Trial Outcomes & Findings for Evaluating the Use of Oseltamivir for the Treatment of Influenza in Adults (NCT NCT01314911)
NCT ID: NCT01314911
Last Updated: 2019-02-05
Results Overview
The central laboratory performed a qualitative PCR test on the NP sample from Day 0 team collected swap in order to confirm influenza infection and to determine the influenza type and subtype. For participants with a positive influenza test result at Day 0 from this qualitative PCR testing, the laboratory then performed qPCR testing of subsequent samples to quantify viral shedding.
COMPLETED
NA
716 participants
At Day 3
2019-02-05
Participant Flow
Participants with an influenza-like illness and diagnosed with influenza by rapid antigen or PCR were recruited at 42 sites from 3 countries: 3 from Argentina, 4 from Thailand and 35 from the U.S., between January 2012 to October 2017.
Seven hundred and sixteen subjects were enrolled per protocol (signed consent). Of these 716 subjects, three subjects were inadvertent enrollments, and one was a repeat enrollment of a subject who had been previously enrolled .One hundred fifty-four subjects were excluded during screening and did not participate in any other aspect of the trial.
Participant milestones
| Measure |
Oseltamivir
Oseltamivir: Subjects were prescribed Oseltamivir twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg.
|
Placebo
Placebo: Subjects were prescribed the matching placebo twice daily for 5 days, and each dose consisted of one capsule of placebo.
|
|---|---|---|
|
Overall Study
STARTED
|
278
|
280
|
|
Overall Study
COMPLETED
|
273
|
274
|
|
Overall Study
NOT COMPLETED
|
5
|
6
|
Reasons for withdrawal
| Measure |
Oseltamivir
Oseltamivir: Subjects were prescribed Oseltamivir twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg.
|
Placebo
Placebo: Subjects were prescribed the matching placebo twice daily for 5 days, and each dose consisted of one capsule of placebo.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
|
Overall Study
Received Non-randomized Study Drug
|
0
|
1
|
|
Overall Study
Never Started Treatment
|
1
|
0
|
Baseline Characteristics
restricted to subjects with confirmed influenza in a study team collected swab on Day 0
Baseline characteristics by cohort
| Measure |
Oseltamivir
n=277 Participants
Oseltamivir: Subjects were prescribed Oseltamivir twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg.
|
Placebo
n=279 Participants
Placebo: Subjects were prescribed the matching placebo twice daily for 5 days, and each dose consisted of one capsule of placebo.
|
Total
n=556 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
6 Participants
n=277 Participants
|
6 Participants
n=279 Participants
|
12 Participants
n=556 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
271 Participants
n=277 Participants
|
273 Participants
n=279 Participants
|
544 Participants
n=556 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=277 Participants
|
0 Participants
n=279 Participants
|
0 Participants
n=556 Participants
|
|
Age, Continuous
|
37 years
n=277 Participants
|
35 years
n=279 Participants
|
36 years
n=556 Participants
|
|
Sex: Female, Male
Female
|
183 Participants
n=277 Participants
|
164 Participants
n=279 Participants
|
347 Participants
n=556 Participants
|
|
Sex: Female, Male
Male
|
94 Participants
n=277 Participants
|
115 Participants
n=279 Participants
|
209 Participants
n=556 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=277 Participants
|
13 Participants
n=279 Participants
|
24 Participants
n=556 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
265 Participants
n=277 Participants
|
266 Participants
n=279 Participants
|
531 Participants
n=556 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=277 Participants
|
0 Participants
n=279 Participants
|
1 Participants
n=556 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
193 Participants
n=277 Participants
|
192 Participants
n=279 Participants
|
385 Participants
n=556 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
74 Participants
n=277 Participants
|
76 Participants
n=279 Participants
|
150 Participants
n=556 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
7 Participants
n=277 Participants
|
11 Participants
n=279 Participants
|
18 Participants
n=556 Participants
|
|
Race/Ethnicity, Customized
Race · Race not available to clinic
|
1 Participants
n=277 Participants
|
0 Participants
n=279 Participants
|
1 Participants
n=556 Participants
|
|
Race/Ethnicity, Customized
Race · Subject does not know
|
1 Participants
n=277 Participants
|
0 Participants
n=279 Participants
|
1 Participants
n=556 Participants
|
|
Race/Ethnicity, Customized
Race · Subject does not want to report
|
1 Participants
n=277 Participants
|
0 Participants
n=279 Participants
|
1 Participants
n=556 Participants
|
|
Region of Enrollment
Argentina
|
4 participants
n=277 Participants
|
8 participants
n=279 Participants
|
12 participants
n=556 Participants
|
|
Region of Enrollment
United States
|
91 participants
n=277 Participants
|
87 participants
n=279 Participants
|
178 participants
n=556 Participants
|
|
Region of Enrollment
Thailand
|
182 participants
n=277 Participants
|
184 participants
n=279 Participants
|
366 participants
n=556 Participants
|
|
Confirmed influenza infection status by central testing
|
246 Participants
n=277 Participants
|
255 Participants
n=279 Participants
|
501 Participants
n=556 Participants
|
|
Influenza type/subtype by central testing
Influenza A/H3N2
|
122 Participants
n=277 Participants
|
129 Participants
n=279 Participants
|
251 Participants
n=556 Participants
|
|
Influenza type/subtype by central testing
Influenza A/H1N1
|
39 Participants
n=277 Participants
|
54 Participants
n=279 Participants
|
93 Participants
n=556 Participants
|
|
Influenza type/subtype by central testing
Influenza B
|
85 Participants
n=277 Participants
|
71 Participants
n=279 Participants
|
156 Participants
n=556 Participants
|
|
Influenza type/subtype by central testing
Negative
|
30 Participants
n=277 Participants
|
22 Participants
n=279 Participants
|
52 Participants
n=556 Participants
|
|
Influenza type/subtype by central testing
Co-infection
|
0 Participants
n=277 Participants
|
1 Participants
n=279 Participants
|
1 Participants
n=556 Participants
|
|
Influenza type/subtype by central testing
Missing
|
1 Participants
n=277 Participants
|
2 Participants
n=279 Participants
|
3 Participants
n=556 Participants
|
|
Hours from onset of influenza-like illness to screening
|
29 Hours
n=277 Participants
|
27 Hours
n=279 Participants
