Trial Outcomes & Findings for A Phase 2a to Evaluate the Safety of MEDI8852 in Adults With Uncomplicated Influenza (NCT NCT02603952)
NCT ID: NCT02603952
Last Updated: 2018-06-08
Results Overview
Solicited influenza symptoms included cough, nasal congestion, sore throat, aches and pains, fatigue (tiredness), headache, chills/sweats (feeling feverish).
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
126 participants
Primary outcome timeframe
Day 1 (post-dose) through Day 10
Results posted on
2018-06-08
Participant Flow
The study was conducted from 07 Dec 2015 to 09 Dec 2016 in Australia, South Africa and United States of America.
A total of 373 participants were screened, of which 247 participants were screen failures and 126 participants were randomized in the study.
Participant milestones
| Measure |
Placebo + Oseltamivir 75 mg
Participants received a single intravenous (IV) infusion of placebo (matched to MEDI8852) on Day 1 and oseltamivir 75 milligrams (mg) capsules orally twice a day (BID) from Day 1 to Day 5.
|
MEDI8852 750 mg + Oseltamivir 75 mg
Participants received a single IV infusion of MEDI8852 750 mg on Day 1 and oseltamivir 75 mg capsules orally BID from Day 1 to Day 5.
|
MEDI8852 3000 mg + Oseltamivir 75 mg
Participants received a single IV infusion of MEDI8852 3000 mg on Day 1 and oseltamivir 75 mg capsules orally BID from Day 1 to Day 5.
|
MEDI8852 3000 mg
Participants received a single IV infusion of MEDI8852 3000 mg on Day 1.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
32
|
31
|
31
|
32
|
|
Overall Study
Treated
|
32
|
31
|
31
|
31
|
|
Overall Study
COMPLETED
|
31
|
31
|
31
|
31
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Placebo + Oseltamivir 75 mg
Participants received a single intravenous (IV) infusion of placebo (matched to MEDI8852) on Day 1 and oseltamivir 75 milligrams (mg) capsules orally twice a day (BID) from Day 1 to Day 5.
|
MEDI8852 750 mg + Oseltamivir 75 mg
Participants received a single IV infusion of MEDI8852 750 mg on Day 1 and oseltamivir 75 mg capsules orally BID from Day 1 to Day 5.
|
MEDI8852 3000 mg + Oseltamivir 75 mg
Participants received a single IV infusion of MEDI8852 3000 mg on Day 1 and oseltamivir 75 mg capsules orally BID from Day 1 to Day 5.
|
MEDI8852 3000 mg
Participants received a single IV infusion of MEDI8852 3000 mg on Day 1.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
|
Overall Study
Received oseltamivir by error
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Phase 2a to Evaluate the Safety of MEDI8852 in Adults With Uncomplicated Influenza
Baseline characteristics by cohort
| Measure |
Placebo + Oseltamivir 75 mg
n=32 Participants
Participants received a single intravenous (IV) infusion of placebo (matched to MEDI8852) on Day 1 and oseltamivir 75 milligrams (mg) capsules orally twice a day (BID) from Day 1 to Day 5.
|
MEDI8852 750 mg + Oseltamivir 75 mg
n=31 Participants
Participants received a single IV infusion of MEDI8852 750 mg on Day 1 and oseltamivir 75 mg capsules orally BID from Day 1 to Day 5.
|
MEDI8852 3000 mg + Oseltamivir 75 mg
n=31 Participants
Participants received a single IV infusion of MEDI8852 3000 mg on Day 1 and oseltamivir 75 mg capsules orally BID from Day 1 to Day 5.
|
MEDI8852 3000 mg
n=32 Participants
Participants received a single IV infusion of MEDI8852 3000 mg on Day 1.
|
Total
n=126 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
42.3 Years
STANDARD_DEVIATION 11.97 • n=5 Participants
|
40.5 Years
STANDARD_DEVIATION 11.97 • n=7 Participants
|
41.7 Years
STANDARD_DEVIATION 12.90 • n=5 Participants
|
44.3 Years
STANDARD_DEVIATION 13.96 • n=4 Participants
|
42.2 Years
STANDARD_DEVIATION 12.66 • n=21 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
66 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
60 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
16 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
70 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
56 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
104 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Day 1 (post-dose) through Day 10Population: As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
Solicited influenza symptoms included cough, nasal congestion, sore throat, aches and pains, fatigue (tiredness), headache, chills/sweats (feeling feverish).
