Trial Outcomes & Findings for PRINCE: Study of Atazanavir (ATV)/Ritonavir (RTV) (NCT NCT01099579)
NCT ID: NCT01099579
Last Updated: 2018-05-24
Results Overview
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
82 participants
Primary outcome timeframe
From Day 1 to Week 48
Results posted on
2018-05-24
Participant Flow
A total of 82 pediatric patients were enrolled, and 56 received treatment. Reasons for not receiving treatment treated were: no longer met study criteria (23 patients), other reason (2 patients), and withdrew consent (1 patient).
Participant milestones
| Measure |
Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg
Patients weighing 5 to \<10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Stage 1: Initial dose was determined by patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation. Stage 2: Patients who reached the age of 6 years or a weight of 25 kg were transitioned to the capsule formulation of ATV. Those who weighed 15 to \<20 kg received ATV, 150 mg, with RTV, 100 mg; those who weighed 20 to \<40 mg received ATV, 200, with RTV, 100 mg; and those who weighed at least 40 mg received ATV, 300 mg, with RTV, 100 mg.
|
Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg
Patients weighing 10 to \<15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Stage 1: Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation. Stage 2: Patients who reached the age of 6 years or a weight 25 kg were transitioned to the capsule formulation of ATV. Those who weighed 15 to \<20 kg received ATV, 150 mg, with RTV, 100 mg; those who weighed 20 to \<40 mg received ATV, 200, with RTV, 100 mg; and those who weighed at least 40 mg received ATV, 300 mg, with RTV, 100 mg.
|
Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg
Patients weighing 15 to \<25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Stage 1: Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation. Stage 2: Patients who reached the age of 6 years or a weight 25 kg were transitioned to the capsule formulation of ATV. Those who weighed 15 to \<20 kg received ATV, 150 mg, with RTV, 100 mg; those who weighed 20 to \<40 mg received ATV, 200, with RTV, 100 mg; and those who weighed at least 40 mg received ATV, 300 mg, with RTV, 100 mg.
|
|---|---|---|---|
|
Stage 1 (ATV Powder Formulation)
STARTED
|
21
|
19
|
16
|
|
Stage 1 (ATV Powder Formulation)
COMPLETED
|
17
|
14
|
15
|
|
Stage 1 (ATV Powder Formulation)
NOT COMPLETED
|
4
|
5
|
1
|
|
Stage 2 (ATV Capsule)
STARTED
|
16
|
14
|
15
|
|
Stage 2 (ATV Capsule)
COMPLETED
|
10
|
9
|
9
|
|
Stage 2 (ATV Capsule)
NOT COMPLETED
|
6
|
5
|
6
|
Reasons for withdrawal
| Measure |
Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg
Patients weighing 5 to \<10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Stage 1: Initial dose was determined by patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation. Stage 2: Patients who reached the age of 6 years or a weight of 25 kg were transitioned to the capsule formulation of ATV. Those who weighed 15 to \<20 kg received ATV, 150 mg, with RTV, 100 mg; those who weighed 20 to \<40 mg received ATV, 200, with RTV, 100 mg; and those who weighed at least 40 mg received ATV, 300 mg, with RTV, 100 mg.
|
Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg
Patients weighing 10 to \<15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Stage 1: Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation. Stage 2: Patients who reached the age of 6 years or a weight 25 kg were transitioned to the capsule formulation of ATV. Those who weighed 15 to \<20 kg received ATV, 150 mg, with RTV, 100 mg; those who weighed 20 to \<40 mg received ATV, 200, with RTV, 100 mg; and those who weighed at least 40 mg received ATV, 300 mg, with RTV, 100 mg.
|
Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg
Patients weighing 15 to \<25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Stage 1: Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation. Stage 2: Patients who reached the age of 6 years or a weight 25 kg were transitioned to the capsule formulation of ATV. Those who weighed 15 to \<20 kg received ATV, 150 mg, with RTV, 100 mg; those who weighed 20 to \<40 mg received ATV, 200, with RTV, 100 mg; and those who weighed at least 40 mg received ATV, 300 mg, with RTV, 100 mg.
|
|---|---|---|---|
|
Stage 1 (ATV Powder Formulation)
Adverse Event
|
4
|
1
|
0
|
|
Stage 1 (ATV Powder Formulation)
Withdrawal by Subject
|
0
|
0
|
1
|
|
Stage 1 (ATV Powder Formulation)
Lack of Efficacy
|
0
|
2
|
0
|
|
Stage 1 (ATV Powder Formulation)
Poor compliance/noncompliance
|
0
|
2
|
0
|
|
Stage 2 (ATV Capsule)
No longer met study criteria
|
2
|
2
|
1
|
|
Stage 2 (ATV Capsule)
Lost to Follow-up
|
1
|
1
|
1
|
|
Stage 2 (ATV Capsule)
Lack of Efficacy
|
0
|
0
|
2
|
|
Stage 2 (ATV Capsule)
Withdrawal by Subject
|
1
|
1
|
1
|
|
Stage 2 (ATV Capsule)
Poor/Non-Compliance
|
2
|
0
|
1
|
|
Stage 2 (ATV Capsule)
Adverse Event
|
0
|
1
|
0
|
Baseline Characteristics
PRINCE: Study of Atazanavir (ATV)/Ritonavir (RTV)
Baseline characteristics by cohort
| Measure |
Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg
n=21 Participants
Patients weighing 5 to \<10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Stage 1: Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation. Stage 2: Patients who reached the age of 6 years or a weight 25 kg were transitioned to the capsule formulation of ATV. RTV capsules or tablets were ingested with food immediately before or after ATV intake.
|
Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg
n=19 Participants
Patients weighing 10 to \<15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Stage 1: Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation. Stage 2: Patients who reached the age of 6 years or a weight 25 kg were transitioned to the capsule formulation of ATV. Those who weighed 15 to 20 kg received ATV, 150 mg, with RTV, 100 mg, and those who weighed 20 to 40 mg received ATV, 200 mg with RTV,100 mg. RTV capsules or tablets were ingested with food immediately before or after ATV intake.
|
Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg
n=16 Participants
Patients weighing 15 to \<25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Stage 1: Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation. Stage 2: Patients who reached the age of 6 years or a weight of 25 kg were transitioned to the capsule formulation of ATV. Those who weighed 20 to 40 mg received ATV, 200 mg, with RTV, 100 mg, and those who weighed at least 40 kg received ATV, 300 mg, with RTV, 100 mg. RTV capsules or tablets were ingested with food immediately before or after ATV intake.
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
7.3 Months
STANDARD_DEVIATION 4.05 • n=5 Participants
|
35.4 Months
STANDARD_DEVIATION 11.63 • n=7 Participants
|
52.1 Months
STANDARD_DEVIATION 10.49 • n=5 Participants
|
29.6 Months
STANDARD_DEVIATION 20.72 • n=4 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Not reported
|
21 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
55 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Country
Chile
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Country
Mexico
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Country
Peru
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Country
South Africa
|
17 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
|
Country
Thailand
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
HIV RNA
|
4.77 Log10 c/mL
STANDARD_DEVIATION 0.602 • n=5 Participants
|
4.83 Log10 c/mL
STANDARD_DEVIATION 0.268 • n=7 Participants
|
4.18 Log10 c/mL
STANDARD_DEVIATION 0.727 • n=5 Participants
|
4.62 Log10 c/mL
STANDARD_DEVIATION 0.617 • n=4 Participants
|
|
HIV RNA
<30,000 c/mL
|
3 c/mL
n=5 Participants
|
2 c/mL
n=7 Participants
|
9 c/mL
n=5 Participants
|
14 c/mL
n=4 Participants
|
|
HIV RNA
30,000 to 100,000 c/mL
|
0 c/mL
n=5 Participants
|
7 c/mL
n=7 Participants
|
3 c/mL
n=5 Participants
|
10 c/mL
n=4 Participants
|
|
HIV RNA
>100,000 c/mL
|
18 c/mL
n=5 Participants
|
10 c/mL
n=7 Participants
|
4 c/mL
n=5 Participants
|
32 c/mL
n=4 Participants
|
|
CD4 Count
|
1594.1 Cells/mm^3
STANDARD_DEVIATION 897.19 • n=5 Participants
|
1107.4 Cells/mm^3
STANDARD_DEVIATION 643.25 • n=7 Participants
|
661.1 Cells/mm^3
STANDARD_DEVIATION 302.60 • n=5 Participants
|
1192.6 Cells/mm^3
STANDARD_DEVIATION 784.08 • n=4 Participants
|
|
CD4 Percent
|
25.4 Percentage
STANDARD_DEVIATION 12.11 • n=5 Participants
|
22.0 Percentage
STANDARD_DEVIATION 9.35 • n=7 Participants
|
27.5 Percentage
STANDARD_DEVIATION 9.85 • n=5 Participants
|
24.8 Percentage
STANDARD_DEVIATION 10.61 • n=4 Participants
|
|
CD4 Percent
<15
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
CD4 Percent
15 to <25
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
CD4 Percent
>=25
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
CD4 Percent
Not reported
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Prior Antiretroviral (ARV) Treatment Use
ARV naive
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Prior Antiretroviral (ARV) Treatment Use
ARV experienced
|
14 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From Day 1 to Week 48Population: All participants who received at least 1 dose of active atazanavir powder.
