who were evaluable for this outcome measure.
BMI = (Weight \[in kg\]) divided by (Stature \[in meters\])\^2. Data was reported as per the dose received and for overall participants.
Outcome measures
| Measure |
Part A: Ivacaftor 50 mg
n=9 Participants
Ivacaftor 50 mg (for participants weighing \<14 kg) q12h from Day 1 through Day 3 and 1 morning dose on Day 4 during Part A of the study.
|
Part A: Ivacaftor 75 mg
n=23 Participants
Ivacaftor 75 mg (for participants weighing \>=14 kg) q12h from Day 1 through Day 3 and 1 morning dose on Day 4 during Part A of the study.
|
Part A: Overall Ivacaftor
n=32 Participants
Ivacaftor 50 mg (for participants weighing \<14 kg) or 75 mg (for participants weighing \>=14 kg) q12h from Day 1 through Day 3 and 1 morning dose on Day 4 during Part A of the study.
|
|---|---|---|---|
|
Part B: Absolute Change From Baseline in Body Mass Index (BMI) at Week 24
|
0.332 kilogram per square meter (kg/m^2)
Standard Deviation 0.5393
|
0.314 kilogram per square meter (kg/m^2)
Standard Deviation 0.5492
|
0.319 kilogram per square meter (kg/m^2)
Standard Deviation 0.5378
|
Adverse Events
Part A: Ivacaftor 50 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part A: Ivacaftor 75 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part A: Overall Ivacaftor
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Part B: Ivacaftor 50 mg
Serious events: 3 serious events
Other events: 9 other events
Deaths: 0 deaths
Part B: Ivacaftor 75 mg
Serious events: 3 serious events
Other events: 23 other events
Deaths: 0 deaths
Part B: Overall Ivacaftor
Serious events: 6 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part A: Ivacaftor 50 mg
n=4 participants at risk
Ivacaftor 50 mg (for participants weighing \<14 kg) q12h from Day 1 through Day 3 and 1 morning dose on Day 4 during Part A of the study.
|
Part A: Ivacaftor 75 mg
n=5 participants at risk
Ivacaftor 75 mg (for participants weighing \>=14 kg) q12h from Day 1 through Day 3 and 1 morning dose on Day 4 during Part A of the study.
|
Part A: Overall Ivacaftor
n=9 participants at risk
Ivacaftor 50 mg (for participants weighing \<14 kg) or 75 mg (for participants weighing \>=14 kg) q12h from Day 1 through Day 3 and 1 morning dose on Day 4 during Part A of the study.
|
Part B: Ivacaftor 50 mg
n=10 participants at risk
Ivacaftor 50 mg (for participants weighing \<14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants.
|
Part B: Ivacaftor 75 mg
n=24 participants at risk
Ivacaftor 75 mg (for participants weighing \>=14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants.
|
Part B: Overall Ivacaftor
n=34 participants at risk
Ivacaftor 50 mg (for participants weighing \<14 kg) or 75 mg (for participants weighing \>=14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Infective pulmonary exacerbation of cystic fibrosis
|
0.00%
0/4 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/5 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/9 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
10.0%
1/10 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
4.2%
1/24 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
5.9%
2/34 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
|
Infections and infestations
Device related sepsis
|
0.00%
0/4 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/5 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/9 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
10.0%
1/10 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/24 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
2.9%
1/34 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
|
Investigations
Pseudomonas test positive
|
0.00%
0/4 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/5 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/9 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
10.0%
1/10 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/24 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
2.9%
1/34 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
|
Investigations
Transaminases increased
|
0.00%
0/4 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/5 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/9 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
10.0%
1/10 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/24 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
2.9%
1/34 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/5 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/9 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/10 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
4.2%
1/24 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
2.9%
1/34 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/4 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/5 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/9 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/10 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
4.2%
1/24 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
2.9%
1/34 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
Other adverse events
| Measure |
Part A: Ivacaftor 50 mg
n=4 participants at risk
Ivacaftor 50 mg (for participants weighing \<14 kg) q12h from Day 1 through Day 3 and 1 morning dose on Day 4 during Part A of the study.
|
Part A: Ivacaftor 75 mg
n=5 participants at risk
Ivacaftor 75 mg (for participants weighing \>=14 kg) q12h from Day 1 through Day 3 and 1 morning dose on Day 4 during Part A of the study.
