Trial Outcomes & Findings for Safety, PK and Effectiveness of IV Peramivir in Elderly and Higher Risk Subjects With Uncomplicated Influenza (NCT NCT02635724)
NCT ID: NCT02635724
Last Updated: 2021-03-23
Results Overview
Safety was evaluated through assessment of Adverse Events (AEs).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
74 participants
Primary outcome timeframe
14 days
Results posted on
2021-03-23
Participant Flow
A single dose of IV peramivir was administered to elderly subjects (≥ 65 years old) and at risk subjects with acute uncomplicated influenza. Subjects received a single IV dose of 600 mg peramivir if they had creatinine clearance (CLCR) ≥ 50 mL/min and a reduced dose if they had CLCR \< 50 mL/min (200 mg for CLCR 30 to 49 mL/min and 100 mg for CLCR 10 to 29 mL/min).
Participant milestones
| Measure |
At Risk (<65 Years)
A single IV dose of peramivir was administered to adults considered at risk, including pregnant women, residents of long-term care facilities, American Indians and Alaskan Natives, as well as those with comorbidities (e.g. asthma, heart disease, diabetes) that increased the risk of complications.
|
Elderly (65-75 Years)
A single IV dose of peramivir was administered to adults aged 65 to 75 years
|
Very Elderly (>75 Years)
A single IV dose of peramivir was administered to adults aged over 75 years
|
|---|---|---|---|
|
Overall Study
STARTED
|
41
|
26
|
7
|
|
Overall Study
ITT Population
|
41
|
26
|
7
|
|
Overall Study
Safety Population
|
41
|
25
|
7
|
|
Overall Study
ITTI Population
|
28
|
19
|
5
|
|
Overall Study
E-R Population
|
28
|
19
|
5
|
|
Overall Study
COMPLETED
|
41
|
25
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
At Risk (<65 Years)
A single IV dose of peramivir was administered to adults considered at risk, including pregnant women, residents of long-term care facilities, American Indians and Alaskan Natives, as well as those with comorbidities (e.g. asthma, heart disease, diabetes) that increased the risk of complications.
|
Elderly (65-75 Years)
A single IV dose of peramivir was administered to adults aged 65 to 75 years
|
Very Elderly (>75 Years)
A single IV dose of peramivir was administered to adults aged over 75 years
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
Baseline Characteristics
Safety, PK and Effectiveness of IV Peramivir in Elderly and Higher Risk Subjects With Uncomplicated Influenza
Baseline characteristics by cohort
| Measure |
At Risk (<65 Years)
n=41 Participants
A single IV dose of peramivir was administered to adults considered at risk
|
Elderly (65-75 Years)
n=25 Participants
A single IV dose of peramivir was administered to adults aged 65 to 75 years
|
Very Elderly (>75 Years)
n=7 Participants
A single IV dose of peramivir was administered to adults aged over 75 years
|
Total
n=73 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
43.1 Age at screening (years)
STANDARD_DEVIATION 10.67 • n=5 Participants
|
68.4 Age at screening (years)
STANDARD_DEVIATION 3.10 • n=7 Participants
|
81.1 Age at screening (years)
STANDARD_DEVIATION 3.03 • n=5 Participants
|
55.4 Age at screening (years)
STANDARD_DEVIATION 16.62 • n=4 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
53 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
37 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
67 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Baseline Influenza Viral Titre
Positive
|
27 participants
n=5 Participants
|
15 participants
n=7 Participants
|
2 participants
n=5 Participants
|
44 participants
n=4 Participants
|
|
Baseline Influenza Viral Titre
Negative
|
12 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
18 participants
n=4 Participants
|
|
Baseline Influenza Viral Titre
Missing
|
2 participants
n=5 Participants
|
7 participants
n=7 Participants
|
2 participants
n=5 Participants
|
11 participants
n=4 Participants
|
|
Baseline Temperature Status
Normal
|
16 participants
n=5 Participants
|
9 participants
n=7 Participants
|
5 participants
n=5 Participants
|
30 participants
n=4 Participants
|
|
Baseline Temperature Status
Fever
|
25 participants
n=5 Participants
|
16 participants
n=7 Participants
|
2 participants
n=5 Participants
|
43 participants
n=4 Participants
|
|
Baseline Composite Influenza Symptom Score
|
14 Composite Influenza Symptom Score
STANDARD_DEVIATION 3.4 • n=5 Participants
|
15 Composite Influenza Symptom Score
STANDARD_DEVIATION 3.0 • n=7 Participants
|
10 Composite Influenza Symptom Score
STANDARD_DEVIATION 5.1 • n=5 Participants
|
14 Composite Influenza Symptom Score
STANDARD_DEVIATION 3.6 • n=4 Participants
|
PRIMARY outcome
Timeframe: 14 daysSafety was evaluated through assessment of Adverse Events (AEs).