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.
Outcome measures
| Measure |
Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg
n=21 Participants
Patients weighing 5 to \<10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
|
Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg
n=19 Participants
Patients weighing 10 to \<15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation.
|
Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg
n=16 Participants
Patients weighing 15 to \<25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
|
|---|---|---|---|
|
Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation
Deaths
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation
SAEs
|
5 Participants
|
2 Participants
|
4 Participants
|
|
Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation
AEs leading to discontinuation
|
4 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: After Day 1 to Week 48Population: All participants who received at least 1 dose of atazanavir; n=number of evaluable participants.
ALT=alanine aminotransferase; SGPT=serum glutamic-pyruvic transaminase; AST=aspartate aminotransferase; SGOT=serum glutamic-oxaloacetic transaminase; ULN=upper limit of normal. Grading by the National Institute of Health Division of AIDs and World Health Organization criteria. Hemoglobin (g/dL): Grade (Gr)1=9.5-11.0; Gr 2=8.0-9.4; Gr 3=6.5-7.9; Gr 4=\<6.5. Neutrophils, absolute (/mm\^3): Gr 1=\>=1000-\<1500; Gr 2= \>=750-\<1000; Gr 3=\>=500-\<750; Gr 4=\<500. ALT/SGPT (\*ULN): Gr 1=1.25-2.5; Gr 2=2.6-5; Gr 3=5.1-10; Gr 4=\>10. AST/SGOT (\*ULN): Gr 1=1.25-2.5; Gr 2=2.6-5; Gr 3=5.1-10; Gr 4=\>10. Alkaline phosphatase(\*ULN): Gr 1=1.25-2.5; Gr 2=2.6-5: Gr 3=5.1-10; Gr 4=\>10. Total bilirubin (\*ULN): Gr 1=1.1-1; Gr 2=1.6-2.5; Gr 3=2.6-5; Gr 4=\>5. Amylase (\*ULN): Gr 1=1.10-39; Gr 2=1.40-2; Gr 3=2.10-5.0; Gr 4=\>5.0. Lipase (\*ULN): Gr 1=1.10-1.39: Gr 2=1.40-2; Gr 3=2.10-5.0; Gr 4=\>5.0. Uric acid (mg/dL): Gr 1=7.5-10.0; Gr 2=10.1-12.0; Gr 3=12.1-15.0; Gr 4=\>15.
Outcome measures
| Measure |
Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg
n=21 Participants
Patients weighing 5 to \<10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
|
Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg
n=19 Participants
Patients weighing 10 to \<15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation.
|
Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg
n=16 Participants
Patients weighing 15 to \<25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
|
|---|---|---|---|
|
Number of Participants With Laboratory Test Results With Worst Toxicity of Grade 3-4
Hemoglobin (n=20, 17, 15)
|
2 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Results With Worst Toxicity of Grade 3-4
Neutrophils, absolute (n=20, 17, 15)
|
3 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Results With Worst Toxicity of Grade 3-4
ALT/SGPT (n=20, 18, 15)
|
5 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Results With Worst Toxicity of Grade 3-4
AST/SGOT (n=20, 18, 15)
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Results With Worst Toxicity of Grade 3-4
Alkaline phosphatase (n=20, 18, 15)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Results With Worst Toxicity of Grade 3-4
Total bilirubin (n=20, 18, 15)
|
2 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants With Laboratory Test Results With Worst Toxicity of Grade 3-4
Amylase (n=20, 18, 15)
|
8 Participants
|
5 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Results With Worst Toxicity of Grade 3-4
Lipase (n=20, 18, 15)
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Results With Worst Toxicity of Grade 3-4
Uric acid n=20, 18, 15)
|
0 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: From Baseline to Week 48Population: All participants who received at least 1 dose of atazanavir and were evaluable
Electrocardiogram parameters were measured at baseline for QTC Bazett, QTC Fridericia, and PR interval. The mean change from baseline at week 48 is reported by arm in milliseconds.
Outcome measures
| Measure |
Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg
n=17 Participants
Patients weighing 5 to \<10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
|
Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg
n=15 Participants
Patients weighing 10 to \<15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation.
|
Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg
n=13 Participants
Patients weighing 15 to \<25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
|
|---|---|---|---|
|
Electrocardiogram Changes From Baseline in PR Interval, QTC Bazett, and QTC Fridericia at Week 48
PR Interval
|
4.9 Milliseconds
Standard Deviation 21.80
|
12.0 Milliseconds
Standard Deviation 8.04
|
6.2 Milliseconds
Standard Deviation 8.54
|
|
Electrocardiogram Changes From Baseline in PR Interval, QTC Bazett, and QTC Fridericia at Week 48
QTC Bazett
|
1.7 Milliseconds
Standard Deviation 17.73
|
-3.2 Milliseconds
Standard Deviation 21.78
|
-4.2 Milliseconds
Standard Deviation 13.02
|
|
Electrocardiogram Changes From Baseline in PR Interval, QTC Bazett, and QTC Fridericia at Week 48
QTC Fridericia
|
7.9 Milliseconds
Standard Deviation 18.36
|
13.2 Milliseconds
Standard Deviation 18.92
|
4.8 Milliseconds
Standard Deviation 11.49
|
PRIMARY outcome
Timeframe: From Day 1 to Week 48CDC Class C events are AIDS-defining events that include recurrent bacterial pneumonia (\>=2 episodes in 12 months); candidiasis of the bronchi, trachea, lungs, or esophagus; invasive cervical carcinoma; disseminated or extrapulmonary coccidioidomycosis; extrapulmonary cryptococcosis; chronic intestinal cryptosporidiosis (\>1 month); cytomegalovirus disease; HIV-related encephalopathy; herpes simplex: chronic ulcers, or bronchitis, pneumonitis, or esophagitis; disseminated or extrapulmonary histoplasmosis; chronic intestinal isosporiasis; Kaposi sarcoma; immunoblastic or primary brain Burkitt lymphoma; mycobacterium avium complex, kansasii, or tuberculosis; mycobacterium, other species; Pneumocystis carinii pneumonia; progressive multifocal leukoencephalopathy; Salmonella septicemia; recurrent toxoplasmosis of brain; HIV wasting syndrome (involuntary weight loss \>10% of baseline body weight) with chronic diarrhea or chronic weakness and documented fever for ≥1 month.
Outcome measures
| Measure |
Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg
n=21 Participants
Patients weighing 5 to \<10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
|
Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg
n=19 Participants
Patients weighing 10 to \<15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation.
|
Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg
n=16 Participants
Patients weighing 15 to \<25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
|
|---|---|---|---|
|
Number of Participants With Centers for Disease Control (CDC) Class C AIDS Events
|
1 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At Week 48Population: Participants who received at least 1 dose of atazanavir and who did not switch to the capsule formulation at or before Week 48
The definition of virologic success included HIV RNA levels \<50 c/mL or 400 c/mL at the Week 48 analysis window. .
Outcome measures
| Measure |
Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg
n=21 Participants
Patients weighing 5 to \<10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
|
Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg
n=19 Participants
Patients weighing 10 to \<15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation.
|
Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg
n=14 Participants
Patients weighing 15 to \<25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
|
|---|---|---|---|
|
Percentage of Participants With HIV RNA Levels <50 c/mL and <400 c/mL at Week 48 by Treatment/Weight
HIV RNA levels <50 c/mL
|
47.6 Percentage of participants
|
68.4 Percentage of participants
|
71.4 Percentage of participants
|
|
Percentage of Participants With HIV RNA Levels <50 c/mL and <400 c/mL at Week 48 by Treatment/Weight
HIV RNA levels <400 c/mL
|
66.7 Percentage of participants
|
73.7 Percentage of participants
|
85.7 Percentage of participants
|
SECONDARY outcome
Timeframe: From Day 1 to Week 48Population: Participants who received at least 1 dose of atazanavir (ATV) and who did not switch to the ATV capsule formulation on or before Week 48
The definition of virologic success included HIV RNA levels \<50 c/mL or \<400 c/mL at the Week 48 analysis.