|
Part A: Overall Ivacaftor
n=9 participants at risk
Ivacaftor 50 mg (for participants weighing \<14 kg) or 75 mg (for participants weighing \>=14 kg) q12h from Day 1 through Day 3 and 1 morning dose on Day 4 during Part A of the study.
|
Part B: Ivacaftor 50 mg
n=10 participants at risk
Ivacaftor 50 mg (for participants weighing \<14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants.
|
Part B: Ivacaftor 75 mg
n=24 participants at risk
Ivacaftor 75 mg (for participants weighing \>=14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants.
|
Part B: Overall Ivacaftor
n=34 participants at risk
Ivacaftor 50 mg (for participants weighing \<14 kg) or 75 mg (for participants weighing \>=14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants.
|
|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/4 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
20.0%
1/5 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
11.1%
1/9 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
40.0%
4/10 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
62.5%
15/24 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
55.9%
19/34 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/4 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/5 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/9 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
40.0%
4/10 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
20.8%
5/24 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
26.5%
9/34 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/4 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
40.0%
2/5 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
22.2%
2/9 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
20.0%
2/10 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
20.8%
5/24 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
20.6%
7/34 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/4 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/5 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/9 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/10 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
12.5%
3/24 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
8.8%
3/34 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
|
Respiratory, thoracic and mediastinal disorders
Dysponea exertional
|
0.00%
0/4 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/5 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/9 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
10.0%
1/10 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/24 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
2.9%
1/34 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/4 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/5 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/9 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/10 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
4.2%
1/24 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
2.9%
1/34 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal inflamation
|
0.00%
0/4 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/5 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/9 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/10 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
4.2%
1/24 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
2.9%
1/34 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/4 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/5 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/9 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/10 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
4.2%
1/24 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
2.9%
1/34 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
|
Respiratory, thoracic and mediastinal disorders
Snoring
|
0.00%
0/4 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/5 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/9 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/10 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
4.2%
1/24 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
2.9%
1/34 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar hypertrophy
|
0.00%
0/4 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/5 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/9 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
10.0%
1/10 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/24 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
2.9%
1/34 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory track congestion
|
0.00%
0/4 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
20.0%
1/5 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
11.1%
1/9 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/10 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
4.2%
1/24 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
2.9%
1/34 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/4 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/5 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/9 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
10.0%
1/10 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
29.2%
7/24 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
23.5%
8/34 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
|
Infections and infestations
Croup infectious
|
0.00%
0/4 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/5 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/9 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
20.0%
2/10 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
4.2%
1/24 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
8.8%
3/34 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
|
Infections and infestations
Infective pulmonary exacerbation of cystic fibrosis
|
0.00%
0/4 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/5 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/9 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/10 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
12.5%
3/24 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
8.8%
3/34 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
|
Infections and infestations
Otitis media
|
0.00%
0/4 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/5 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/9 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
20.0%
2/10 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
4.2%
1/24 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
8.8%
3/34 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/4 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/5 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/9 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
20.0%
2/10 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
4.2%
1/24 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
8.8%
3/34 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
|
Infections and infestations
Gastroentritis
|
0.00%
0/4 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/5 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/9 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/10 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
8.3%
2/24 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
5.9%
2/34 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/4 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/5 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/9 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/10 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
8.3%
2/24 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
5.9%
2/34 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
|
Infections and infestations
Bacterial disease carrier
|
0.00%
0/4 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/5 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/9 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/10 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
4.2%
1/24 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
2.9%
1/34 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
|
Infections and infestations
Genital candidiasis
|
0.00%
0/4 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/5 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/9 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
10.0%
1/10 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/24 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
2.9%
1/34 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
0.00%
0/4 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/5 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/9 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/10 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
4.2%
1/24 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
2.9%
1/34 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
|
Infections and infestations
Infectious mononucleosis
|
0.00%
0/4 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/5 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/9 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
10.0%
1/10 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/24 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
2.9%
1/34 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
|
Infections and infestations
Lung infection
|
0.00%
0/4 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/5 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/9 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/10 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
4.2%
1/24 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
2.9%
1/34 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/4 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/5 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/9 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/10 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
4.2%
1/24 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
2.9%
1/34 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/4 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/5 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/9 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/10 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
4.2%
1/24 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
2.9%
1/34 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/4 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/5 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/9 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
10.0%
1/10 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/24 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
2.9%
1/34 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/4 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/5 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/9 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/10 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
4.2%
1/24 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
2.9%
1/34 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
|
Infections and infestations
Viral rash
|
0.00%
0/4 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/5 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/9 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
10.0%
1/10 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/24 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
2.9%