Outcome measures
| Measure |
At Risk (<65 Years)
n=41 Participants
A single IV dose of peramivir was administered to adults considered at risk
|
Elderly (65-75 Years)
n=25 Participants
A single IV dose of peramivir was administered to adults aged 65 to 75 years
|
Very Elderly (>75 Years)
n=7 Participants
A single IV dose of peramivir was administered to adults aged over 75 years
|
|---|---|---|---|
|
Safety and Tolerability, as Measured by the Number of Adverse Events.
Subjects with at Least 1 Adverse Event Leading to Study Discontinuation
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability, as Measured by the Number of Adverse Events.
Subjects with at Least 1 Severe or Life-Threatening Adverse Event
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability, as Measured by the Number of Adverse Events.
Subjects with at Least 1 Severe or Life-Threatening Adverse Event Related to Study Drug
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability, as Measured by the Number of Adverse Events.
Subjects with at Least 1 Adverse Event
|
17 Participants
|
9 Participants
|
1 Participants
|
|
Safety and Tolerability, as Measured by the Number of Adverse Events.
Subjects with at Least 1 Adverse Event Related to Study Drug
|
5 Participants
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: up to 3 hours post peramivir infusionPopulation: 73 subjects from the ITT population had sufficient PK samples collected for inclusion in the peramivir PK analysis
Up to 3 plasma samples will be drawn, where possible: immediately following infusion, 30 mins to 1 hr post-infusion \& 1 to 3 hrs post-infusion. Maximum concentration (Cmax), area under the concentration vs. time curve (AUC) from time 0 to 1 hour (AUC0-1), AUC from time 0 to 1.5 hours (AUC0-1.5), and AUC from time 0 to the last measurable time point (AUC0-last) were calculated in Phoenix® WinNonlin® v6.4. No summary statistics were reported due to the variation in the infusion time and sampling times.
Outcome measures
| Measure |
At Risk (<65 Years)
n=41 Participants
A single IV dose of peramivir was administered to adults considered at risk
|
Elderly (65-75 Years)
n=25 Participants
A single IV dose of peramivir was administered to adults aged 65 to 75 years
|
Very Elderly (>75 Years)
n=7 Participants
A single IV dose of peramivir was administered to adults aged over 75 years
|
|---|---|---|---|
|
Plasma Exposure of IV Peramivir as Measured by Drug Concentrations up to 3 Hours Post Infusion
AUC0-last
|
42400 h*ng/mL
Standard Deviation 15630
|
68300 h*ng/mL
Standard Deviation 116800
|
64600 h*ng/mL
Standard Deviation 66380
|
|
Plasma Exposure of IV Peramivir as Measured by Drug Concentrations up to 3 Hours Post Infusion
AUC0-1
|
30600 h*ng/mL
Standard Deviation 15260
|
53600 h*ng/mL
Standard Deviation 107400
|
54400 h*ng/mL
Standard Deviation 63620
|
|
Plasma Exposure of IV Peramivir as Measured by Drug Concentrations up to 3 Hours Post Infusion
AUC0-1.5
|
38200 h*ng/mL
Standard Deviation 12800
|
85800 h*ng/mL
Standard Deviation 168000
|
35000 h*ng/mL
Standard Deviation 0
|
SECONDARY outcome
Timeframe: 14 daysPopulation: Intent to treat infected (ITTI) population. Subjects who did not have resolution of fever were censored at the time of their last non-missing post-baseline temperature assessment; this included 1 subject in the 'At Risk (\<65 years)' group. Twelve subjects were excluded from summaries due to missing data or events resolving prior to initiation of study drug.
