Trial Outcomes & Findings for A Study of MK-0869 (Aprepitant) and MK-0517 (Fosaprepitant) in Pediatric Participants Receiving Chemotherapy (MK-0869-134) (NCT NCT00818259)
NCT ID: NCT00818259
Last Updated: 2018-09-25
Results Overview
AUC is a measure of the amount of aprepitant in the plasma. Fosaprepitant is a prodrug for aprepitant and is rapidly converted to aprepitant after IV administration. Blood samples for pharmacokinetic (PK) assessment were collected at the following time points: Part IA - Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 6, 8 and 24 hours (hr) post fosaprepitant dose; Part IB - Pre-dose and -0.75, -0.5, 0, 0.5, 1.5, 3, 4, 6, 8 and 24 hr post start of chemotherapy; Parts II and IV - Pre-dose and 1.5, 3, 4, 6, 8 and 24 hr post aprepitant dose; Part V - Pre-dose and -0.75, -0.5, 0, 1.5, 3, 4, 6, 8 and 24 hr post start of chemotherapy.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
92 participants
Primary outcome timeframe
Up to 24 hours post fosaprepitant/aprepitant dose
Results posted on
2018-09-25
Participant Flow
Of the 92 unique participants who were enrolled and randomized in Parts I (n=23), II (n=39), III (n=19), IV (n=5) and V (n=6), 91 took part in this study. One participant randomized in Part IIB was discontinued prior to treatment.
Participant milestones
| Measure |
Part IA-fosaprepitant 115 mg/Aprepitant
Day 1, fosaprepitant intravenous (IV) at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg orally (PO), prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
|
Part IB-fosaprepitant 150 mg
Day 1, fosaprepitant, IV at a dose of 150 mg, prior to chemotherapy for participants 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
|
Part IIA-aprepitant 80 mg Equiv.
Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 6 months to \<12 years of age - 47 mg/m\^2; 4 months to \<6 months of age - 2.0 mg/kg; 1 month to \<4 months of age - 1.0 mg/kg; birth to \<1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
|
Part IIB-aprepitant 125 mg Equiv.
Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 2 years to \<12 years of age - 74 mg/m\^2; 6 months to \<2 years of age - 1.3 mg/kg; 4 months to \<6 months of age - 3.0 mg/kg; 1 month to \<4 months of age - 1.5 mg/kg; birth to \<1 month of age - 0.75 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
|
Part III-ondansetron
Ondansetron administered IV per local standard of care on Days 1, 2, and 3 prior to chemotherapy for participants from birth to \<12 years of age. The use of IV dexamethasone is optional with the exception of the birth to one year old cohort.
|
Part IV-aprepitant Regimen
Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to \<12 years of age - 3.0 mg/kg; 1 month to \<4 months of age - 1.5 mg/kg; Birth to \<1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to \<12 years of age - 2.0 mg/kg; 1 month to \<4 months of age - 1.0 mg/kg; Birth to \<1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.
|
Part IV-Additional Enrollers
Additional participants were enrolled in Part IV. Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to \<12 years of age - 3.0 mg/kg; 1 month to \<4 months of age - 1.5 mg/kg; Birth to \<1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to \<12 years of age - 2.0 mg/kg; 1 month to \<4 months of age - 1.0 mg/kg; Birth to \<1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.
|
Part V-fosaprepitant Regimen
Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to \<12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
|
Part V-Additional Enrollers
Additional participants were enrolled in Part V. Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to \<12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
|
|---|---|---|---|---|---|---|---|---|---|
|
Randomization
STARTED
|
12
|
11
|
19
|
20
|
19
|
0
|
5
|
0
|
6
|
|
Randomization
COMPLETED
|
12
|
11
|
19
|
20
|
19
|
0
|
5
|
0
|
6
|
|
Randomization
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part I
STARTED
|
12
|
11
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part I
COMPLETED
|
11
|
11
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part I
NOT COMPLETED
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part II
STARTED
|
0
|
0
|
19
|
20
|
0
|
0
|
0
|
0
|
0
|
|
Part II
Treated
|
0
|
0
|
19
|
19
|
0
|
0
|
0
|
0
|
0
|
|
Part II
COMPLETED
|
0
|
0
|
18
|
18
|
0
|
0
|
0
|
0
|
0
|
|
Part II
NOT COMPLETED
|
0
|
0
|
1
|
2
|
0
|
0
|
0
|
0
|
0
|
|
Part III
STARTED
|
0
|
0
|
0
|
0
|
19
|
0
|
0
|
0
|
0
|
|
Part III
COMPLETED
|
0
|
0
|
0
|
0
|
19
|
0
|
0
|
0
|
0
|
|
Part III
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part IV
STARTED
|
0
|
0
|
0
|
0
|
0
|
15
|
5
|
0
|
0
|
|
Part IV
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
14
|
5
|
0
|
0
|
|
Part IV
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Part V
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
17
|
6
|
|
Part V
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
16
|
6
|
|
Part V
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Part IA-fosaprepitant 115 mg/Aprepitant
Day 1, fosaprepitant intravenous (IV) at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg orally (PO), prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
|
Part IB-fosaprepitant 150 mg
Day 1, fosaprepitant, IV at a dose of 150 mg, prior to chemotherapy for participants 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
|
Part IIA-aprepitant 80 mg Equiv.
Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 6 months to \<12 years of age - 47 mg/m\^2; 4 months to \<6 months of age - 2.0 mg/kg; 1 month to \<4 months of age - 1.0 mg/kg; birth to \<1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
|
Part IIB-aprepitant 125 mg Equiv.
Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 2 years to \<12 years of age - 74 mg/m\^2; 6 months to \<2 years of age - 1.3 mg/kg; 4 months to \<6 months of age - 3.0 mg/kg; 1 month to \<4 months of age - 1.5 mg/kg; birth to \<1 month of age - 0.75 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
|
Part III-ondansetron
Ondansetron administered IV per local standard of care on Days 1, 2, and 3 prior to chemotherapy for participants from birth to \<12 years of age. The use of IV dexamethasone is optional with the exception of the birth to one year old cohort.
|
Part IV-aprepitant Regimen
Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to \<12 years of age - 3.0 mg/kg; 1 month to \<4 months of age - 1.5 mg/kg; Birth to \<1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to \<12 years of age - 2.0 mg/kg; 1 month to \<4 months of age - 1.0 mg/kg; Birth to \<1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.
|
Part IV-Additional Enrollers
Additional participants were enrolled in Part IV. Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to \<12 years of age - 3.0 mg/kg; 1 month to \<4 months of age - 1.5 mg/kg; Birth to \<1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to \<12 years of age - 2.0 mg/kg; 1 month to \<4 months of age - 1.0 mg/kg; Birth to \<1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.
