Trial Outcomes & Findings for An Open-label Safety, Tolerability and Dose-Range Finding Study of Multiple Doses of Nusinersen (ISIS 396443) in Participants With Spinal Muscular Atrophy (NCT NCT01703988)
NCT ID: NCT01703988
Last Updated: 2021-04-13
Results Overview
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the study or use of the investigational drug product, whether or not the AE is considered related to the investigational drug product. An SAE is any AE that, in the view of either the Investigator or Sponsor, meets any of the following criteria: results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions; results in congenital anomaly or birth defect; and is an important medical event in the judgment of the investigator. Drug-related is an event related or possibly related to study drug. Severity of AEs was assessed as mild, moderate, or severe.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
34 participants
Primary outcome timeframe
Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days
Results posted on
2021-04-13
Participant Flow
Participant milestones
| Measure |
Nusinersen 3 mg
3 mg nusinersen on Days 1, 29, 85, intrathecal (IT) injection
|
Nusinersen 6 mg
6 mg nusinersen on Days 1, 29, 85, IT injection
|
Nusinersen 9 mg
9 mg nusinersen on Days 1 and 85, IT injection
|
Nusinersen 12 mg
12 mg nusinersen on Days 1, 29, 85, IT injection
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
9
|
9
|
|
Overall Study
COMPLETED
|
8
|
8
|
9
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Nusinersen 3 mg
3 mg nusinersen on Days 1, 29, 85, intrathecal (IT) injection
|
Nusinersen 6 mg
6 mg nusinersen on Days 1, 29, 85, IT injection
|
Nusinersen 9 mg
9 mg nusinersen on Days 1 and 85, IT injection
|
Nusinersen 12 mg
12 mg nusinersen on Days 1, 29, 85, IT injection
|
|---|---|---|---|---|
|
Overall Study
Investigator Judgment
|
0
|
0
|
0
|
1
|
Baseline Characteristics
An Open-label Safety, Tolerability and Dose-Range Finding Study of Multiple Doses of Nusinersen (ISIS 396443) in Participants With Spinal Muscular Atrophy
Baseline characteristics by cohort
| Measure |
Nusinersen 3 mg
n=8 Participants
3 mg nusinersen on Days 1, 29, 85, IT injection
|
Nusinersen 6 mg
n=8 Participants
6 mg nusinersen on Days 1, 29, 85, IT injection
|
Nusinersen 9 mg
n=9 Participants
9 mg nusinersen on Days 1 and 85, IT injection
|
Nusinersen 12 mg
n=9 Participants
12 mg nusinersen on Days 1, 29, 85, IT injection
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
8.6 years
STANDARD_DEVIATION 5.4 • n=99 Participants
|
8.1 years
STANDARD_DEVIATION 5.2 • n=107 Participants
|
6.0 years
STANDARD_DEVIATION 4.0 • n=206 Participants
|
6.9 years
STANDARD_DEVIATION 4.3 • n=7 Participants
|
7.4 years
STANDARD_DEVIATION 4.6 • n=31 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
14 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
20 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) daysPopulation: Safety Population, defined as all enrolled participants who received at least 1 dose of study drug.
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the study or use of the investigational drug product, whether or not the AE is considered related to the investigational drug product. An SAE is any AE that, in the view of either the Investigator or Sponsor, meets any of the following criteria: results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions; results in congenital anomaly or birth defect; and is an important medical event in the judgment of the investigator. Drug-related is an event related or possibly related to study drug. Severity of AEs was assessed as mild, moderate, or severe.
Outcome measures
| Measure |
Nusinersen 3 mg
n=8 Participants
3 mg nusinersen on Days 1, 29, 85, IT injection
|
Nusinersen 6 mg
n=8 Participants
6 mg nusinersen on Days 1, 29, 85, IT injection
|
Nusinersen 9 mg
n=9 Participants
9 mg nusinersen on Days 1 and 85, IT injection
|
Nusinersen 12 mg
n=9 Participants
12 mg nusinersen on Days 1, 29, 85, IT injection
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Discontinuations Due to AEs, and Highest Severity of AEs
Any AE
|
8 Participants
|
6 Participants
|
9 Participants
|
9 Participants
|
|
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Discontinuations Due to AEs, and Highest Severity of AEs
Any drug-related AE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Discontinuations Due to AEs, and Highest Severity of AEs
Any SAE
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Discontinuations Due to AEs, and Highest Severity of AEs
Discontinued due to an AE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Discontinuations Due to AEs, and Highest Severity of AEs
Highest severity of AE=mild
|
2 Participants
|
2 Participants
|
6 Participants
|
5 Participants
|
|
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Discontinuations Due to AEs, and Highest Severity of AEs
Highest severity of AE=moderate
|
4 Participants
|
2 Participants
|
3 Participants
|
4 Participants
|
|
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Discontinuations Due to AEs, and Highest Severity of AEs
Highest severity of AE=severe
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 and Day 85Population: Pharmacokinetic (PK) Population, defined as all enrolled participants who have evaluable PK data; number analyzed=participants with an assessment at given time point.
