Trial Outcomes & Findings for Safety, PK and Effectiveness of IV Peramivir Versus Oseltamivir in Pediatric Subjects With Uncomplicated Influenza (NCT NCT02369159)
NCT ID: NCT02369159
Last Updated: 2021-03-23
Results Overview
Safety evaluation included assessment of Adverse Events (AEs).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
137 participants
Primary outcome timeframe
14 days
Results posted on
2021-03-23
Participant Flow
Participant milestones
| Measure |
Peramivir
Age-appropriate dose Peramivir, administered as a single short iv infusion:
Subjects ≥12 years - 600 mg. Subjects \<12 years - 12 mg/kg (max. 600 mg). Subjects \< 6 months - 8 mg/kg.
|
Oseltamivir
Age appropriate oral dose of Oseltamivir BID for 5 days:
Subjects ≥ 13 years - 75mg dose as a capsule or oral suspension. Subjects \< 13 years - weight-based dose as a capsule or oral suspension.
|
|---|---|---|
|
Overall Study
STARTED
|
114
|
23
|
|
Overall Study
ITT Population
|
114
|
23
|
|
Overall Study
Safety Population
|
107
|
23
|
|
Overall Study
ITTI Population
|
81
|
16
|
|
Overall Study
E-R Population
|
80
|
0
|
|
Overall Study
COMPLETED
|
106
|
21
|
|
Overall Study
NOT COMPLETED
|
8
|
2
|
Reasons for withdrawal
| Measure |
Peramivir
Age-appropriate dose Peramivir, administered as a single short iv infusion:
Subjects ≥12 years - 600 mg. Subjects \<12 years - 12 mg/kg (max. 600 mg). Subjects \< 6 months - 8 mg/kg.
|
Oseltamivir
Age appropriate oral dose of Oseltamivir BID for 5 days:
Subjects ≥ 13 years - 75mg dose as a capsule or oral suspension. Subjects \< 13 years - weight-based dose as a capsule or oral suspension.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
7
|
0
|
Baseline Characteristics
Mean age (SD) is reported for the overall ITT population and for each of the 4 age groups
Baseline characteristics by cohort
| Measure |
Peramivir
n=114 Participants
Age-appropriate single dose Peramivir, administered as a single short iv infusion:
Subjects ≥12 years - 600 mg. Subjects \<12 years - 12 mg/kg (max. 600 mg). Subjects \< 6 months - 8 mg/kg.
|
Oseltamivir
n=23 Participants
Age appropriate oral dose of Oseltamivir BID for 5 days:
Subjects ≥ 13 years - 75mg dose as a capsule or oral suspension. Subjects \< 13 years - weight-based dose as a capsule or oral suspension.
|
Total
n=137 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
Overall
|
8.0 Age at time of randomisation - years
STANDARD_DEVIATION 5.07 • n=114 Participants • Mean age (SD) is reported for the overall ITT population and for each of the 4 age groups
|
9.9 Age at time of randomisation - years
STANDARD_DEVIATION 4.99 • n=23 Participants • Mean age (SD) is reported for the overall ITT population and for each of the 4 age groups
|
8.4 Age at time of randomisation - years
STANDARD_DEVIATION 5.09 • n=137 Participants • Mean age (SD) is reported for the overall ITT population and for each of the 4 age groups
|
|
Age, Continuous
≥ 28 days to < 2-year-old cohort
|
1.3 Age at time of randomisation - years
STANDARD_DEVIATION 0.47 • n=20 Participants • Mean age (SD) is reported for the overall ITT population and for each of the 4 age groups
|
1.0 Age at time of randomisation - years
STANDARD_DEVIATION NA • n=1 Participants • Mean age (SD) is reported for the overall ITT population and for each of the 4 age groups
|
1.3 Age at time of randomisation - years
STANDARD_DEVIATION 0.47 • n=21 Participants • Mean age (SD) is reported for the overall ITT population and for each of the 4 age groups
|
|
Age, Continuous
≥ 2 to < 7-year-old cohort
|
4.9 Age at time of randomisation - years
STANDARD_DEVIATION 1.47 • n=32 Participants • Mean age (SD) is reported for the overall ITT population and for each of the 4 age groups
|
4.7 Age at time of randomisation - years
STANDARD_DEVIATION 1.60 • n=6 Participants • Mean age (SD) is reported for the overall ITT population and for each of the 4 age groups
|
4.8 Age at time of randomisation - years
STANDARD_DEVIATION 1.47 • n=38 Participants • Mean age (SD) is reported for the overall ITT population and for each of the 4 age groups
|
|
Age, Continuous
≥ 7 to < 13-year-old cohort
|
9.6 Age at time of randomisation - years
STANDARD_DEVIATION 1.75 • n=39 Participants • Mean age (SD) is reported for the overall ITT population and for each of the 4 age groups
|
9.7 Age at time of randomisation - years
STANDARD_DEVIATION 1.92 • n=9 Participants • Mean age (SD) is reported for the overall ITT population and for each of the 4 age groups