|
Part V-fosaprepitant Regimen
Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to \<12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
|
Part V-Additional Enrollers
Additional participants were enrolled in Part V. Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to \<12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part I
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part II
Physician Decision
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part II
Lack of Efficacy
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Part II
Not Treated
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Part IV
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Part V
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Study of MK-0869 (Aprepitant) and MK-0517 (Fosaprepitant) in Pediatric Participants Receiving Chemotherapy (MK-0869-134)
Baseline characteristics by cohort
| Measure |
Part IA-fosaprepitant 115 mg/Aprepitant
n=12 Participants
Day 1, fosaprepitant IV at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg PO, prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
|
Part IB-fosaprepitant 150 mg
n=11 Participants
Day 1, fosaprepitant, IV at a dose of 150 mg, prior to chemotherapy for participants 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
|
Part IIA-aprepitant 80 mg Equiv.
n=19 Participants
Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 6 months to \<12 years of age - 47 mg/m\^2; 4 months to \<6 months of age - 2.0 mg/kg; 1 month to \<4 months of age - 1.0 mg/kg; birth to \<1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
|
Part IIB-aprepitant 125 mg Equiv.
n=20 Participants
Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 2 years to \<12 years of age - 74 mg/m\^2; 6 months to \<2 years of age - 1.3 mg/kg; 4 months to \<6 months of age - 3.0 mg/kg; 1 month to \<4 months of age - 1.5 mg/kg; birth to \<1 month of age - 0.75 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
|
Part III-ondansetron
n=19 Participants
Ondansetron administered IV per local standard of care on Days 1, 2, and 3 prior to chemotherapy for participants from birth to \<12 years of age. The use of IV dexamethasone is optional with the exception of the birth to one year old cohort.
|
Part IV-aprepitant Regimen
n=5 Participants
Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to \<12 years of age - 3.0 mg/kg; 1 month to \<4 months of age - 1.5 mg/kg; Birth to \<1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to \<12 years of age - 2.0 mg/kg; 1 month to \<4 months of age - 1.0 mg/kg; Birth to \<1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.
|
Part V-fosaprepitant Regimen
n=6 Participants
Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to \<12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
|
Total
n=92 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Customized
6 months to <2 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
6 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
19 Participants
n=40 Participants
|
|
Age, Customized
2 years to <6 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
8 Participants
n=483 Participants
|
6 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
25 Participants
n=40 Participants
|
|
Age, Customized
6 years to <12 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
7 Participants
n=36 Participants
|
4 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
25 Participants
n=40 Participants
|
|
Age, Customized
12 years to 17 years
|
12 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
23 Participants
n=40 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
14 Participants
n=483 Participants
|
13 Participants
n=36 Participants
|
3 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
62 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
6 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
30 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: Up to 24 hours post fosaprepitant/aprepitant dosePopulation: The population consisted of all participants who received at least one dose of fosaprepitant and/or aprepitant and were evaluable for this PK parameter. No PK assessements were performed on the Part III-ondansetron group; this group received no aprepitant.
AUC is a measure of the amount of aprepitant in the plasma. Fosaprepitant is a prodrug for aprepitant and is rapidly converted to aprepitant after IV administration. Blood samples for pharmacokinetic (PK) assessment were collected at the following time points: Part IA - Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 6, 8 and 24 hours (hr) post fosaprepitant dose; Part IB - Pre-dose and -0.75, -0.5, 0, 0.5, 1.5, 3, 4, 6, 8 and 24 hr post start of chemotherapy; Parts II and IV - Pre-dose and 1.5, 3, 4, 6, 8 and 24 hr post aprepitant dose; Part V - Pre-dose and -0.75, -0.5, 0, 1.5, 3, 4, 6, 8 and 24 hr post start of chemotherapy.
Outcome measures
| Measure |
Part IA-fosaprepitant 115 mg/Aprepitant
n=8 Participants
Day 1, fosaprepitant IV at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg PO, prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
|
Part IB-fosaprepitant 150 mg
n=11 Participants
Day 1, fosaprepitant, IV at a dose of 150 mg, prior to chemotherapy for participants 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
|
Part IIA-aprepitant 80 mg Equiv.
n=19 Participants
Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 6 months to \<12 years of age - 47 mg/m\^2; 4 months to \<6 months of age - 2.0 mg/kg; 1 month to \<4 months of age - 1.0 mg/kg; birth to \<1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
|
Part IIB-aprepitant 125 mg Equiv.
n=18 Participants
Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 2 years to \<12 years of age - 74 mg/m\^2; 6 months to \<2 years of age - 1.3 mg/kg; 4 months to \<6 months of age - 3.0 mg/kg; 1 month to \<4 months of age - 1.5 mg/kg; birth to \<1 month of age - 0.75 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
|
Part III-ondansetron
Ondansetron administered IV per local standard of care on Days 1, 2, and 3 prior to chemotherapy for participants from birth to \<12 years of age. The use of IV dexamethasone is optional with the exception of the birth to one year old cohort.
|
Part IV-aprepitant Regimen
n=18 Participants
Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to \<12 years of age - 3.0 mg/kg; 1 month to \<4 months of age - 1.5 mg/kg; Birth to \<1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to \<12 years of age - 2.0 mg/kg; 1 month to \<4 months of age - 1.0 mg/kg; Birth to \<1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.
|
Part V-fosaprepitant Regimen
n=21 Participants
Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to \<12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
|
|---|---|---|---|---|---|---|---|
|
Area Under the Time-Concentration Curve From 0 to 24 Hours (AUC 0-24hr) for Aprepitant
6 months to <2 years (n=0, 0, 5, 5, 0, 6, 6)
|
NA hr*ng/mL
Standard Deviation NA
Not assessed
|
NA hr*ng/mL
Standard Deviation NA
Not assessed
|
20000 hr*ng/mL
Standard Deviation 7890
|
6310 hr*ng/mL
Standard Deviation 2040
|
—
|
21100 hr*ng/mL
Standard Deviation 11800
|
11700 hr*ng/mL
Standard Deviation 6980
|
|
Area Under the Time-Concentration Curve From 0 to 24 Hours (AUC 0-24hr) for Aprepitant
2 years to <6 years (n=0, 0, 8, 7, 0, 6, 7)
|
NA hr*ng/mL
Standard Deviation NA
Not assessed
|
NA hr*ng/mL
Standard Deviation NA
Not assessed
|
16400 hr*ng/mL
Standard Deviation 8080
|
23000 hr*ng/mL
Standard Deviation 8390
|
—
|
17300 hr*ng/mL
Standard Deviation 5060
|
18300 hr*ng/mL
Standard Deviation 11100
|
|
Area Under the Time-Concentration Curve From 0 to 24 Hours (AUC 0-24hr) for Aprepitant
6 years to <12 years (n=0, 0, 6, 6, 0, 6, 8)
|
NA hr*ng/mL
Standard Deviation NA
Not assessed
|
NA hr*ng/mL
Standard Deviation NA
Not assessed
|
16000 hr*ng/mL
Standard Deviation 4810
|
22000 hr*ng/mL
Standard Deviation 9440
|
—
|
24400 hr*ng/mL
Standard Deviation 15800
|
19500 hr*ng/mL
Standard Deviation 6720
|
|
Area Under the Time-Concentration Curve From 0 to 24 Hours (AUC 0-24hr) for Aprepitant
12 years to 17 years (n=8, 11, 0, 0, 0, 0, 0)
|
19500 hr*ng/mL
Standard Deviation 8010
|
30800 hr*ng/mL
Standard Deviation 7020
|
NA hr*ng/mL
Standard Deviation NA
Not assessed
|
NA hr*ng/mL
Standard Deviation NA
Not assessed
|
—
|
NA hr*ng/mL
Standard Deviation NA
Not assessed
|
NA hr*ng/mL
Standard Deviation NA
Not assessed
|
PRIMARY outcome
Timeframe: Up to 72 hours post fosaprepitant/aprepitant dosePopulation: The population consisted of all participants who received at least one dose of fosaprepitant and/or aprepitant and were evaluable for this PK parameter. No PK assessements were performed on the Part III-ondansetron group; this group received no aprepitant.