Outcome measures
| Measure |
Placebo + Oseltamivir 75 mg
n=32 Participants
Participants received a single intravenous (IV) infusion of placebo (matched to MEDI8852) on Day 1 and oseltamivir 75 milligrams (mg) capsules orally twice a day (BID) from Day 1 to Day 5.
|
MEDI8852 750 mg + Oseltamivir 75 mg
n=31 Participants
Participants received a single IV infusion of MEDI8852 750 mg on Day 1 and oseltamivir 75 mg capsules orally BID from Day 1 to Day 5.
|
MEDI8852 3000 mg + Oseltamivir 75 mg
n=31 Participants
Participants received a single IV infusion of MEDI8852 3000 mg on Day 1 and oseltamivir 75 mg capsules orally BID from Day 1 to Day 5.
|
MEDI8852 3000 mg
n=31 Participants
Participants received a single IV infusion of MEDI8852 3000 mg on Day 1.
|
|---|---|---|---|---|
|
Number of Participants With Any Solicited Influenza Symptoms From Day 1 Through Day 10
Any symptom
|
32 Participants
|
31 Participants
|
31 Participants
|
31 Participants
|
PRIMARY outcome
Timeframe: Day 10 through Day 13Population: As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
Solicited influenza symptoms included cough, nasal congestion, sore throat, aches and pains, fatigue (tiredness), headache, chills/sweats (feeling feverish).
Outcome measures
| Measure |
Placebo + Oseltamivir 75 mg
n=32 Participants
Participants received a single intravenous (IV) infusion of placebo (matched to MEDI8852) on Day 1 and oseltamivir 75 milligrams (mg) capsules orally twice a day (BID) from Day 1 to Day 5.
|
MEDI8852 750 mg + Oseltamivir 75 mg
n=31 Participants
Participants received a single IV infusion of MEDI8852 750 mg on Day 1 and oseltamivir 75 mg capsules orally BID from Day 1 to Day 5.
|
MEDI8852 3000 mg + Oseltamivir 75 mg
n=31 Participants
Participants received a single IV infusion of MEDI8852 3000 mg on Day 1 and oseltamivir 75 mg capsules orally BID from Day 1 to Day 5.
|
MEDI8852 3000 mg
n=31 Participants
Participants received a single IV infusion of MEDI8852 3000 mg on Day 1.
|
|---|---|---|---|---|
|
Number of Participants With Any Solicited Influenza Symptoms From Day 10 Through Day 13
Any symptom
|
11 Participants
|
14 Participants
|
18 Participants
|
11 Participants
|
PRIMARY outcome
Timeframe: Day 1 (post-dose) through Day 28Population: As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
An adverse event (AE) is any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent events were between administration of study drug and Day 28 that were absent before treatment or that worsened relative to pre-treatment state.
Outcome measures
| Measure |
Placebo + Oseltamivir 75 mg
n=32 Participants
Participants received a single intravenous (IV) infusion of placebo (matched to MEDI8852) on Day 1 and oseltamivir 75 milligrams (mg) capsules orally twice a day (BID) from Day 1 to Day 5.
|
MEDI8852 750 mg + Oseltamivir 75 mg
n=31 Participants
Participants received a single IV infusion of MEDI8852 750 mg on Day 1 and oseltamivir 75 mg capsules orally BID from Day 1 to Day 5.
|
MEDI8852 3000 mg + Oseltamivir 75 mg
n=31 Participants
Participants received a single IV infusion of MEDI8852 3000 mg on Day 1 and oseltamivir 75 mg capsules orally BID from Day 1 to Day 5.
|
MEDI8852 3000 mg
n=31 Participants
Participants received a single IV infusion of MEDI8852 3000 mg on Day 1.
|
|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
|
9 Participants
|
11 Participants
|
15 Participants
|
12 Participants
|
PRIMARY outcome
Timeframe: Day 1 (post-dose) through Day 101Population: As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent events were between administration of study drug and Day 101 that were absent before treatment or that worsened relative to pre-treatment state.