|
9.6 Age at time of randomisation - years
STANDARD_DEVIATION 1.76 • n=48 Participants • Mean age (SD) is reported for the overall ITT population and for each of the 4 age groups
|
|
Age, Continuous
≥ 13 to < 18-year-old cohort
|
15.7 Age at time of randomisation - years
STANDARD_DEVIATION 1.45 • n=23 Participants • Mean age (SD) is reported for the overall ITT population and for each of the 4 age groups
|
15.9 Age at time of randomisation - years
STANDARD_DEVIATION 1.50 • n=7 Participants • Mean age (SD) is reported for the overall ITT population and for each of the 4 age groups
|
15.7 Age at time of randomisation - years
STANDARD_DEVIATION 1.44 • n=30 Participants • Mean age (SD) is reported for the overall ITT population and for each of the 4 age groups
|
|
Sex: Female, Male
Female
|
59 Participants
n=114 Participants
|
14 Participants
n=23 Participants
|
73 Participants
n=137 Participants
|
|
Sex: Female, Male
Male
|
55 Participants
n=114 Participants
|
9 Participants
n=23 Participants
|
64 Participants
n=137 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=114 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=137 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=114 Participants
|
0 Participants
n=23 Participants
|
1 Participants
n=137 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=114 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=137 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=114 Participants
|
0 Participants
n=23 Participants
|
8 Participants
n=137 Participants
|
|
Race (NIH/OMB)
White
|
98 Participants
n=114 Participants
|
23 Participants
n=23 Participants
|
121 Participants
n=137 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=114 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=137 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=114 Participants
|
0 Participants
n=23 Participants
|
7 Participants
n=137 Participants
|
|
Baseline Influenza Viral Titer
Positive
|
70 Participants
n=114 Participants
|
14 Participants
n=23 Participants
|
84 Participants
n=137 Participants
|
|
Baseline Influenza Viral Titer
Negative
|
37 Participants
n=114 Participants
|
9 Participants
n=23 Participants
|
46 Participants
n=137 Participants
|
|
Baseline Influenza Viral Titer
Missing
|
7 Participants
n=114 Participants
|
0 Participants
n=23 Participants
|
7 Participants
n=137 Participants
|
PRIMARY outcome
Timeframe: 14 daysPopulation: The Safety population included all randomized subjects who received ≥ 1 partial dose of peramivir or oseltamivir.
Safety evaluation included assessment of Adverse Events (AEs).
Outcome measures
| Measure |
Peramivir
n=107 Participants
Age-appropriate single dose Peramivir, administered as a single short iv infusion:
Subjects ≥12 years - 600 mg. Subjects \<12 years - 12 mg/kg (max. 600 mg). Subjects \< 6 months - 8 mg/kg.
|
Oseltamivir
n=23 Participants
Age appropriate oral dose of Oseltamivir BID for 5 days:
Subjects ≥ 13 years - 75mg dose as a capsule or oral suspension. Subjects \< 13 years - weight-based dose as a capsule or oral suspension.
|
Peramivir (≥ 7 - < 13 Years)
Age-appropriate dose Peramivir, administered as a single short iv infusion:
Subjects ≥12 years - 600 mg. Subjects \<12 years - 12 mg/kg (max. 600 mg).
|
Peramivir (≥ 13 - < 18 Years)
600 mg dose Peramivir, administered as a single short iv infusion
|
Peramivir (≥ 7 - < 13 Years)
Age-appropriate dose Peramivir, administered as a single short iv infusion:
Subjects ≥12 years - 600 mg. Subjects \<12 years - 12 mg/kg (max. 600 mg).
|
Oseltamivir (≥ 7 - < 13 Years)
Weight-based dose of Oseltamivir as a capsule or oral suspension BID for 5 days.
|
Peramivir (≥ 13 - < 18 Years)
600 mg dose Peramivir, administered as a single short iv infusion
|
Oseltamivir (≥ 13 - < 18 Years)
75mg dose of Oseltamivir as a capsule or oral suspension BID for 5 days.
|
|---|---|---|---|---|---|---|---|---|
|
Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events.
Adverse Event
|
22 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events.
Severe or life-threatening Adverse Event
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events.
Adverse Event possibly, probably, or definitely related to study drug
|
8 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events.
Serious Adverse Events
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events.
Adverse Event leading to discontinuation from study
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events.