Cmax is a measure of the maximum amount of aprepitant in the plasma. Fosaprepitant is a prodrug for aprepitant and is rapidly converted to aprepitant after IV administration. Blood samples for PK assessment were collected at the following time points: Part IA - Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 6, 8 and 24 hr post fosaprepitant dose; Part IB - Pre-dose and -0.75, -0.5, 0, 0.5, 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post start of chemotherapy; Parts II and IV - Pre-dose and 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post aprepitant dose; Part V - Pre-dose and -0.75, -0.5, 0, 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post start of chemotherapy.
Outcome measures
| Measure |
Part IA-fosaprepitant 115 mg/Aprepitant
n=12 Participants
Day 1, fosaprepitant IV at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg PO, prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
|
Part IB-fosaprepitant 150 mg
n=11 Participants
Day 1, fosaprepitant, IV at a dose of 150 mg, prior to chemotherapy for participants 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
|
Part IIA-aprepitant 80 mg Equiv.
n=19 Participants
Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 6 months to \<12 years of age - 47 mg/m\^2; 4 months to \<6 months of age - 2.0 mg/kg; 1 month to \<4 months of age - 1.0 mg/kg; birth to \<1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
|
Part IIB-aprepitant 125 mg Equiv.
n=18 Participants
Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 2 years to \<12 years of age - 74 mg/m\^2; 6 months to \<2 years of age - 1.3 mg/kg; 4 months to \<6 months of age - 3.0 mg/kg; 1 month to \<4 months of age - 1.5 mg/kg; birth to \<1 month of age - 0.75 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
|
Part III-ondansetron
Ondansetron administered IV per local standard of care on Days 1, 2, and 3 prior to chemotherapy for participants from birth to \<12 years of age. The use of IV dexamethasone is optional with the exception of the birth to one year old cohort.
|
Part IV-aprepitant Regimen
n=19 Participants
Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to \<12 years of age - 3.0 mg/kg; 1 month to \<4 months of age - 1.5 mg/kg; Birth to \<1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to \<12 years of age - 2.0 mg/kg; 1 month to \<4 months of age - 1.0 mg/kg; Birth to \<1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.
|
Part V-fosaprepitant Regimen
n=22 Participants
Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to \<12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
|
|---|---|---|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) for Aprepitant
2 years to <6 years (n=0, 0, 8, 7, 0, 6, 7)
|
NA ng/mL
Standard Deviation NA
Not assessed
|
NA ng/mL
Standard Deviation NA
Not assessed
|
1300 ng/mL
Standard Deviation 609
|
2100 ng/mL
Standard Deviation 1170
|
—
|
1840 ng/mL
Standard Deviation 933
|
2430 ng/mL
Standard Deviation 1100
|
|
Maximum Plasma Concentration (Cmax) for Aprepitant
6 months to <2 years (n=0, 0, 5, 5, 0, 6, 7)
|
NA ng/mL
Standard Deviation NA
Not assessed
|
NA ng/mL
Standard Deviation NA
Not assessed
|
1930 ng/mL
Standard Deviation 1000
|
659 ng/mL
Standard Deviation 107
|
—
|
1810 ng/mL
Standard Deviation 925
|
1700 ng/mL
Standard Deviation 636
|
|
Maximum Plasma Concentration (Cmax) for Aprepitant
6 years to <12 years (n=0, 0, 6, 6, 0, 7, 8)
|
NA ng/mL
Standard Deviation NA
Not assessed
|
NA ng/mL
Standard Deviation NA
Not assessed
|
1300 ng/mL
Standard Deviation 275
|
1930 ng/mL
Standard Deviation 873
|
—
|
1800 ng/mL
Standard Deviation 1610
|
2850 ng/mL
Standard Deviation 641
|
|
Maximum Plasma Concentration (Cmax) for Aprepitant
12 years to 17 years (n=12, 11, 0, 0, 0, 0, 0)
|
3240 ng/mL
Standard Deviation 1280
|
5870 ng/mL
Standard Deviation 2770
|
NA ng/mL
Standard Deviation NA
Not assessed
|
NA ng/mL
Standard Deviation NA
Not assessed
|
—
|
NA ng/mL
Standard Deviation NA
Not assessed
|
NA ng/mL
Standard Deviation NA
Not assessed
|
PRIMARY outcome
Timeframe: Up to 72 hours post fosaprepitant/aprepitant dosePopulation: The population consisted of all participants who received at least one dose of fosaprepitant and/or aprepitant and were evaluable for this PK parameter. No PK assessements were performed on the Part III-ondansetron group; this group received no aprepitant.
Tmax is a measure of the amount of time after dosing to when the maximum concentration of aprepitant was achieved. Fosaprepitant is a prodrug for aprepitant and is rapidly converted to aprepitant after IV administration. Blood samples for PK assessment were collected at the following time points: Part IA - Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 6, 8 and 24 hr post fosaprepitant dose; Part IB - Pre-dose and -0.75, -0.5, 0, 0.5, 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post start of chemotherapy; Parts II and IV - Pre-dose and 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post aprepitant dose; Part V - Pre-dose and -0.75, -0.5, 0, 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post start of chemotherapy.
Outcome measures
| Measure |
Part IA-fosaprepitant 115 mg/Aprepitant
n=12 Participants
Day 1, fosaprepitant IV at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg PO, prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
|
Part IB-fosaprepitant 150 mg
n=11 Participants
Day 1, fosaprepitant, IV at a dose of 150 mg, prior to chemotherapy for participants 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
|
Part IIA-aprepitant 80 mg Equiv.
n=19 Participants
Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 6 months to \<12 years of age - 47 mg/m\^2; 4 months to \<6 months of age - 2.0 mg/kg; 1 month to \<4 months of age - 1.0 mg/kg; birth to \<1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
|
Part IIB-aprepitant 125 mg Equiv.
n=18 Participants
Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 2 years to \<12 years of age - 74 mg/m\^2; 6 months to \<2 years of age - 1.3 mg/kg; 4 months to \<6 months of age - 3.0 mg/kg; 1 month to \<4 months of age - 1.5 mg/kg; birth to \<1 month of age - 0.75 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
|
Part III-ondansetron
Ondansetron administered IV per local standard of care on Days 1, 2, and 3 prior to chemotherapy for participants from birth to \<12 years of age. The use of IV dexamethasone is optional with the exception of the birth to one year old cohort.