|
28 Hours
n=556 Participants
|
|
Hours from randomization to treatment initiation
|
1 hours
n=277 Participants
|
1 hours
n=279 Participants
|
1 hours
n=556 Participants
|
|
Ever smoke tobacco
|
35 Participants
n=277 Participants
|
33 Participants
n=279 Participants
|
68 Participants
n=556 Participants
|
|
Vaccination for season of enrollment
|
34 Participants
n=277 Participants
|
23 Participants
n=279 Participants
|
57 Participants
n=556 Participants
|
|
BMI
|
24.8 kg/m²
n=277 Participants
|
24.7 kg/m²
n=279 Participants
|
24.7 kg/m²
n=556 Participants
|
|
Overall symptom score, excluding 'other'
|
13 units on a scale
n=277 Participants
|
13 units on a scale
n=279 Participants
|
13 units on a scale
n=556 Participants
|
|
Global assessment in the morning at Day 0
Subject feels as good today as before flu
|
13 Participants
n=277 Participants
|
6 Participants
n=279 Participants
|
19 Participants
n=556 Participants
|
|
Global assessment in the morning at Day 0
Subject functions as well today as before flu
|
49 Participants
n=277 Participants
|
40 Participants
n=279 Participants
|
89 Participants
n=556 Participants
|
|
Functional status
Pre-illness status
|
100 units on a scale
n=277 Participants
|
100 units on a scale
n=279 Participants
|
100 units on a scale
n=556 Participants
|
|
Functional status
Day 0 status
|
65 units on a scale
n=277 Participants
|
65 units on a scale
n=279 Participants
|
65 units on a scale
n=556 Participants
|
|
Complications of influenza
Sinusitis
|
4 Participants
n=277 Participants
|
3 Participants
n=279 Participants
|
7 Participants
n=556 Participants
|
|
Complications of influenza
Otitis Media
|
0 Participants
n=277 Participants
|
1 Participants
n=279 Participants
|
1 Participants
n=556 Participants
|
|
Complications of influenza
Bronchitis/Bronchiolitis
|
4 Participants
n=277 Participants
|
2 Participants
n=279 Participants
|
6 Participants
n=556 Participants
|
|
Complications of influenza
Pneumonia
|
0 Participants
n=277 Participants
|
1 Participants
n=279 Participants
|
1 Participants
n=556 Participants
|
|
Complications of influenza
Using antibiotic for other reasons
|
6 Participants
n=277 Participants
|
5 Participants
n=279 Participants
|
11 Participants
n=556 Participants
|
|
Viral shedding by team-collected samples
|
6.9 log10 copies/mL
n=246 Participants • restricted to subjects with confirmed influenza in a study team collected swab on Day 0
|
6.9 log10 copies/mL
n=255 Participants • restricted to subjects with confirmed influenza in a study team collected swab on Day 0
|
6.9 log10 copies/mL
n=501 Participants • restricted to subjects with confirmed influenza in a study team collected swab on Day 0
|
|
Category of virus by team-collected samples
>= LLOQ
|
237 Participants
n=246 Participants • restricted to subjects with confirmed influenza in a study team collected swab on Day 0
|
245 Participants
n=255 Participants • restricted to subjects with confirmed influenza in a study team collected swab on Day 0
|
482 Participants
n=501 Participants • restricted to subjects with confirmed influenza in a study team collected swab on Day 0
|
|
Category of virus by team-collected samples
>= LOD, < LLOQ
|
6 Participants
n=246 Participants • restricted to subjects with confirmed influenza in a study team collected swab on Day 0
|
5 Participants
n=255 Participants • restricted to subjects with confirmed influenza in a study team collected swab on Day 0
|
11 Participants
n=501 Participants • restricted to subjects with confirmed influenza in a study team collected swab on Day 0
|
|
Category of virus by team-collected samples
< LOD
|
3 Participants
n=246 Participants • restricted to subjects with confirmed influenza in a study team collected swab on Day 0
|
5 Participants
n=255 Participants • restricted to subjects with confirmed influenza in a study team collected swab on Day 0
|
8 Participants
n=501 Participants • restricted to subjects with confirmed influenza in a study team collected swab on Day 0
|
|
Viral shedding by self-collected samples
|
6.1 log10 copies/mL
n=246 Participants • restricted to subjects with confirmed influenza in a study team collected swab on Day 0
|
6.2 log10 copies/mL
n=255 Participants • restricted to subjects with confirmed influenza in a study team collected swab on Day 0
|
6.2 log10 copies/mL
n=501 Participants • restricted to subjects with confirmed influenza in a study team collected swab on Day 0
|
|
Category of virus by self-collected samples
>= LLOQ
|
217 Participants
n=246 Participants • restricted to subjects with confirmed influenza in a study team collected swab on Day 0
|
225 Participants
n=255 Participants • restricted to subjects with confirmed influenza in a study team collected swab on Day 0
|
442 Participants
n=501 Participants • restricted to subjects with confirmed influenza in a study team collected swab on Day 0
|
|
Category of virus by self-collected samples
>= LOD, < LLOQ
|
11 Participants
n=246 Participants • restricted to subjects with confirmed influenza in a study team collected swab on Day 0
|
6 Participants
n=255 Participants • restricted to subjects with confirmed influenza in a study team collected swab on Day 0
|
17 Participants
n=501 Participants • restricted to subjects with confirmed influenza in a study team collected swab on Day 0
|
|
Category of virus by self-collected samples
< LOD
|
17 Participants
n=246 Participants • restricted to subjects with confirmed influenza in a study team collected swab on Day 0
|
23 Participants
n=255 Participants • restricted to subjects with confirmed influenza in a study team collected swab on Day 0
|
40 Participants
n=501 Participants • restricted to subjects with confirmed influenza in a study team collected swab on Day 0
|
|
Category of virus by self-collected samples
Missing
|
1 Participants
n=246 Participants • restricted to subjects with confirmed influenza in a study team collected swab on Day 0
|
1 Participants
n=255 Participants • restricted to subjects with confirmed influenza in a study team collected swab on Day 0
|
2 Participants
n=501 Participants • restricted to subjects with confirmed influenza in a study team collected swab on Day 0
|
PRIMARY outcome
Timeframe: At Day 3Population: The population analyzed was restricted to the 455 participants who had a confirmed positive test (from team collected sample) for influenza by qPCR in the central laboratory testing and were not in the pilot study for IRC004. 6 participants (3 in each arm) had missing endpoint samples so were excluded from the analysis.