Time for fever resolution based on subject diary record of temperature recorded twice daily. A subject had resolution of fever if he/she had an oral temperature \< 37.4°C/99.4°F oral and no antipyretic medications were taken for at least 12 hours. The time to resolution of fever was estimated for each age group and overall using the Kaplan-Meier method with temperature and symptom relief medication information obtained from the Subject Diary data. Subjects who did not have resolution of fever were censored at the time of their last non-missing post-baseline temperature assessment.
Outcome measures
| Measure |
At Risk (<65 Years)
n=22 Participants
A single IV dose of peramivir was administered to adults considered at risk
|
Elderly (65-75 Years)
n=14 Participants
A single IV dose of peramivir was administered to adults aged 65 to 75 years
|
Very Elderly (>75 Years)
n=4 Participants
A single IV dose of peramivir was administered to adults aged over 75 years
|
|---|---|---|---|
|
Time to Resolution of Fever
|
41.5 hours
Interval 10.1 to 52.3
|
29.3 hours
Interval 15.5 to 43.8
|
9.4 hours
Interval 1.4 to 19.0
|
SECONDARY outcome
Timeframe: 14 daysPopulation: Intent to treat infected (ITTI) population. Subjects who did not experience alleviation of symptoms were censored at the date of their last non-missing post-baseline assessment; this included 5 subjects in the 'At Risk (\<65 years)' group, 4 subjects in the 'Elderly (65-75 years)' group and 2 subjects in the 'Very Elderly (\>75 years)' group.
Subjects were asked to provide an assessment of 7 influenza symptoms (cough, sore throat, nasal congestion, myalgia \[aches and pains\], headache, feverishness, and fatigue) on a 4-point severity scale (0, absent; 1, mild; 2, moderate; 3, severe) beginning at Screening then twice daily beginning on Day 1 through to Day 13, and prior to the subject's clinic visit on Day 14. Once all symptoms were scored a 0 or 1 for at least 48 hours, recordings were discontinued. The time to alleviation of symptoms, defined as the time from initiation of study drug until the start of the 21.5-hour period (24 hours less 10%), where all symptoms of influenza were recorded as none (0) or mild (1), was estimated overall and for each age group using the Kaplan-Meier method.
Outcome measures
| Measure |
At Risk (<65 Years)
n=28 Participants
A single IV dose of peramivir was administered to adults considered at risk
|
Elderly (65-75 Years)
n=19 Participants
A single IV dose of peramivir was administered to adults aged 65 to 75 years
|
Very Elderly (>75 Years)
n=5 Participants
A single IV dose of peramivir was administered to adults aged over 75 years
|
|---|---|---|---|
|
Time to Resolution of Influenza Symptoms
|
124.8 hours
Standard Deviation 10.59
|
114.5 hours
Standard Deviation 20.37
|
54.0 hours
Standard Deviation 9.45
|
SECONDARY outcome
Timeframe: Change from baseline assessed on days 3, 7 and 14.Population: The Intent To Treat Infected (ITTI) population included all subjects who were enrolled, received study drug, and had confirmed influenza A and/or B by PCR. Eight subjects were excluded due to a negative or missing BL titer.
Change in influenza viral titers was defined as the time-weighted change from Baseline in log\_10 tissue culture infective dose\_50 (TCID50/mL) and was summarized for each treatment group.
Outcome measures
| Measure |
At Risk (<65 Years)
n=27 Participants
A single IV dose of peramivir was administered to adults considered at risk
|
Elderly (65-75 Years)
n=15 Participants
A single IV dose of peramivir was administered to adults aged 65 to 75 years
|
Very Elderly (>75 Years)
n=2 Participants
A single IV dose of peramivir was administered to adults aged over 75 years
|
|---|---|---|---|
|
Changes in Influenza Virus Titer in Nasopharyngeal Samples in Response to Treatment.