|
Part IV-aprepitant Regimen
n=19 Participants
Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to \<12 years of age - 3.0 mg/kg; 1 month to \<4 months of age - 1.5 mg/kg; Birth to \<1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to \<12 years of age - 2.0 mg/kg; 1 month to \<4 months of age - 1.0 mg/kg; Birth to \<1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.
|
Part V-fosaprepitant Regimen
n=22 Participants
Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to \<12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
|
|---|---|---|---|---|---|---|---|
|
Time to Cmax (Tmax) for Aprepitant
12 years to 17 years (n=12, 11, 0, 0, 0, 0, 0)
|
0.41 hr
Standard Deviation 0.27
|
0.64 hr
Standard Deviation 0.30
|
NA hr
Standard Deviation NA
Not assessed
|
NA hr
Standard Deviation NA
Not assessed
|
—
|
NA hr
Standard Deviation NA
Not assessed
|
NA hr
Standard Deviation NA
Not assessed
|
|
Time to Cmax (Tmax) for Aprepitant
6 months to <2 years (n=0, 0, 5, 5, 0, 6, 7)
|
NA hr
Standard Deviation NA
Not assessed
|
NA hr
Standard Deviation NA
Not assessed
|
2.33 hr
Standard Deviation 1.16
|
3.45 hr
Standard Deviation 2.89
|
—
|
7.34 hr
Standard Deviation 8.28
|
1.13 hr
Standard Deviation 0.17
|
|
Time to Cmax (Tmax) for Aprepitant
2 years to <6 years (n=0, 0, 8, 7, 0, 6, 7)
|
NA hr
Standard Deviation NA
Not assessed
|
NA hr
Standard Deviation NA
Not assessed
|
3.78 hr
Standard Deviation 1.92
|
5.28 hr
Standard Deviation 1.97
|
—
|
4.92 hr
Standard Deviation 2.20
|
1.41 hr
Standard Deviation 0.83
|
|
Time to Cmax (Tmax) for Aprepitant
6 years to <12 years (n=0, 0, 6, 6, 0, 7, 8)
|
NA hr
Standard Deviation NA
Not assessed
|
NA hr
Standard Deviation NA
Not assessed
|
5.17 hr
Standard Deviation 1.83
|
3.08 hr
Standard Deviation 0.95
|
—
|
6.42 hr
Standard Deviation 7.84
|
1.07 hr
Standard Deviation 0.11
|
PRIMARY outcome
Timeframe: Up to 72 hours post fosaprepitant/aprepitant dosePopulation: The population consisted of all participants who received at least one dose of fosaprepitant and/or aprepitant and were evaluable for this PK parameter. No PK assessements were performed on the Part III-ondansetron group; this group received no aprepitant.
t1/2 is the amount of time from dosing until half of the aprepitant was metabolized from the body. Fosaprepitant is a prodrug for aprepitant and is rapidly converted to aprepitant after IV administration. Blood samples for PK assessment were collected at the following time points: Part IA - Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 6, 8 and 24 hr post fosaprepitant dose; Part IB - Pre-dose and -0.75, -0.5, 0, 0.5, 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post start of chemotherapy; Parts II and IV - Pre-dose and 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post aprepitant dose; Part V - Pre-dose and -0.75, -0.5, 0, 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post start of chemotherapy.
Outcome measures
| Measure |
Part IA-fosaprepitant 115 mg/Aprepitant
n=6 Participants
Day 1, fosaprepitant IV at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg PO, prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
|
Part IB-fosaprepitant 150 mg
n=11 Participants
Day 1, fosaprepitant, IV at a dose of 150 mg, prior to chemotherapy for participants 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
|
Part IIA-aprepitant 80 mg Equiv.
n=16 Participants
Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 6 months to \<12 years of age - 47 mg/m\^2; 4 months to \<6 months of age - 2.0 mg/kg; 1 month to \<4 months of age - 1.0 mg/kg; birth to \<1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
|
Part IIB-aprepitant 125 mg Equiv.
n=13 Participants
Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 2 years to \<12 years of age - 74 mg/m\^2; 6 months to \<2 years of age - 1.3 mg/kg; 4 months to \<6 months of age - 3.0 mg/kg; 1 month to \<4 months of age - 1.5 mg/kg; birth to \<1 month of age - 0.75 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
|
Part III-ondansetron
Ondansetron administered IV per local standard of care on Days 1, 2, and 3 prior to chemotherapy for participants from birth to \<12 years of age. The use of IV dexamethasone is optional with the exception of the birth to one year old cohort.
|
Part IV-aprepitant Regimen
n=12 Participants
Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to \<12 years of age - 3.0 mg/kg; 1 month to \<4 months of age - 1.5 mg/kg; Birth to \<1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to \<12 years of age - 2.0 mg/kg; 1 month to \<4 months of age - 1.0 mg/kg; Birth to \<1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.
|
Part V-fosaprepitant Regimen
n=21 Participants
Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to \<12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
|
|---|---|---|---|---|---|---|---|
|
Apparent Terminal Half-life (t1/2) for Aprepitant
6 months to <2 years (n=0, 0, 5, 3, 0, 3, 6)
|
NA hr
Standard Deviation NA
Not assessed
|
NA hr
Standard Deviation NA
Not assessed
|
7.28 hr
Standard Deviation 1.47
|
8.09 hr
Standard Deviation 2.54
|
—
|
6.18 hr
Standard Deviation 4.12
|
7.71 hr
Standard Deviation 3.10
|
|
Apparent Terminal Half-life (t1/2) for Aprepitant
2 years to <6 years (n=0, 0, 6, 4, 0, 5, 7)
|
NA hr
Standard Deviation NA
Not assessed
|
NA hr
Standard Deviation NA
Not assessed
|
8.27 hr
Standard Deviation 2.67
|
6.06 hr
Standard Deviation 3.03
|
—
|
9.21 hr
Standard Deviation 5.57
|
6.44 hr
Standard Deviation 2.35
|
|
Apparent Terminal Half-life (t1/2) for Aprepitant
6 years to <12 years (n=0, 0, 5, 6, 0, 4, 8)
|
NA hr
Standard Deviation NA
Not assessed
|
NA hr
Standard Deviation NA
Not assessed
|
9.17 hr
Standard Deviation 4.00
|
6.89 hr
Standard Deviation 1.35
|
—
|
10.8 hr
Standard Deviation 4.27
|
8.76 hr
Standard Deviation 3.34
|
|
Apparent Terminal Half-life (t1/2) for Aprepitant
12 years to 17 years (n=6 11, 0, 0, 0, 0, 0)
|
11.0 hr
Standard Deviation 4.42
|
22.2 hr
Standard Deviation 19.8
|
NA hr
Standard Deviation NA
Not assessed
|
NA hr
Standard Deviation NA
Not assessed
|
—
|
NA hr
Standard Deviation NA
Not assessed
|
NA hr
Standard Deviation NA
Not assessed
|
PRIMARY outcome
Timeframe: Up to 72 hours post fosaprepitant dosePopulation: The population consisted of all participants who received at least one dose of fosaprepitant \& were evaluable for this PK parameter. No PK analyses were performed on the Part 1A-fosaprepitant 115 mg/aprepitant group; blood samples from this group were not handled correctly. Part IIA, Part IIB, Part III \& Part IV groups received no fosaprepitant.
