Trial Outcomes & Findings for Safety Study of IV Peramivir in Hospitalized Subjects With Confirmed or Suspected Influenza (NCT NCT00957996)
NCT ID: NCT00957996
Last Updated: 2015-02-12
Results Overview
The time-weighted change from baseline in log10 tissue culture infective dose50 (TCID50/mL) was calculated on a by-subject basis through 48 hours using the trapezoidal rule with all available data minus the baseline value. Ninety-five percent confidence intervals about the median time-weighted change from baseline were presented for each treatment group.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
234 participants
Primary outcome timeframe
Baseline and 48 hours
Results posted on
2015-02-12
Participant Flow
Participant milestones
| Measure |
Peramivir 300 mg
Peramivir 300 mg twice daily
|
Peramivir 600 mg
Peramivir 600 mg once daily
|
|---|---|---|
|
Overall Study
STARTED
|
117
|
117
|
|
Overall Study
COMPLETED
|
91
|
89
|
|
Overall Study
NOT COMPLETED
|
26
|
28
|
Reasons for withdrawal
| Measure |
Peramivir 300 mg
Peramivir 300 mg twice daily
|
Peramivir 600 mg
Peramivir 600 mg once daily
|
|---|---|---|
|
Overall Study
Death
|
4
|
10
|
|
Overall Study
Lost to Follow-up
|
4
|
7
|
|
Overall Study
Withdrawal by Subject
|
9
|
2
|
|
Overall Study
Adverse Event
|
2
|
1
|
|
Overall Study
Physician Decision
|
1
|
1
|
|
Overall Study
Influenza-related complication
|
0
|
1
|
|
Overall Study
Missing
|
1
|
0
|
|
Overall Study
Noncompliance; Protocol Deviations
|
5
|
6
|
Baseline Characteristics
Safety Study of IV Peramivir in Hospitalized Subjects With Confirmed or Suspected Influenza
Baseline characteristics by cohort
| Measure |
Peramivir 300mg
n=117 Participants
300 mg twice daily
Peramivir: 300 mg twice daily
|
Peramivir 600mg
n=117 Participants
600 mg once daily
Peramivir: 600 mg once daily
|
Total
n=234 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.3 years
n=5 Participants
|
48.4 years
n=7 Participants
|
48.3 years
n=5 Participants
|
|
Age, Customized
Children 6-11 years
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Age, Customized
Adolescents 12-17 years
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Age, Customized
Adults 18-24 years
|
4 participants
n=5 Participants
|
8 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Age, Customized
Adults 25-34 years
|
17 participants
n=5 Participants
|
19 participants
n=7 Participants
|
36 participants
n=5 Participants
|
|
Age, Customized
Adults 35-44 years
|
29 participants
n=5 Participants
|
18 participants
n=7 Participants
|
47 participants
n=5 Participants
|
|
Age, Customized
Adults 45-54 years
|
26 participants
n=5 Participants
|
29 participants
n=7 Participants
|
55 participants
n=5 Participants
|
|
Age, Customized
Adults 55-64 years
|
18 participants
n=5 Participants
|
27 participants
n=7 Participants
|
45 participants
n=5 Participants
|
|
Age, Customized
Adults 65-74 years
|
11 participants
n=5 Participants
|
10 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
Age, Customized
Adults ≥75 years
|
9 participants
n=5 Participants
|
5 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
74 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
139 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
78 participants
n=5 Participants
|
84 participants
n=7 Participants
|
162 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black, of African Heritage or African American
|
16 participants
n=5 Participants
|
13 participants
n=7 Participants
|
29 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
15 participants
n=5 Participants
|
11 participants
n=7 Participants
|
26 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
0 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Body mass index (BMI)
|
32 kg/m^2
n=5 Participants
|
31 kg/m^2
n=7 Participants
|
31 kg/m^2
n=5 Participants
|
|
Smoking status
Current smoker
|
43 participants
n=5 Participants
|
45 participants
n=7 Participants
|
88 participants
n=5 Participants
|
|
Smoking status
Not current smoker
|
73 participants
n=5 Participants
|
72 participants
n=7 Participants
|
145 participants
n=5 Participants
|
|
Smoking status
Missing
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Influenza vaccination status
Not vaccinated this year
|
74 participants
n=5 Participants
|
81 participants
n=7 Participants
|
155 participants
n=5 Participants
|
|
Influenza vaccination status
Vaccinated this year
|
41 participants
n=5 Participants
|
36 participants
n=7 Participants
|
77 participants
n=5 Participants
|
|
Influenza vaccination status
Missing
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Number of subjects with ICU admission at Baseline
|
18 participants
n=5 Participants
|
21 participants
n=7 Participants
|
39 participants
n=5 Participants
|
|
APACHE II Score
|
14 units on a scale
STANDARD_DEVIATION 7.5 • n=5 Participants
|
17 units on a scale
STANDARD_DEVIATION 5.4 • n=7 Participants
|
15 units on a scale
STANDARD_DEVIATION 6.6 • n=5 Participants
|
|
Chest X-ray at Screening
Normal
|
82 participants
n=5 Participants
|
86 participants
n=7 Participants
|
168 participants
n=5 Participants
|
|
Chest X-ray at Screening
Abnormal
|
31 participants
n=5 Participants
|
28 participants
n=7 Participants
|
59 participants
n=5 Participants
|
|
Chest X-ray at Screening
Missing
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Duration of illness
≤48 hours
|
18 participants
n=5 Participants
|
16 participants
n=7 Participants
|
34 participants
n=5 Participants
|
|
Duration of illness
>48 hours
|
99 participants
n=5 Participants
|
101 participants
n=7 Participants
|
200 participants
n=5 Participants
|
|
Hemisphere of enrollment
Northern Hemisphere 09-10
|
107 participants
n=5 Participants
|
108 participants
n=7 Participants
|
215 participants
n=5 Participants
|
|
Hemisphere of enrollment
Southern Hemisphere 10
|
10 participants
n=5 Participants
|
9 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Moderate renal impairment
Impaired
|
10 participants
n=5 Participants
|
11 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
Moderate renal impairment
Not impaired
|
103 participants
n=5 Participants
|
105 participants
n=7 Participants
|
208 participants
n=5 Participants
|
|
Moderate renal impairment
Missing
|
4 participants
n=5 Participants
|
1 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Screening serum albumin
Grade 3
|
6 participants
n=5 Participants
|
8 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Screening serum albumin
Other Grade
|
105 participants
n=5 Participants
|
103 participants
n=7 Participants
|
208 participants
n=5 Participants
|
|
Screening serum albumin
Missing
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Screening lymphocytes
Grade 3/4
|
15 participants
n=5 Participants
|
22 participants
n=7 Participants
|
37 participants
n=5 Participants
|
|
Screening lymphocytes
Other Grade
|
89 participants
n=5 Participants
|
89 participants
n=7 Participants
|
178 participants
n=5 Participants
|
|
Screening lymphocytes
Missing
|
13 participants
n=5 Participants
|
6 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Screening neutrophils
Grade 3/4
|
0 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Screening neutrophils
Other Grade
|
104 participants
n=5 Participants
|
108 participants
n=7 Participants
|
212 participants
n=5 Participants
|
|
Screening neutrophils
Missing
|
13 participants
n=5 Participants
|
6 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Supplemental oxygen required at Screening
Yes
|
75 participants
n=5 Participants
|
83 participants
n=7 Participants
|
158 participants
n=5 Participants
|
|
Supplemental oxygen required at Screening
No
|
41 participants
n=5 Participants
|
32 participants
n=7 Participants
|
73 participants
n=5 Participants
|
|
Supplemental oxygen required at Screening
Missing
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Subjects who received antivirals prior to treatment
|
88 participants
n=5 Participants
|
82 participants
n=7 Participants
|
170 participants
n=5 Participants
|
|
Duration of hospital admission prior to first dose
|
1.1 days
STANDARD_DEVIATION 0.98 • n=5 Participants
|
1.3 days
STANDARD_DEVIATION 2.86 • n=7 Participants
|
1.2 days
STANDARD_DEVIATION 2.13 • n=5 Participants
|
|
Corticosteroid at enrollment
Yes
|
52 participants
n=5 Participants
|
68 participants
n=7 Participants
|
120 participants
n=5 Participants
|
|
Corticosteroid at enrollment
No
|
65 participants
n=5 Participants
|
49 participants
n=7 Participants
|
114 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 48 hoursPopulation: The Intent-to-Treat Infected (ITTI) population included all randomized subjects who received at least 1 dose/infusion of study drug, and had confirmed influenza A or B by culture, PCR, or serology. Overall, 83 subjects were excluded due to negative Baseline titers (log10 TCID50 0.5).
The time-weighted change from baseline in log10 tissue culture infective dose50 (TCID50/mL) was calculated on a by-subject basis through 48 hours using the trapezoidal rule with all available data minus the baseline value. Ninety-five percent confidence intervals about the median time-weighted change from baseline were presented for each treatment group.
Outcome measures
| Measure |
Peramivir 300 mg
n=20 Participants
300 mg twice daily
Peramivir: 300 mg twice daily
|
Peramivir 600 mg
n=24 Participants
600 mg once daily
Peramivir: 600 mg once daily
|
|---|---|---|
|
Change From Baseline in Influenza Virus Titer (48 Hours)
|
-1.66 log10 TCID50/mL
Interval -2.32 to -0.61
|
-1.47 log10 TCID50/mL
Interval -1.89 to -0.75
|
SECONDARY outcome
Timeframe: Baseline, 48, 108, 216 hoursPopulation: The Intent-to-Treat Infected (ITTI) population included all randomized subjects who received at least 1 dose/infusion of study drug, and had confirmed influenza A or B by culture, PCR, or serology. Overall, 41 subjects were excluded due to negative Baseline titers (viral particles/mL RT-PCR value 1.58 for Influenza A and 1.49 for Influenza B).
The time-weighted change from baseline in viral titer measured by RT-PCR was calculated on a by-subject basis through 216 hours using the trapezoidal rule with all available data minus the baseline value. Ninety-five percent confidence intervals about the median time-weighted change from baseline were presented for each treatment group.
Outcome measures
| Measure |
Peramivir 300 mg
n=37 Participants
300 mg twice daily
Peramivir: 300 mg twice daily
|
Peramivir 600 mg
n=49 Participants
600 mg once daily
Peramivir: 600 mg once daily
|
|---|---|---|
|
Change in Influenza Virus Titer, as Measured by Quantitative RT-PCR (log10 vp/mL)
Change from baseline, 48 hours
|
-1.00 log10 viral particles/mL
Interval -1.52 to -0.77
|
-1.07 log10 viral particles/mL
Interval -1.24 to -0.67
|
|
Change in Influenza Virus Titer, as Measured by Quantitative RT-PCR (log10 vp/mL)
Change from baseline, 108 hours
|
-1.65 log10 viral particles/mL
Interval -1.99 to -1.45
|
-1.59 log10 viral particles/mL
Interval -1.86 to -1.24
|
|
Change in Influenza Virus Titer, as Measured by Quantitative RT-PCR (log10 vp/mL)
Change from baseline, 216 hours
|
-2.15 log10 viral particles/mL
Interval -2.38 to -1.96
|
-1.79 log10 viral particles/mL
Interval -2.11 to -1.35
|
SECONDARY outcome
Timeframe: 28 daysPopulation: The Intent-to-Treat Infected (ITTI) population included all randomized subjects who received at least 1 dose/infusion of study drug, and had confirmed influenza A or B by culture, PCR, or serology.
Time to clinical resolution was the number of hours from initiation of study treatment until 4 of the 5 signs of clinical stability (including both body temperature and transcutaneous oxygen saturation) met resolution criteria that was maintained for at least 24 hours. The median time to clinical resolution and associated 95% confidence interval were estimated for each treatment group using the method of Kaplan-Meier. Subjects who did not achieve clinical resolution were censored at the time of their last assessment.
Outcome measures
| Measure |
Peramivir 300 mg
n=56 Participants
300 mg twice daily
Peramivir: 300 mg twice daily
|
Peramivir 600 mg
n=70 Participants
600 mg once daily
Peramivir: 600 mg once daily
|
|---|---|---|
|
Time to Clinical Resolution
|
44.7 hours
Interval 40.7 to 118.5
|
166.1 hours
Interval 84.0 to 273.1
|
SECONDARY outcome
Timeframe: 28 daysPopulation: The Intent-to-Treat Infected (ITTI) population included all randomized subjects who received at least 1 dose/infusion of study drug, and had confirmed influenza A or B by culture, PCR, or serology.
Clinical resolution was defined as normalization of at least 4 of the 5 signs of clinical stability (including both body temperature and transcutaneous oxygen saturation) for at least 24 hours.
Outcome measures
| Measure |
Peramivir 300 mg
n=57 Participants
300 mg twice daily
Peramivir: 300 mg twice daily
|
Peramivir 600 mg
n=70 Participants
600 mg once daily
Peramivir: 600 mg once daily
|
|---|---|---|
|
Number of Participants With Clinical Resolution
|
41 participants
|
42 participants
|
SECONDARY outcome
Timeframe: 28 daysPopulation: The Intent-to-Treat Infected (ITTI) population included all randomized subjects who received at least 1 dose/infusion of study drug, and had confirmed influenza A or B by culture, PCR, or serology. Symptom data for 18 subjects was missing.
Time to alleviation of symptoms, defined as the time from initiation of study drug until the start of the 24 hour period where all seven symptoms of influenza are recorded as none or mild, was estimated using the method of Kaplan-Meier (adolescents and adults). The 95% confidence interval about the median was presented. Subjects who did not experience alleviation of symptoms were censored at the time of the last non-missing symptom assessment.
Outcome measures
| Measure |
Peramivir 300 mg
n=51 Participants
300 mg twice daily
Peramivir: 300 mg twice daily
|
Peramivir 600 mg
n=58 Participants
600 mg once daily
Peramivir: 600 mg once daily
|
|---|---|---|
|
Time to Alleviation of Symptoms
|
135 hours
Interval 89.0 to 184.0
|
158 hours
Interval 103.0 to 306.0
|
SECONDARY outcome
Timeframe: 28 daysPopulation: The Intent-to-Treat Infected (ITTI) population included all randomized subjects who received at least 1 dose/infusion of study drug, and had confirmed influenza A or B by culture, PCR, or serology.
Time to resolution of fever was the number of hours from initiation of study treatment until temperature was ≤37.2°C/≤99°F oral or ≤37.8°C/≤100°F rectal or tympanic for at least 24 hours with no antipyretic medication taken within 4 hours prior to the temperature measurement. Subjects who did not achieve resolution of fever were censored at the time of their last assessment. The 95% confidence interval about the median were presented.
Outcome measures
| Measure |
Peramivir 300 mg
n=57 Participants
300 mg twice daily
Peramivir: 300 mg twice daily
|
Peramivir 600 mg
n=70 Participants
600 mg once daily
Peramivir: 600 mg once daily
|
|---|---|---|
|
Time to Resolution of Fever
|
27.2 hours
Interval 12.5 to 37.0
|
24.2 hours
Interval 12.8 to 54.0
|
SECONDARY outcome
Timeframe: 28 daysPopulation: The Intent-to-Treat Infected (ITTI) population included all randomized subjects who received at least 1 dose/infusion of study drug, and had confirmed influenza A or B by culture, PCR, or serology.
Subject's ability to perform usual activities as determined from the visual analog scale (scale ranges from 0 to 10 where 0 indicates subject was unable to perform usual activities at all and 10 indicates subject is able to perform all usual activities fully) was summarized by study visit day and treatment group. The median time to resumption of usual daily activities and associated 95% CI was estimated using the method of Kaplan-Meier for adults and adolescents. Subjects who did not return to the pre-study level of performance of usual daily activities were censored at the time of their last non-missing visual analog scale value. A separate analysis was conducted for children.
Outcome measures
| Measure |
Peramivir 300 mg
n=53 Participants
300 mg twice daily
Peramivir: 300 mg twice daily
|
Peramivir 600 mg
n=59 Participants
600 mg once daily
Peramivir: 600 mg once daily
|
|---|---|---|
|
Time to Resumption of Usual Activities
|
27.7 hours
Interval 17.8 to
The number of observed events was too small to allow estimation of the required parameter.
|
24.9 hours
Interval 13.5 to 28.8
|
SECONDARY outcome
Timeframe: 28 daysPopulation: The Intent-to-Treat Infected (ITTI) population included all randomized subjects who received at least 1 dose/infusion of study drug, and had confirmed influenza A or B by culture, PCR, or serology.
Time to hospital discharge, defined as the number of days from initiation of study drug until the subject is discharged from the hospital, was estimated using the method of Kaplan-Meier. The 95% confidence interval about the median was presented. Subjects who were not discharged during the study period were censored at the last study visit. Subjects who died prior to discharge were censored at the longest observed time to discharge.
Outcome measures
| Measure |
Peramivir 300 mg
n=57 Participants
300 mg twice daily
Peramivir: 300 mg twice daily
|
Peramivir 600 mg
n=70 Participants
600 mg once daily
Peramivir: 600 mg once daily
|
|---|---|---|
|
Time to Hospital Discharge
|
6 days
Interval 5.0 to 8.0
|
6 days
Interval 6.0 to 11.0
|
SECONDARY outcome
Timeframe: 28 daysPopulation: The Intent-to-Treat Infected (ITTI) population included all randomized subjects who received at least 1 dose/infusion of study drug, and had confirmed influenza A or B by culture, PCR, or serology.
Influenza-related complications were defined as the occurrence of sinusitis, otitis, bronchitis and pneumonia as reported on the Influenza-related complications CRF.
Outcome measures
| Measure |
Peramivir 300 mg
n=57 Participants
300 mg twice daily
Peramivir: 300 mg twice daily
|
Peramivir 600 mg
n=70 Participants
600 mg once daily
Peramivir: 600 mg once daily
|
|---|---|---|
|
Number of Participants Experiencing Influenza-related Complications
|
39 participants
|
48 participants
|
SECONDARY outcome
Timeframe: 28 daysPopulation: The Intent-to-Treat Infected (ITTI) population included all randomized subjects who received at least 1 dose/infusion of study drug, and had confirmed influenza A or B by culture, PCR, or serology.
The number of subjects experiencing ICU admission after initiation of treatment.
Outcome measures
| Measure |
Peramivir 300 mg
n=57 Participants
300 mg twice daily
Peramivir: 300 mg twice daily
|
Peramivir 600 mg
n=70 Participants
600 mg once daily
Peramivir: 600 mg once daily
|
|---|---|---|
|
Number of Participants Admitted to ICU After Initiation of Treatment
|
2 participants
|
6 participants
|
SECONDARY outcome
Timeframe: 28 daysPopulation: The Intent-to-Treat Infected (ITTI) population included all randomized subjects who received at least 1 dose/infusion of study drug, and had confirmed influenza A or B by culture, PCR, or serology.
The duration of ICU admission after initiation of treatment was estimated by the method of Kaplan-Meier. Subjects who were not discharged from the ICU were censored at the time of their last assessment
Outcome measures
| Measure |
Peramivir 300 mg
n=57 Participants
300 mg twice daily
Peramivir: 300 mg twice daily
|
Peramivir 600 mg
n=70 Participants
600 mg once daily
Peramivir: 600 mg once daily
|
|---|---|---|
|
Duration of Postbaseline ICU Admission (Kaplan-Meier Estimate)
|
7 days
Interval 2.0 to 11.0
|
7 days
Interval 4.0 to 9.0
|
SECONDARY outcome
Timeframe: 14 and 28 daysPopulation: The Intent-to-Treat Infected (ITTI) population included all randomized subjects who received at least 1 dose/infusion of study drug, and had confirmed influenza A or B by culture, PCR, or serology.
Survival was calculated as the number of days from initiation of study drug until death or last contact. Overall survival was estimated by the method of Kaplan-Meier; 95% confidence intervals for 14- and 28-day survival were presented by treatment group. Subjects who had not died were censored at the date of last contact.
Outcome measures
| Measure |
Peramivir 300 mg
n=57 Participants
300 mg twice daily
Peramivir: 300 mg twice daily
|
Peramivir 600 mg
n=70 Participants
600 mg once daily
Peramivir: 600 mg once daily
|
|---|---|---|
|
Survival (Kaplan-Meier Estimates)
14 Day Survival
|
98 Percent Survival
Interval 88.0 to 100.0
|
93 Percent Survival
Interval 83.0 to 97.0
|
|
Survival (Kaplan-Meier Estimates)
28 Day Survival
|
94 Percent Survival
Interval 83.0 to 98.0
|
86 Percent Survival
Interval 75.0 to 93.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 28 daysPopulation: The Intent-to-Treat Infected (ITTI) population included all randomized subjects who received at least 1 dose/infusion of study drug, and had confirmed influenza A or B by culture, PCR, or serology.
The number of subjects who continued more than 5 days were as reported on the Continuation of Treatment CRF page.
Outcome measures
| Measure |
Peramivir 300 mg
n=57 Participants
300 mg twice daily
Peramivir: 300 mg twice daily
|
Peramivir 600 mg
n=70 Participants
600 mg once daily
Peramivir: 600 mg once daily
|
|---|---|---|
|
Number of Participants Who Required More Than 5 Days of Peramivir Treatment
|
16 participants
|
28 participants
|
Adverse Events
Peramivir 300 mg
Serious events: 21 serious events
Other events: 69 other events
Deaths: 0 deaths
Peramivir 600 mg
Serious events: 26 serious events
Other events: 65 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Peramivir 300 mg
n=114 participants at risk
300 mg twice daily
Peramivir: 300 mg twice daily
|
Peramivir 600 mg
n=116 participants at risk
600 mg once daily
Peramivir: 600 mg once daily
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.6%
3/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
2.6%
3/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.88%
1/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
2.6%
3/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.8%
2/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
0.86%
1/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
1.7%
2/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Infections and infestations
Septic shock
|
0.88%
1/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
2.6%
3/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Infections and infestations
Sepsis
|
0.88%
1/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
1.7%
2/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Infections and infestations
Pneumonia bacterial
|
1.8%
2/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
0.00%
0/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Infections and infestations
Pneumonia staphylococcal
|
1.8%
2/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
0.00%
0/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Renal and urinary disorders
Renal failure acute
|
0.88%
1/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
2.6%
3/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.88%
1/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
0.86%
1/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.88%
1/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
0.86%
1/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.88%
1/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
0.00%
0/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.88%
1/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
0.00%
0/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
0.86%
1/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
0.86%
1/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Infections and infestations
Pneumonia
|
0.88%
1/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
0.86%
1/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Infections and infestations
Bronchiolitis
|
0.88%
1/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
0.00%
0/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Infections and infestations
HIV Infection
|
0.88%
1/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
0.00%
0/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
0.88%
1/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
0.00%
0/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Infections and infestations
Meningococcal Bacteraemia
|
0.88%
1/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
0.00%
0/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Infections and infestations
Pneumonia Necrotising
|
0.00%
0/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
0.86%
1/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Infections and infestations
Pseudomonal Bacteraemia
|
0.00%
0/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
0.86%
1/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
0.86%
1/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
0.86%
1/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Cardiac disorders
Acute myocardial infarction
|
0.88%
1/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
0.00%
0/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
0.86%
1/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
0.86%
1/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
0.86%
1/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
0.86%
1/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
0.86%
1/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Cardiac disorders
Ventricular fibrillation
|
0.00%
0/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
0.86%
1/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Vascular disorders
Hypertension
|
0.00%
0/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
0.86%
1/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
0.86%
1/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Vascular disorders
Hypoperfusion
|
0.00%
0/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
0.86%
1/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Vascular disorders
Hypotension
|
0.00%
0/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
0.86%
1/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
0.86%
1/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.88%
1/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
0.00%
0/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.00%
0/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
0.86%
1/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
1.7%
2/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.88%
1/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
0.00%
0/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
General disorders
Multi-organ failure
|
0.00%
0/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
0.86%
1/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
0.86%
1/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
0.86%
1/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Injury, poisoning and procedural complications
Overdose
|
0.88%
1/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
0.00%
0/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Investigations
Alanine aminotransferase increased
|
0.88%
1/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
0.00%
0/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Investigations
Aspartate aminotransferase increased
|
0.88%
1/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
0.00%
0/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
0.86%
1/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
1.7%
2/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.88%
1/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
0.00%
0/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Congenital, familial and genetic disorders
Cystic fibrosis
|
0.00%
0/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
0.86%
1/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
0.86%
1/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
0.86%
1/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma stage IV
|
0.00%
0/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
0.86%
1/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Psychiatric disorders
Mental status changes
|
0.88%
1/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
0.00%
0/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.88%
1/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
0.00%
0/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
Other adverse events
| Measure |
Peramivir 300 mg
n=114 participants at risk
300 mg twice daily
Peramivir: 300 mg twice daily
|
Peramivir 600 mg
n=116 participants at risk
600 mg once daily
Peramivir: 600 mg once daily
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
16.7%
19/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
9.5%
11/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Gastrointestinal disorders
Diarrhoea
|
10.5%
12/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
13.8%
16/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Gastrointestinal disorders
Nausea
|
8.8%
10/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
6.9%
8/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Gastrointestinal disorders
Vomiting
|
3.5%
4/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
3.4%
4/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Gastrointestinal disorders
Abdominal Distension
|
0.00%
0/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
4.3%
5/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Gastrointestinal disorders
Gastrointestinal Sounds Abnormal
|
0.00%
0/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
2.6%
3/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
7.0%
8/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
12.1%
14/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
6.1%
7/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
6.0%
7/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
4.4%
5/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
3.4%
4/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Metabolism and nutrition disorders
Fluid Overload
|
2.6%
3/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
3.4%
4/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
3.5%
4/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
2.6%
3/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
2.6%
3/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
3.4%
4/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Metabolism and nutrition disorders
Metabolic Alkalosis
|
1.8%
2/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
4.3%
5/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
2.6%
3/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
2.6%
3/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.88%
1/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
2.6%
3/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
General disorders
Oedema Peripheral
|
8.8%
10/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
6.9%
8/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
General disorders
Oedema
|
1.8%
2/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
5.2%
6/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
General disorders
Generalised Oedema
|
2.6%
3/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
1.7%
2/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
General disorders
Pain
|
2.6%
3/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
0.86%
1/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
General disorders
Catheter Related Complication
|
2.6%
3/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
0.00%
0/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Psychiatric disorders
Insomnia
|
11.4%
13/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
3.4%
4/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Psychiatric disorders
Agitation
|
1.8%
2/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
5.2%
6/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Psychiatric disorders
Anxiety
|
4.4%
5/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
2.6%
3/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.5%
4/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
1.7%
2/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.4%
5/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
0.86%
1/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
4.4%
5/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
0.86%
1/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
4.3%
5/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.88%
1/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
3.4%
4/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.88%
1/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
2.6%
3/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Alkalosis
|
0.88%
1/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
2.6%
3/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
0.00%
0/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
2.6%
3/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Vascular disorders
Hypotension
|
6.1%
7/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
9.5%
11/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Vascular disorders
Hypertension
|
4.4%
5/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
6.9%
8/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Blood and lymphatic system disorders
Anaemia
|
4.4%
5/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
11.2%
13/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Blood and lymphatic system disorders
Leukocytosis
|
3.5%
4/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
3.4%
4/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.88%
1/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
3.4%
4/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Nervous system disorders
Headache
|
6.1%
7/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
4.3%
5/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Nervous system disorders
Dizziness
|
3.5%
4/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
0.00%
0/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Nervous system disorders
Migraine
|
0.00%
0/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
2.6%
3/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Infections and infestations
Urinary Tract Infection
|
4.4%
5/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
1.7%
2/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Infections and infestations
Fungal Skin Infection
|
2.6%
3/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
1.7%
2/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Infections and infestations
Oral Herpes
|
2.6%
3/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
1.7%
2/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Investigations
Alanine Aminotransferase Increased
|
3.5%
4/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
1.7%
2/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Investigations
Blood Triglycerides Increased
|
1.8%
2/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
3.4%
4/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Investigations
Aspartate Aminotransferase Increased
|
2.6%
3/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
1.7%
2/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Investigations
Blood Potassium Decreased
|
3.5%
4/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
0.86%
1/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
1.8%
2/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
2.6%
3/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
2.6%
3/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
1.7%
2/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.88%
1/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
2.6%
3/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.6%
3/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
4.3%
5/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.88%
1/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
2.6%
3/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Cardiac disorders
Atrial Fibrillation
|
2.6%
3/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
1.7%
2/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Cardiac disorders
Cardiac Failure Congestive
|
1.8%
2/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
2.6%
3/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Renal and urinary disorders
Renal Failure Acute
|
0.00%
0/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
3.4%
4/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
|
Renal and urinary disorders
Haematuria
|
2.6%
3/114 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
0.00%
0/116 • Reports of AEs were collected from the time of study drug administration through the follow-up period ending on Day 14 or Day 28.
For subjects who experienced the same coded event more than once, only one event is presented. Four of 234 randomized subjects did not receive treatment; safety analyses included 230 subjects (114 in the Peramivir 300 mg arm and 116 in the Peramivir 600 mg arm).
|
Additional Information
William P. Sheridan, MBBS
BioCryst Pharmaceuticals, Inc.
Phone: 919-859-1302
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place