Adverse Event leading to Death
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 6 hours post peramivir infusionPopulation: The Intent-to-Treat (ITTI) population included all randomized subjects. Of these 114 subjects, 106 had sufficient PK samples collected for inclusion in the peramivir PK analysis
Up to 4 blood samples will be drawn, where possible: immediately following infusion and 30 to 60 mins, 1 to 3 hrs and 4 to 6 hrs post-infusions. AUC calculations were performed in Phoenix WinNonlin using the linear/log trapezoidal rule. AUC0-last was calculated between start of the infusion and the time of the last measurable concentration.
Outcome measures
| Measure |
Peramivir
n=18 Participants
Age-appropriate single dose Peramivir, administered as a single short iv infusion:
Subjects ≥12 years - 600 mg. Subjects \<12 years - 12 mg/kg (max. 600 mg). Subjects \< 6 months - 8 mg/kg.
|
Oseltamivir
n=29 Participants
Age appropriate oral dose of Oseltamivir BID for 5 days:
Subjects ≥ 13 years - 75mg dose as a capsule or oral suspension. Subjects \< 13 years - weight-based dose as a capsule or oral suspension.
|
Peramivir (≥ 7 - < 13 Years)
n=39 Participants
Age-appropriate dose Peramivir, administered as a single short iv infusion:
Subjects ≥12 years - 600 mg. Subjects \<12 years - 12 mg/kg (max. 600 mg).
|
Peramivir (≥ 13 - < 18 Years)
n=20 Participants
600 mg dose Peramivir, administered as a single short iv infusion
|
Peramivir (≥ 7 - < 13 Years)
Age-appropriate dose Peramivir, administered as a single short iv infusion:
Subjects ≥12 years - 600 mg. Subjects \<12 years - 12 mg/kg (max. 600 mg).
|
Oseltamivir (≥ 7 - < 13 Years)
Weight-based dose of Oseltamivir as a capsule or oral suspension BID for 5 days.
|
Peramivir (≥ 13 - < 18 Years)
600 mg dose Peramivir, administered as a single short iv infusion
|
Oseltamivir (≥ 13 - < 18 Years)
75mg dose of Oseltamivir as a capsule or oral suspension BID for 5 days.
|
|---|---|---|---|---|---|---|---|---|
|
Plasma Exposure of IV Peramivir as Measured by the Drug Concentration Over 6 Hours Post-dose
AUC0-last
|
56200 ng*h/mL
Standard Deviation 21430
|
71200 ng*h/mL
Standard Deviation 31380
|
87000 ng*h/mL
Standard Deviation 40750
|
72400 ng*h/mL
Standard Deviation 19970
|
—
|
—
|
—
|
—
|
|
Plasma Exposure of IV Peramivir as Measured by the Drug Concentration Over 6 Hours Post-dose
AUC0-3
|
53300 ng*h/mL
Standard Deviation 19100
|
68100 ng*h/mL
Standard Deviation 27060
|
81400 ng*h/mL
Standard Deviation 35090
|
68300 ng*h/mL
Standard Deviation 19190
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 14 daysPopulation: Intent to treat infected (ITTI) population. Subjects who did not have resolution of fever were censored at the time of their last non-missing post-baseline temperature assessment; this included 1 subject in the '≥ 28 days - \< 2 years' cohort treated with Peramivir. Seventeen subjects were excluded from summaries due to missing data or events resolving prior to initiation of study drug.
Time for fever resolution based on subject diary record of temperature recorded twice daily. A subject had resolution of fever if he/she had oral temperature of \< 99.4°F or an axillary temperature of \< 98.4°F and no antipyretic medications were taken for ≥ 12 hours. The time to resolution of fever was estimated for each age group and overall using the Kaplan-Meier method with temperature and symptom relief medication information obtained from the Subject Diary data.
Outcome measures
| Measure |
Peramivir
n=10 Participants
Age-appropriate single dose Peramivir, administered as a single short iv infusion:
Subjects ≥12 years - 600 mg. Subjects \<12 years - 12 mg/kg (max. 600 mg). Subjects \< 6 months - 8 mg/kg.
|
Oseltamivir
n=1 Participants
Age appropriate oral dose of Oseltamivir BID for 5 days:
Subjects ≥ 13 years - 75mg dose as a capsule or oral suspension. Subjects \< 13 years - weight-based dose as a capsule or oral suspension.
|
Peramivir (≥ 7 - < 13 Years)
n=21 Participants
Age-appropriate dose Peramivir, administered as a single short iv infusion:
Subjects ≥12 years - 600 mg. Subjects \<12 years - 12 mg/kg (max. 600 mg).
|
Peramivir (≥ 13 - < 18 Years)
n=2 Participants
600 mg dose Peramivir, administered as a single short iv infusion
|
Peramivir (≥ 7 - < 13 Years)
n=27 Participants
Age-appropriate dose Peramivir, administered as a single short iv infusion:
Subjects ≥12 years - 600 mg. Subjects \<12 years - 12 mg/kg (max. 600 mg).