Cmax is a measure of the maximum amount of fosaprepitant in the plasma. Blood samples for PK assessment were collected at the following time points: Part IA - Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 6, 8 and 24 hr post fosaprepitant dose; Part V - Pre-dose and -0.75, -0.5, 0, 0.5, 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post start of chemotherapy.
Outcome measures
| Measure |
Part IA-fosaprepitant 115 mg/Aprepitant
Day 1, fosaprepitant IV at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg PO, prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
|
Part IB-fosaprepitant 150 mg
n=11 Participants
Day 1, fosaprepitant, IV at a dose of 150 mg, prior to chemotherapy for participants 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
|
Part IIA-aprepitant 80 mg Equiv.
Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 6 months to \<12 years of age - 47 mg/m\^2; 4 months to \<6 months of age - 2.0 mg/kg; 1 month to \<4 months of age - 1.0 mg/kg; birth to \<1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
|
Part IIB-aprepitant 125 mg Equiv.
Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 2 years to \<12 years of age - 74 mg/m\^2; 6 months to \<2 years of age - 1.3 mg/kg; 4 months to \<6 months of age - 3.0 mg/kg; 1 month to \<4 months of age - 1.5 mg/kg; birth to \<1 month of age - 0.75 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
|
Part III-ondansetron
Ondansetron administered IV per local standard of care on Days 1, 2, and 3 prior to chemotherapy for participants from birth to \<12 years of age. The use of IV dexamethasone is optional with the exception of the birth to one year old cohort.
|
Part IV-aprepitant Regimen
Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to \<12 years of age - 3.0 mg/kg; 1 month to \<4 months of age - 1.5 mg/kg; Birth to \<1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to \<12 years of age - 2.0 mg/kg; 1 month to \<4 months of age - 1.0 mg/kg; Birth to \<1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.
|
Part V-fosaprepitant Regimen
n=23 Participants
Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to \<12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
|
|---|---|---|---|---|---|---|---|
|
Cmax for Fosaprepitant
6 months to <2 years (n=0, 0, 0, 0, 0, 0, 7)
|
—
|
NA ng/mL
Standard Deviation NA
Not assessed
|
—
|
—
|
—
|
—
|
2756 ng/mL
Standard Deviation 3364
|
|
Cmax for Fosaprepitant
2 years to <6 years (n=0, 0, 0, 0, 0, 0, 8)
|
—
|
NA ng/mL
Standard Deviation NA
Not assessed
|
—
|
—
|
—
|
—
|
3034 ng/mL
Standard Deviation 1718
|
|
Cmax for Fosaprepitant
6 years to <12 years (n=0, 0, 0, 0, 0, 0, 8)
|
—
|
NA ng/mL
Standard Deviation NA
Not assessed
|
—
|
—
|
—
|
—
|
1654 ng/mL
Standard Deviation 1995
|
|
Cmax for Fosaprepitant
12 years to 17 years (n=0, 11, 0, 0, 0, 0, 0)
|
—
|
1310 ng/mL
Standard Deviation 964
|
—
|
—
|
—
|
—
|
NA ng/mL
Standard Deviation NA
Not assessed
|
PRIMARY outcome
Timeframe: Up to 72 hours post fosaprepitant dosePopulation: The population consisted of all participants who received at least one dose of fosaprepitant \& were evaluable for this PK parameter. No PK analyses were performed on the Part 1A-fosaprepitant 115 mg/aprepitant group; blood samples from this group were not handled correctly. Part IIA, Part IIB, Part III \& Part IV groups received no fosaprepitant.
Tmax is a measure of the amount of time after dosing to when the maximum concentration of fosaprepitant was achieved. Blood samples for PK assessment were collected at the following time points: Part IA - Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 6, 8 and 24 hr post fosaprepitant dose; Part V - Pre-dose and -0.75, -0.5, 0, 0.5, 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post start of chemotherapy.
Outcome measures
| Measure |
Part IA-fosaprepitant 115 mg/Aprepitant
Day 1, fosaprepitant IV at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg PO, prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
|
Part IB-fosaprepitant 150 mg
n=11 Participants
Day 1, fosaprepitant, IV at a dose of 150 mg, prior to chemotherapy for participants 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
|
Part IIA-aprepitant 80 mg Equiv.
Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 6 months to \<12 years of age - 47 mg/m\^2; 4 months to \<6 months of age - 2.0 mg/kg; 1 month to \<4 months of age - 1.0 mg/kg; birth to \<1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
|
Part IIB-aprepitant 125 mg Equiv.
Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 2 years to \<12 years of age - 74 mg/m\^2; 6 months to \<2 years of age - 1.3 mg/kg; 4 months to \<6 months of age - 3.0 mg/kg; 1 month to \<4 months of age - 1.5 mg/kg; birth to \<1 month of age - 0.75 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
|
Part III-ondansetron
Ondansetron administered IV per local standard of care on Days 1, 2, and 3 prior to chemotherapy for participants from birth to \<12 years of age. The use of IV dexamethasone is optional with the exception of the birth to one year old cohort.
|
Part IV-aprepitant Regimen
Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to \<12 years of age - 3.0 mg/kg; 1 month to \<4 months of age - 1.5 mg/kg; Birth to \<1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to \<12 years of age - 2.0 mg/kg; 1 month to \<4 months of age - 1.0 mg/kg; Birth to \<1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.
|
Part V-fosaprepitant Regimen
n=22 Participants
Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to \<12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
|
|---|---|---|---|---|---|---|---|
|
Tmax for Fosaprepitant
6 months to <2 years (n=0, 0, 0, 0, 0, 0, 7)
|
—
|
NA hr
Standard Deviation NA
Not assessed
|
—
|
—
|
—
|
—
|
1.13 hr
Standard Deviation 0.175
|
|
Tmax for Fosaprepitant
2 years to <6 years (n=0, 0, 0, 0, 0, 0, 7)
|
—
|
NA hr
Standard Deviation NA
Not assessed
|
—
|
—
|
—
|
—
|
1.05 hr
Standard Deviation 0.089
|
|
Tmax for Fosaprepitant
6 years to <12 years (n=0, 0, 0, 0, 0, 0, 8)
|
—
|
NA hr
Standard Deviation NA
Not assessed
|
—
|
—
|
—
|
—
|
1.04 hr
Standard Deviation 0.088
|
|
Tmax for Fosaprepitant
12 years to 17 years (n=0, 11, 0, 0, 0, 0, 0)
|
—
|
0.614 hr
Standard Deviation 0.251
|
—
|
—
|
—
|
—
|
NA hr
Standard Deviation NA
Not assessed
|
PRIMARY outcome
Timeframe: Up to 14 days after last dose of study drug (Up to 17 days)Population: The All Subjects as Treated (ASaT) population consisted of all randomized participants who received at least one dose of study drug.
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Participants were monitored for the occurrence AEs for up to 14 days after last dose of study drug.