Outcome measures
| Measure |
Placebo + Oseltamivir 75 mg
n=32 Participants
Participants received a single intravenous (IV) infusion of placebo (matched to MEDI8852) on Day 1 and oseltamivir 75 milligrams (mg) capsules orally twice a day (BID) from Day 1 to Day 5.
|
MEDI8852 750 mg + Oseltamivir 75 mg
n=31 Participants
Participants received a single IV infusion of MEDI8852 750 mg on Day 1 and oseltamivir 75 mg capsules orally BID from Day 1 to Day 5.
|
MEDI8852 3000 mg + Oseltamivir 75 mg
n=31 Participants
Participants received a single IV infusion of MEDI8852 3000 mg on Day 1 and oseltamivir 75 mg capsules orally BID from Day 1 to Day 5.
|
MEDI8852 3000 mg
n=31 Participants
Participants received a single IV infusion of MEDI8852 3000 mg on Day 1.
|
|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs)
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 (post-dose) through Day 101Population: As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
An AE is any untoward medical occurrence attributed to study drug in a participant who received study drug. An AESI was one of scientific and medical interest specific to understanding of the study drug and may have required close monitoring and rapid communication by the investigator to the sponsor. Treatment-emergent events were between administration of study drug and Day 101 that were absent before treatment or that worsened relative to pre treatment state.
Outcome measures
| Measure |
Placebo + Oseltamivir 75 mg
n=32 Participants
Participants received a single intravenous (IV) infusion of placebo (matched to MEDI8852) on Day 1 and oseltamivir 75 milligrams (mg) capsules orally twice a day (BID) from Day 1 to Day 5.
|
MEDI8852 750 mg + Oseltamivir 75 mg
n=31 Participants
Participants received a single IV infusion of MEDI8852 750 mg on Day 1 and oseltamivir 75 mg capsules orally BID from Day 1 to Day 5.
|
MEDI8852 3000 mg + Oseltamivir 75 mg
n=31 Participants
Participants received a single IV infusion of MEDI8852 3000 mg on Day 1 and oseltamivir 75 mg capsules orally BID from Day 1 to Day 5.
|
MEDI8852 3000 mg
n=31 Participants
Participants received a single IV infusion of MEDI8852 3000 mg on Day 1.
|
|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events of Special Interest (TEAESIs)
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Days 3, 5, 7, 9, 11, and 13Population: Per-protocol (PP) population included all randomized participants who received any portion of their protocol-specified treatment regimen with valid assay results from nasopharyngeal specimens obtained at any post-dosing time point. Participants without confirmed influenza A at baseline were excluded from the PP population.
Quantitative real-time polymerase chain reaction (qRT-PCR) was used to measure influenza viral shedding from the nasopharyngeal swabs. Percentage of participants who shed influenza virus are reported.
Outcome measures
| Measure |
Placebo + Oseltamivir 75 mg
n=30 Participants
Participants received a single intravenous (IV) infusion of placebo (matched to MEDI8852) on Day 1 and oseltamivir 75 milligrams (mg) capsules orally twice a day (BID) from Day 1 to Day 5.
|
MEDI8852 750 mg + Oseltamivir 75 mg
n=27 Participants
Participants received a single IV infusion of MEDI8852 750 mg on Day 1 and oseltamivir 75 mg capsules orally BID from Day 1 to Day 5.
|
MEDI8852 3000 mg + Oseltamivir 75 mg
n=23 Participants
Participants received a single IV infusion of MEDI8852 3000 mg on Day 1 and oseltamivir 75 mg capsules orally BID from Day 1 to Day 5.
|
MEDI8852 3000 mg
n=24 Participants
Participants received a single IV infusion of MEDI8852 3000 mg on Day 1.