Day 14 - Change from baseline
|
-3.88 influenza viral titer - log10 TCID50/mL
Interval -6.0 to -0.5
|
-3.25 influenza viral titer - log10 TCID50/mL
Interval -3.75 to -0.75
|
—
|
|
Changes in Influenza Virus Titer in Nasopharyngeal Samples in Response to Treatment.
Baseline
|
4.50 influenza viral titer - log10 TCID50/mL
Interval 1.0 to 6.5
|
4.45 influenza viral titer - log10 TCID50/mL
Interval 1.25 to 6.45
|
4.70 influenza viral titer - log10 TCID50/mL
Interval 3.45 to 5.95
|
|
Changes in Influenza Virus Titer in Nasopharyngeal Samples in Response to Treatment.
Day 3 - Change from baseline
|
-3.25 influenza viral titer - log10 TCID50/mL
Interval -5.0 to 3.5
|
-3.00 influenza viral titer - log10 TCID50/mL
Interval -5.25 to 1.25
|
—
|
|
Changes in Influenza Virus Titer in Nasopharyngeal Samples in Response to Treatment.
Day 7 - Change from baseline
|
-4.00 influenza viral titer - log10 TCID50/mL
Interval -6.0 to -0.5
|
-2.13 influenza viral titer - log10 TCID50/mL
Interval -3.75 to -0.75
|
—
|
SECONDARY outcome
Timeframe: 14 daysPopulation: Intent to treat infected (ITTI) population + ITT population with positive baseline influenza viral titers \[\> 0.5 log10 TCID50/mL\]. Eight subjects were excluded due to a negative or missing Baseline titer.
Assessment of viral shedding in bilateral, mid-nasal swab specimens taken at baseline and then on Day 3, 7 and 14.
Outcome measures
| Measure |
At Risk (<65 Years)
n=27 Participants
A single IV dose of peramivir was administered to adults considered at risk
|
Elderly (65-75 Years)
n=15 Participants
A single IV dose of peramivir was administered to adults aged 65 to 75 years
|
Very Elderly (>75 Years)
n=2 Participants
A single IV dose of peramivir was administered to adults aged over 75 years
|
|---|---|---|---|
|
Time to Reduction in Viral Shedding
Baseline
|
27 Participants
|
15 Participants
|
2 Participants
|
|
Time to Reduction in Viral Shedding
Day 3
|
13 Participants
|
4 Participants
|
0 Participants
|
|
Time to Reduction in Viral Shedding
Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Time to Reduction in Viral Shedding
Day 14
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 14 daysPopulation: Intent-to-treat infected (ITTI) population
Study personnel evaluated the subject at Screening and Days 3, 7, and 14 for the presence of clinical signs and/or symptoms of the following influenza-related complications: Sinusitis, Otitis media, Bronchitis \& Pneumonia. Note that subjects with clinical signs and/or symptoms consistent with bacterial infections, including otitis media, bronchitis, sinusitis, and/or pneumonia at Screening, were not eligible for enrollment in this study. If an influenza-related complication was suspected, then a targeted physical examination was to be conducted to confirm the presence or absence of the influenza-related complication.
Outcome measures
| Measure |
At Risk (<65 Years)
n=28 Participants
A single IV dose of peramivir was administered to adults considered at risk
|
Elderly (65-75 Years)
n=19 Participants
A single IV dose of peramivir was administered to adults aged 65 to 75 years
|
Very Elderly (>75 Years)
n=5 Participants
A single IV dose of peramivir was administered to adults aged over 75 years
|
|---|---|---|---|
|
Incidence of Influenza-related Complications
Otitis
|
1 participants
|
0 participants
|
0 participants
|
|
Incidence of Influenza-related Complications
Pneumonia
|
0 participants
|
1 participants
|
0 participants
|
|
Incidence of Influenza-related Complications
Sinusitis
|
0 participants
|
1 participants
|
0 participants
|
|
Incidence of Influenza-related Complications
Bronchitis
|
2 participants
|
2 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 14 daysPopulation: Subjects who did not return to normal activities were censored at the time of their last non-missing post-baseline assessment; this included 9 subjects in the 'At Risk (\<65 years)' group, 12 subjects in the 'Elderly (65-75 years)' group and 2 subjects in the 'Very Elderly (\>75 years)' group. Two subjects were excluded from summaries due to missing data or events resolving prior to initiation of study treatment.