The central laboratory performed a qualitative PCR test on the NP sample from Day 0 team collected swap in order to confirm influenza infection and to determine the influenza type and subtype. For participants with a positive influenza test result at Day 0 from this qualitative PCR testing, the laboratory then performed qPCR testing of subsequent samples to quantify viral shedding.
Outcome measures
| Measure |
Oseltamivir
n=220 Participants
Oseltamivir: Subjects were prescribed Oseltamivir twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg.
|
Placebo
n=229 Participants
Placebo: Subjects were prescribed the matching placebo twice daily for 5 days, and each dose consisted of one capsule of placebo.
|
|---|---|---|
|
Percentage of Participants With Virus Detectable by Quantitative PCR (qPCR) in Nasopharyngeal (NP) Swabs at Day 3 -- Team Collected Samples
|
99 Participants
|
131 Participants
|
SECONDARY outcome
Timeframe: At Day 0, 3 and 7Population: The population analyzed is the Primary Efficacy Population (PEP), which included all participants who were randomized properly, had received at least one dose of study drug, and had influenza virus isolated and typed(from team collected sample) in the qualitative PCR evaluation at Day 0 from central laboratory testing.
Number of participants who had undetectable values (less than the limit of detection \[LOD\]), who had values between the LOD and the lower limit of quantification (LLOQ), and who had values ≥LLOQ
Outcome measures
| Measure |
Oseltamivir
n=246 Participants
Oseltamivir: Subjects were prescribed Oseltamivir twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg.
|
Placebo
n=255 Participants
Placebo: Subjects were prescribed the matching placebo twice daily for 5 days, and each dose consisted of one capsule of placebo.
|
|---|---|---|
|
Number of Participants by Virus Detection Status--Team Collected Samples
Day 0 · >= LLOQ
|
237 Participants
|
245 Participants
|
|
Number of Participants by Virus Detection Status--Team Collected Samples
Day 0 · >= LOD, < LLOQ
|
6 Participants
|
5 Participants
|
|
Number of Participants by Virus Detection Status--Team Collected Samples
Day 0 · < LOD
|
3 Participants
|
5 Participants
|
|
Number of Participants by Virus Detection Status--Team Collected Samples
Day 0 · Missing
|
0 Participants
|
0 Participants
|
|
Number of Participants by Virus Detection Status--Team Collected Samples
Day 3 · >= LLOQ
|
85 Participants
|
109 Participants
|
|
Number of Participants by Virus Detection Status--Team Collected Samples
Day 3 · >= LOD, < LLOQ
|
24 Participants
|
36 Participants
|
|
Number of Participants by Virus Detection Status--Team Collected Samples
Day 3 · < LOD
|
134 Participants
|
107 Participants
|
|
Number of Participants by Virus Detection Status--Team Collected Samples
Day 3 · Missing
|
3 Participants
|
3 Participants
|
|
Number of Participants by Virus Detection Status--Team Collected Samples
Day 7 · >= LLOQ
|
16 Participants
|
21 Participants
|
|
Number of Participants by Virus Detection Status--Team Collected Samples
Day 7 · >= LOD, < LLOQ
|
11 Participants
|
5 Participants
|
|
Number of Participants by Virus Detection Status--Team Collected Samples
Day 7 · < LOD
|
214 Participants
|
224 Participants
|
|
Number of Participants by Virus Detection Status--Team Collected Samples
Day 7 · Missing
|
5 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: At Day 0, 3 and 7Population: The population analyzed is the Primary Efficacy Population (PEP), which included all participants who were randomized properly, had received at least one dose of study drug, and had influenza virus isolated and typed (from team collected sample) in the qualitative PCR evaluation at Day 0 from central laboratory testing.
Median, 25% and 75% percentile of the value of viral shedding (Results \<LOD were imputed as the LOD value, and Results \>= LOD, \<LLOQ were imputed as the LLOQ value.)