Outcome measures
| Measure |
Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg
n=20 Participants
Patients weighing 5 to \<10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
|
Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg
n=34 Participants
Patients weighing 10 to \<15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation.
|
Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg
Patients weighing 15 to \<25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
|
|---|---|---|---|
|
Percentage of Participants With HIV RNA Levels <50 c/mL and <400 c/mL at Week 48 by Prior Antiretroviral (ARV) Treatment Status
HIV RNA levels <50 c/mL
|
56.3 Percentage of participants
|
68.2 Percentage of participants
|
—
|
|
Percentage of Participants With HIV RNA Levels <50 c/mL and <400 c/mL at Week 48 by Prior Antiretroviral (ARV) Treatment Status
HIV RNA levels <400 c/mL
|
65.6 Percentage of participants
|
86.4 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: From Baseline to Week 48Population: Participants who received at least 1 dose of atazanavir and who had HIV RNA while taking atazanavir powder at Week 48
Participants who received at least 1 dose of atazanavir (ATV) and had an HIV RNA measurement on ATV powder at did not switch to the capsule formulation before Week 48
Outcome measures
| Measure |
Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg
n=17 Participants
Patients weighing 5 to \<10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
|
Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg
n=15 Participants
Patients weighing 10 to \<15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation.
|
Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg
n=13 Participants
Patients weighing 15 to \<25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
|
|---|---|---|---|
|
Mean Change From Baseline in HIV RNA Levels at Week 48 by Treatment/Weight
|
-2.61 Log10 c/mL
Standard Error 0.3111
|
-2.93 Log10 c/mL
Standard Error 0.1678
|
-2.40 Log10 c/mL
Standard Error 0.2412
|
SECONDARY outcome
Timeframe: From Baseline to Week 48Population: Participants who received at least 1 dose of atazanavir (ATV) and who had an HIV RNA measurement on ATV powder at Week 48
Outcome measures
| Measure |
Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg
n=34 Participants
Patients weighing 5 to \<10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
|
Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg
n=22 Participants
Patients weighing 10 to \<15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation.
|
Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg
Patients weighing 15 to \<25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
|
|---|---|---|---|
|
Mean Change From Baseline in HIV RNA Levels at Week 48 by Prior Antiretroviral (ARV) Treatment Status
|
-2.53 Log10 c/mL
Standard Error 0.2452
|
-2.81 Log10 c/mL
Standard Error 0.1296
|
—
|
SECONDARY outcome
Timeframe: From Baseline to Week 48Population: Participants who received at least 1 dose of atazanavir (ATV) and who had CD4 at baseline and Week 48 while taking ATV powder
Outcome measures
| Measure |
Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg
n=13 Participants
Patients weighing 5 to \<10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
|
Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg
n=11 Participants
Patients weighing 10 to \<15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation.
|
Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg
n=5 Participants
Patients weighing 15 to \<25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
|
|---|---|---|---|
|
CD4 Cell Count Changes From Baseline at Week 48 by Treatment/Weight
|
550.1 Cells/mm^3
Standard Error 285.24
|
225.3 Cells/mm^3
Standard Error 198.34
|
373.8 Cells/mm^3
Standard Error 68.83
|
SECONDARY outcome
Timeframe: From Baseline to Week 48Population: Participants who received at least 1 dose of atazanavir (ATV) and who had CD4 at baseline and Week 48 while taking ATV powder
Outcome measures
| Measure |
Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg
n=34 Participants
Patients weighing 5 to \<10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
|
Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg
n=22 Participants
Patients weighing 10 to \<15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation.
|
Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg
Patients weighing 15 to \<25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
|
|---|---|---|---|
|
CD4 Cell Count Changes From Baseline at Week 48 by Prior Antiretroviral (ARV) Treatment Status
|
437.9 Cells/mm^3
Standard Error 253.123
|
352.1 Cells/mm^3
Standard Error 152.600
|
—
|
SECONDARY outcome
Timeframe: From Baseline to Week 48Population: Participants who received at least 1 dose of atazanavir (ATV) and who had CD4 percent at baseline and Week 48 while taking ATV powder
Outcome measures
| Measure |
Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg
n=14 Participants
Patients weighing 5 to \<10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
|
Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg
n=12 Participants
Patients weighing 10 to \<15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation.
|
Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg
n=6 Participants
Patients weighing 15 to \<25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
|
|---|---|---|---|
|
Mean CD4 Percent Changes From Baseline at Week 48 by Treatment/Weight
|
6.1 Percentage of lymphocytes
Standard Error 1.56
|
7.3 Percentage of lymphocytes
Standard Error 2.26
|
8.8 Percentage of lymphocytes
Standard Error 1.14
|
SECONDARY outcome
Timeframe: From Baseline to Week 48Population: Participants who received at least 1 dose of atazanavir (ATV) and who had CD4 percent at baseline and Week 48 while taking ATV powder
Outcome measures
| Measure |
Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg
n=34 Participants
Patients weighing 5 to \<10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
|
Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg
n=22 Participants
Patients weighing 10 to \<15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation.
|
Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg
Patients weighing 15 to \<25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
|
|---|---|---|---|
|
Mean CD4 Percent Changes From Baseline at Week 48 by Antiretroviral (ARV) Treatment Status
|
4.3 Percentage of lymphocytes
Standard Error 1.316
|
9.8 Percentage of lymphocytes
Standard Error 1.496
|
—
|
SECONDARY outcome
Timeframe: After Day 1 to Week 48Population: Participants who met the criteria for virologic failure
Criteria for resistance testing= meeting at least 1 of the following: \<1 log10 drop from baseline in HIV RNA level by Week 16 and confirmed by a second HIV RNA level; an HIV RNA level \>200 copies/mL after Week 24, confirmed by a second HIV RNA level; repeated HIV RNA levels ≥50 copies/mL after Week 48; an HIV RNA level ≥400 copies/mL confirmed by a second HIV RNA level of ≥400 copies/mL at any time in a participant who had previously achieved a plasma HIV RNA level \<50 copies/mL; or discontinued due to lack of efficacy. Virologic failure was defined as an incomplete virologic response to therapy or as a viral rebound after the achievement of virologic suppression. The phenotypic resistance to a drug is defined as a fold change (ie, ratio of the 50% inhibitory concentration \[IC50\] of the clinical isolate to the IC50 of the reference strain) greater than the cut-off for reduced susceptibility.
Outcome measures
| Measure |
Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg
n=6 Participants
Patients weighing 5 to \<10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
|
Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg
n=8 Participants
Patients weighing 10 to \<15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation.
|
Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg
Patients weighing 15 to \<25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
|
|---|---|---|---|
|
Number of Participants Who Acquired Phenotypic Resistance to Atazanavir or Atazanovir/Ritonavir
Atazanavir
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Who Acquired Phenotypic Resistance to Atazanavir or Atazanovir/Ritonavir
Ritonavir
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: At Week 2 at Hour 0 predose and at Hours 1.5, 2.5, 4, 6, 8, 12, and 24 postdosePopulation: All participants who had received study drug and had adequate pharmacokinetic profiles (n=number evaluable)
Outcome measures
| Measure |
Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg
n=20 Participants
Patients weighing 5 to \<10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
|
Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg
n=18 Participants
Patients weighing 10 to \<15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation.
|
Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg
n=15 Participants
Patients weighing 15 to \<25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
|
|---|---|---|---|
|
Maximum Observed Concentration (Cmax) and Minimum Observed Concentration (Cmin) of Atazanavir and Ritonavir
Atazanavir Cmax
|
4131 ng/mL
Interval 1110.0 to 9660.0
|
5197 ng/mL
Interval 390.0 to 15000.0
|
6172 ng/mL
Interval 3560.0 to 10400.0
|
|
Maximum Observed Concentration (Cmax) and Minimum Observed Concentration (Cmin) of Atazanavir and Ritonavir
Atazanavir Cmin
|
336 ng/mL
Interval 11.4 to 1330.0
|
572 ng/mL
Interval 11.2 to 4870.0
|
698 ng/mL
Interval 238.0 to 2410.0
|
|
Maximum Observed Concentration (Cmax) and Minimum Observed Concentration (Cmin) of Atazanavir and Ritonavir
Ritonavir Cmax (n=19, 18, 15)
|
2919 ng/mL
Interval 188.0 to 9160.0
|
2634 ng/mL
Interval 163.0 to 17700.0
|
1838 ng/mL
Interval 582.0 to 4960.0
|
|
Maximum Observed Concentration (Cmax) and Minimum Observed Concentration (Cmin) of Atazanavir and Ritonavir
Ritonavir Cmin (n=18, 16, 15)
|
41.8 ng/mL
Interval 12.7 to 311.0
|
143 ng/mL
Interval 14.2 to 1610.0
|
51.0 ng/mL
Interval 9.0 to 468.0
|
SECONDARY outcome
Timeframe: At Week 2 at Hour 0 predose and at Hours 1.5, 2.5, 4, 6, 8, 12, and 24 postdosePopulation: All participants who had received study drug and had adequate pharmacokinetic profiles (n=number evaluable)
Outcome measures
| Measure |
Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg
n=20 Participants
Patients weighing 5 to \<10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
|
Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg
n=18 Participants
Patients weighing 10 to \<15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation.