|
Oseltamivir (≥ 7 - < 13 Years)
n=5 Participants
Weight-based dose of Oseltamivir as a capsule or oral suspension BID for 5 days.
|
Peramivir (≥ 13 - < 18 Years)
n=9 Participants
600 mg dose Peramivir, administered as a single short iv infusion
|
Oseltamivir (≥ 13 - < 18 Years)
n=5 Participants
75mg dose of Oseltamivir as a capsule or oral suspension BID for 5 days.
|
|---|---|---|---|---|---|---|---|---|
|
Time to Resolution of Fever
|
39.7 hours
Standard Deviation 6.55
|
61.8 hours
Standard Deviation NA
Only one participant in group
|
58.8 hours
Standard Deviation 8.42
|
16.0 hours
Standard Deviation 2.38
|
36.3 hours
Standard Deviation 5.00
|
29.7 hours
Standard Deviation 7.82
|
51.3 hours
Standard Deviation 11.59
|
43.9 hours
Standard Deviation 13.67
|
SECONDARY outcome
Timeframe: 14 daysPopulation: Intent to treat infected (ITTI) population. Subjects with no alleviation of symptoms were censored at date of last post-baseline assessment; including 1 subject in the '≥ 28 days to \< 2 yrs, Peramivir' group, 1 subject in the '≥ 2 to \< 7 yrs, Peramivir' group, 4 subjects in the '≥ 7 to \< 13 yrs, Peramivir' group and 1 subject each in the '≥ 13 to \< 18 yrs' Peramivir and Oseltamivir groups. Seven subjects were excluded due to missing data or events resolving prior to initiation of study drug.
Subjects or parents or caregivers were asked to provide an assessment of age-appropriate influenza symptoms on a 4-point severity scale (0,absent; 1, mild; 2, moderate; 3, severe) twice daily beginning before screening on Day 1 until symptoms resolved or until the last follow-up visit. Time to alleviation of symptoms was the number of hours from initiation of study drug until the start of the time period in which all age-appropriate symptoms of influenza were either absent or present at a level no greater than mild for at least 21.5 (24 - 10%) hours. Subjects who did not experience alleviation of symptoms were censored at the last observed symptom assessment.
Outcome measures
| Measure |
Peramivir
n=10 Participants
Age-appropriate single dose Peramivir, administered as a single short iv infusion:
Subjects ≥12 years - 600 mg. Subjects \<12 years - 12 mg/kg (max. 600 mg). Subjects \< 6 months - 8 mg/kg.
|
Oseltamivir
n=1 Participants
Age appropriate oral dose of Oseltamivir BID for 5 days:
Subjects ≥ 13 years - 75mg dose as a capsule or oral suspension. Subjects \< 13 years - weight-based dose as a capsule or oral suspension.
|
Peramivir (≥ 7 - < 13 Years)
n=24 Participants
Age-appropriate dose Peramivir, administered as a single short iv infusion:
Subjects ≥12 years - 600 mg. Subjects \<12 years - 12 mg/kg (max. 600 mg).
|
Peramivir (≥ 13 - < 18 Years)
n=2 Participants
600 mg dose Peramivir, administered as a single short iv infusion
|
Peramivir (≥ 7 - < 13 Years)
n=28 Participants
Age-appropriate dose Peramivir, administered as a single short iv infusion:
Subjects ≥12 years - 600 mg. Subjects \<12 years - 12 mg/kg (max. 600 mg).
|
Oseltamivir (≥ 7 - < 13 Years)
n=7 Participants
Weight-based dose of Oseltamivir as a capsule or oral suspension BID for 5 days.
|
Peramivir (≥ 13 - < 18 Years)
n=13 Participants
600 mg dose Peramivir, administered as a single short iv infusion
|
Oseltamivir (≥ 13 - < 18 Years)
n=5 Participants
75mg dose of Oseltamivir as a capsule or oral suspension BID for 5 days.
|
|---|---|---|---|---|---|---|---|---|
|
Time to Resolution of Influenza Symptoms
|
76.1 hours
Standard Deviation 19.77
|
98.9 hours
Standard Deviation NA
Only one participant in group
|
94.1 hours
Standard Deviation 11.53
|
20.7 hours
Standard Deviation 2.32
|
66.6 hours
Standard Deviation 7.83
|
134.4 hours
Standard Deviation 15.74
|
101.3 hours
Standard Deviation 18.46
|
75.5 hours
Standard Deviation 12.76
|
SECONDARY outcome
Timeframe: 14 daysPopulation: Intent to treat infected (ITTI) population + ITT population with positive baseline influenza viral titers \[\> 0.5 log10 TCID50/mL\]; a total of 84 subjects.