|
|---|---|---|---|---|
|
Percentage of Participants With Influenza Viral Shedding as Measured by Quantitative Reverse Transcription-Polymerase Chain Reaction (qRT-PCR)
Baseline (Day 1)
|
100 Percentage of Participants
Interval 88.4 to 100.0
|
100 Percentage of Participants
Interval 87.2 to 100.0
|
100 Percentage of Participants
Interval 85.2 to 100.0
|
100 Percentage of Participants
Interval 85.8 to 100.0
|
|
Percentage of Participants With Influenza Viral Shedding as Measured by Quantitative Reverse Transcription-Polymerase Chain Reaction (qRT-PCR)
Day 3
|
90 Percentage of Participants
Interval 73.5 to 97.9
|
88.9 Percentage of Participants
Interval 70.8 to 97.6
|
91.3 Percentage of Participants
Interval 72.0 to 98.9
|
95.8 Percentage of Participants
Interval 78.9 to 99.9
|
|
Percentage of Participants With Influenza Viral Shedding as Measured by Quantitative Reverse Transcription-Polymerase Chain Reaction (qRT-PCR)
Day 5
|
56.7 Percentage of Participants
Interval 37.4 to 74.5
|
85.2 Percentage of Participants
Interval 66.3 to 95.8
|
60.9 Percentage of Participants
Interval 38.5 to 80.3
|
54.2 Percentage of Participants
Interval 32.8 to 74.4
|
|
Percentage of Participants With Influenza Viral Shedding as Measured by Quantitative Reverse Transcription-Polymerase Chain Reaction (qRT-PCR)
Day 7
|
33.3 Percentage of Participants
Interval 17.3 to 52.8
|
59.3 Percentage of Participants
Interval 38.8 to 77.6
|
30.4 Percentage of Participants
Interval 13.2 to 52.9
|
37.5 Percentage of Participants
Interval 18.8 to 59.4
|
|
Percentage of Participants With Influenza Viral Shedding as Measured by Quantitative Reverse Transcription-Polymerase Chain Reaction (qRT-PCR)
Day 9
|
3.3 Percentage of Participants
Interval 0.1 to 17.2
|
7.4 Percentage of Participants
Interval 0.9 to 24.3
|
4.3 Percentage of Participants
Interval 0.1 to 21.9
|
0.0 Percentage of Participants
Interval 0.0 to 14.2
|
|
Percentage of Participants With Influenza Viral Shedding as Measured by Quantitative Reverse Transcription-Polymerase Chain Reaction (qRT-PCR)
Day 11
|
0.0 Percentage of Participants
Interval 0.0 to 11.6
|
0.0 Percentage of Participants
Interval 0.0 to 12.8
|
0.0 Percentage of Participants
Interval 0.0 to 14.8
|
4.2 Percentage of Participants
Interval 0.1 to 21.1
|
|
Percentage of Participants With Influenza Viral Shedding as Measured by Quantitative Reverse Transcription-Polymerase Chain Reaction (qRT-PCR)
Day 13
|
0.0 Percentage of Participants
Interval 0.0 to 11.6
|
0.0 Percentage of Participants
Interval 0.0 to 12.8
|
0.0 Percentage of Participants
Interval 0.0 to 14.8
|
0.0 Percentage of Participants
Interval 0.0 to 14.2
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Days 3, 5, 7, 9, 11, and 13Population: PP population included all randomized participants who received any portion of their protocol-specified treatment regimen with valid assay results from nasopharyngeal specimens obtained at any post-dosing time point. Participants without confirmed influenza A at baseline were excluded from the PP population.
qRT-PCR was used to measure influenza viral shedding from the nasopharyngeal swabs.
Outcome measures
| Measure |
Placebo + Oseltamivir 75 mg
n=30 Participants
Participants received a single intravenous (IV) infusion of placebo (matched to MEDI8852) on Day 1 and oseltamivir 75 milligrams (mg) capsules orally twice a day (BID) from Day 1 to Day 5.
|
MEDI8852 750 mg + Oseltamivir 75 mg
n=27 Participants
Participants received a single IV infusion of MEDI8852 750 mg on Day 1 and oseltamivir 75 mg capsules orally BID from Day 1 to Day 5.
|
MEDI8852 3000 mg + Oseltamivir 75 mg
n=23 Participants
Participants received a single IV infusion of MEDI8852 3000 mg on Day 1 and oseltamivir 75 mg capsules orally BID from Day 1 to Day 5.
|
MEDI8852 3000 mg
n=24 Participants
Participants received a single IV infusion of MEDI8852 3000 mg on Day 1.