|
Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg
n=15 Participants
Patients weighing 15 to \<25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
|
|---|---|---|---|
|
Area Under the Concentration Curve (in 1 Dosing Interval From Time 0 to 24 Hours Post Observed Dose) (AUC[TAU])of Atazanavir and Ritonavir
AUC(TAU) Atazanavir
|
32503 ng*h/mL
Interval 10441.0 to 94352.0
|
50305 ng*h/mL
Interval 6697.0 to 189971.0
|
61485 ng*h/mL
Interval 31599.0 to 117171.0
|
|
Area Under the Concentration Curve (in 1 Dosing Interval From Time 0 to 24 Hours Post Observed Dose) (AUC[TAU])of Atazanavir and Ritonavir
AUC(TAU) Ritonavir (n=19, 18, 15)
|
17439 ng*h/mL
Interval 1322.0 to 56864.0
|
20510 ng*h/mL
Interval 971.0 to 229777.0
|
13640 ng*h/mL
Interval 3376.0 to 40806.0
|
SECONDARY outcome
Timeframe: At Week 2 at Hour 0 predose and at Hours 1.5, 2.5, 4, 6, 8, 12, and 24 postdosePopulation: All participants who had received study drug and had adequate pharmacokinetic profiles (n=number evaluable)
Outcome measures
| Measure |
Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg
n=20 Participants
Patients weighing 5 to \<10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
|
Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg
n=18 Participants
Patients weighing 10 to \<15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation.
|
Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg
n=15 Participants
Patients weighing 15 to \<25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
|
|---|---|---|---|
|
Time to Maximum Observed Concentration (Tmax) of Atazanavir and Ritonavir
Tmax Atazanavir
|
1.58 Hours
Interval 1.4 to 12.0
|
1.97 Hours
Interval 1.0 to 6.0
|
4.0 Hours
Interval 1.5 to 6.0
|
|
Time to Maximum Observed Concentration (Tmax) of Atazanavir and Ritonavir
Tmax Ritonavir
|
1.8 Hours
Interval 1.3 to 11.9
|
2.9 Hours
Interval 1.0 to 8.0
|
4.0 Hours
Interval 1.5 to 6.0
|
SECONDARY outcome
Timeframe: At Week 2Population: All participants who had received study drug and had adequate pharmacokinetic profiles (n=number evaluable)
Calculated as dose divided by AUC(TAU). AUC(TAU)=area under the concentration-time curve in 1 dosing interval from time 0 to 24 hours post observed dose.
Outcome measures
| Measure |
Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg
n=20 Participants
Patients weighing 5 to \<10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
|
Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg
n=18 Participants
Patients weighing 10 to \<15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation.
|
Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg
n=15 Participants
Patients weighing 15 to \<25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
|
|---|---|---|---|
|
Apparent Total Body Clearance (CLT/F) of Atazanavir and Ritonavir
CLT/F Atazanavir
|
4.61 L/h
Interval 1.6 to 14.4
|
3.98 L/h
Interval 1.1 to 29.9
|
4.07 L/h
Interval 2.1 to 7.9
|
|
Apparent Total Body Clearance (CLT/F) of Atazanavir and Ritonavir
CLT/F Ritonavir (n=19, 18, 15
|
4.59 L/h
Interval 1.4 to 60.5
|
3.90 L/h
Interval 0.3 to 82.4
|
5.87 L/h
Interval 2.0 to 23.7
|
SECONDARY outcome
Timeframe: At Week 2Population: All participants who had received study drug and had adequate pharmacokinetic profiles (n=number evaluable)
Calculated as CLT/F divided by body weight
Outcome measures
| Measure |
Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg
n=20 Participants
Patients weighing 5 to \<10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
|
Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg
n=18 Participants
Patients weighing 10 to \<15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation.
|
Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg
n=15 Participants
Patients weighing 15 to \<25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
|
|---|---|---|---|
|
Apparent Total Body Clearance Per Body Weight (CLT/F) Per Kilogram of Atazanavir and Ritonavir
CLT/F per kilogram Atazanavir
|
0.65 L/h per kilogram
Interval 0.2 to 1.8
|
0.32 L/h per kilogram
Interval 0.1 to 2.6
|
0.24 L/h per kilogram
Interval 0.1 to 0.5
|
|
Apparent Total Body Clearance Per Body Weight (CLT/F) Per Kilogram of Atazanavir and Ritonavir
CLT/F per kilogram Ritonavir (n=19, 18, 15)
|
0.65 L/h per kilogram
Interval 0.2 to 7.5
|
0.32 L/h per kilogram
Interval 0.04 to 5.9
|
0.35 L/h per kilogram
Interval 0.1 to 1.4
|
Adverse Events
B/L Weight 5 to Less Than 10 kg
Serious events: 7 serious events
Other events: 21 other events
Deaths: 0 deaths
B/L Weight 10 to Less Than 15 kg
Serious events: 5 serious events
Other events: 18 other events
Deaths: 0 deaths
B/L Weight 15 to Less Than 25 kg
Serious events: 5 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
B/L Weight 5 to Less Than 10 kg
n=21 participants at risk
|
B/L Weight 10 to Less Than 15 kg
n=19 participants at risk
|
B/L Weight 15 to Less Than 25 kg
n=16 participants at risk
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
4.8%
1/21 • From Day 1 to Week 48
|
0.00%
0/19 • From Day 1 to Week 48
|
6.2%
1/16 • From Day 1 to Week 48
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/21 • From Day 1 to Week 48
|
0.00%
0/19 • From Day 1 to Week 48
|
6.2%
1/16 • From Day 1 to Week 48
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/21 • From Day 1 to Week 48
|
5.3%
1/19 • From Day 1 to Week 48
|
0.00%
0/16 • From Day 1 to Week 48
|
|
Infections and infestations
Dengue fever
|
0.00%
0/21 • From Day 1 to Week 48
|
5.3%
1/19 • From Day 1 to Week 48
|
0.00%
0/16 • From Day 1 to Week 48
|
|
Infections and infestations
Gastroenteritis
|
4.8%
1/21 • From Day 1 to Week 48
|
0.00%
0/19 • From Day 1 to Week 48
|
0.00%
0/16 • From Day 1 to Week 48
|
|
Infections and infestations
Herpes zoster disseminated
|
0.00%
0/21 • From Day 1 to Week 48
|
0.00%
0/19 • From Day 1 to Week 48
|
6.2%
1/16 • From Day 1 to Week 48
|
|
Infections and infestations
Influenza
|
4.8%
1/21 • From Day 1 to Week 48
|
0.00%
0/19 • From Day 1 to Week 48
|
0.00%
0/16 • From Day 1 to Week 48
|
|
Infections and infestations
Lymphadenitis bacterial
|
4.8%
1/21 • From Day 1 to Week 48
|
0.00%
0/19 • From Day 1 to Week 48
|
0.00%
0/16 • From Day 1 to Week 48
|
|
Infections and infestations
Meningitis
|
4.8%
1/21 • From Day 1 to Week 48
|
0.00%
0/19 • From Day 1 to Week 48
|
6.2%
1/16 • From Day 1 to Week 48
|
|
Infections and infestations
Otitis media chronic
|
0.00%
0/21 • From Day 1 to Week 48
|
0.00%
0/19 • From Day 1 to Week 48
|
6.2%
1/16 • From Day 1 to Week 48
|
|
Infections and infestations
Pneumonia
|
9.5%
2/21 • From Day 1 to Week 48
|
0.00%
0/19 • From Day 1 to Week 48
|
0.00%
0/16 • From Day 1 to Week 48
|