Assessment of viral shedding in bilateral, mid-nasal swab specimens taken at baseline and then on Day 3, 7 and 14.
Outcome measures
| Measure |
Peramivir
n=8 Participants
Age-appropriate single dose Peramivir, administered as a single short iv infusion:
Subjects ≥12 years - 600 mg. Subjects \<12 years - 12 mg/kg (max. 600 mg). Subjects \< 6 months - 8 mg/kg.
|
Oseltamivir
n=1 Participants
Age appropriate oral dose of Oseltamivir BID for 5 days:
Subjects ≥ 13 years - 75mg dose as a capsule or oral suspension. Subjects \< 13 years - weight-based dose as a capsule or oral suspension.
|
Peramivir (≥ 7 - < 13 Years)
n=23 Participants
Age-appropriate dose Peramivir, administered as a single short iv infusion:
Subjects ≥12 years - 600 mg. Subjects \<12 years - 12 mg/kg (max. 600 mg).
|
Peramivir (≥ 13 - < 18 Years)
n=2 Participants
600 mg dose Peramivir, administered as a single short iv infusion
|
Peramivir (≥ 7 - < 13 Years)
n=27 Participants
Age-appropriate dose Peramivir, administered as a single short iv infusion:
Subjects ≥12 years - 600 mg. Subjects \<12 years - 12 mg/kg (max. 600 mg).
|
Oseltamivir (≥ 7 - < 13 Years)
n=6 Participants
Weight-based dose of Oseltamivir as a capsule or oral suspension BID for 5 days.
|
Peramivir (≥ 13 - < 18 Years)
n=12 Participants
600 mg dose Peramivir, administered as a single short iv infusion
|
Oseltamivir (≥ 13 - < 18 Years)
n=5 Participants
75mg dose of Oseltamivir as a capsule or oral suspension BID for 5 days.
|
|---|---|---|---|---|---|---|---|---|
|
Time to Reduction in Viral Shedding
Day 7
|
1 participants with positive viral titer
|
0 participants with positive viral titer
|
2 participants with positive viral titer
|
0 participants with positive viral titer
|
1 participants with positive viral titer
|
0 participants with positive viral titer
|
0 participants with positive viral titer
|
0 participants with positive viral titer
|
|
Time to Reduction in Viral Shedding
Baseline
|
8 participants with positive viral titer
|
1 participants with positive viral titer
|
23 participants with positive viral titer
|
2 participants with positive viral titer
|
27 participants with positive viral titer
|
6 participants with positive viral titer
|
12 participants with positive viral titer
|
5 participants with positive viral titer
|
|
Time to Reduction in Viral Shedding
Day 3
|
6 participants with positive viral titer
|
1 participants with positive viral titer
|
12 participants with positive viral titer
|
1 participants with positive viral titer
|
13 participants with positive viral titer
|
6 participants with positive viral titer
|
6 participants with positive viral titer
|
2 participants with positive viral titer
|
|
Time to Reduction in Viral Shedding
Day 14
|
0 participants with positive viral titer
|
0 participants with positive viral titer
|
0 participants with positive viral titer
|
0 participants with positive viral titer
|
0 participants with positive viral titer
|
0 participants with positive viral titer
|
0 participants with positive viral titer
|
0 participants with positive viral titer
|
SECONDARY outcome
Timeframe: Change from baseline assessed on days 3, 7 and 14.Population: The Intent To Treat Infected (ITTI) population included all subjects who were enrolled, received study drug, and had confirmed influenza A and/or B by PCR. Thirteen subjects were excluded due to a negative or missing baseline titer.
Change in influenza viral titers was defined as the time-weighted change from Baseline in log\_10 tissue culture infective dose\_50 (TCID50/mL) and was summarized for each treatment group.
Outcome measures
| Measure |
Peramivir
n=70 Participants
Age-appropriate single dose Peramivir, administered as a single short iv infusion:
Subjects ≥12 years - 600 mg. Subjects \<12 years - 12 mg/kg (max. 600 mg). Subjects \< 6 months - 8 mg/kg.
|
Oseltamivir
n=14 Participants
Age appropriate oral dose of Oseltamivir BID for 5 days:
Subjects ≥ 13 years - 75mg dose as a capsule or oral suspension. Subjects \< 13 years - weight-based dose as a capsule or oral suspension.
|
Peramivir (≥ 7 - < 13 Years)
Age-appropriate dose Peramivir, administered as a single short iv infusion:
Subjects ≥12 years - 600 mg. Subjects \<12 years - 12 mg/kg (max. 600 mg).