|
|---|---|---|---|---|
|
Quantitation of Influenza Viral Shedding as Measured by qRT-PCR
Baseline (Day 1)
|
6.37 Log10 (viral copies/mL)
Standard Deviation 1.52
|
6.62 Log10 (viral copies/mL)
Standard Deviation 1.30
|
6.92 Log10 (viral copies/mL)
Standard Deviation 1.17
|
6.34 Log10 (viral copies/mL)
Standard Deviation 1.47
|
|
Quantitation of Influenza Viral Shedding as Measured by qRT-PCR
Day 3
|
4.35 Log10 (viral copies/mL)
Standard Deviation 1.36
|
4.75 Log10 (viral copies/mL)
Standard Deviation 1.31
|
4.89 Log10 (viral copies/mL)
Standard Deviation 1.39
|
4.63 Log10 (viral copies/mL)
Standard Deviation 1.33
|
|
Quantitation of Influenza Viral Shedding as Measured by qRT-PCR
Day 5
|
3.45 Log10 (viral copies/mL)
Standard Deviation 1.03
|
3.31 Log10 (viral copies/mL)
Standard Deviation 0.73
|
3.43 Log10 (viral copies/mL)
Standard Deviation 1.22
|
3.73 Log10 (viral copies/mL)
Standard Deviation 1.23
|
|
Quantitation of Influenza Viral Shedding as Measured by qRT-PCR
Day 7
|
2.94 Log10 (viral copies/mL)
Standard Deviation 0.47
|
3.13 Log10 (viral copies/mL)
Standard Deviation 0.93
|
2.97 Log10 (viral copies/mL)
Standard Deviation 0.71
|
3.03 Log10 (viral copies/mL)
Standard Deviation 0.57
|
|
Quantitation of Influenza Viral Shedding as Measured by qRT-PCR
Day 9
|
3.12 Log10 (viral copies/mL)
Standard Deviation 0.85
|
3.76 Log10 (viral copies/mL)
Standard Deviation 1.60
|
2.80 Log10 (viral copies/mL)
Standard Deviation 0.00
|
2.80 Log10 (viral copies/mL)
Standard Deviation 0.00
|
|
Quantitation of Influenza Viral Shedding as Measured by qRT-PCR
Day 11
|
2.80 Log10 (viral copies/mL)
Standard Deviation 0.00
|
2.80 Log10 (viral copies/mL)
Standard Deviation 0.00
|
2.80 Log10 (viral copies/mL)
Standard Deviation 0.00
|
3.11 Log10 (viral copies/mL)
Standard Deviation 0.63
|
|
Quantitation of Influenza Viral Shedding as Measured by qRT-PCR
Day 13
|
—
|
—
|
—
|
2.80 Log10 (viral copies/mL)
Standard Deviation NA
Standard deviation (SD) data not applicable as only one participant was evaluable for this time point.
|
SECONDARY outcome
Timeframe: From Baseline (Day 1) to Day 7; and Day 9 to Day 13Population: PP population. Participants without confirmed influenza A at baseline were excluded from the PP population. Participants with shedding data available for Day 1 to Day 7 and Day 9 to Day 13 were analyzed for this outcome measure.
Number of days of viral shedding for participants who shed influenza virus is reported. qRT-PCR was used to measure influenza viral shedding from the nasopharyngeal swabs.
Outcome measures
| Measure |
Placebo + Oseltamivir 75 mg
n=30 Participants
Participants received a single intravenous (IV) infusion of placebo (matched to MEDI8852) on Day 1 and oseltamivir 75 milligrams (mg) capsules orally twice a day (BID) from Day 1 to Day 5.
|
MEDI8852 750 mg + Oseltamivir 75 mg
n=27 Participants
Participants received a single IV infusion of MEDI8852 750 mg on Day 1 and oseltamivir 75 mg capsules orally BID from Day 1 to Day 5.
|
MEDI8852 3000 mg + Oseltamivir 75 mg
n=23 Participants
Participants received a single IV infusion of MEDI8852 3000 mg on Day 1 and oseltamivir 75 mg capsules orally BID from Day 1 to Day 5.
|
MEDI8852 3000 mg
n=24 Participants
Participants received a single IV infusion of MEDI8852 3000 mg on Day 1.
|
|---|---|---|---|---|
|
Number of Days of Influenza Viral Shedding as Measured by qRT-PCR
Day 1 to Day 7
|
4.7 Days
Standard Deviation 2.05
|
5.8 Days
Standard Deviation 1.84
|
4.9 Days
Standard Deviation 1.95
|
4.8 Days
Standard Deviation 2.18
|
|
Number of Days of Influenza Viral Shedding as Measured by qRT-PCR
Day 9 to Day 13
|
5.4 Days
Standard Deviation 2.94
|
6.3 Days
Standard Deviation 2.60
|
6.0 Days
Standard Deviation 2.45
|
5.5 Days
Standard Deviation 2.78
|
SECONDARY outcome
Timeframe: From Baseline (Day 1) to Day 13Population: PP population. Participants without confirmed influenza A at baseline were excluded from the PP population. Participants with confirmed Influenza A positive and Influenza A concentrations greater than the lower limit of quantification (LLOQ) were analyzed.