|
Infections and infestations
Sepsis
|
4.8%
1/21 • From Day 1 to Week 48
|
0.00%
0/19 • From Day 1 to Week 48
|
0.00%
0/16 • From Day 1 to Week 48
|
|
Infections and infestations
Varicella zoster virus infection
|
0.00%
0/21 • From Day 1 to Week 48
|
0.00%
0/19 • From Day 1 to Week 48
|
6.2%
1/16 • From Day 1 to Week 48
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/21 • From Day 1 to Week 48
|
5.3%
1/19 • From Day 1 to Week 48
|
0.00%
0/16 • From Day 1 to Week 48
|
|
Investigations
Electrocardiogram qt prolonged
|
0.00%
0/21 • From Day 1 to Week 48
|
5.3%
1/19 • From Day 1 to Week 48
|
0.00%
0/16 • From Day 1 to Week 48
|
|
Investigations
Transaminases increased
|
0.00%
0/21 • From Day 1 to Week 48
|
0.00%
0/19 • From Day 1 to Week 48
|
6.2%
1/16 • From Day 1 to Week 48
|
|
Nervous system disorders
Febrile convulsion
|
0.00%
0/21 • From Day 1 to Week 48
|
0.00%
0/19 • From Day 1 to Week 48
|
6.2%
1/16 • From Day 1 to Week 48
|
|
Nervous system disorders
Seizure
|
4.8%
1/21 • From Day 1 to Week 48
|
0.00%
0/19 • From Day 1 to Week 48
|
0.00%
0/16 • From Day 1 to Week 48
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/21 • From Day 1 to Week 48
|
0.00%
0/19 • From Day 1 to Week 48
|
6.2%
1/16 • From Day 1 to Week 48
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.00%
0/21 • From Day 1 to Week 48
|
5.3%
1/19 • From Day 1 to Week 48
|
0.00%
0/16 • From Day 1 to Week 48
|
Other adverse events
| Measure |
B/L Weight 5 to Less Than 10 kg
n=21 participants at risk
|
B/L Weight 10 to Less Than 15 kg
n=19 participants at risk
|
B/L Weight 15 to Less Than 25 kg
n=16 participants at risk
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
4.8%
1/21 • From Day 1 to Week 48
|
10.5%
2/19 • From Day 1 to Week 48
|
0.00%
0/16 • From Day 1 to Week 48
|
|
Blood and lymphatic system disorders
Basophilia
|
4.8%
1/21 • From Day 1 to Week 48
|
5.3%
1/19 • From Day 1 to Week 48
|
6.2%
1/16 • From Day 1 to Week 48
|
|
Blood and lymphatic system disorders
Basophilopenia
|
0.00%
0/21 • From Day 1 to Week 48
|
0.00%
0/19 • From Day 1 to Week 48
|
6.2%
1/16 • From Day 1 to Week 48
|
|
Blood and lymphatic system disorders
Eosinophilia
|
4.8%
1/21 • From Day 1 to Week 48
|
10.5%
2/19 • From Day 1 to Week 48
|
12.5%
2/16 • From Day 1 to Week 48
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/21 • From Day 1 to Week 48
|
5.3%
1/19 • From Day 1 to Week 48
|
6.2%
1/16 • From Day 1 to Week 48
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
9.5%
2/21 • From Day 1 to Week 48
|
0.00%
0/19 • From Day 1 to Week 48
|
0.00%
0/16 • From Day 1 to Week 48
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
19.0%
4/21 • From Day 1 to Week 48
|
21.1%
4/19 • From Day 1 to Week 48
|
0.00%
0/16 • From Day 1 to Week 48
|
|
Blood and lymphatic system disorders
Lymphocytosis
|
4.8%
1/21 • From Day 1 to Week 48
|
5.3%
1/19 • From Day 1 to Week 48
|
6.2%
1/16 • From Day 1 to Week 48
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/21 • From Day 1 to Week 48
|
5.3%
1/19 • From Day 1 to Week 48
|
6.2%
1/16 • From Day 1 to Week 48
|
|
Blood and lymphatic system disorders
Monocytopenia
|
0.00%
0/21 • From Day 1 to Week 48
|
5.3%
1/19 • From Day 1 to Week 48
|
6.2%
1/16 • From Day 1 to Week 48
|
|
Blood and lymphatic system disorders
Monocytosis
|
0.00%
0/21 • From Day 1 to Week 48
|
0.00%
0/19 • From Day 1 to Week 48
|
6.2%
1/16 • From Day 1 to Week 48
|
|
Blood and lymphatic system disorders
Neutropenia
|
4.8%
1/21 • From Day 1 to Week 48
|
5.3%
1/19 • From Day 1 to Week 48
|
6.2%
1/16 • From Day 1 to Week 48
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.00%
0/21 • From Day 1 to Week 48
|
5.3%
1/19 • From Day 1 to Week 48
|
0.00%
0/16 • From Day 1 to Week 48
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/21 • From Day 1 to Week 48
|
0.00%
0/19 • From Day 1 to Week 48
|
6.2%
1/16 • From Day 1 to Week 48
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.00%
0/21 • From Day 1 to Week 48
|
0.00%
0/19 • From Day 1 to Week 48
|
18.8%
3/16 • From Day 1 to Week 48
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/21 • From Day 1 to Week 48
|
5.3%
1/19 • From Day 1 to Week 48
|
18.8%
3/16 • From Day 1 to Week 48
|
|
Ear and labyrinth disorders
Excessive cerumen production
|
4.8%
1/21 • From Day 1 to Week 48
|
5.3%
1/19 • From Day 1 to Week 48
|
0.00%
0/16 • From Day 1 to Week 48
|
|
Ear and labyrinth disorders
Otorrhoea
|
0.00%
0/21 • From Day 1 to Week 48
|
0.00%
0/19 • From Day 1 to Week 48
|
12.5%
2/16 • From Day 1 to Week 48
|
|
Ear and labyrinth disorders
Tympanic membrane perforation
|
4.8%
1/21 • From Day 1 to Week 48
|
5.3%
1/19 • From Day 1 to Week 48
|
6.2%
1/16 • From Day 1 to Week 48
|
|
Eye disorders
Conjunctival hyperaemia
|
0.00%
0/21 • From Day 1 to Week 48
|
0.00%
0/19 • From Day 1 to Week 48
|
6.2%
1/16 • From Day 1 to Week 48
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/21 • From Day 1 to Week 48
|
5.3%
1/19 • From Day 1 to Week 48
|
0.00%
0/16 • From Day 1 to Week 48
|
|
Eye disorders
Eye pruritus
|
0.00%
0/21 • From Day 1 to Week 48
|
5.3%
1/19 • From Day 1 to Week 48
|
0.00%
0/16 • From Day 1 to Week 48
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/21 • From Day 1 to Week 48
|
0.00%
0/19 • From Day 1 to Week 48
|
6.2%
1/16 • From Day 1 to Week 48
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/21 • From Day 1 to Week 48
|
5.3%
1/19 • From Day 1 to Week 48
|
12.5%
2/16 • From Day 1 to Week 48
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/21 • From Day 1 to Week 48
|
0.00%
0/19 • From Day 1 to Week 48
|
6.2%
1/16 • From Day 1 to Week 48
|
|
Gastrointestinal disorders
Anal pruritus
|
0.00%
0/21 • From Day 1 to Week 48
|
0.00%
0/19 • From Day 1 to Week 48
|
6.2%
1/16 • From Day 1 to Week 48
|
|
Gastrointestinal disorders
Dental caries
|
19.0%
4/21 • From Day 1 to Week 48
|
15.8%
3/19 • From Day 1 to Week 48
|
18.8%
3/16 • From Day 1 to Week 48
|
|
Gastrointestinal disorders
Diarrhoea
|
52.4%
11/21 • From Day 1 to Week 48
|
31.6%
6/19 • From Day 1 to Week 48
|
43.8%
7/16 • From Day 1 to Week 48
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/21 • From Day 1 to Week 48
|
5.3%
1/19 • From Day 1 to Week 48
|
0.00%
0/16 • From Day 1 to Week 48
|
|
Gastrointestinal disorders
Oral mucosal blistering
|
0.00%
0/21 • From Day 1 to Week 48
|
5.3%
1/19 • From Day 1 to Week 48
|
0.00%
0/16 • From Day 1 to Week 48
|
|
Gastrointestinal disorders
Tongue geographic
|
0.00%
0/21 • From Day 1 to Week 48
|
5.3%
1/19 • From Day 1 to Week 48
|
0.00%
0/16 • From Day 1 to Week 48
|
|
Gastrointestinal disorders
Toothache
|
4.8%
1/21 • From Day 1 to Week 48
|
10.5%
2/19 • From Day 1 to Week 48
|
12.5%