Outcome measures
| Measure |
Part IA-fosaprepitant 115 mg/Aprepitant
n=12 Participants
Day 1, fosaprepitant IV at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg PO, prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
|
Part IB-fosaprepitant 150 mg
n=11 Participants
Day 1, fosaprepitant, IV at a dose of 150 mg, prior to chemotherapy for participants 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
|
Part IIA-aprepitant 80 mg Equiv.
n=19 Participants
Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 6 months to \<12 years of age - 47 mg/m\^2; 4 months to \<6 months of age - 2.0 mg/kg; 1 month to \<4 months of age - 1.0 mg/kg; birth to \<1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
|
Part IIB-aprepitant 125 mg Equiv.
n=19 Participants
Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 2 years to \<12 years of age - 74 mg/m\^2; 6 months to \<2 years of age - 1.3 mg/kg; 4 months to \<6 months of age - 3.0 mg/kg; 1 month to \<4 months of age - 1.5 mg/kg; birth to \<1 month of age - 0.75 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
|
Part III-ondansetron
n=19 Participants
Ondansetron administered IV per local standard of care on Days 1, 2, and 3 prior to chemotherapy for participants from birth to \<12 years of age. The use of IV dexamethasone is optional with the exception of the birth to one year old cohort.
|
Part IV-aprepitant Regimen
n=20 Participants
Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to \<12 years of age - 3.0 mg/kg; 1 month to \<4 months of age - 1.5 mg/kg; Birth to \<1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to \<12 years of age - 2.0 mg/kg; 1 month to \<4 months of age - 1.0 mg/kg; Birth to \<1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.
|
Part V-fosaprepitant Regimen
n=23 Participants
Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to \<12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants Experiencing Adverse Events (AEs)
|
11 Participants
|
6 Participants
|
18 Participants
|
16 Participants
|
15 Participants
|
13 Participants
|
17 Participants
|
PRIMARY outcome
Timeframe: Day 1 up to Day 3Population: The ASaT population consisted of all randomized participants who received at least one dose of study drug.
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. The number of participants who discontinued from the study due to an AE are summarized.
Outcome measures
| Measure |
Part IA-fosaprepitant 115 mg/Aprepitant
n=12 Participants
Day 1, fosaprepitant IV at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg PO, prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
|
Part IB-fosaprepitant 150 mg
n=11 Participants
Day 1, fosaprepitant, IV at a dose of 150 mg, prior to chemotherapy for participants 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
|
Part IIA-aprepitant 80 mg Equiv.
n=19 Participants
Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 6 months to \<12 years of age - 47 mg/m\^2; 4 months to \<6 months of age - 2.0 mg/kg; 1 month to \<4 months of age - 1.0 mg/kg; birth to \<1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
|
Part IIB-aprepitant 125 mg Equiv.
n=19 Participants
Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 2 years to \<12 years of age - 74 mg/m\^2; 6 months to \<2 years of age - 1.3 mg/kg; 4 months to \<6 months of age - 3.0 mg/kg; 1 month to \<4 months of age - 1.5 mg/kg; birth to \<1 month of age - 0.75 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
|
Part III-ondansetron
n=19 Participants
Ondansetron administered IV per local standard of care on Days 1, 2, and 3 prior to chemotherapy for participants from birth to \<12 years of age. The use of IV dexamethasone is optional with the exception of the birth to one year old cohort.
|
Part IV-aprepitant Regimen
n=20 Participants
Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to \<12 years of age - 3.0 mg/kg; 1 month to \<4 months of age - 1.5 mg/kg; Birth to \<1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to \<12 years of age - 2.0 mg/kg; 1 month to \<4 months of age - 1.0 mg/kg; Birth to \<1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.
|
Part V-fosaprepitant Regimen
n=23 Participants
Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to \<12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants Discontinuing Study Drug Due to an AE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 24 hours post dexamethasone dosePopulation: This population was to consist of all participants from birth to 1 year of age who received at least one dose of dexamethasone and were evaluable for this PK parameter. These analyses were not conducted; enrollment of this cohort was not opened as enrollment of participants from birth to \<6 months of age into Part II was unsuccessful.
Blood samples for PK assessment were to be collected at the following time points: Parts II and V - Pre-dose and 1.5, 3, 4, 6, 8 and 24 hr post start of chemotherapy; Parts III and IV - Immediately after infusion of dexamethsone and 0.5, 1.5, 3, 8 and 24 hr post start of chemotherapy.
Outcome measures
Outcome data not reported
Adverse Events
Part IA-fosaprepitant 115 mg/Aprepitant
Serious events: 4 serious events
Other events: 11 other events
Deaths: 0 deaths
Part IB-fosaprepitant 150 mg
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Part IIA-aprepitant 80 mg Equiv.
Serious events: 7 serious events
Other events: 18 other events
Deaths: 0 deaths
Part IIB-aprepitant 125 mg Equiv.
Serious events: 4 serious events
Other events: 15 other events
Deaths: 0 deaths
Part III-ondansetron
Serious events: 5 serious events
Other events: 15 other events
Deaths: 0 deaths
Part IV-aprepitant Regimen
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
Part V-fosaprepitant Regimen
Serious events: 9 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part IA-fosaprepitant 115 mg/Aprepitant
n=12 participants at risk
Day 1, fosaprepitant IV at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg PO, prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
|
Part IB-fosaprepitant 150 mg
n=11 participants at risk
Day 1, fosaprepitant, IV at a dose of 150 mg, prior to chemotherapy for participants 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
|
Part IIA-aprepitant 80 mg Equiv.
n=19 participants at risk
Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 6 months to \<12 years of age - 47 mg/m\^2; 4 months to \<6 months of age - 2.0 mg/kg; 1 month to \<4 months of age - 1.0 mg/kg; birth to \<1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
|
Part IIB-aprepitant 125 mg Equiv.
n=19 participants at risk
Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 2 years to \<12 years of age - 74 mg/m\^2; 6 months to \<2 years of age - 1.3 mg/kg; 4 months to \<6 months of age - 3.0 mg/kg; 1 month to \<4 months of age - 1.5 mg/kg; birth to \<1 month of age - 0.75 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
|
Part III-ondansetron
n=19 participants at risk
Ondansetron administered IV per local standard of care on Days 1, 2, and 3 prior to chemotherapy for participants from birth to \<12 years of age. The use of IV dexamethasone is optional with the exception of the birth to one year old cohort.
|
Part IV-aprepitant Regimen
n=20 participants at risk
Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to \<12 years of age - 3.0 mg/kg; 1 month to \<4 months of age - 1.5 mg/kg; Birth to \<1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to \<12 years of age - 2.0 mg/kg; 1 month to \<4 months of age - 1.0 mg/kg; Birth to \<1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.