Outcome measures
| Measure |
Oseltamivir
n=246 Participants
Oseltamivir: Subjects were prescribed Oseltamivir twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg.
|
Placebo
n=255 Participants
Placebo: Subjects were prescribed the matching placebo twice daily for 5 days, and each dose consisted of one capsule of placebo.
|
|---|---|---|
|
qPCR Viral Shedding -- Team Collected Samples
Day 0
|
6.85 log10 copies/mL
Interval 5.8 to 7.6
|
6.9 log10 copies/mL
Interval 5.9 to 7.6
|
|
qPCR Viral Shedding -- Team Collected Samples
Day 3
|
3.4 log10 copies/mL
Interval 3.2 to 4.5
|
3.9 log10 copies/mL
Interval 3.2 to 4.9
|
|
qPCR Viral Shedding -- Team Collected Samples
Day 7
|
3.2 log10 copies/mL
Interval 3.2 to 3.4
|
3.2 log10 copies/mL
Interval 3.2 to 3.4
|
SECONDARY outcome
Timeframe: At day 3 and 7.Population: The population analyzed is the Primary Efficacy Population (PEP), which included all participants who were randomized properly, had received at least one dose of study drug, and had influenza virus isolated and typed (from team collected sample) in the qualitative PCR evaluation at Day 0 from central laboratory testing.
Number of participants with undetectable viral load at both Day 3 and Day 7; detectable at Day 3 and undetectable at Day 7; detectable at Day 7 (irrespective of whether or not detectable at Day 3).
Outcome measures
| Measure |
Oseltamivir
n=246 Participants
Oseltamivir: Subjects were prescribed Oseltamivir twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg.
|
Placebo
n=255 Participants
Placebo: Subjects were prescribed the matching placebo twice daily for 5 days, and each dose consisted of one capsule of placebo.
|
|---|---|---|
|
Number Of Participants Shedding Virus -- Team Collected Samples
Undetectable at both Day 3 and 7
|
126 Participants
|
100 Participants
|
|
Number Of Participants Shedding Virus -- Team Collected Samples
Detectable at Day 3 and undetectable at Day 7
|
87 Participants
|
124 Participants
|
|
Number Of Participants Shedding Virus -- Team Collected Samples
Detectable at Day 7
|
27 Participants
|
26 Participants
|
|
Number Of Participants Shedding Virus -- Team Collected Samples
Missing result at Day 3 and/or Day 7
|
6 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: From treatment initiation to Day 28Population: The population analyzed is the Intention To Treat (ITT) Population, which included all participants who were randomized properly and who had received at least one dose of study drug.
The assessed symptoms were cough, nasal obstruction (stuffy nose), sore throat, fatigue, headache, muscle aches, feverishness, rhinorrhea, nausea, vomiting, diarrhea. Duration of clinical symptoms was defined as the time from Day 0 to the first of two successive measurements at which all clinical symptoms were grade 0 (absent) or 1 (mild). A measurement was considered to be the 8AM or 8PM assessment during Days 0 to 7 (so two measurements were obtained per day) and then the daily assessment thereafter. Time was calculated in half-days through to Day 7. If a subject's first two assessments on (baseline assessment and first subsequent diary card assessment) satisfied this criterion, then the duration was set to zero. For participants who did not have two successive records meeting this criterion, follow-up was censored for analysis purposes at the time of the last but one diary card record with symptoms evaluated.
Outcome measures
| Measure |
Oseltamivir
n=277 Participants
Oseltamivir: Subjects were prescribed Oseltamivir twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg.
|
Placebo
n=279 Participants
Placebo: Subjects were prescribed the matching placebo twice daily for 5 days, and each dose consisted of one capsule of placebo.
|
|---|---|---|
|
Time to Alleviation of Influenza Clinical Symptoms
|
4 days
Interval 3.5 to 4.5
|
4 days
Interval 3.5 to 4.5
|
SECONDARY outcome
Timeframe: From treatment initiation to Day 28Population: The population analyzed is the Intention To Treat (ITT) Population, which included all participants who were randomized properly and who had received at least one dose of study drug.
Fever was considered present based on the diary cards if a subject reported a maximal temperature ≥38.0°C (for the period since the diary card was previously completed) or reported having taken an antipyretic drug (also for the period since the diary card was previously completed). Otherwise, fever was considered not present during the period since the diary card was previously completed, except that the evaluation was considered missing if either the temperature or the antipyretic drug use entry was not completed on the diary card. The duration of fever was defined as the time from Day 0 to the first of two successive assessments (through to Day 7) or to the first assessment (Day 8 onwards) at which no fever was present according to this definition.For participants who did not have two successive records meeting this criterion, follow-up was censored for analysis purposes at the time of the last but one diary card record with fever evaluated.
Outcome measures
| Measure |
Oseltamivir
n=277 Participants
Oseltamivir: Subjects were prescribed Oseltamivir twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg.
|
Placebo
n=279 Participants
Placebo: Subjects were prescribed the matching placebo twice daily for 5 days, and each dose consisted of one capsule of placebo.
|
|---|---|---|
|
Time to Absence of Fever
|
1 days
Interval 0.5 to 1.0
|
1 days
Interval 0.5 to 1.0
|
SECONDARY outcome
Timeframe: From treatment initiation to Day 28Population: The population analyzed is the Intention To Treat (ITT) Population, which includes all participants who were randomized properly and who had received at least one dose of study drug.