Genotypic analysis was performed to identify all amino acid changes in MEDI8852 binding site between each baseline (Day1) sample and the participant's corresponding last sample sequenced. Percentage of participants with changes in the amino acid corresponding to MEDI8852 binding site is reported. Due to the fact that the percentage of participants with amino acid changes in MEDI8852 binding site was zero across all participant samples analyzed, no additional per arm analyses were performed.
Outcome measures
| Measure |
Placebo + Oseltamivir 75 mg
n=94 Participants
Participants received a single intravenous (IV) infusion of placebo (matched to MEDI8852) on Day 1 and oseltamivir 75 milligrams (mg) capsules orally twice a day (BID) from Day 1 to Day 5.
|
MEDI8852 750 mg + Oseltamivir 75 mg
Participants received a single IV infusion of MEDI8852 750 mg on Day 1 and oseltamivir 75 mg capsules orally BID from Day 1 to Day 5.
|
MEDI8852 3000 mg + Oseltamivir 75 mg
Participants received a single IV infusion of MEDI8852 3000 mg on Day 1 and oseltamivir 75 mg capsules orally BID from Day 1 to Day 5.
|
MEDI8852 3000 mg
Participants received a single IV infusion of MEDI8852 3000 mg on Day 1.
|
|---|---|---|---|---|
|
Percentage of Participants With Amino Acid Changes in MEDI8852 Binding Site
|
0 Percentage of Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Baseline (Day 1) to Day 13Population: PP population. Participants without confirmed influenza A at baseline were excluded from the PP population. Participants with quantifiable Influenza A (greater than LLOQ) and a unique hemagglutinin gene sequence were analyzed.
Viral susceptibility to MEDI8852 was measured by a Madin-Darby canine kidney (MDCK) cell-based microneutralization assay (Virospot) for viruses recovered from baseline samples and viruses recovered from samples following treatment that contain amino acid changes within the MEDI8852 binding site. Participants with detectable levels (50% tissue culture infectious dose \[TCID50\]) of virus were considered susceptible and were reported. Due to the fact that the number of participants with viral susceptibility to MEDI8852 binding site was zero across all participant samples analyzed, no additional per arm analyses were performed.
Outcome measures
| Measure |
Placebo + Oseltamivir 75 mg
n=35 Participants
Participants received a single intravenous (IV) infusion of placebo (matched to MEDI8852) on Day 1 and oseltamivir 75 milligrams (mg) capsules orally twice a day (BID) from Day 1 to Day 5.
|
MEDI8852 750 mg + Oseltamivir 75 mg
Participants received a single IV infusion of MEDI8852 750 mg on Day 1 and oseltamivir 75 mg capsules orally BID from Day 1 to Day 5.
|
MEDI8852 3000 mg + Oseltamivir 75 mg
Participants received a single IV infusion of MEDI8852 3000 mg on Day 1 and oseltamivir 75 mg capsules orally BID from Day 1 to Day 5.
|
MEDI8852 3000 mg
Participants received a single IV infusion of MEDI8852 3000 mg on Day 1.
|
|---|---|---|---|---|
|
Number of Participants With Viral Susceptibility to MEDI8852 as Determined by a Cell Based Microneutralization Assay
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Baseline (Day 1) to Day 13Population: PP population. Participants without confirmed influenza A at baseline were excluded from the PP population. Participants with confirmed Influenza A positive and Influenza A concentrations greater than the LLOQ were analyzed.
Genotypic analysis was performed to identify all amino acid changes in neuraminidase (NA) gene between each baseline (Day1) sample and the participant's corresponding last sample sequenced. Percentage of participants with virus containing known oseltamivir resistance-associated mutations (change in the NA genes) is reported. Due to the fact that the percentage of participants with virus containing known oseltamivir resistance-associated mutation was zero across all participant samples analyzed, no additional per arm analyses were performed.