|
Part V-fosaprepitant Regimen
n=23 participants at risk
Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to \<12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
16.7%
2/12 • Number of events 2 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
21.1%
4/19 • Number of events 4 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
10.5%
2/19 • Number of events 2 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
21.1%
4/19 • Number of events 4 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
10.0%
2/20 • Number of events 2 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
17.4%
4/23 • Number of events 4 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/12 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.3%
1/19 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/23 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Blood and lymphatic system disorders
Neutropenia
|
8.3%
1/12 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
10.5%
2/19 • Number of events 2 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.3%
1/19 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
8.7%
2/23 • Number of events 2 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
8.3%
1/12 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.3%
1/19 • Number of events 2 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/23 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/12 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.3%
1/19 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/23 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/12 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.3%
1/19 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/23 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/12 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.3%
1/19 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/23 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/12 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
10.5%
2/19 • Number of events 2 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/23 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
General disorders
Device dislocation
|
0.00%
0/12 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.3%
1/19 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/23 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/12 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
4.3%
1/23 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Infections and infestations
Catheter site cellulitis
|
0.00%
0/12 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.3%
1/19 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/23 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Infections and infestations
Enterobacter bacteraemia
|
0.00%
0/12 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
9.1%
1/11 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/23 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Infections and infestations
Septic shock
|
8.3%
1/12 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/23 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Infections and infestations
Vulval abscess
|
0.00%
0/12 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.3%
1/19 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/23 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/12 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
4.3%
1/23 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/12 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.3%
1/19 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/23 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/12 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
4.3%
1/23 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/12 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.3%
1/19 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/23 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/12 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
4.3%
1/23 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
Other adverse events
| Measure |
Part IA-fosaprepitant 115 mg/Aprepitant
n=12 participants at risk
Day 1, fosaprepitant IV at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg PO, prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
|
Part IB-fosaprepitant 150 mg
n=11 participants at risk
Day 1, fosaprepitant, IV at a dose of 150 mg, prior to chemotherapy for participants 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
|
Part IIA-aprepitant 80 mg Equiv.
n=19 participants at risk
Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 6 months to \<12 years of age - 47 mg/m\^2; 4 months to \<6 months of age - 2.0 mg/kg; 1 month to \<4 months of age - 1.0 mg/kg; birth to \<1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
|
Part IIB-aprepitant 125 mg Equiv.
n=19 participants at risk
Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 2 years to \<12 years of age - 74 mg/m\^2; 6 months to \<2 years of age - 1.3 mg/kg; 4 months to \<6 months of age - 3.0 mg/kg; 1 month to \<4 months of age - 1.5 mg/kg; birth to \<1 month of age - 0.75 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
|
Part III-ondansetron
n=19 participants at risk
Ondansetron administered IV per local standard of care on Days 1, 2, and 3 prior to chemotherapy for participants from birth to \<12 years of age. The use of IV dexamethasone is optional with the exception of the birth to one year old cohort.
|
Part IV-aprepitant Regimen
n=20 participants at risk
Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to \<12 years of age - 3.0 mg/kg; 1 month to \<4 months of age - 1.5 mg/kg; Birth to \<1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to \<12 years of age - 2.0 mg/kg; 1 month to \<4 months of age - 1.0 mg/kg; Birth to \<1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.
|
Part V-fosaprepitant Regimen
n=23 participants at risk
Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to \<12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
|
|---|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/12 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.3%
1/19 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/23 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Blood and lymphatic system disorders
Anaemia
|
25.0%
3/12 • Number of events 3 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
26.3%
5/19 • Number of events 5 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
26.3%
5/19 • Number of events 5 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
15.0%
3/20 • Number of events 3 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
13.0%
3/23 • Number of events 3 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Blood and lymphatic system disorders
Bone marrow failure
|
8.3%
1/12 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/23 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/12 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.3%
1/19 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/23 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
8.3%
1/12 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
10.5%
2/19 • Number of events 2 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.0%
1/20 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/23 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/12 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.3%
1/19 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/23 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/12 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
9.1%
1/11 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/23 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
8.3%
1/12 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.3%
1/19 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/23 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Blood and lymphatic system disorders
Neutropenia
|
8.3%
1/12 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
10.5%
2/19 • Number of events 2 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
21.1%
4/19 • Number of events 4 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
15.8%
3/19 • Number of events 3 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
15.0%
3/20 • Number of events 3 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
21.7%
5/23 • Number of events 5 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
16.7%
2/12 • Number of events 2 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
15.8%
3/19 • Number of events 3 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
21.1%
4/19 • Number of events 5 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
25.0%
5/20 • Number of events 5 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
17.4%
4/23 • Number of events 5 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/12 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
9.1%
1/11 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/23 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/12 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.3%
1/19 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/23 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Congenital, familial and genetic disorders
Aplasia
|
0.00%
0/12 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.3%
1/19 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/23 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/12 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.3%
1/19 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
4.3%
1/23 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Eye disorders
Eye irritation
|
0.00%
0/12 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
9.1%
1/11 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/23 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Eye disorders
Eye pain
|
0.00%
0/12 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.3%
1/19 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/23 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Eye disorders
Eye pruritus
|
0.00%
0/12 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.3%
1/19 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/23 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Eye disorders
Vision blurred
|
8.3%
1/12 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/23 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Gastrointestinal disorders
Abdominal pain
|
8.3%
1/12 • Number of events 2 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
10.5%
2/19 • Number of events 2 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
21.1%
4/19 • Number of events 4 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.3%
1/19 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.0%
1/20 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
13.0%
3/23 • Number of events 4 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/12 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
9.1%
1/11 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
15.8%
3/19 • Number of events 3 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.0%
1/20 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
4.3%
1/23 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/12 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
9.1%
1/11 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.3%
1/19 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.3%
1/19 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
15.8%
3/19 • Number of events 3 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.0%
1/20 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
8.7%
2/23 • Number of events 2 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Gastrointestinal disorders
Flatulence
|
8.3%
1/12 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/23 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Gastrointestinal disorders
Gingival bleeding
|
8.3%
1/12 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/23 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/12 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.3%
1/19 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/23 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Gastrointestinal disorders
Lip blister
|
0.00%
0/12 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.3%
1/19 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/23 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Gastrointestinal disorders
Nausea
|
25.0%
3/12 • Number of events 4 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
10.5%
2/19 • Number of events 3 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
31.6%
6/19 • Number of events 6 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.0%
1/20 • Number of events 2 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
4.3%
1/23 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Gastrointestinal disorders
Odynophagia
|
8.3%
1/12 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
10.5%
2/19 • Number of events 2 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
4.3%
1/23 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Gastrointestinal disorders
Perianal erythema
|
0.00%
0/12 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.3%
1/19 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/23 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Gastrointestinal disorders
Retching
|
8.3%
1/12 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.3%
1/19 • Number of events 2 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.3%
1/19 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.3%
1/19 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/23 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
8.3%
1/12 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/23 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/12 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
9.1%
1/11 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
15.8%
3/19 • Number of events 3 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/23 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Gastrointestinal disorders
Tongue ulceration
|
0.00%
0/12 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.3%
1/19 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/23 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Gastrointestinal disorders
Toothache
|
8.3%
1/12 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/23 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Gastrointestinal disorders
Vomiting
|
41.7%
5/12 • Number of events 7 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
47.4%
9/19 • Number of events 23 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
42.1%
8/19 • Number of events 21 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
10.5%
2/19 • Number of events 2 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.0%
1/20 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
21.7%
5/23 • Number of events 7 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
General disorders
Chest pain
|
8.3%
1/12 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.3%
1/19 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
4.3%
1/23 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
General disorders
Chills
|
8.3%
1/12 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/23 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
General disorders
Fatigue
|
8.3%
1/12 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
9.1%
1/11 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.3%
1/19 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
4.3%
1/23 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
General disorders
Hyperthermia
|
8.3%
1/12 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/23 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
General disorders
Implant site reaction
|
0.00%
0/12 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.3%
1/19 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/23 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