The ability to perform usual daily activities was assessed on a VAS (Visual Analogue Scale), where 0 indicates "unable to perform usual activities at all" and 10 indicates "able to perform usual activities.". The time to return to usual activities was the number of days from initiation of study drug until the subject recorded a rating of 10 (able to perform all usual activities fully) on the VAS; this was estimated for each age group and overall using the Kaplan-Meier method.
Outcome measures
| Measure |
At Risk (<65 Years)
n=27 Participants
A single IV dose of peramivir was administered to adults considered at risk
|
Elderly (65-75 Years)
n=19 Participants
A single IV dose of peramivir was administered to adults aged 65 to 75 years
|
Very Elderly (>75 Years)
n=4 Participants
A single IV dose of peramivir was administered to adults aged over 75 years
|
|---|---|---|---|
|
Time to Return to Usual Activities
|
10.0 days
Standard Deviation 0.59
|
12.1 days
Standard Deviation 0.91
|
9.8 days
Standard Deviation 2.76
|
Adverse Events
At Risk (<65 Years)
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Elderly (65-75 Years)
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Very Elderly (>75 Years)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
At Risk (<65 Years)
n=41 participants at risk
A single IV dose of peramivir was administered to adults considered at risk
|
Elderly (65-75 Years)
n=25 participants at risk
A single IV dose of peramivir was administered to adults aged 65 to 75 years
|
Very Elderly (>75 Years)
n=7 participants at risk
A single IV dose of peramivir was administered to adults aged over 75 years
|
|---|---|---|---|
|
Investigations
Breath sounds abnormal
|
4.9%
2/41 • Number of events 2 • Reports of AEs were to be collected from the time the subject signed the informed consent through to the follow-up period ending on Day 14.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
0.00%
0/25 • Reports of AEs were to be collected from the time the subject signed the informed consent through to the follow-up period ending on Day 14.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
0.00%
0/7 • Reports of AEs were to be collected from the time the subject signed the informed consent through to the follow-up period ending on Day 14.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.3%
3/41 • Number of events 3 • Reports of AEs were to be collected from the time the subject signed the informed consent through to the follow-up period ending on Day 14.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
4.0%
1/25 • Number of events 1 • Reports of AEs were to be collected from the time the subject signed the informed consent through to the follow-up period ending on Day 14.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
14.3%
1/7 • Number of events 1 • Reports of AEs were to be collected from the time the subject signed the informed consent through to the follow-up period ending on Day 14.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
4.9%
2/41 • Number of events 2 • Reports of AEs were to be collected from the time the subject signed the informed consent through to the follow-up period ending on Day 14.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
4.0%
1/25 • Number of events 1 • Reports of AEs were to be collected from the time the subject signed the informed consent through to the follow-up period ending on Day 14.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
14.3%
1/7 • Number of events 1 • Reports of AEs were to be collected from the time the subject signed the informed consent through to the follow-up period ending on Day 14.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
|
Nervous system disorders
Dizziness
|
2.4%
1/41 • Number of events 1 • Reports of AEs were to be collected from the time the subject signed the informed consent through to the follow-up period ending on Day 14.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
8.0%
2/25 • Number of events 2 • Reports of AEs were to be collected from the time the subject signed the informed consent through to the follow-up period ending on Day 14.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
0.00%
0/7 • Reports of AEs were to be collected from the time the subject signed the informed consent through to the follow-up period ending on Day 14.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/41 • Reports of AEs were to be collected from the time the subject signed the informed consent through to the follow-up period ending on Day 14.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
8.0%
2/25 • Number of events 2 • Reports of AEs were to be collected from the time the subject signed the informed consent through to the follow-up period ending on Day 14.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
0.00%
0/7 • Reports of AEs were to be collected from the time the subject signed the informed consent through to the follow-up period ending on Day 14.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
|
Investigations
Blood pressure increased
|
2.4%
1/41 • Number of events 1 • Reports of AEs were to be collected from the time the subject signed the informed consent through to the follow-up period ending on Day 14.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
4.0%
1/25 • Number of events 1 • Reports of AEs were to be collected from the time the subject signed the informed consent through to the follow-up period ending on Day 14.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
0.00%