2/16 • From Day 1 to Week 48
|
|
Gastrointestinal disorders
Vomiting
|
42.9%
9/21 • From Day 1 to Week 48
|
42.1%
8/19 • From Day 1 to Week 48
|
25.0%
4/16 • From Day 1 to Week 48
|
|
General disorders
Asthenia
|
0.00%
0/21 • From Day 1 to Week 48
|
0.00%
0/19 • From Day 1 to Week 48
|
12.5%
2/16 • From Day 1 to Week 48
|
|
General disorders
Local swelling
|
0.00%
0/21 • From Day 1 to Week 48
|
5.3%
1/19 • From Day 1 to Week 48
|
0.00%
0/16 • From Day 1 to Week 48
|
|
General disorders
Pyrexia
|
14.3%
3/21 • From Day 1 to Week 48
|
36.8%
7/19 • From Day 1 to Week 48
|
31.2%
5/16 • From Day 1 to Week 48
|
|
Hepatobiliary disorders
Hepatomegaly
|
19.0%
4/21 • From Day 1 to Week 48
|
5.3%
1/19 • From Day 1 to Week 48
|
0.00%
0/16 • From Day 1 to Week 48
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
4.8%
1/21 • From Day 1 to Week 48
|
10.5%
2/19 • From Day 1 to Week 48
|
25.0%
4/16 • From Day 1 to Week 48
|
|
Hepatobiliary disorders
Jaundice
|
4.8%
1/21 • From Day 1 to Week 48
|
15.8%
3/19 • From Day 1 to Week 48
|
12.5%
2/16 • From Day 1 to Week 48
|
|
Hepatobiliary disorders
Ocular icterus
|
9.5%
2/21 • From Day 1 to Week 48
|
5.3%
1/19 • From Day 1 to Week 48
|
6.2%
1/16 • From Day 1 to Week 48
|
|
Infections and infestations
Acarodermatitis
|
28.6%
6/21 • From Day 1 to Week 48
|
0.00%
0/19 • From Day 1 to Week 48
|
6.2%
1/16 • From Day 1 to Week 48
|
|
Infections and infestations
Bacteriuria
|
4.8%
1/21 • From Day 1 to Week 48
|
5.3%
1/19 • From Day 1 to Week 48
|
6.2%
1/16 • From Day 1 to Week 48
|
|
Infections and infestations
Bronchitis
|
9.5%
2/21 • From Day 1 to Week 48
|
21.1%
4/19 • From Day 1 to Week 48
|
12.5%
2/16 • From Day 1 to Week 48
|
|
Infections and infestations
Candida nappy rash
|
23.8%
5/21 • From Day 1 to Week 48
|
0.00%
0/19 • From Day 1 to Week 48
|
0.00%
0/16 • From Day 1 to Week 48
|
|
Infections and infestations
Conjunctivitis
|
9.5%
2/21 • From Day 1 to Week 48
|
10.5%
2/19 • From Day 1 to Week 48
|
6.2%
1/16 • From Day 1 to Week 48
|
|
Infections and infestations
Ear infection
|
4.8%
1/21 • From Day 1 to Week 48
|
5.3%
1/19 • From Day 1 to Week 48
|
0.00%
0/16 • From Day 1 to Week 48
|
|
Infections and infestations
Enterobiasis
|
0.00%
0/21 • From Day 1 to Week 48
|
0.00%
0/19 • From Day 1 to Week 48
|
6.2%
1/16 • From Day 1 to Week 48
|
|
Infections and infestations
Folliculitis
|
4.8%
1/21 • From Day 1 to Week 48
|
0.00%
0/19 • From Day 1 to Week 48
|
6.2%
1/16 • From Day 1 to Week 48
|
|
Infections and infestations
Fungal infection
|
0.00%
0/21 • From Day 1 to Week 48
|
5.3%
1/19 • From Day 1 to Week 48
|
0.00%
0/16 • From Day 1 to Week 48
|
|
Infections and infestations
Fungal skin infection
|
9.5%
2/21 • From Day 1 to Week 48
|
5.3%
1/19 • From Day 1 to Week 48
|
0.00%
0/16 • From Day 1 to Week 48
|
|
Infections and infestations
Gastroenteritis
|
42.9%
9/21 • From Day 1 to Week 48
|
26.3%
5/19 • From Day 1 to Week 48
|
12.5%
2/16 • From Day 1 to Week 48
|
|
Infections and infestations
Helminthic infection
|
23.8%
5/21 • From Day 1 to Week 48
|
10.5%
2/19 • From Day 1 to Week 48
|
6.2%
1/16 • From Day 1 to Week 48
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/21 • From Day 1 to Week 48
|
5.3%
1/19 • From Day 1 to Week 48
|
0.00%
0/16 • From Day 1 to Week 48
|
|
Infections and infestations
Hordeolum
|
0.00%
0/21 • From Day 1 to Week 48
|
0.00%
0/19 • From Day 1 to Week 48
|
6.2%
1/16 • From Day 1 to Week 48
|
|
Infections and infestations
Impetigo
|
19.0%
4/21 • From Day 1 to Week 48
|
10.5%
2/19 • From Day 1 to Week 48
|
12.5%
2/16 • From Day 1 to Week 48
|
|
Infections and infestations
Influenza
|
14.3%
3/21 • From Day 1 to Week 48
|
5.3%
1/19 • From Day 1 to Week 48
|
12.5%
2/16 • From Day 1 to Week 48
|
|
Infections and infestations
Lice infestation
|
0.00%
0/21 • From Day 1 to Week 48
|
0.00%
0/19 • From Day 1 to Week 48
|
6.2%
1/16 • From Day 1 to Week 48
|
|
Infections and infestations
Lower respiratory tract infection
|
9.5%
2/21 • From Day 1 to Week 48
|
15.8%
3/19 • From Day 1 to Week 48
|
6.2%
1/16 • From Day 1 to Week 48
|
|
Infections and infestations
Lower respiratory tract infection viral
|
0.00%
0/21 • From Day 1 to Week 48
|
5.3%
1/19 • From Day 1 to Week 48
|
0.00%
0/16 • From Day 1 to Week 48
|
|
Infections and infestations
Molluscum contagiosum
|
0.00%
0/21 • From Day 1 to Week 48
|
5.3%
1/19 • From Day 1 to Week 48
|
6.2%
1/16 • From Day 1 to Week 48
|
|
Infections and infestations
Nasopharyngitis
|
14.3%
3/21 • From Day 1 to Week 48
|
5.3%
1/19 • From Day 1 to Week 48
|
31.2%
5/16 • From Day 1 to Week 48
|
|
Infections and infestations
Oral candidiasis
|
42.9%
9/21 • From Day 1 to Week 48
|
0.00%
0/19 • From Day 1 to Week 48
|
0.00%
0/16 • From Day 1 to Week 48
|
|
Infections and infestations
Oral herpes
|
0.00%
0/21 • From Day 1 to Week 48
|
5.3%
1/19 • From Day 1 to Week 48
|
12.5%
2/16 • From Day 1 to Week 48
|
|
Infections and infestations
Otitis externa
|
14.3%
3/21 • From Day 1 to Week 48
|
15.8%
3/19 • From Day 1 to Week 48
|
6.2%
1/16 • From Day 1 to Week 48
|
|
Infections and infestations
Otitis media
|
38.1%
8/21 • From Day 1 to Week 48
|
21.1%
4/19 • From Day 1 to Week 48
|
25.0%
4/16 • From Day 1 to Week 48
|
|
Infections and infestations
Otitis media acute
|
14.3%
3/21 • From Day 1 to Week 48
|
10.5%
2/19 • From Day 1 to Week 48
|
12.5%
2/16 • From Day 1 to Week 48
|
|
Infections and infestations
Otitis media chronic
|
14.3%
3/21 • From Day 1 to Week 48
|
5.3%
1/19 • From Day 1 to Week 48
|
12.5%
2/16 • From Day 1 to Week 48
|
|
Infections and infestations
Parasitic gastroenteritis
|
0.00%
0/21 • From Day 1 to Week 48
|
0.00%
0/19 • From Day 1 to Week 48
|
6.2%
1/16 • From Day 1 to Week 48
|
|
Infections and infestations
Pharyngitis
|
23.8%
5/21 • From Day 1 to Week 48
|
21.1%
4/19 • From Day 1 to Week 48
|
25.0%
4/16 • From Day 1 to Week 48
|
|
Infections and infestations
Pharyngotonsillitis
|
4.8%
1/21 • From Day 1 to Week 48
|
0.00%
0/19 • From Day 1 to Week 48
|
12.5%
2/16 • From Day 1 to Week 48
|
|
Infections and infestations
Pneumonia
|
19.0%
4/21 • From Day 1 to Week 48
|
10.5%
2/19 • From Day 1 to Week 48
|
0.00%
0/16 • From Day 1 to Week 48
|
|
Infections and infestations
Pulmonary tuberculosis
|
9.5%
2/21 • From Day 1 to Week 48
|
0.00%
0/19 • From Day 1 to Week 48
|
0.00%
0/16 • From Day 1 to Week 48
|
|
Infections and infestations
Respiratory tract infection
|
4.8%
1/21 • From Day 1 to Week 48
|
5.3%
1/19 • From Day 1 to Week 48
|
12.5%
2/16 • From Day 1 to Week 48
|
|
Infections and infestations
Rhinitis
|
4.8%
1/21 • From Day 1 to Week 48
|
5.3%
1/19 • From Day 1 to Week 48
|
12.5%
2/16 • From Day 1 to Week 48
|
|
Infections and infestations