The assessed symptoms were cough, nasal obstruction (stuffy nose), sore throat, fatigue, headache, muscle aches, feverishness, rhinorrhea, nausea, vomiting, diarrhea. Fever was considered present based on the diary cards if a subject reported a maximal temperature ≥38.0°C (for the period since the diary card was previously completed) or reported having taken an antipyretic drug (also for the period since the diary card was previously completed). Time to resolution of all clinical symptoms and fever is defined as the time from Day 0 to the first of two successive measurements at which all clinical symptoms are grade 0 (absent) or 1(mild) and no fever \>=38.0 C or antipyretic drug is reported. For participants who did not have two successive records meeting this criterion, follow-up was censored for analysis purposes at the time of the last but one diary card record with symptoms and fever evaluated.
Outcome measures
| Measure |
Oseltamivir
n=277 Participants
Oseltamivir: Subjects were prescribed Oseltamivir twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg.
|
Placebo
n=279 Participants
Placebo: Subjects were prescribed the matching placebo twice daily for 5 days, and each dose consisted of one capsule of placebo.
|
|---|---|---|
|
Time to Resolution of All Symptoms AND Fever
|
4.0 days
Interval 3.5 to 4.5
|
4.0 days
Interval 3.5 to 4.5
|
SECONDARY outcome
Timeframe: From treatment initiation to Day 28Population: The population analyzed is the Intention To Treat (ITT) Population, which included all participants who were randomized properly and who had received at least one dose of study drug.
Time to feeling as good as before influenza is defined as time to the first of two successive 'yes' responses to the question of 'feeling as good as you did before you had the flu'.For participants who did not have two successive records meeting this criterion, follow-up was censored for analysis purposes at the time of the last but one diary card record with question answered.
Outcome measures
| Measure |
Oseltamivir
n=277 Participants
Oseltamivir: Subjects were prescribed Oseltamivir twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg.
|
Placebo
n=279 Participants
Placebo: Subjects were prescribed the matching placebo twice daily for 5 days, and each dose consisted of one capsule of placebo.
|
|---|---|---|
|
Time to Feeling as Good as Before the Onset of the Influenza Illness
|
6.0 days
Interval 5.0 to 6.5
|
6.0 days
Interval 5.5 to 6.5
|
SECONDARY outcome
Timeframe: From treatment initiation to Day 28Population: The population analyzed is the Intention To Treat (ITT) Population, which included all participants who were randomized properly and who had received at least one dose of study drug.
Time to return to pre-influenza function is defined as the time from Day 0 to the first of two successive 'Yes' answers to the global assessment question 'Are you functioning as well as you were before you had the flu'.For participants who did not have two successive records meeting this criterion, follow-up was censored for analysis purposes at the time of the last but one diary card record with question answered.
Outcome measures
| Measure |
Oseltamivir
n=277 Participants
Oseltamivir: Subjects were prescribed Oseltamivir twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg.
|
Placebo
n=279 Participants
Placebo: Subjects were prescribed the matching placebo twice daily for 5 days, and each dose consisted of one capsule of placebo.
|
|---|---|---|
|
Time to Return to Pre-influenza Function
|
3.5 days
Interval 3.5 to 4.5
|
5.0 days
Interval 4.0 to 5.0
|
SECONDARY outcome
Timeframe: From treatment initiation to Day 28Population: The population analyzed is the Intention To Treat (ITT) Population, which included all participants who were randomized properly and who had received at least one dose of study drug.
Time to return of physical function to pre-illness level was defined as the time from Day 0 to the first of two successive measurements at which the physical function score equals or is better than the pre-illness score (obtained by recall at enrollment). For subjects who did not have two successive records meeting this criterion, follow-up was censored for analysis purposes at the time of the last but one diary card record with physical function evaluated.
Outcome measures
| Measure |
Oseltamivir
n=277 Participants
Oseltamivir: Subjects were prescribed Oseltamivir twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg.
|
Placebo
n=279 Participants
Placebo: Subjects were prescribed the matching placebo twice daily for 5 days, and each dose consisted of one capsule of placebo.
|
|---|---|---|
|
Time to Return of Physical Function to Pre-illness Level
|
7.0 days
Interval 6.0 to 8.0
|
7.0 days
Interval 6.0 to 7.0
|
SECONDARY outcome
Timeframe: From treatment initiation to Day 5Population: The population analyzed is the Intention To Treat (ITT) Population, which included all participants who were randomized properly and who had received at least one dose of study drug.
For each of the 5 days of treatment, participants were asked whether they took all study drug for that day. All participants were assumed to have taken at least some study drug even if they had zero days with all study drug reported as taken. Missing reports for some or all days were imputed as not having taken all study drug for the days concerned.
Outcome measures
| Measure |
Oseltamivir
n=277 Participants
Oseltamivir: Subjects were prescribed Oseltamivir twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg.
|
Placebo
n=279 Participants
Placebo: Subjects were prescribed the matching placebo twice daily for 5 days, and each dose consisted of one capsule of placebo.
|
|---|---|---|
|
Number of Participants With Treatment Compliance Status
0 day with all study drug reported as taken
|
1 Participants
|
2 Participants
|
|
Number of Participants With Treatment Compliance Status
1 day with all study drug reported as taken
|
2 Participants
|
2 Participants
|
|
Number of Participants With Treatment Compliance Status
3 days with all study drug reported as taken
|
2 Participants
|
1 Participants
|
|
Number of Participants With Treatment Compliance Status
4 days with all study drug reported as taken
|
2 Participants
|
1 Participants
|
|
Number of Participants With Treatment Compliance Status
5 days with all study drug reported as taken
|
270 Participants
|
273 Participants
|
SECONDARY outcome
Timeframe: From treatment initiation to Day 28Population: The population analyzed is the Intention To Treat (ITT) Population, which included all participants who were randomized properly and who had received at least one dose of study drug.
The percentage of participants hospitalized by 28 days was constructed by inverting an exact binomial test of the actual percentages (ignoring loss to follow-up).
Outcome measures
| Measure |
Oseltamivir
n=277 Participants
Oseltamivir: Subjects were prescribed Oseltamivir twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg.
|
Placebo
n=279 Participants
Placebo: Subjects were prescribed the matching placebo twice daily for 5 days, and each dose consisted of one capsule of placebo.
|
|---|---|---|
|
Percentage of Participants Who Required Hospitalization.
|
1.4 percentage of participants
Interval 0.4 to 3.7
|
0.7 percentage of participants
Interval 0.1 to 2.6
|
SECONDARY outcome
Timeframe: From treatment initiation to Day 28Population: The population analyzed is the Intention To Treat (ITT) Population, which included all participants who were randomized properly and who had received at least one dose of study drug. The categories in the table are not mutually exclusive (because some participants had multiple complications) and the last row of the table summarizes all incidents.
Participants were assessed for the signs/symptoms suggestive of one of the following complications: Sinusitis, Otitis Media ,Bronchitis / Bronchiolitis, Pneumonia and antibiotic use for reason other than above.
Outcome measures
| Measure |
Oseltamivir
n=277 Participants
Oseltamivir: Subjects were prescribed Oseltamivir twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg.
|
Placebo
n=279 Participants
Placebo: Subjects were prescribed the matching placebo twice daily for 5 days, and each dose consisted of one capsule of placebo.
|
|---|---|---|
|
Percentage of Participants Who Develop Bronchitis, Pneumonia, or Other Complications Requiring An Antibiotic Use, After Day 0.
Sinusitis
|
3.2 percentage of participants
|
1.8 percentage of participants
|
|
Percentage of Participants Who Develop Bronchitis, Pneumonia, or Other Complications Requiring An Antibiotic Use, After Day 0.
Otitis Media
|
0.4 percentage of participants
|
0.4 percentage of participants
|
|
Percentage of Participants Who Develop Bronchitis, Pneumonia, or Other Complications Requiring An Antibiotic Use, After Day 0.
Bronchitis Bronchiolitis
|
2.5 percentage of participants
|
2.2 percentage of participants
|
|
Percentage of Participants Who Develop Bronchitis, Pneumonia, or Other Complications Requiring An Antibiotic Use, After Day 0.
Pneumonia
|
0.4 percentage of participants
|
0.4 percentage of participants
|
|
Percentage of Participants Who Develop Bronchitis, Pneumonia, or Other Complications Requiring An Antibiotic Use, After Day 0.
Antibiotic use
|
2.5 percentage of participants
|
3.6 percentage of participants
|
|
Percentage of Participants Who Develop Bronchitis, Pneumonia, or Other Complications Requiring An Antibiotic Use, After Day 0.
If have at least one Complication
|
7.2 percentage of participants
|
6.8 percentage of participants
|
SECONDARY outcome
Timeframe: From treatment initiation to Day 28Population: The population analyzed is the Intention To Treat (ITT) Population, which included all participants who were randomized properly and who had received at least one dose of study drug.
Number of deaths
Outcome measures
| Measure |
Oseltamivir
n=277 Participants
Oseltamivir: Subjects were prescribed Oseltamivir twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg.
|
Placebo
n=279 Participants
Placebo: Subjects were prescribed the matching placebo twice daily for 5 days, and each dose consisted of one capsule of placebo.
|
|---|---|---|
|
28-day Mortality
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At Day 3Population: The population analyzed was restricted to the 455 participants who had a confirmed positive test (from team collected sample) for influenza in the central laboratory testing and were not in the pilot study for IRC004. 9 participants (4 in the Oseltamivir arm and 5 in the Placebo arm) had missing endpoint samples so were excluded from the analysis.
For participants with a positive influenza test result at Day 0 from qualitative PCR testing on the team collected sample, the laboratory then performed qPCR testing of self-collected samples to quantify viral shedding.
Outcome measures
| Measure |
Oseltamivir
n=219 Participants
Oseltamivir: Subjects were prescribed Oseltamivir twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg.
|
Placebo
n=227 Participants
Placebo: Subjects were prescribed the matching placebo twice daily for 5 days, and each dose consisted of one capsule of placebo.
|
|---|---|---|
|
Percentage of Participants With Virus Detectable by Quantitative PCR (qPCR) in Nasopharyngeal (NP) Swabs --Self Collected Samples
|
56 Participants
|
89 Participants
|
SECONDARY outcome
Timeframe: At Day 0, Day 0 evening, Day 1, Day 1 evening, Day 2, Day 2 evening and Day 3Population: The population analyzed is the Primary Efficacy Population (PEP), which included all participants who were randomized properly, had received at least one dose of study drug, and had influenza virus isolated and typed (from team collected sample) in the qualitative PCR evaluation at Day 0 from central laboratory testing.
Number of participants who had undetectable values (less than the limit of detection \[LOD\]), who had values between the LOD and the lower limit of quantification (LLOQ), and who had values ≥LLOQ. Evening samples on Day 0, 1 and 2 were only required under protocol versions 1.0-4.0 and so were only collected for about 20% of participants.