0/7 • Reports of AEs were to be collected from the time the subject signed the informed consent through to the follow-up period ending on Day 14.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
|
Infections and infestations
Cystitis
|
0.00%
0/41 • Reports of AEs were to be collected from the time the subject signed the informed consent through to the follow-up period ending on Day 14.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
4.0%
1/25 • Number of events 1 • Reports of AEs were to be collected from the time the subject signed the informed consent through to the follow-up period ending on Day 14.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
0.00%
0/7 • Reports of AEs were to be collected from the time the subject signed the informed consent through to the follow-up period ending on Day 14.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/41 • Reports of AEs were to be collected from the time the subject signed the informed consent through to the follow-up period ending on Day 14.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
4.0%
1/25 • Number of events 1 • Reports of AEs were to be collected from the time the subject signed the informed consent through to the follow-up period ending on Day 14.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
0.00%
0/7 • Reports of AEs were to be collected from the time the subject signed the informed consent through to the follow-up period ending on Day 14.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/41 • Reports of AEs were to be collected from the time the subject signed the informed consent through to the follow-up period ending on Day 14.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
4.0%
1/25 • Number of events 1 • Reports of AEs were to be collected from the time the subject signed the informed consent through to the follow-up period ending on Day 14.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
0.00%
0/7 • Reports of AEs were to be collected from the time the subject signed the informed consent through to the follow-up period ending on Day 14.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/41 • Reports of AEs were to be collected from the time the subject signed the informed consent through to the follow-up period ending on Day 14.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
4.0%
1/25 • Number of events 1 • Reports of AEs were to be collected from the time the subject signed the informed consent through to the follow-up period ending on Day 14.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
0.00%
0/7 • Reports of AEs were to be collected from the time the subject signed the informed consent through to the follow-up period ending on Day 14.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.00%
0/41 • Reports of AEs were to be collected from the time the subject signed the informed consent through to the follow-up period ending on Day 14.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
4.0%
1/25 • Number of events 1 • Reports of AEs were to be collected from the time the subject signed the informed consent through to the follow-up period ending on Day 14.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
0.00%
0/7 • Reports of AEs were to be collected from the time the subject signed the informed consent through to the follow-up period ending on Day 14.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
|
Ear and labyrinth disorders
Eustachian tube dysfunction
|
0.00%
0/41 • Reports of AEs were to be collected from the time the subject signed the informed consent through to the follow-up period ending on Day 14.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
4.0%
1/25 • Number of events 1 • Reports of AEs were to be collected from the time the subject signed the informed consent through to the follow-up period ending on Day 14.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
0.00%
0/7 • Reports of AEs were to be collected from the time the subject signed the informed consent through to the follow-up period ending on Day 14.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
|
Eye disorders
Eye pain
|
0.00%
0/41 • Reports of AEs were to be collected from the time the subject signed the informed consent through to the follow-up period ending on Day 14.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
4.0%
1/25 • Number of events 1 • Reports of AEs were to be collected from the time the subject signed the informed consent through to the follow-up period ending on Day 14.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
0.00%
0/7 • Reports of AEs were to be collected from the time the subject signed the informed consent through to the follow-up period ending on Day 14.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
|
Eye disorders
Vision blurred
|
0.00%
0/41 • Reports of AEs were to be collected from the time the subject signed the informed consent through to the follow-up period ending on Day 14.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
4.0%
1/25 • Number of events 1 • Reports of AEs were to be collected from the time the subject signed the informed consent through to the follow-up period ending on Day 14.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
0.00%
0/7 • Reports of AEs were to be collected from the time the subject signed the informed consent through to the follow-up period ending on Day 14.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
|
Investigations
Blood lactate dehydrogenase increased
|
2.4%
1/41 • Number of events 1 • Reports of AEs were to be collected from the time the subject signed the informed consent through to the follow-up period ending on Day 14.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