|
Peramivir (≥ 13 - < 18 Years)
600 mg dose Peramivir, administered as a single short iv infusion
|
Peramivir (≥ 7 - < 13 Years)
Age-appropriate dose Peramivir, administered as a single short iv infusion:
Subjects ≥12 years - 600 mg. Subjects \<12 years - 12 mg/kg (max. 600 mg).
|
Oseltamivir (≥ 7 - < 13 Years)
Weight-based dose of Oseltamivir as a capsule or oral suspension BID for 5 days.
|
Peramivir (≥ 13 - < 18 Years)
600 mg dose Peramivir, administered as a single short iv infusion
|
Oseltamivir (≥ 13 - < 18 Years)
75mg dose of Oseltamivir as a capsule or oral suspension BID for 5 days.
|
|---|---|---|---|---|---|---|---|---|
|
Changes in Influenza Virus Titer in Nasopharyngeal Samples in Response to Treatment.
Baseline
|
4.38 influenza viral titer - log10 TCID50/mL
Interval 0.75 to 6.5
|
4.50 influenza viral titer - log10 TCID50/mL
Interval 1.5 to 5.75
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Changes in Influenza Virus Titer in Nasopharyngeal Samples in Response to Treatment.
Day 3 - Change rom baseline
|
-2.75 influenza viral titer - log10 TCID50/mL
Interval -6.0 to 2.5
|
-3.25 influenza viral titer - log10 TCID50/mL
Interval -5.0 to 1.25
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Changes in Influenza Virus Titer in Nasopharyngeal Samples in Response to Treatment.
Day 7 - Change from baseline
|
-3.75 influenza viral titer - log10 TCID50/mL
Interval -6.0 to 1.0
|
-4.00 influenza viral titer - log10 TCID50/mL
Interval -5.25 to -1.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Changes in Influenza Virus Titer in Nasopharyngeal Samples in Response to Treatment.
Day 14 - Change from baseline
|
-3.75 influenza viral titer - log10 TCID50/mL
Interval -6.0 to -0.25
|
-4.00 influenza viral titer - log10 TCID50/mL
Interval -5.25 to -1.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 14 daysPopulation: Intent-to-treat infected (ITTI) population
The investigator performed a full physical exam at baseline. At each follow-up visit, study personnel evaluated the subject for the presence of clinical signs and symptoms of the following influenza-related complications: sinusitis, otitis media, bronchitis, and pneumonia requiring antibiotic use, diagnosed after initiation of treatment.
Outcome measures
| Measure |
Peramivir
n=81 Participants
Age-appropriate single dose Peramivir, administered as a single short iv infusion:
Subjects ≥12 years - 600 mg. Subjects \<12 years - 12 mg/kg (max. 600 mg). Subjects \< 6 months - 8 mg/kg.
|
Oseltamivir
n=16 Participants
Age appropriate oral dose of Oseltamivir BID for 5 days:
Subjects ≥ 13 years - 75mg dose as a capsule or oral suspension. Subjects \< 13 years - weight-based dose as a capsule or oral suspension.
|
Peramivir (≥ 7 - < 13 Years)
Age-appropriate dose Peramivir, administered as a single short iv infusion:
Subjects ≥12 years - 600 mg. Subjects \<12 years - 12 mg/kg (max. 600 mg).
|
Peramivir (≥ 13 - < 18 Years)
600 mg dose Peramivir, administered as a single short iv infusion
|
Peramivir (≥ 7 - < 13 Years)
Age-appropriate dose Peramivir, administered as a single short iv infusion:
Subjects ≥12 years - 600 mg. Subjects \<12 years - 12 mg/kg (max. 600 mg).
|
Oseltamivir (≥ 7 - < 13 Years)
Weight-based dose of Oseltamivir as a capsule or oral suspension BID for 5 days.
|
Peramivir (≥ 13 - < 18 Years)
600 mg dose Peramivir, administered as a single short iv infusion
|
Oseltamivir (≥ 13 - < 18 Years)
75mg dose of Oseltamivir as a capsule or oral suspension BID for 5 days.
|
|---|---|---|---|---|---|---|---|---|
|
Influenza-Related Complications Assessment.
Otitis
|
3 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Influenza-Related Complications Assessment.
Sinusitis
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Influenza-Related Complications Assessment.
Bronchitis
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Influenza-Related Complications Assessment.