1/34 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/4 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/5 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/9 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/10 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
4.2%
1/24 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
2.9%
1/34 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
40.0%
2/5 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
22.2%
2/9 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
30.0%
3/10 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
25.0%
6/24 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
26.5%
9/34 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/4 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
20.0%
1/5 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
11.1%
1/9 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/10 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
16.7%
4/24 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
11.8%
4/34 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/4 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
20.0%
1/5 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
11.1%
1/9 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
10.0%
1/10 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/24 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
2.9%
1/34 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
20.0%
1/5 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
11.1%
1/9 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/10 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
4.2%
1/24 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
2.9%
1/34 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/4 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/5 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/9 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/10 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
4.2%
1/24 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
2.9%
1/34 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
|
Gastrointestinal disorders
Lip blister
|
0.00%
0/4 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/5 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/9 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/10 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
4.2%
1/24 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
2.9%
1/34 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/5 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/9 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/10 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
4.2%
1/24 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
2.9%
1/34 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
|
Gastrointestinal disorders
Oral mucosal erythema
|
0.00%
0/4 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/5 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/9 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/10 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
4.2%
1/24 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
2.9%
1/34 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/4 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/5 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/9 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/10 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
4.2%
1/24 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
2.9%
1/34 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
|
Gastrointestinal disorders
Teething
|
0.00%
0/4 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/5 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/9 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
10.0%
1/10 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/24 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
2.9%
1/34 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/4 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
20.0%
1/5 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
11.1%
1/9 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/10 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/24 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/34 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
|
Investigations
Bacterial test positive
|
0.00%
0/4 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/5 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/9 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/10 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
12.5%
3/24 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
8.8%
3/34 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
|
Investigations
Haemophilus test positive
|
0.00%
0/4 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/5 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/9 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/10 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
12.5%
3/24 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
8.8%
3/34 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/4 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/5 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/9 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
20.0%
2/10 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/24 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
5.9%
2/34 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/4 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/5 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/9 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
10.0%
1/10 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/24 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
2.9%
1/34 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/4 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
20.0%
1/5 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
11.1%
1/9 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/10 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
4.2%
1/24 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
2.9%
1/34 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
|
Investigations
Antibiotic resistant Staphylococcus test positive
|
0.00%
0/4 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/5 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/9 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
10.0%
1/10 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/24 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
2.9%
1/34 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/4 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
20.0%
1/5 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
11.1%
1/9 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/10 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
4.2%
1/24 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
2.9%
1/34 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
|
Investigations
Blood creatine increased
|
0.00%
0/4 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/5 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/9 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/10 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
4.2%
1/24 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
2.9%
1/34 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/4 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/5 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/9 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/10 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
4.2%
1/24 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
2.9%
1/34 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
|
Investigations
Liver function test abnormal
|
0.00%
0/4 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/5 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/9 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/10 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
4.2%
1/24 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
2.9%
1/34 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
|
Investigations
Lymphocyte count increased
|
0.00%
0/4 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/5 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/9 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/10 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
4.2%
1/24 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
2.9%
1/34 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
|
Investigations
Respiratory rate increased
|
0.00%
0/4 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/5 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/9 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
10.0%
1/10 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/24 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
2.9%
1/34 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
|
Investigations
Pancreatic enzyme increased
|
0.00%
0/4 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
20.0%
1/5 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
11.1%
1/9 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/10 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/24 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/34 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
|
Investigations
Staphylococcus test positive
|
0.00%
0/4 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/5 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/9 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/10 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
4.2%
1/24 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
2.9%
1/34 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
|
Investigations
White blood cell count increased
|
0.00%
0/4 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/5 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/9 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/10 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
4.2%
1/24 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
2.9%
1/34 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/4 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/5 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/9 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
20.0%
2/10 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
8.3%
2/24 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
11.8%
4/34 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/4 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/5 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/9 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/10 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
4.2%
1/24 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
2.9%
1/34 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/4 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/5 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/9 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
10.0%
1/10 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/24 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
2.9%
1/34 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/4 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/5 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/9 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/10 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
4.2%
1/24 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
2.9%
1/34 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/4 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/5 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/9 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