0.00%
0/25 • Reports of AEs were to be collected from the time the subject signed the informed consent through to the follow-up period ending on Day 14.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
0.00%
0/7 • Reports of AEs were to be collected from the time the subject signed the informed consent through to the follow-up period ending on Day 14.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
|
Investigations
Blood pressure diastolic increased
|
2.4%
1/41 • Number of events 1 • Reports of AEs were to be collected from the time the subject signed the informed consent through to the follow-up period ending on Day 14.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
0.00%
0/25 • Reports of AEs were to be collected from the time the subject signed the informed consent through to the follow-up period ending on Day 14.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
0.00%
0/7 • Reports of AEs were to be collected from the time the subject signed the informed consent through to the follow-up period ending on Day 14.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
|
Investigations
Blood urine present
|
2.4%
1/41 • Number of events 1 • Reports of AEs were to be collected from the time the subject signed the informed consent through to the follow-up period ending on Day 14.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
0.00%
0/25 • Reports of AEs were to be collected from the time the subject signed the informed consent through to the follow-up period ending on Day 14.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
0.00%
0/7 • Reports of AEs were to be collected from the time the subject signed the informed consent through to the follow-up period ending on Day 14.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
|
Investigations
Carbon dioxide decreased
|
2.4%
1/41 • Number of events 1 • Reports of AEs were to be collected from the time the subject signed the informed consent through to the follow-up period ending on Day 14.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
0.00%
0/25 • Reports of AEs were to be collected from the time the subject signed the informed consent through to the follow-up period ending on Day 14.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
0.00%
0/7 • Reports of AEs were to be collected from the time the subject signed the informed consent through to the follow-up period ending on Day 14.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
|
Investigations
Nitrite urine present
|
2.4%
1/41 • Number of events 1 • Reports of AEs were to be collected from the time the subject signed the informed consent through to the follow-up period ending on Day 14.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
0.00%
0/25 • Reports of AEs were to be collected from the time the subject signed the informed consent through to the follow-up period ending on Day 14.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
0.00%
0/7 • Reports of AEs were to be collected from the time the subject signed the informed consent through to the follow-up period ending on Day 14.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
|
Investigations
Red blood cells urine positive
|
2.4%
1/41 • Number of events 1 • Reports of AEs were to be collected from the time the subject signed the informed consent through to the follow-up period ending on Day 14.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
0.00%
0/25 • Reports of AEs were to be collected from the time the subject signed the informed consent through to the follow-up period ending on Day 14.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
0.00%
0/7 • Reports of AEs were to be collected from the time the subject signed the informed consent through to the follow-up period ending on Day 14.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
|
Investigations
White blood cells urine positive
|
2.4%
1/41 • Number of events 1 • Reports of AEs were to be collected from the time the subject signed the informed consent through to the follow-up period ending on Day 14.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
0.00%
0/25 • Reports of AEs were to be collected from the time the subject signed the informed consent through to the follow-up period ending on Day 14.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
0.00%
0/7 • Reports of AEs were to be collected from the time the subject signed the informed consent through to the follow-up period ending on Day 14.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.4%
1/41 • Number of events 1 • Reports of AEs were to be collected from the time the subject signed the informed consent through to the follow-up period ending on Day 14.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
0.00%
0/25 • Reports of AEs were to be collected from the time the subject signed the informed consent through to the follow-up period ending on Day 14.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
0.00%
0/7 • Reports of AEs were to be collected from the time the subject signed the informed consent through to the follow-up period ending on Day 14.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
|
Infections and infestations
Hordeolum
|
2.4%
1/41 • Number of events 1 • Reports of AEs were to be collected from the time the subject signed the informed consent through to the follow-up period ending on Day 14.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
0.00%
0/25 • Reports of AEs were to be collected from the time the subject signed the informed consent through to the follow-up period ending on Day 14.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