General disorders
Irritability
|
0.00%
0/12 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.3%
1/19 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.0%
1/20 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
4.3%
1/23 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/12 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.3%
1/19 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/23 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
General disorders
Pain
|
0.00%
0/12 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.3%
1/19 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/23 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
General disorders
Product taste abnormal
|
0.00%
0/12 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.3%
1/19 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/23 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
General disorders
Pyrexia
|
0.00%
0/12 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
10.5%
2/19 • Number of events 2 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.3%
1/19 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.3%
1/19 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.0%
1/20 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
30.4%
7/23 • Number of events 8 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
General disorders
Secretion discharge
|
0.00%
0/12 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.3%
1/19 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/23 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Hepatobiliary disorders
Liver disorder
|
0.00%
0/12 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
9.1%
1/11 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/23 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Infections and infestations
Cystitis
|
8.3%
1/12 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/23 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Infections and infestations
Influenza
|
8.3%
1/12 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/23 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/12 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.3%
1/19 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
10.0%
2/20 • Number of events 2 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
4.3%
1/23 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Infections and infestations
Oral bacterial infection
|
0.00%
0/12 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.3%
1/19 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/23 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Infections and infestations
Oral candidiasis
|
8.3%
1/12 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.0%
1/20 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/23 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/12 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.3%
1/19 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/23 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/12 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.3%
1/19 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/23 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/12 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.3%
1/19 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/23 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.00%
0/12 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.3%
1/19 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/23 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Investigations
Alanine aminotranferase increased
|
8.3%
1/12 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.0%
1/20 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
4.3%
1/23 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Investigations
Aspartate aminotransferase increased
|
8.3%
1/12 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.0%
1/20 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/23 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Investigations
Blood bicarbonate decreased
|
8.3%
1/12 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.3%
1/19 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/23 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Investigations
Blood glucose increased
|
8.3%
1/12 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/23 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Investigations
Blood phosphorus decreased
|
0.00%
0/12 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.3%
1/19 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/23 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Investigations
Blood potassium decreased
|
8.3%
1/12 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/23 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Investigations
Blood sodium decreased
|
8.3%
1/12 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.3%
1/19 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.3%
1/19 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/23 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Investigations
Blood uric acid increased
|
0.00%
0/12 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.3%
1/19 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/23 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Investigations
Body temperature increased
|
8.3%
1/12 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/23 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Investigations
Drug clearance decreased
|
0.00%
0/12 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
9.1%
1/11 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/23 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/12 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.3%
1/19 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/23 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Investigations
Glucose urine present
|
0.00%
0/12 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.3%
1/19 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/23 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Investigations
Haemoglobin decreased
|
8.3%
1/12 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.3%
1/19 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.3%
1/19 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.3%
1/19 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/23 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/12 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
15.8%
3/19 • Number of events 4 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/23 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Investigations
Neutrophil count decreased
|
8.3%
1/12 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.3%
1/19 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
15.8%
3/19 • Number of events 3 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/23 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Investigations
Platelet count decreased
|
0.00%
0/12 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.3%
1/19 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.3%
1/19 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
15.8%
3/19 • Number of events 3 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.0%
1/20 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/23 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Investigations
Red blood cell count decreased
|
0.00%
0/12 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.3%
1/19 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/23 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Investigations
Staphylococcus test positive
|
0.00%
0/12 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.3%
1/19 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/23 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Investigations
Weight decreased
|
0.00%
0/12 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
10.5%
2/19 • Number of events 2 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/23 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Investigations
White blood cell count decreased
|
8.3%
1/12 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
10.5%
2/19 • Number of events 2 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
15.8%
3/19 • Number of events 3 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/23 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/12 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.3%
1/19 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
10.0%
2/20 • Number of events 2 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
4.3%
1/23 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Metabolism and nutrition disorders
Dehydration
|
8.3%
1/12 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
10.0%
2/20 • Number of events 2 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/23 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/12 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.3%
1/19 • Number of events 2 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
4.3%
1/23 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/12 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
10.5%
2/19 • Number of events 2 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
10.0%
2/20 • Number of events 2 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
4.3%
1/23 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/12 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
10.5%
2/19 • Number of events 2 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.0%
1/20 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/23 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/12 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
10.5%
2/19 • Number of events 2 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/23 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/12 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.3%
1/19 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.3%
1/19 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.0%
1/20 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/23 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/12 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.3%
1/19 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.0%
1/20 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
4.3%
1/23 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/12 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
9.1%
1/11 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
4.3%
1/23 • Number of events 2 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/12 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.3%
1/19 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/23 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/12 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.3%
1/19 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.3%
1/19 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/23 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oncologic complication
|
0.00%
0/12 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.3%
1/19 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/23 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Nervous system disorders
Dizziness
|
25.0%
3/12 • Number of events 3 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.0%
1/20 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
4.3%
1/23 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/12 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.3%
1/19 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/23 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Nervous system disorders
Formication
|
8.3%
1/12 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/23 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Nervous system disorders
Headache
|
0.00%
0/12 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
10.5%
2/19 • Number of events 4 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.3%
1/19 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
15.8%
3/19 • Number of events 3 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.0%
1/20 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
8.7%
2/23 • Number of events 2 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Nervous system disorders
Parosmia
|
0.00%
0/12 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.3%
1/19 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/23 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Nervous system disorders
Sensory disturbance
|
0.00%
0/12 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
9.1%
1/11 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/23 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/12 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
9.1%
1/11 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
4.3%
1/23 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Reproductive system and breast disorders
Perineal erythema
|
0.00%
0/12 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.3%
1/19 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/23 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/12 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.3%
1/19 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/23 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Respiratory, thoracic and mediastinal disorders
Asthmatic crisis
|
0.00%
0/12 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.3%
1/19 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/23 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/12 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.3%
1/19 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
10.5%
2/19 • Number of events 2 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.0%
1/20 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
8.7%
2/23 • Number of events 2 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.3%
1/12 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/23 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/12 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.3%
1/19 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
4.3%
1/23 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/12 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.3%
1/19 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.3%
1/19 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/23 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/12 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
9.1%
1/11 • Number of events 2 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.3%
1/19 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/23 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
8.3%
1/12 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/23 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/12 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.3%
1/19 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/23 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/12 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
10.5%
2/19 • Number of events 3 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.3%
1/19 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
5.0%
1/20 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/23 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
8.3%
1/12 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/11 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/23 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
|
Vascular disorders
Hypotension
|
0.00%
0/12 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
9.1%
1/11 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/19 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
8.7%
2/23 • Number of events 2 • Up to 14 days after last dose of study drug (Up to 17 days)
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation.
- Publication restrictions are in place
Restriction type: OTHER