10.0%
1/10 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/24 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
2.9%
1/34 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/4 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/5 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/9 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
10.0%
1/10 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/24 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
2.9%
1/34 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/4 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
40.0%
2/5 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
22.2%
2/9 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/10 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/24 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/34 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
25.0%
1/4 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/5 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
11.1%
1/9 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/10 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/24 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/34 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
|
Infections and infestations
Bronchitis viral
|
0.00%
0/4 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
20.0%
1/5 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
11.1%
1/9 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/10 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/24 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/34 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
|
General disorders
Pyrexia
|
50.0%
2/4 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
40.0%
2/5 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
44.4%
4/9 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
40.0%
4/10 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
8.3%
2/24 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
17.6%
6/34 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
|
General disorders
Application site rash
|
0.00%
0/4 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/5 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/9 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/10 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
4.2%
1/24 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
2.9%
1/34 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
|
General disorders
Fatigue
|
0.00%
0/4 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
20.0%
1/5 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
11.1%
1/9 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/10 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
4.2%
1/24 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
2.9%
1/34 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
|
General disorders
Product taste abnormal
|
0.00%
0/4 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
20.0%
1/5 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
11.1%
1/9 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/10 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
4.2%
1/24 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
2.9%
1/34 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/4 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/5 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/9 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/10 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
8.3%
2/24 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
5.9%
2/34 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
|
Injury, poisoning and procedural complications
Face injury
|
0.00%
0/4 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/5 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/9 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/10 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
4.2%
1/24 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
2.9%
1/34 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/4 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/5 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/9 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/10 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
4.2%
1/24 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
2.9%
1/34 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
|
Injury, poisoning and procedural complications
Mouth injury
|
0.00%
0/4 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/5 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/9 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/10 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
4.2%
1/24 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
2.9%
1/34 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
|
Injury, poisoning and procedural complications
Open wound
|
0.00%
0/4 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/5 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/9 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/10 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
4.2%
1/24 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
2.9%
1/34 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
|
Injury, poisoning and procedural complications
Traumatic haemorrhage
|
0.00%
0/4 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/5 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/9 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/10 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
4.2%
1/24 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
2.9%
1/34 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/4 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/5 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/9 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/10 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
4.2%
1/24 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
2.9%
1/34 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
20.0%
1/5 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
11.1%
1/9 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/10 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
8.3%
2/24 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
5.9%
2/34 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
|
Nervous system disorders
Drooling
|
0.00%
0/4 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/5 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/9 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/10 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
4.2%
1/24 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
2.9%
1/34 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/4 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/5 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/9 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/10 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
4.2%
1/24 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
2.9%
1/34 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/4 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/5 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/9 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
10.0%
1/10 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
4.2%
1/24 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
5.9%
2/34 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
|
Metabolism and nutrition disorders
Weight gain poor
|
0.00%
0/4 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/5 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/9 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/10 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
4.2%
1/24 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
2.9%
1/34 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
|
Eye disorders
Amblyopia
|
0.00%
0/4 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/5 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/9 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/10 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
4.2%
1/24 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
2.9%
1/34 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
|
Eye disorders
Anisometropia
|
0.00%
0/4 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/5 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/9 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/10 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
4.2%
1/24 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
2.9%
1/34 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
|
Eye disorders
Eye inflammation
|
0.00%
0/4 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/5 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/9 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/10 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
4.2%
1/24 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
2.9%
1/34 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/4 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/5 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/9 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/10 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
4.2%
1/24 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
2.9%
1/34 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/4 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/5 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/9 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/10 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
4.2%
1/24 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
2.9%
1/34 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/4 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/5 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/9 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
10.0%
1/10 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/24 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
2.9%
1/34 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/4 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/5 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/9 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/10 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
4.2%
1/24 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
2.9%
1/34 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/4 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/5 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/9 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
0.00%
0/10 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
4.2%
1/24 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
2.9%
1/34 • Part A: up to 93 days; Part B: up to 28 weeks
Adverse events were reported separately for each part and as per the dose received and for overall participants in each part.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI is free to publish results of the study after (1) the first multi-center publication, (2) if the sponsor elects not to publish the results, or (3) 18 months after close of the study, whichever occurs first. Proposed publications are to be submitted to the sponsor for review and comment for a period of at least 45 days (which may be extended under certain circumstances related to protection of intellectual property); the sponsor cannot require changes to the proposed publications.
- Publication restrictions are in place
Restriction type: OTHER