Sinusitis
|
0.00%
0/21 • From Day 1 to Week 48
|
0.00%
0/19 • From Day 1 to Week 48
|
12.5%
2/16 • From Day 1 to Week 48
|
|
Infections and infestations
Skin infection
|
0.00%
0/21 • From Day 1 to Week 48
|
0.00%
0/19 • From Day 1 to Week 48
|
6.2%
1/16 • From Day 1 to Week 48
|
|
Infections and infestations
Tinea capitis
|
19.0%
4/21 • From Day 1 to Week 48
|
10.5%
2/19 • From Day 1 to Week 48
|
12.5%
2/16 • From Day 1 to Week 48
|
|
Infections and infestations
Tinea faciei
|
0.00%
0/21 • From Day 1 to Week 48
|
0.00%
0/19 • From Day 1 to Week 48
|
6.2%
1/16 • From Day 1 to Week 48
|
|
Infections and infestations
Tinea infection
|
4.8%
1/21 • From Day 1 to Week 48
|
5.3%
1/19 • From Day 1 to Week 48
|
18.8%
3/16 • From Day 1 to Week 48
|
|
Infections and infestations
Tonsillitis
|
33.3%
7/21 • From Day 1 to Week 48
|
10.5%
2/19 • From Day 1 to Week 48
|
6.2%
1/16 • From Day 1 to Week 48
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/21 • From Day 1 to Week 48
|
0.00%
0/19 • From Day 1 to Week 48
|
6.2%
1/16 • From Day 1 to Week 48
|
|
Infections and infestations
Upper respiratory tract infection
|
52.4%
11/21 • From Day 1 to Week 48
|
31.6%
6/19 • From Day 1 to Week 48
|
31.2%
5/16 • From Day 1 to Week 48
|
|
Infections and infestations
Urinary tract infection
|
28.6%
6/21 • From Day 1 to Week 48
|
10.5%
2/19 • From Day 1 to Week 48
|
0.00%
0/16 • From Day 1 to Week 48
|
|
Infections and infestations
Varicella
|
9.5%
2/21 • From Day 1 to Week 48
|
5.3%
1/19 • From Day 1 to Week 48
|
6.2%
1/16 • From Day 1 to Week 48
|
|
Infections and infestations
Viral rash
|
4.8%
1/21 • From Day 1 to Week 48
|
0.00%
0/19 • From Day 1 to Week 48
|
6.2%
1/16 • From Day 1 to Week 48
|
|
Infections and infestations
Viral upper respiratory tract infection
|
19.0%
4/21 • From Day 1 to Week 48
|
42.1%
8/19 • From Day 1 to Week 48
|
25.0%
4/16 • From Day 1 to Week 48
|
|
Infections and infestations
Vulvovaginal candidiasis
|
4.8%
1/21 • From Day 1 to Week 48
|
5.3%
1/19 • From Day 1 to Week 48
|
0.00%
0/16 • From Day 1 to Week 48
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/21 • From Day 1 to Week 48
|
5.3%
1/19 • From Day 1 to Week 48
|
0.00%
0/16 • From Day 1 to Week 48
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
23.8%
5/21 • From Day 1 to Week 48
|
0.00%
0/19 • From Day 1 to Week 48
|
6.2%
1/16 • From Day 1 to Week 48
|
|
Injury, poisoning and procedural complications
Burns first degree
|
0.00%
0/21 • From Day 1 to Week 48
|
0.00%
0/19 • From Day 1 to Week 48
|
6.2%
1/16 • From Day 1 to Week 48
|
|
Injury, poisoning and procedural complications
Contusion
|
4.8%
1/21 • From Day 1 to Week 48
|
5.3%
1/19 • From Day 1 to Week 48
|
0.00%
0/16 • From Day 1 to Week 48
|
|
Injury, poisoning and procedural complications
Foreign body
|
0.00%
0/21 • From Day 1 to Week 48
|
5.3%
1/19 • From Day 1 to Week 48
|
0.00%
0/16 • From Day 1 to Week 48
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/21 • From Day 1 to Week 48
|
0.00%
0/19 • From Day 1 to Week 48
|
6.2%
1/16 • From Day 1 to Week 48
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/21 • From Day 1 to Week 48
|
0.00%
0/19 • From Day 1 to Week 48
|
6.2%
1/16 • From Day 1 to Week 48
|
|
Injury, poisoning and procedural complications
Scar
|
4.8%
1/21 • From Day 1 to Week 48
|
10.5%
2/19 • From Day 1 to Week 48
|
6.2%
1/16 • From Day 1 to Week 48
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/21 • From Day 1 to Week 48
|
5.3%
1/19 • From Day 1 to Week 48
|
6.2%
1/16 • From Day 1 to Week 48
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/21 • From Day 1 to Week 48
|
0.00%
0/19 • From Day 1 to Week 48
|
6.2%
1/16 • From Day 1 to Week 48
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/21 • From Day 1 to Week 48
|
0.00%
0/19 • From Day 1 to Week 48
|
6.2%
1/16 • From Day 1 to Week 48
|
|
Investigations
Amylase increased
|
9.5%
2/21 • From Day 1 to Week 48
|
0.00%
0/19 • From Day 1 to Week 48
|
6.2%
1/16 • From Day 1 to Week 48
|
|
Investigations
Blood bilirubin increased
|
4.8%
1/21 • From Day 1 to Week 48
|
0.00%
0/19 • From Day 1 to Week 48
|
6.2%
1/16 • From Day 1 to Week 48
|
|
Investigations
Blood sodium increased
|
0.00%
0/21 • From Day 1 to Week 48
|
0.00%
0/19 • From Day 1 to Week 48
|
6.2%
1/16 • From Day 1 to Week 48
|
|
Investigations
Body temperature increased
|
4.8%
1/21 • From Day 1 to Week 48
|
0.00%
0/19 • From Day 1 to Week 48
|
6.2%
1/16 • From Day 1 to Week 48
|
|
Investigations
Cardiac murmur
|
0.00%
0/21 • From Day 1 to Week 48
|
0.00%
0/19 • From Day 1 to Week 48
|
6.2%
1/16 • From Day 1 to Week 48
|
|
Investigations
Crystal urine present
|
0.00%
0/21 • From Day 1 to Week 48
|
5.3%
1/19 • From Day 1 to Week 48
|
6.2%
1/16 • From Day 1 to Week 48
|
|
Investigations
Electrocardiogram abnormal
|
0.00%
0/21 • From Day 1 to Week 48
|
5.3%
1/19 • From Day 1 to Week 48
|
0.00%
0/16 • From Day 1 to Week 48
|
|
Investigations
Lipase increased
|
9.5%
2/21 • From Day 1 to Week 48
|
5.3%
1/19 • From Day 1 to Week 48
|
0.00%
0/16 • From Day 1 to Week 48
|
|
Investigations
Urinary sediment present
|
0.00%
0/21 • From Day 1 to Week 48
|
5.3%
1/19 • From Day 1 to Week 48
|
0.00%
0/16 • From Day 1 to Week 48
|
|
Investigations
Weight decreased
|
19.0%
4/21 • From Day 1 to Week 48
|
15.8%
3/19 • From Day 1 to Week 48
|
6.2%
1/16 • From Day 1 to Week 48
|
|
Metabolism and nutrition disorders
Decreased appetite
|
23.8%
5/21 • From Day 1 to Week 48
|
15.8%
3/19 • From Day 1 to Week 48
|
12.5%
2/16 • From Day 1 to Week 48
|
|
Metabolism and nutrition disorders
Hyperamylasaemia
|
0.00%
0/21 • From Day 1 to Week 48
|
0.00%
0/19 • From Day 1 to Week 48
|
6.2%
1/16 • From Day 1 to Week 48
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
4.8%
1/21 • From Day 1 to Week 48
|
0.00%
0/19 • From Day 1 to Week 48
|
6.2%
1/16 • From Day 1 to Week 48
|
|
Metabolism and nutrition disorders
Hyperlipasaemia
|
4.8%
1/21 • From Day 1 to Week 48
|
5.3%
1/19 • From Day 1 to Week 48
|
0.00%
0/16 • From Day 1 to Week 48
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/21 • From Day 1 to Week 48
|
0.00%
0/19 • From Day 1 to Week 48
|
6.2%
1/16 • From Day 1 to Week 48
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/21 • From Day 1 to Week 48
|
0.00%
0/19 • From Day 1 to Week 48
|
6.2%
1/16 • From Day 1 to Week 48
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.8%
1/21 • From Day 1 to Week 48
|
0.00%
0/19 • From Day 1 to Week 48
|
6.2%
1/16 • From Day 1 to Week 48
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/21 • From Day 1 to Week 48
|
0.00%
0/19 • From Day 1 to Week 48
|
6.2%
1/16 • From Day 1 to Week 48