Pneumonia
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Peramivir
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Oseltamivir
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Peramivir
n=107 participants at risk
Age-appropriate single dose Peramivir, administered as a single short iv infusion:
Subjects ≥12 years - 600 mg. Subjects \<12 years - 12 mg/kg (max. 600 mg). Subjects \< 6 months - 8 mg/kg.
|
Oseltamivir
n=23 participants at risk
Age appropriate oral dose of Oseltamivir BID for 5 days:
Subjects ≥ 13 years - 75mg dose as a capsule or oral suspension. Subjects \< 13 years - weight-based dose as a capsule or oral suspension.
|
|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
3.7%
4/107 • Number of events 4 • AEs were recorded on Day 1, Day 3, Day 7 and Day 14/Early Withdraw visit.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
8.7%
2/23 • Number of events 2 • AEs were recorded on Day 1, Day 3, Day 7 and Day 14/Early Withdraw visit.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.9%
2/107 • Number of events 2 • AEs were recorded on Day 1, Day 3, Day 7 and Day 14/Early Withdraw visit.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
0.00%
0/23 • AEs were recorded on Day 1, Day 3, Day 7 and Day 14/Early Withdraw visit.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/107 • AEs were recorded on Day 1, Day 3, Day 7 and Day 14/Early Withdraw visit.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
8.7%
2/23 • Number of events 2 • AEs were recorded on Day 1, Day 3, Day 7 and Day 14/Early Withdraw visit.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
|
General disorders
Pyrexia
|
1.9%
2/107 • Number of events 2 • AEs were recorded on Day 1, Day 3, Day 7 and Day 14/Early Withdraw visit.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
0.00%
0/23 • AEs were recorded on Day 1, Day 3, Day 7 and Day 14/Early Withdraw visit.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
|
Ear and labyrinth disorders
Tympanic membrane hyperaemia
|
1.9%
2/107 • Number of events 2 • AEs were recorded on Day 1, Day 3, Day 7 and Day 14/Early Withdraw visit.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
0.00%
0/23 • AEs were recorded on Day 1, Day 3, Day 7 and Day 14/Early Withdraw visit.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
|
Investigations
Elevated aspartate aminotransferase
|
1.9%
2/107 • Number of events 2 • AEs were recorded on Day 1, Day 3, Day 7 and Day 14/Early Withdraw visit.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
0.00%
0/23 • AEs were recorded on Day 1, Day 3, Day 7 and Day 14/Early Withdraw visit.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
|
Investigations
Elevated blood lactate dehydrogenase
|
1.9%
2/107 • Number of events 2 • AEs were recorded on Day 1, Day 3, Day 7 and Day 14/Early Withdraw visit.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
0.00%
0/23 • AEs were recorded on Day 1, Day 3, Day 7 and Day 14/Early Withdraw visit.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/107 • AEs were recorded on Day 1, Day 3, Day 7 and Day 14/Early Withdraw visit.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
4.3%
1/23 • Number of events 1 • AEs were recorded on Day 1, Day 3, Day 7 and Day 14/Early Withdraw visit.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/107 • AEs were recorded on Day 1, Day 3, Day 7 and Day 14/Early Withdraw visit.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
4.3%
1/23 • Number of events 1 • AEs were recorded on Day 1, Day 3, Day 7 and Day 14/Early Withdraw visit.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
|
General disorders
Chest discomfort
|
0.93%
1/107 • Number of events 1 • AEs were recorded on Day 1, Day 3, Day 7 and Day 14/Early Withdraw visit.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
0.00%
0/23 • AEs were recorded on Day 1, Day 3, Day 7 and Day 14/Early Withdraw visit.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
|
General disorders
Injection site coldness
|
0.93%
1/107 • Number of events 1 • AEs were recorded on Day 1, Day 3, Day 7 and Day 14/Early Withdraw visit.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
0.00%
0/23 • AEs were recorded on Day 1, Day 3, Day 7 and Day 14/Early Withdraw visit.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
|
General disorders
Injection site paraesthesia
|
0.93%
1/107 • Number of events 1 • AEs were recorded on Day 1, Day 3, Day 7 and Day 14/Early Withdraw visit.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
0.00%
0/23 • AEs were recorded on Day 1, Day 3, Day 7 and Day 14/Early Withdraw visit.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
|
General disorders
Injection site rash
|
0.93%
1/107 • Number of events 1 • AEs were recorded on Day 1, Day 3, Day 7 and Day 14/Early Withdraw visit.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
0.00%
0/23 • AEs were recorded on Day 1, Day 3, Day 7 and Day 14/Early Withdraw visit.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
|
Infections and infestations
Gastroenteritis
|
0.93%
1/107 • Number of events 1 • AEs were recorded on Day 1, Day 3, Day 7 and Day 14/Early Withdraw visit.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
0.00%
0/23 • AEs were recorded on Day 1, Day 3, Day 7 and Day 14/Early Withdraw visit.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
|
Infections and infestations
Paronychia
|
0.93%