Outcome measures
| Measure |
Oseltamivir
n=246 Participants
Oseltamivir: Subjects were prescribed Oseltamivir twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg.
|
Placebo
n=255 Participants
Placebo: Subjects were prescribed the matching placebo twice daily for 5 days, and each dose consisted of one capsule of placebo.
|
|---|---|---|
|
Number of Participants by Virus Detection Status --Self Collected Samples
Day 0 · >= LLOQ
|
217 Participants
|
225 Participants
|
|
Number of Participants by Virus Detection Status --Self Collected Samples
Day 0 · >= LOD, < LLOQ
|
11 Participants
|
6 Participants
|
|
Number of Participants by Virus Detection Status --Self Collected Samples
Day 0 · < LOD
|
17 Participants
|
23 Participants
|
|
Number of Participants by Virus Detection Status --Self Collected Samples
Day 0 · Missing
|
1 Participants
|
1 Participants
|
|
Number of Participants by Virus Detection Status --Self Collected Samples
Day 0 evening · >= LLOQ
|
37 Participants
|
48 Participants
|
|
Number of Participants by Virus Detection Status --Self Collected Samples
Day 0 evening · >= LOD, < LLOQ
|
4 Participants
|
1 Participants
|
|
Number of Participants by Virus Detection Status --Self Collected Samples
Day 0 evening · < LOD
|
8 Participants
|
5 Participants
|
|
Number of Participants by Virus Detection Status --Self Collected Samples
Day 0 evening · Missing
|
197 Participants
|
201 Participants
|
|
Number of Participants by Virus Detection Status --Self Collected Samples
Day 1 · >= LLOQ
|
138 Participants
|
147 Participants
|
|
Number of Participants by Virus Detection Status --Self Collected Samples
Day 1 · >= LOD, < LLOQ
|
30 Participants
|
27 Participants
|
|
Number of Participants by Virus Detection Status --Self Collected Samples
Day 1 · < LOD
|
75 Participants
|
76 Participants
|
|
Number of Participants by Virus Detection Status --Self Collected Samples
Day 1 evening · < LOD
|
24 Participants
|
13 Participants
|
|
Number of Participants by Virus Detection Status --Self Collected Samples
Day 1 · Missing
|
3 Participants
|
5 Participants
|
|
Number of Participants by Virus Detection Status --Self Collected Samples
Day 1 evening · >= LLOQ
|
23 Participants
|
29 Participants
|
|
Number of Participants by Virus Detection Status --Self Collected Samples
Day 1 evening · >= LOD, < LLOQ
|
4 Participants
|
9 Participants
|
|
Number of Participants by Virus Detection Status --Self Collected Samples
Day 1 evening · Missing
|
195 Participants
|
204 Participants
|
|
Number of Participants by Virus Detection Status --Self Collected Samples
Day 2 · >= LLOQ
|
70 Participants
|
92 Participants
|
|
Number of Participants by Virus Detection Status --Self Collected Samples
Day 2 · >= LOD, < LLOQ
|
26 Participants
|
31 Participants
|
|
Number of Participants by Virus Detection Status --Self Collected Samples
Day 2 · < LOD
|
146 Participants
|
129 Participants
|
|
Number of Participants by Virus Detection Status --Self Collected Samples
Day 2 · Missing
|
4 Participants
|
3 Participants
|
|
Number of Participants by Virus Detection Status --Self Collected Samples
Day 2 evening · >= LLOQ
|
11 Participants
|
12 Participants
|
|
Number of Participants by Virus Detection Status --Self Collected Samples
Day 2 evening · >= LOD, < LLOQ
|
6 Participants
|
4 Participants
|
|
Number of Participants by Virus Detection Status --Self Collected Samples
Day 2 evening · < LOD
|
32 Participants
|
41 Participants
|
|
Number of Participants by Virus Detection Status --Self Collected Samples
Day 2 evening · Missing
|
197 Participants
|
198 Participants
|
|
Number of Participants by Virus Detection Status --Self Collected Samples
Day 3 · >= LLOQ
|
39 Participants
|
65 Participants
|
|
Number of Participants by Virus Detection Status --Self Collected Samples
Day 3 · >= LOD, < LLOQ
|
25 Participants
|
35 Participants
|
|
Number of Participants by Virus Detection Status --Self Collected Samples
Day 3 · < LOD
|
178 Participants
|
149 Participants
|
|
Number of Participants by Virus Detection Status --Self Collected Samples
Day 3 · Missing
|
4 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: At Day 0, Day 0 evening, Day 1, Day 1 evening, Day 2, Day 2 evening and Day 3Population: The population analyzed is the Primary Efficacy Population (PEP), which included all participants who were randomized properly, had received at least one dose of study drug, and had influenza virus isolated and typed (from team collected sample) in the qualitative PCR evaluation at Day 0 from central laboratory testing.
Median, 25% and 75% percentile of the value of viral shedding (Results \<LOD were imputed as the LOD value, and Results \>= LOD, \<LLOQ were imputed as the LLOQ value.). Evening samples on Day 0, 1 and 2 were only required under protocol versions 1.0-4.0 and so were only collected for about 20% of participants.
Outcome measures
| Measure |
Oseltamivir
n=246 Participants
Oseltamivir: Subjects were prescribed Oseltamivir twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg.
|
Placebo
n=255 Participants
Placebo: Subjects were prescribed the matching placebo twice daily for 5 days, and each dose consisted of one capsule of placebo.