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/21 • From Day 1 to Week 48
|
0.00%
0/19 • From Day 1 to Week 48
|
6.2%
1/16 • From Day 1 to Week 48
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/21 • From Day 1 to Week 48
|
0.00%
0/19 • From Day 1 to Week 48
|
12.5%
2/16 • From Day 1 to Week 48
|
|
Nervous system disorders
Dizziness
|
0.00%
0/21 • From Day 1 to Week 48
|
0.00%
0/19 • From Day 1 to Week 48
|
6.2%
1/16 • From Day 1 to Week 48
|
|
Nervous system disorders
Headache
|
0.00%
0/21 • From Day 1 to Week 48
|
0.00%
0/19 • From Day 1 to Week 48
|
18.8%
3/16 • From Day 1 to Week 48
|
|
Psychiatric disorders
Enuresis
|
0.00%
0/21 • From Day 1 to Week 48
|
5.3%
1/19 • From Day 1 to Week 48
|
0.00%
0/16 • From Day 1 to Week 48
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/21 • From Day 1 to Week 48
|
5.3%
1/19 • From Day 1 to Week 48
|
0.00%
0/16 • From Day 1 to Week 48
|
|
Renal and urinary disorders
Leukocyturia
|
0.00%
0/21 • From Day 1 to Week 48
|
0.00%
0/19 • From Day 1 to Week 48
|
6.2%
1/16 • From Day 1 to Week 48
|
|
Renal and urinary disorders
Proteinuria
|
4.8%
1/21 • From Day 1 to Week 48
|
0.00%
0/19 • From Day 1 to Week 48
|
6.2%
1/16 • From Day 1 to Week 48
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
4.8%
1/21 • From Day 1 to Week 48
|
5.3%
1/19 • From Day 1 to Week 48
|
6.2%
1/16 • From Day 1 to Week 48
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.00%
0/21 • From Day 1 to Week 48
|
5.3%
1/19 • From Day 1 to Week 48
|
0.00%
0/16 • From Day 1 to Week 48
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
4.8%
1/21 • From Day 1 to Week 48
|
5.3%
1/19 • From Day 1 to Week 48
|
0.00%
0/16 • From Day 1 to Week 48
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
7/21 • From Day 1 to Week 48
|
31.6%
6/19 • From Day 1 to Week 48
|
43.8%
7/16 • From Day 1 to Week 48
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/21 • From Day 1 to Week 48
|
5.3%
1/19 • From Day 1 to Week 48
|
6.2%
1/16 • From Day 1 to Week 48
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/21 • From Day 1 to Week 48
|
5.3%
1/19 • From Day 1 to Week 48
|
0.00%
0/16 • From Day 1 to Week 48
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
19.0%
4/21 • From Day 1 to Week 48
|
15.8%
3/19 • From Day 1 to Week 48
|
0.00%
0/16 • From Day 1 to Week 48
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/21 • From Day 1 to Week 48
|
0.00%
0/19 • From Day 1 to Week 48
|
6.2%
1/16 • From Day 1 to Week 48
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/21 • From Day 1 to Week 48
|
0.00%
0/19 • From Day 1 to Week 48
|
6.2%
1/16 • From Day 1 to Week 48
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
19.0%
4/21 • From Day 1 to Week 48
|
15.8%
3/19 • From Day 1 to Week 48
|
6.2%
1/16 • From Day 1 to Week 48
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
23.8%
5/21 • From Day 1 to Week 48
|
10.5%
2/19 • From Day 1 to Week 48
|
6.2%
1/16 • From Day 1 to Week 48
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/21 • From Day 1 to Week 48
|
5.3%
1/19 • From Day 1 to Week 48
|
6.2%
1/16 • From Day 1 to Week 48
|
|
Skin and subcutaneous tissue disorders
Dandruff
|
0.00%
0/21 • From Day 1 to Week 48
|
5.3%
1/19 • From Day 1 to Week 48
|
0.00%
0/16 • From Day 1 to Week 48
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
9.5%
2/21 • From Day 1 to Week 48
|
5.3%
1/19 • From Day 1 to Week 48
|
6.2%
1/16 • From Day 1 to Week 48
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
4.8%
1/21 • From Day 1 to Week 48
|
0.00%
0/19 • From Day 1 to Week 48
|
6.2%
1/16 • From Day 1 to Week 48
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
28.6%
6/21 • From Day 1 to Week 48
|
5.3%
1/19 • From Day 1 to Week 48
|
0.00%
0/16 • From Day 1 to Week 48
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
4.8%
1/21 • From Day 1 to Week 48
|
5.3%
1/19 • From Day 1 to Week 48
|
0.00%
0/16 • From Day 1 to Week 48
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/21 • From Day 1 to Week 48
|
0.00%
0/19 • From Day 1 to Week 48
|
6.2%
1/16 • From Day 1 to Week 48
|
|
Skin and subcutaneous tissue disorders
Eczema
|
33.3%
7/21 • From Day 1 to Week 48
|
21.1%
4/19 • From Day 1 to Week 48
|
6.2%
1/16 • From Day 1 to Week 48
|
|
Skin and subcutaneous tissue disorders
Lipodystrophy acquired
|
0.00%
0/21 • From Day 1 to Week 48
|
0.00%
0/19 • From Day 1 to Week 48
|
6.2%
1/16 • From Day 1 to Week 48
|
|
Skin and subcutaneous tissue disorders
Macule
|
0.00%
0/21 • From Day 1 to Week 48
|
0.00%
0/19 • From Day 1 to Week 48
|
6.2%
1/16 • From Day 1 to Week 48
|
|
Skin and subcutaneous tissue disorders
Onychomadesis
|
0.00%
0/21 • From Day 1 to Week 48
|
0.00%
0/19 • From Day 1 to Week 48
|
6.2%
1/16 • From Day 1 to Week 48
|
|
Skin and subcutaneous tissue disorders
Pityriasis alba
|
9.5%
2/21 • From Day 1 to Week 48
|
0.00%
0/19 • From Day 1 to Week 48
|
6.2%
1/16 • From Day 1 to Week 48
|
|
Skin and subcutaneous tissue disorders
Prurigo
|
0.00%
0/21 • From Day 1 to Week 48
|
5.3%
1/19 • From Day 1 to Week 48
|
6.2%
1/16 • From Day 1 to Week 48
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/21 • From Day 1 to Week 48
|
5.3%
1/19 • From Day 1 to Week 48
|
0.00%
0/16 • From Day 1 to Week 48
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.5%
2/21 • From Day 1 to Week 48
|
10.5%
2/19 • From Day 1 to Week 48
|
12.5%
2/16 • From Day 1 to Week 48
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
9.5%
2/21 • From Day 1 to Week 48
|
0.00%
0/19 • From Day 1 to Week 48
|
6.2%
1/16 • From Day 1 to Week 48
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
14.3%
3/21 • From Day 1 to Week 48
|
0.00%
0/19 • From Day 1 to Week 48
|
0.00%
0/16 • From Day 1 to Week 48
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/21 • From Day 1 to Week 48
|
0.00%
0/19 • From Day 1 to Week 48
|
6.2%
1/16 • From Day 1 to Week 48
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/21 • From Day 1 to Week 48
|
0.00%
0/19 • From Day 1 to Week 48
|
6.2%
1/16 • From Day 1 to Week 48
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/21 • From Day 1 to Week 48
|
0.00%
0/19 • From Day 1 to Week 48
|
6.2%
1/16 • From Day 1 to Week 48
|
|
Skin and subcutaneous tissue disorders
Urticaria papular
|
9.5%
2/21 • From Day 1 to Week 48
|
0.00%
0/19 • From Day 1 to Week 48
|
0.00%
0/16 • From Day 1 to Week 48
|
|
Social circumstances
Physical assault
|
0.00%
0/21 • From Day 1 to Week 48
|
0.00%
0/19 • From Day 1 to Week 48
|
6.2%
1/16 • From Day 1 to Week 48
|
|
Vascular disorders
Haematoma
|
0.00%
0/21 • From Day 1 to Week 48
|
0.00%
0/19 • From Day 1 to Week 48
|
6.2%
1/16 • From Day 1 to Week 48
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER