Trial Outcomes & Findings for Evaluation of the Efficacy and Safety of Peramivir in Subjects With Uncomplicated Acute Influenza. (NCT NCT00419263)
NCT ID: NCT00419263
Last Updated: 2015-02-12
Results Overview
Descriptive statistics for the primary efficacy variables were tabulated by treatment group. Alleviation of symptoms was determined by data recorded in the Subject Diary. Treatment differences were assessed using a Cox Regression model with effects for current smoking behavior, treatment, and geographic region. Subjects who did not experience alleviation of symptoms were censored at the date of their last assessment. A Bonferroni adjustment for the primary comparisons of each active dose with placebo was performed.
COMPLETED
PHASE2
344 participants
Up to 14 days
2015-02-12
Participant Flow
Participant milestones
| Measure |
Placebo
Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of placebo).
|
Peramivir 150 mg
Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (one injection of peramivir 150 mg and one injection of placebo).
|
Peramivir 300 mg
Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of peramivir 150 mg).
|
|---|---|---|---|
|
Overall Study
STARTED
|
115
|
114
|
115
|
|
Overall Study
COMPLETED
|
112
|
112
|
112
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
3
|
Reasons for withdrawal
| Measure |
Placebo
Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of placebo).
|
Peramivir 150 mg
Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (one injection of peramivir 150 mg and one injection of placebo).
|
Peramivir 300 mg
Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of peramivir 150 mg).
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
1
|
|
Overall Study
Randomized in Error, Not Treated
|
1
|
1
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
Baseline Characteristics
Evaluation of the Efficacy and Safety of Peramivir in Subjects With Uncomplicated Acute Influenza.
Baseline characteristics by cohort
| Measure |
Placebo
n=114 Participants
Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of placebo).
|
Peramivir 150 mg
n=113 Participants
Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (one injection of peramivir 150 mg and one injection of placebo).
|
Peramivir 300 mg
n=115 Participants
Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of peramivir 150 mg).
|
Total
n=342 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
33.9 years
STANDARD_DEVIATION 12.05 • n=99 Participants
|
36.2 years
STANDARD_DEVIATION 15.59 • n=107 Participants
|
36.2 years
STANDARD_DEVIATION 13.25 • n=206 Participants
|
35.4 years
STANDARD_DEVIATION 13.71 • n=7 Participants
|
|
Age, Customized
18 - 27 years old
|
41 participants
n=99 Participants
|
37 participants
n=107 Participants
|
34 participants
n=206 Participants
|
112 participants
n=7 Participants
|
|
Age, Customized
28 - 37 years old
|
37 participants
n=99 Participants
|
31 participants
n=107 Participants
|
35 participants
n=206 Participants
|
103 participants
n=7 Participants
|
|
Age, Customized
38 - 47 years old
|
19 participants
n=99 Participants
|
21 participants
n=107 Participants
|
25 participants
n=206 Participants
|
65 participants
n=7 Participants
|
|
Age, Customized
48 - 57 years old
|
9 participants
n=99 Participants
|
10 participants
n=107 Participants
|
12 participants
n=206 Participants
|
31 participants
n=7 Participants
|
|
Age, Customized
≥ 58 years old
|
8 participants
n=99 Participants
|
13 participants
n=107 Participants
|
9 participants
n=206 Participants
|
30 participants
n=7 Participants
|
|
Age, Customized
Missing
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
0 participants
n=206 Participants
|
1 participants
n=7 Participants
|
|
Sex: Female, Male
Female
|
54 Participants
n=99 Participants
|
67 Participants
n=107 Participants
|
62 Participants
n=206 Participants
|
183 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
60 Participants
n=99 Participants
|
46 Participants
n=107 Participants
|
53 Participants
n=206 Participants
|
159 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
19 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
108 Participants
n=99 Participants
|
104 Participants
n=107 Participants
|
111 Participants
n=206 Participants
|
323 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
18 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
6 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
18 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
21 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
56 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
77 Participants
n=99 Participants
|
78 Participants
n=107 Participants
|
81 Participants
n=206 Participants
|
236 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
14 Participants
n=7 Participants
|
|
Body Mass Index at Screening
|
26.5 kg/m^2
STANDARD_DEVIATION 5.69 • n=99 Participants
|
27.5 kg/m^2
STANDARD_DEVIATION 6.23 • n=107 Participants
|
27.8 kg/m^2
STANDARD_DEVIATION 6.35 • n=206 Participants
|
27.2 kg/m^2
STANDARD_DEVIATION 6.11 • n=7 Participants
|
|
Current Smoking Behavior at Randomization
Smoker
|
26 participants
n=99 Participants
|
22 participants
n=107 Participants
|
25 participants
n=206 Participants
|
73 participants
n=7 Participants
|
|
Current Smoking Behavior at Randomization
Nonsmoker
|
88 participants
n=99 Participants
|
91 participants
n=107 Participants
|
90 participants
n=206 Participants
|
269 participants
n=7 Participants
|
|
Estimated Time of Onset of Symptoms at Screening
0 - 12 hours ago
|
1 participants
n=99 Participants
|
4 participants
n=107 Participants
|
4 participants
n=206 Participants
|
9 participants
n=7 Participants
|
|
Estimated Time of Onset of Symptoms at Screening
> 12 - 24 hours ago
|
37 participants
n=99 Participants
|
32 participants
n=107 Participants
|
25 participants
n=206 Participants
|
94 participants
n=7 Participants
|
|
Estimated Time of Onset of Symptoms at Screening
> 24 - 36 hours ago
|
45 participants
n=99 Participants
|
43 participants
n=107 Participants
|
46 participants
n=206 Participants
|
134 participants
n=7 Participants
|
|
Estimated Time of Onset of Symptoms at Screening
> 36 - 48 hours ago
|
31 participants
n=99 Participants
|
34 participants
n=107 Participants
|
40 participants
n=206 Participants
|
105 participants
n=7 Participants
|
|
Initial Composite Symptom Score
|
14.3 units on a scale
STANDARD_DEVIATION 3.70 • n=99 Participants
|
14.3 units on a scale
STANDARD_DEVIATION 3.22 • n=107 Participants
|
14.1 units on a scale
STANDARD_DEVIATION 3.92 • n=206 Participants
|
14.2 units on a scale
STANDARD_DEVIATION 3.62 • n=7 Participants
|
|
Influenza Infection
Negative
|
5 participants
n=99 Participants
|
9 participants
n=107 Participants
|
9 participants
n=206 Participants
|
23 participants
n=7 Participants
|
|
Influenza Infection
Positive
|
109 participants
n=99 Participants
|
104 participants
n=107 Participants
|
105 participants
n=206 Participants
|
318 participants
n=7 Participants
|
|
Influenza Infection
Missing
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
1 participants
n=7 Participants
|
|
Body Surface Area
|
1.9 m^2
STANDARD_DEVIATION 0.26 • n=99 Participants
|
1.9 m^2
STANDARD_DEVIATION 0.25 • n=107 Participants
|
1.9 m^2
STANDARD_DEVIATION 0.28 • n=206 Participants
|
1.9 m^2
STANDARD_DEVIATION 0.26 • n=7 Participants
|
PRIMARY outcome
Timeframe: Up to 14 daysPopulation: The intent-to-treat infected (ITTI) population included all randomized subjects who received study drug and had proven influenza by culture, PCR, or paired serology showing ≥ 4-fold increase in antibody to influenza A or B. Of the 318 subjects in the ITTI population, one subject had insufficient data to determine Time to Alleviation of Symptoms.
Descriptive statistics for the primary efficacy variables were tabulated by treatment group. Alleviation of symptoms was determined by data recorded in the Subject Diary. Treatment differences were assessed using a Cox Regression model with effects for current smoking behavior, treatment, and geographic region. Subjects who did not experience alleviation of symptoms were censored at the date of their last assessment. A Bonferroni adjustment for the primary comparisons of each active dose with placebo was performed.
Outcome measures
| Measure |
Placebo
n=108 Participants
Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of placebo).
|
Peramivir 150 mg
n=104 Participants
Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (one injection of peramivir 150 mg and one injection of placebo).
|
Peramivir 300 mg
n=105 Participants
Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of peramivir 150 mg).
|
|---|---|---|---|
|
Time to Alleviation of Symptoms (Kaplan-Meier Estimate)
|
136.2 Hours
Interval 114.3 to 165.8
|
114.1 Hours
Interval 95.2 to 145.5
|
117.4 Hours
Interval 78.0 to 135.9
|
SECONDARY outcome
Timeframe: Up to 14 daysPopulation: The ITTI population included all subjects who were randomized, received study drug, and had proven influenza by any one of the following: culture, PCR, or paired serology showing ≥ 4-fold increase in antibody to influenza A or B. Subjects were analyzed according to the treatment to which they were randomized.
The time to resolution of fever (defined as the number of hours from initiation of study drug until temperature is less than 37.2 degrees C \[99.0 degrees F\] and no antipyretic medications had been taken in the previous 12 hours) was estimated using the method of Kaplan-Meier. Differences between the treatment groups were assessed using the log rank statistic controlling for current smoking behavior. Subjects who did not have resolution of fever were censored at the time of the last assessment. No adjustment for multiple comparisons was performed.
Outcome measures
| Measure |
Placebo
n=108 Participants
Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of placebo).
|
Peramivir 150 mg
n=104 Participants
Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (one injection of peramivir 150 mg and one injection of placebo).
|
Peramivir 300 mg
n=104 Participants
Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of peramivir 150 mg).
|
|---|---|---|---|
|
Time to Resolution of Fever
|
58.1 Hours
Interval 43.0 to 67.7
|
43.6 Hours
Interval 40.9 to 49.1
|
42.9 Hours
Interval 40.2 to 46.1
|
SECONDARY outcome
Timeframe: Up to 14 daysPopulation: The ITTI population included all subjects who were randomized, received study drug, and had proven influenza by any one of the following: culture, PCR, or paired serology showing ≥ 4-fold increase in antibody to influenza A or B. Subjects were analyzed according to the treatment to which they were randomized.
The time to resumption of a subject's self-assessed ability to perform his or her usual activities was estimated using the method of Kaplan-Meier. Differences between the treatment groups were assessed using the log rank statistic controlling for current smoking behavior. Subjects who were not able to resume performance of usual activities were censored at the time of the last assessment.
Outcome measures
| Measure |
Placebo
n=108 Participants
Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of placebo).
|
Peramivir 150 mg
n=104 Participants
Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (one injection of peramivir 150 mg and one injection of placebo).
|
Peramivir 300 mg
n=103 Participants
Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of peramivir 150 mg).
|
|---|---|---|---|
|
Time to Resumption of Ability to Perform Usual Activities
|
10.1 Days
Interval 9.1 to 11.4
|
9.2 Days
Interval 8.1 to 11.4
|
8.3 Days
Interval 7.3 to 10.4
|
SECONDARY outcome
Timeframe: Baseline and approximately 24 hours after treatmentPopulation: The ITTI population included all subjects who were randomized, received study drug, and had proven influenza by any one of the following: culture, PCR, or paired serology showing ≥ 4-fold increase in antibody to influenza A or B. Subjects were analyzed according to the treatment to which they were randomized.
The change in viral titers was defined as the time-weighted change from baseline in log\_10 tissue culture infective dose\_50 (TCID\_50/mL) and was summarized for each treatment group. The differences between the treatment groups were evaluated using a Wilcoxon Rank Sum Test controlling for current smoking behavior. Specimens for virologic culture and determination of influenza virus TCID\_50/mL were obtained on Day 2 (approximately 24 hours after treatment), on Day 3 (approximately 48 hours after treatment), on Day 5 (approximately 96 hours after treatment), and on Day 9 (approximately 192 hours after treatment).
Outcome measures
| Measure |
Placebo
n=103 Participants
Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of placebo).
|
Peramivir 150 mg
n=97 Participants
Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (one injection of peramivir 150 mg and one injection of placebo).
|
Peramivir 300 mg
n=100 Participants
Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of peramivir 150 mg).
|
|---|---|---|---|
|
Change From Baseline to Day 2 in Influenza Virus Titer
|
-1.50 log10(TCID50/mL)
Interval -5.25 to 2.5
|
-2.00 log10(TCID50/mL)
Interval -5.25 to 2.25
|
-2.25 log10(TCID50/mL)
Interval -5.25 to 1.25
|
SECONDARY outcome
Timeframe: Baseline and approximately 48 hours after treatmentPopulation: The ITTI population included all subjects who were randomized, received study drug, and had proven influenza by any one of the following: culture, PCR, or paired serology showing ≥ 4-fold increase in antibody to influenza A or B. Subjects were analyzed according to the treatment to which they were randomized.
The change in viral titers was defined as the time-weighted change from baseline in log\_10 tissue culture infective dose\_50 (TCID\_50/mL) and was summarized for each treatment group. The differences between the treatment groups were evaluated using a Wilcoxon Rank Sum Test controlling for current smoking behavior. Specimens for virologic culture and determination of influenza virus TCID\_50/mL were obtained on Day 2 (approximately 24 hours after treatment), on Day 3 (approximately 48 hours after treatment), on Day 5 (approximately 96 hours after treatment), and on Day 9 (approximately 192 hours after treatment).
Outcome measures
| Measure |
Placebo
n=104 Participants
Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of placebo).
|
Peramivir 150 mg
n=98 Participants
Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (one injection of peramivir 150 mg and one injection of placebo).
|
Peramivir 300 mg
n=98 Participants
Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of peramivir 150 mg).
|
|---|---|---|---|
|
Change From Baseline to Day 3 in Influenza Virus Titer
|
-2.75 log10(TCID50/mL)
Interval -5.0 to 1.0
|
-3.00 log10(TCID50/mL)
Interval -5.25 to 1.0
|
-3.25 log10(TCID50/mL)
Interval -6.0 to 1.25
|
SECONDARY outcome
Timeframe: Baseline and approximately 96 hours after treatmentPopulation: The ITTI population included all subjects who were randomized, received study drug, and had proven influenza by any one of the following: culture, PCR, or paired serology showing ≥ 4-fold increase in antibody to influenza A or B. Subjects were analyzed according to the treatment to which they were randomized.
The change in viral titers was defined as the time-weighted change from baseline in log\_10 tissue culture infective dose\_50 (TCID\_50/mL) and was summarized for each treatment group. The differences between the treatment groups were evaluated using a Wilcoxon Rank Sum Test controlling for current smoking behavior. Specimens for virologic culture and determination of influenza virus TCID\_50/mL were obtained on Day 2 (approximately 24 hours after treatment), on Day 3 (approximately 48 hours after treatment), on Day 5 (approximately 96 hours after treatment), and on Day 9 (approximately 192 hours after treatment).
Outcome measures
| Measure |
Placebo
n=103 Participants
Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of placebo).
|
Peramivir 150 mg
n=98 Participants
Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (one injection of peramivir 150 mg and one injection of placebo).
|
Peramivir 300 mg
n=100 Participants
Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of peramivir 150 mg).
|
|---|---|---|---|
|
Change From Baseline to Day 5 in Influenza Virus Titer
|
-3.75 log10(TCID50/mL)
Interval -5.5 to -0.25
|
-3.38 log10(TCID50/mL)
Interval -6.5 to 0.0
|
-3.63 log10(TCID50/mL)
Interval -6.5 to 0.5
|
SECONDARY outcome
Timeframe: Baseline and approximately 192 hours after treatmentPopulation: The ITTI population included all subjects who were randomized, received study drug, and had proven influenza by any one of the following: culture, PCR, or paired serology showing ≥ 4-fold increase in antibody to influenza A or B. Subjects were analyzed according to the treatment to which they were randomized.
The change in viral titers was defined as the time-weighted change from baseline in log\_10 tissue culture infective dose\_50 (TCID\_50/mL) and was summarized for each treatment group. The differences between the treatment groups were evaluated using a Wilcoxon Rank Sum Test controlling for current smoking behavior. Specimens for virologic culture and determination of influenza virus TCID\_50/mL were obtained on Day 2 (approximately 24 hours after treatment), on Day 3 (approximately 48 hours after treatment), on Day 5 (approximately 96 hours after treatment), and on Day 9 (approximately 192 hours after treatment).
Outcome measures
| Measure |
Placebo
n=103 Participants
Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of placebo).
|
Peramivir 150 mg
n=97 Participants
Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (one injection of peramivir 150 mg and one injection of placebo).
|
Peramivir 300 mg
n=100 Participants
Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of peramivir 150 mg).
|
|---|---|---|---|
|
Change From Baseline to Day 9 in Influenza Virus Titer
|
-3.75 log10(TCID50/mL)
Interval -5.75 to -0.25
|
-3.75 log10(TCID50/mL)
Interval -6.5 to 2.0
|
-3.75 log10(TCID50/mL)
Interval -6.75 to -0.5
|
Adverse Events
Placebo
Peramivir 150 mg
Peramivir 300 mg
Total
Serious adverse events
| Measure |
Placebo
n=114 participants at risk
Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of placebo).
|
Peramivir 150 mg
n=113 participants at risk
Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (one injection of peramivir 150 mg and one injection of placebo).
|
Peramivir 300 mg
n=115 participants at risk
Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of peramivir 150 mg).
|
Total
n=342 participants at risk
Total number of subjects who received at least 1 dose of study drug
|
|---|---|---|---|---|
|
Infections and infestations
Meningitis
|
0.00%
0/114
|
0.00%
0/113
|
0.87%
1/115 • Number of events 1
|
0.29%
1/342 • Number of events 1
|
|
Infections and infestations
Pyelonephritis
|
0.88%
1/114 • Number of events 1
|
0.00%
0/113
|
0.00%
0/115
|
0.29%
1/342 • Number of events 1
|
Other adverse events
| Measure |
Placebo
n=114 participants at risk
Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of placebo).
|
Peramivir 150 mg
n=113 participants at risk
Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (one injection of peramivir 150 mg and one injection of placebo).
|
Peramivir 300 mg
n=115 participants at risk
Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of peramivir 150 mg).
|
Total
n=342 participants at risk
Total number of subjects who received at least 1 dose of study drug
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
4.4%
5/114
|
4.4%
5/113
|
5.2%
6/115
|
4.7%
16/342
|
|
Gastrointestinal disorders
Nausea
|
6.1%
7/114
|
6.2%
7/113
|
7.8%
9/115
|
6.7%
23/342
|
|
Gastrointestinal disorders
Vomiting
|
4.4%
5/114
|
3.5%
4/113
|
1.7%
2/115
|
3.2%
11/342
|
|
Nervous system disorders
Dizziness
|
2.6%
3/114
|
2.7%
3/113
|
4.3%
5/115
|
3.2%
11/342
|
|
Nervous system disorders
Syncope vasovagal
|
3.5%
4/114
|
1.8%
2/113
|
0.00%
0/115
|
1.8%
6/342
|
|
Renal and urinary disorders
Proteinuria
|
6.1%
7/114
|
8.8%
10/113
|
4.3%
5/115
|
6.4%
22/342
|
|
Investigations
Aspartate aminotransferase increased
|
1.8%
2/114
|
1.8%
2/113
|
2.6%
3/115
|
2.0%
7/342
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
3.5%
4/114
|
0.88%
1/113
|
0.87%
1/115
|
1.8%
6/342
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/114
|
0.88%
1/113
|
2.6%
3/115
|
1.2%
4/342
|
|
Psychiatric disorders
Insomnia
|
1.8%
2/114
|
4.4%
5/113
|
0.00%
0/115
|
2.0%
7/342
|
Additional Information
William P. Sheridan, MBBS
BioCryst Pharmaceuticals, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place