0.00%
0/7 • Reports of AEs were to be collected from the time the subject signed the informed consent through to the follow-up period ending on Day 14.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
|
Infections and infestations
Pharyngitis
|
2.4%
1/41 • Number of events 1 • Reports of AEs were to be collected from the time the subject signed the informed consent through to the follow-up period ending on Day 14.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
0.00%
0/25 • Reports of AEs were to be collected from the time the subject signed the informed consent through to the follow-up period ending on Day 14.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
0.00%
0/7 • Reports of AEs were to be collected from the time the subject signed the informed consent through to the follow-up period ending on Day 14.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
|
Infections and infestations
Respiratory tract infection
|
2.4%
1/41 • Number of events 1 • Reports of AEs were to be collected from the time the subject signed the informed consent through to the follow-up period ending on Day 14.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
0.00%
0/25 • Reports of AEs were to be collected from the time the subject signed the informed consent through to the follow-up period ending on Day 14.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
0.00%
0/7 • Reports of AEs were to be collected from the time the subject signed the informed consent through to the follow-up period ending on Day 14.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
2.4%
1/41 • Number of events 1 • Reports of AEs were to be collected from the time the subject signed the informed consent through to the follow-up period ending on Day 14.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
0.00%
0/25 • Reports of AEs were to be collected from the time the subject signed the informed consent through to the follow-up period ending on Day 14.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
0.00%
0/7 • Reports of AEs were to be collected from the time the subject signed the informed consent through to the follow-up period ending on Day 14.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.4%
1/41 • Number of events 1 • Reports of AEs were to be collected from the time the subject signed the informed consent through to the follow-up period ending on Day 14.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
0.00%
0/25 • Reports of AEs were to be collected from the time the subject signed the informed consent through to the follow-up period ending on Day 14.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
0.00%
0/7 • Reports of AEs were to be collected from the time the subject signed the informed consent through to the follow-up period ending on Day 14.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
|
Nervous system disorders
Migraine
|
2.4%
1/41 • Number of events 1 • Reports of AEs were to be collected from the time the subject signed the informed consent through to the follow-up period ending on Day 14.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
0.00%
0/25 • Reports of AEs were to be collected from the time the subject signed the informed consent through to the follow-up period ending on Day 14.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
0.00%
0/7 • Reports of AEs were to be collected from the time the subject signed the informed consent through to the follow-up period ending on Day 14.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
|
General disorders
Infusion site extravasation
|
2.4%
1/41 • Number of events 1 • Reports of AEs were to be collected from the time the subject signed the informed consent through to the follow-up period ending on Day 14.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
0.00%
0/25 • Reports of AEs were to be collected from the time the subject signed the informed consent through to the follow-up period ending on Day 14.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
0.00%
0/7 • Reports of AEs were to be collected from the time the subject signed the informed consent through to the follow-up period ending on Day 14.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.4%
1/41 • Number of events 1 • Reports of AEs were to be collected from the time the subject signed the informed consent through to the follow-up period ending on Day 14.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
0.00%
0/25 • Reports of AEs were to be collected from the time the subject signed the informed consent through to the follow-up period ending on Day 14.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
0.00%
0/7 • Reports of AEs were to be collected from the time the subject signed the informed consent through to the follow-up period ending on Day 14.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
|
Psychiatric disorders
Insomnia
|
2.4%
1/41 • Number of events 1 • Reports of AEs were to be collected from the time the subject signed the informed consent through to the follow-up period ending on Day 14.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
0.00%
0/25 • Reports of AEs were to be collected from the time the subject signed the informed consent through to the follow-up period ending on Day 14.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
0.00%
0/7 • Reports of AEs were to be collected from the time the subject signed the informed consent through to the follow-up period ending on Day 14.
Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place