|
|---|---|---|
|
qPCR Viral Shedding -- Self Collected Samples
Day 0 evening
|
5.5 log10 copies/mL
Interval 4.3 to 6.2
|
6.0 log10 copies/mL
Interval 5.0 to 6.6
|
|
qPCR Viral Shedding -- Self Collected Samples
Day 0
|
6.1 log10 copies/mL
Interval 4.9 to 6.9
|
6.2 log10 copies/mL
Interval 5.4 to 6.9
|
|
qPCR Viral Shedding -- Self Collected Samples
Day 1
|
4.2 log10 copies/mL
Interval 3.4 to 5.5
|
4.5 log10 copies/mL
Interval 3.4 to 5.9
|
|
qPCR Viral Shedding -- Self Collected Samples
Day 1 evening
|
3.9 log10 copies/mL
Interval 3.2 to 7.2
|
4.0 log10 copies/mL
Interval 3.4 to 5.6
|
|
qPCR Viral Shedding -- Self Collected Samples
Day 2
|
3.4 log10 copies/mL
Interval 3.2 to 4.3
|
3.4 log10 copies/mL
Interval 3.2 to 4.8
|
|
qPCR Viral Shedding -- Self Collected Samples
Day 2 evening
|
3.2 log10 copies/mL
Interval 3.2 to 3.9
|
3.2 log10 copies/mL
Interval 3.2 to 3.9
|
|
qPCR Viral Shedding -- Self Collected Samples
Day 3
|
3.2 log10 copies/mL
Interval 3.2 to 3.9
|
3.4 log10 copies/mL
Interval 3.2 to 4.0
|
SECONDARY outcome
Timeframe: From Day 0 to Day 3Population: The population analyzed is the Primary Efficacy Population (PEP). The two subjects with missing values at Day 0 (one in each randomized arm) were excluded from this analysis.
This AUC was calculated using the trapezoidal rule and the units of measurement are (days\*log10 copies/mL) with the fact that it was the level of virus above the LLOQ being considered. The calculation of AUC was undertaken using measurements from Day 0 to Day 3 which were collected under all versions of the protocol (i.e. evening measurements on Days 0, 1 and 2 were not used as these were collected for only about 20% of subjects). Missing values during follow-up were ignored. This is equivalent to imputing a missing value using linear interpolation between the preceding and succeeding available values. For the five subjects with missing values following a last available measurement which was above the LLOQ, the remaining values were assumed to be the mean of preceding value and LLOQ in calculating the AUC.
Outcome measures
| Measure |
Oseltamivir
n=245 Participants
Oseltamivir: Subjects were prescribed Oseltamivir twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg.
|
Placebo
n=254 Participants
Placebo: Subjects were prescribed the matching placebo twice daily for 5 days, and each dose consisted of one capsule of placebo.
|
|---|---|---|
|
Area Under The Curve (AUC) Of Viral Shedding For Self Collected Samples
|
12.5 days*log10 copies/mL
Interval 11.35 to 14.55
|
13.18 days*log10 copies/mL
Interval 11.55 to 15.75
|
Adverse Events
Oseltamivir
Placebo
Serious adverse events
| Measure |
Oseltamivir
n=277 participants at risk
Oseltamivir: Subjects were prescribed Oseltamivir twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg.
|
Placebo
n=279 participants at risk
Placebo: Subjects were prescribed the matching placebo twice daily for 5 days, and each dose consisted of one capsule of placebo.
|
|---|---|---|
|
Infections and infestations
Influenza
|
0.72%
2/277 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
All worsening symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.
|
0.36%
1/279 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
All worsening symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.
|
|
Infections and infestations
Sinusitis
|
0.36%
1/277 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
All worsening symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.
|
0.00%
0/279 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
All worsening symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.
|
|
Gastrointestinal disorders
Vomiting
|
0.36%
1/277 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
All worsening symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.
|
0.00%
0/279 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
All worsening symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.36%
1/277 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
All worsening symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.
|
0.00%
0/279 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
All worsening symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.
|
|
General disorders
Chest pain
|
0.00%
0/277 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
All worsening symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.
|
0.36%
1/279 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
All worsening symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.
|
Other adverse events
| Measure |
Oseltamivir
n=277 participants at risk
Oseltamivir: Subjects were prescribed Oseltamivir twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg.
|
Placebo
n=279 participants at risk
Placebo: Subjects were prescribed the matching placebo twice daily for 5 days, and each dose consisted of one capsule of placebo.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
23.5%
65/277 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
All worsening symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.
|
21.9%
61/279 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
All worsening symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.
|
|
Gastrointestinal disorders
Diarrhoea
|
14.8%
41/277 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
All worsening symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.
|
16.8%
47/279 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
All worsening symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.
|
|
Gastrointestinal disorders
Vomiting
|
12.6%
35/277 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
All worsening symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.
|
12.9%
36/279 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
All worsening symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.1%
28/277 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
All worsening symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.
|
11.5%
32/279 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
All worsening symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
8.7%
24/277 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
All worsening symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.
|
9.0%
25/279 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
All worsening symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
9.4%
26/277 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
All worsening symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.
|
8.2%
23/279 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
All worsening symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
7.2%
20/277 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
All worsening symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.
|
5.7%
16/279 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
All worsening symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.
|
|
General disorders
Pyrexia
|
11.2%
31/277 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
All worsening symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.
|
9.7%
27/279 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
All worsening symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.
|
|
General disorders
Fatigue
|
8.7%
24/277 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
All worsening symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.
|
9.3%
26/279 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
All worsening symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.
|
|
Nervous system disorders
Headache
|
10.1%
28/277 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
All worsening symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.
|
8.6%
24/279 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
All worsening symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.
|
|
Nervous system disorders
Dizziness
|
7.9%
22/277 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
All worsening symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.
|
5.4%
15/279 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
All worsening symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.8%
16/277 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
All worsening symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.
|
7.5%
21/279 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
All worsening symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.
|
|
Vascular disorders
Hypertension
|
5.4%
15/277 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
All worsening symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.
|
7.2%
20/279 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
All worsening symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.
|
Additional Information
John Beigel, M.D
Leidos Biomedical Research, Inc. is support to the National Institute of Allergy and Infectious Diseases (NIAID)
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place