1/107 • Number of events 1 • AEs were recorded on Day 1, Day 3, Day 7 and Day 14/Early Withdraw visit.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
0.00%
0/23 • AEs were recorded on Day 1, Day 3, Day 7 and Day 14/Early Withdraw visit.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
|
Infections and infestations
Rhinitis
|
0.93%
1/107 • Number of events 1 • AEs were recorded on Day 1, Day 3, Day 7 and Day 14/Early Withdraw visit.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
0.00%
0/23 • AEs were recorded on Day 1, Day 3, Day 7 and Day 14/Early Withdraw visit.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.93%
1/107 • Number of events 1 • AEs were recorded on Day 1, Day 3, Day 7 and Day 14/Early Withdraw visit.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
0.00%
0/23 • AEs were recorded on Day 1, Day 3, Day 7 and Day 14/Early Withdraw visit.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
|
Infections and infestations
Urinary tract infection
|
0.93%
1/107 • Number of events 1 • AEs were recorded on Day 1, Day 3, Day 7 and Day 14/Early Withdraw visit.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
0.00%
0/23 • AEs were recorded on Day 1, Day 3, Day 7 and Day 14/Early Withdraw visit.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.93%
1/107 • Number of events 1 • AEs were recorded on Day 1, Day 3, Day 7 and Day 14/Early Withdraw visit.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
0.00%
0/23 • AEs were recorded on Day 1, Day 3, Day 7 and Day 14/Early Withdraw visit.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.93%
1/107 • Number of events 1 • AEs were recorded on Day 1, Day 3, Day 7 and Day 14/Early Withdraw visit.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
0.00%
0/23 • AEs were recorded on Day 1, Day 3, Day 7 and Day 14/Early Withdraw visit.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar disorder
|
0.93%
1/107 • Number of events 1 • AEs were recorded on Day 1, Day 3, Day 7 and Day 14/Early Withdraw visit.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
0.00%
0/23 • AEs were recorded on Day 1, Day 3, Day 7 and Day 14/Early Withdraw visit.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar hypertrophy
|
0.93%
1/107 • Number of events 1 • AEs were recorded on Day 1, Day 3, Day 7 and Day 14/Early Withdraw visit.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
0.00%
0/23 • AEs were recorded on Day 1, Day 3, Day 7 and Day 14/Early Withdraw visit.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
|
Ear and labyrinth disorders
Tympanic membrane disorder
|
0.93%
1/107 • Number of events 1 • AEs were recorded on Day 1, Day 3, Day 7 and Day 14/Early Withdraw visit.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
0.00%
0/23 • AEs were recorded on Day 1, Day 3, Day 7 and Day 14/Early Withdraw visit.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
|
Investigations
Alanine aminotransferase increased
|
0.93%
1/107 • Number of events 1 • AEs were recorded on Day 1, Day 3, Day 7 and Day 14/Early Withdraw visit.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
0.00%
0/23 • AEs were recorded on Day 1, Day 3, Day 7 and Day 14/Early Withdraw visit.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.93%
1/107 • Number of events 1 • AEs were recorded on Day 1, Day 3, Day 7 and Day 14/Early Withdraw visit.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
0.00%
0/23 • AEs were recorded on Day 1, Day 3, Day 7 and Day 14/Early Withdraw visit.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
|
Investigations
Carbon dioxide decreased
|
0.93%
1/107 • Number of events 1 • AEs were recorded on Day 1, Day 3, Day 7 and Day 14/Early Withdraw visit.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
0.00%
0/23 • AEs were recorded on Day 1, Day 3, Day 7 and Day 14/Early Withdraw visit.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
|
Nervous system disorders
Psychomotor hyperactivity
|
0.93%
1/107 • Number of events 1 • AEs were recorded on Day 1, Day 3, Day 7 and Day 14/Early Withdraw visit.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
0.00%
0/23 • AEs were recorded on Day 1, Day 3, Day 7 and Day 14/Early Withdraw visit.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.93%
1/107 • Number of events 1 • AEs were recorded on Day 1, Day 3, Day 7 and Day 14/Early Withdraw visit.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
0.00%
0/23 • AEs were recorded on Day 1, Day 3, Day 7 and Day 14/Early Withdraw visit.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.93%
1/107 • Number of events 1 • AEs were recorded on Day 1, Day 3, Day 7 and Day 14/Early Withdraw visit.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
0.00%
0/23 • AEs were recorded on Day 1, Day 3, Day 7 and Day 14/Early Withdraw visit.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.93%
1/107 • Number of events 1 • AEs were recorded on Day 1, Day 3, Day 7 and Day 14/Early Withdraw visit.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
0.00%
0/23 • AEs were recorded on Day 1, Day 3, Day 7 and Day 14/Early Withdraw visit.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.93%
1/107 • Number of events 1 • AEs were recorded on Day 1, Day 3, Day 7 and Day 14/Early Withdraw visit.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
0.00%
0/23 • AEs were recorded on Day 1, Day 3, Day 7 and Day 14/Early Withdraw visit.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place