Outcome measures
| Measure |
Placebo + Oseltamivir 75 mg
n=94 Participants
Participants received a single intravenous (IV) infusion of placebo (matched to MEDI8852) on Day 1 and oseltamivir 75 milligrams (mg) capsules orally twice a day (BID) from Day 1 to Day 5.
|
MEDI8852 750 mg + Oseltamivir 75 mg
Participants received a single IV infusion of MEDI8852 750 mg on Day 1 and oseltamivir 75 mg capsules orally BID from Day 1 to Day 5.
|
MEDI8852 3000 mg + Oseltamivir 75 mg
Participants received a single IV infusion of MEDI8852 3000 mg on Day 1 and oseltamivir 75 mg capsules orally BID from Day 1 to Day 5.
|
MEDI8852 3000 mg
Participants received a single IV infusion of MEDI8852 3000 mg on Day 1.
|
|---|---|---|---|---|
|
Percentage of Participants With Virus Containing Known Oseltamivir Resistance-Associated Mutations
|
0 Percentage of Participants
|
—
|
—
|
—
|
Adverse Events
Placebo + Oseltamivir 75 mg
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
MEDI8852 750 mg + Oseltamivir 75 mg
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
MEDI8852 3000 mg + Oseltamivir 75 mg
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
MEDI8852 3000 mg
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo + Oseltamivir 75 mg
n=32 participants at risk
Participants received a single intravenous (IV) infusion of placebo (matched to MEDI8852) on Day 1 and oseltamivir 75 milligrams (mg) capsules orally twice a day (BID) from Day 1 to Day 5.
|
MEDI8852 750 mg + Oseltamivir 75 mg
n=31 participants at risk
Participants received a single IV infusion of MEDI8852 750 mg on Day 1 and oseltamivir 75 mg capsules orally BID from Day 1 to Day 5.
|
MEDI8852 3000 mg + Oseltamivir 75 mg
n=31 participants at risk
Participants received a single IV infusion of MEDI8852 3000 mg on Day 1 and oseltamivir 75 mg capsules orally BID from Day 1 to Day 5.
|
MEDI8852 3000 mg
n=31 participants at risk
Participants received a single IV infusion of MEDI8852 3000 mg on Day 1.
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/32 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
0.00%
0/31 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
3.2%
1/31 • Number of events 1 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
0.00%
0/31 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
|
Nervous system disorders
Syncope
|
3.1%
1/32 • Number of events 1 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
0.00%
0/31 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
0.00%
0/31 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
0.00%
0/31 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
Other adverse events
| Measure |
Placebo + Oseltamivir 75 mg
n=32 participants at risk
Participants received a single intravenous (IV) infusion of placebo (matched to MEDI8852) on Day 1 and oseltamivir 75 milligrams (mg) capsules orally twice a day (BID) from Day 1 to Day 5.
|
MEDI8852 750 mg + Oseltamivir 75 mg
n=31 participants at risk
Participants received a single IV infusion of MEDI8852 750 mg on Day 1 and oseltamivir 75 mg capsules orally BID from Day 1 to Day 5.
|
MEDI8852 3000 mg + Oseltamivir 75 mg
n=31 participants at risk
Participants received a single IV infusion of MEDI8852 3000 mg on Day 1 and oseltamivir 75 mg capsules orally BID from Day 1 to Day 5.
|
MEDI8852 3000 mg
n=31 participants at risk
Participants received a single IV infusion of MEDI8852 3000 mg on Day 1.
|
|---|---|---|---|---|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/32 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
0.00%
0/31 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
3.2%
1/31 • Number of events 1 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
0.00%
0/31 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/32 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
0.00%
0/31 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
6.5%
2/31 • Number of events 2 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
6.5%
2/31 • Number of events 2 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/32 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
3.2%
1/31 • Number of events 1 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
3.2%
1/31 • Number of events 1 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
0.00%
0/31 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
|
Gastrointestinal disorders
Nausea
|
6.2%
2/32 • Number of events 2 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
6.5%
2/31 • Number of events 2 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
3.2%
1/31 • Number of events 1 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
3.2%
1/31 • Number of events 1 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
|
Gastrointestinal disorders
Vomiting
|
3.1%
1/32 • Number of events 1 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
3.2%
1/31 • Number of events 1 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
3.2%
1/31 • Number of events 2 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
3.2%
1/31 • Number of events 1 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
|
Infections and infestations
Bronchitis
|
3.1%
1/32 • Number of events 1 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
12.9%
4/31 • Number of events 4 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
16.1%
5/31 • Number of events 5 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
6.5%
2/31 • Number of events 2 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
|
Infections and infestations
Pharyngitis
|
3.1%
1/32 • Number of events 1 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
6.5%
2/31 • Number of events 2 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
0.00%
0/31 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
3.2%
1/31 • Number of events 1 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/32 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
0.00%
0/31 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
3.2%
1/31 • Number of events 1 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
3.2%
1/31 • Number of events 1 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/32 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
3.2%
1/31 • Number of events 1 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
3.2%
1/31 • Number of events 1 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
0.00%
0/31 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/32 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
3.2%
1/31 • Number of events 1 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
9.7%
3/31 • Number of events 3 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
0.00%
0/31 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
|
Nervous system disorders
Dizziness
|
3.1%
1/32 • Number of events 1 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
0.00%
0/31 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
0.00%
0/31 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
3.2%
1/31 • Number of events 1 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
|
Nervous system disorders
Dysgeusia
|
3.1%
1/32 • Number of events 1 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
3.2%
1/31 • Number of events 1 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
6.5%
2/31 • Number of events 2 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
0.00%
0/31 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
|
Nervous system disorders
Paraesthesia
|
6.2%
2/32 • Number of events 2 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
0.00%
0/31 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
0.00%
0/31 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
0.00%
0/31 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.00%
0/32 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
6.5%
2/31 • Number of events 2 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
0.00%
0/31 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
0.00%
0/31 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/32 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
3.2%
1/31 • Number of events 1 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
3.2%
1/31 • Number of events 1 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
0.00%
0/31 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/32 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
3.2%
1/31 • Number of events 1 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
0.00%
0/31 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
0.00%
0/31 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
|
Gastrointestinal disorders
Paraesthesia oral
|
3.1%
1/32 • Number of events 1 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
0.00%
0/31 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
0.00%
0/31 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
0.00%
0/31 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/32 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
3.2%
1/31 • Number of events 1 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
0.00%
0/31 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
0.00%
0/31 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
|
Infections and infestations
Ear infection
|
3.1%
1/32 • Number of events 1 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
0.00%
0/31 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
0.00%
0/31 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
0.00%
0/31 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
|
Infections and infestations
Furuncle
|
0.00%
0/32 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
0.00%
0/31 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
0.00%
0/31 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
3.2%
1/31 • Number of events 1 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/32 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
3.2%
1/31 • Number of events 1 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
0.00%
0/31 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
0.00%
0/31 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/32 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
0.00%
0/31 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
3.2%
1/31 • Number of events 1 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
0.00%
0/31 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus discomfort
|
3.1%
1/32 • Number of events 1 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
0.00%
0/31 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
0.00%
0/31 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
0.00%
0/31 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
|
Blood and lymphatic system disorders
Polycythaemia
|
0.00%
0/32 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
0.00%
0/31 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
3.2%
1/31 • Number of events 1 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
0.00%
0/31 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/32 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
0.00%
0/31 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
0.00%
0/31 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
3.2%
1/31 • Number of events 1 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
|
Ear and labyrinth disorders
Middle ear effusion
|
3.1%
1/32 • Number of events 1 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
0.00%
0/31 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
0.00%
0/31 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
0.00%
0/31 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/32 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
3.2%
1/31 • Number of events 1 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
0.00%
0/31 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
0.00%
0/31 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
|
Psychiatric disorders
Insomnia
|
3.1%
1/32 • Number of events 1 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
0.00%
0/31 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
0.00%
0/31 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
0.00%
0/31 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/32 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
0.00%
0/31 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
3.2%
1/31 • Number of events 1 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
0.00%
0/31 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/32 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
0.00%
0/31 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
0.00%
0/31 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
3.2%
1/31 • Number of events 1 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
|
Gastrointestinal disorders
Constipation
|
3.1%
1/32 • Number of events 1 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
0.00%
0/31 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
0.00%
0/31 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
0.00%
0/31 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
|
General disorders
Administration site thrombosis
|
0.00%
0/32 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
0.00%
0/31 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
0.00%
0/31 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
3.2%
1/31 • Number of events 1 • Treatment-Emergent Adverse Events (TEAEs) : Day 1 (post-dose) through Day 28; Treatment-Emergent Serious Adverse Events (TESAEs) : Day 1 (post-dose) through Day 101
Safety analyses were performed on the as-treated population. As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee MedImmune has 60 days to review results communications prior to public release and may delete information that compromises on-going studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
- Publication restrictions are in place
Restriction type: OTHER