Outcome measures
| Measure |
Nusinersen 3 mg
n=8 Participants
3 mg nusinersen on Days 1, 29, 85, IT injection
|
Nusinersen 6 mg
n=8 Participants
6 mg nusinersen on Days 1, 29, 85, IT injection
|
Nusinersen 9 mg
n=9 Participants
9 mg nusinersen on Days 1 and 85, IT injection
|
Nusinersen 12 mg
n=9 Participants
12 mg nusinersen on Days 1, 29, 85, IT injection
|
|---|---|---|---|---|
|
Plasma Pharmacokinetics: Maximal Observed Plasma Drug Concentration (Cmax)
Day 1
|
51.5 ng/mL
Standard Deviation 72.7
|
79.8 ng/mL
Standard Deviation 57.2
|
141.0 ng/mL
Standard Deviation 52.8
|
208.0 ng/mL
Standard Deviation 110.0
|
|
Plasma Pharmacokinetics: Maximal Observed Plasma Drug Concentration (Cmax)
Day 85
|
32.5 ng/mL
Standard Deviation 32.3
|
52.8 ng/mL
Standard Deviation 33.5
|
127.0 ng/mL
Standard Deviation 37.7
|
132.0 ng/mL
Standard Deviation 85.6
|
SECONDARY outcome
Timeframe: Day 1 and Day 85Population: PK Population, defined as all enrolled participants who have evaluable PK data; number analyzed=participants with an assessment at given time point.
Outcome measures
| Measure |
Nusinersen 3 mg
n=8 Participants
3 mg nusinersen on Days 1, 29, 85, IT injection
|
Nusinersen 6 mg
n=8 Participants
6 mg nusinersen on Days 1, 29, 85, IT injection
|
Nusinersen 9 mg
n=9 Participants
9 mg nusinersen on Days 1 and 85, IT injection
|
Nusinersen 12 mg
n=9 Participants
12 mg nusinersen on Days 1, 29, 85, IT injection
|
|---|---|---|---|---|
|
Plasma Pharmacokinetics: Time to Reach Cmax in Plasma
Day 1
|
5.09 hours
Interval 2.03 to 12.0
|
5.93 hours
Interval 2.0 to 23.0
|
3.92 hours
Interval 2.0 to 8.03
|
4.05 hours
Interval 1.97 to 12.0
|
|
Plasma Pharmacokinetics: Time to Reach Cmax in Plasma
Day 85
|
6.08 hours
Interval 4.12 to 6.17
|
6.04 hours
Interval 5.97 to 6.25
|
4.12 hours
Interval 2.0 to 6.25
|
5.92 hours
Interval 1.95 to 6.07
|
SECONDARY outcome
Timeframe: Day 1 and Day 85Population: PK Population, defined as all enrolled participants who have evaluable PK data; number analyzed=participants with an assessment at given time point.
Outcome measures
| Measure |
Nusinersen 3 mg
n=8 Participants
3 mg nusinersen on Days 1, 29, 85, IT injection
|
Nusinersen 6 mg
n=8 Participants
6 mg nusinersen on Days 1, 29, 85, IT injection
|
Nusinersen 9 mg
n=9 Participants
9 mg nusinersen on Days 1 and 85, IT injection
|
Nusinersen 12 mg
n=9 Participants
12 mg nusinersen on Days 1, 29, 85, IT injection
|
|---|---|---|---|---|
|
Plasma Pharmacokinetics: Plasma Pharmacokinetics: Area Under the Plasma Concentration Time Curve From the Time of the IT Dose to 6 Hours After Dosing (AUC0-6hr)
Day 1
|
181 ng*hr/mL
Standard Deviation 225
|
306 ng*hr/mL
Standard Deviation 259
|
601 ng*hr/mL
Standard Deviation 249
|
823 ng*hr/mL
Standard Deviation 442
|
|
Plasma Pharmacokinetics: Plasma Pharmacokinetics: Area Under the Plasma Concentration Time Curve From the Time of the IT Dose to 6 Hours After Dosing (AUC0-6hr)
Day 85
|
110 ng*hr/mL
Standard Deviation 107
|
179 ng*hr/mL
Standard Deviation 135
|
524 ng*hr/mL
Standard Deviation 185
|
555 ng*hr/mL
Standard Deviation 398
|
SECONDARY outcome
Timeframe: Day 1, Day 29, and Day 85Population: PK Population, defined as all enrolled participants who have evaluable PK data; number analyzed=participants with an assessment at given time point. (This study includes participants previously enrolled in Study ISIS 396443 - CS1 (NCT01494701).
Outcome measures
| Measure |
Nusinersen 3 mg
n=8 Participants
3 mg nusinersen on Days 1, 29, 85, IT injection
|
Nusinersen 6 mg
n=8 Participants
6 mg nusinersen on Days 1, 29, 85, IT injection
|
Nusinersen 9 mg
n=9 Participants
9 mg nusinersen on Days 1 and 85, IT injection
|
Nusinersen 12 mg
n=9 Participants
12 mg nusinersen on Days 1, 29, 85, IT injection
|
|---|---|---|---|---|
|
Cerebrospinal Fluid (CSF) Pharmacokinetics: Predose CSF Drug Concentrations
Day 1
|
0.0651 ng/mL
Standard Deviation 0.117
|
0.0560 ng/mL
Standard Deviation 0.104
|
NA ng/mL
Standard Deviation NA
below the limit of quantification (50 pg/mL)
|
NA ng/mL
Standard Deviation NA
below the limit of quantification (50 pg/mL)
|
|
Cerebrospinal Fluid (CSF) Pharmacokinetics: Predose CSF Drug Concentrations
Day 29
|
1.41 ng/mL
Standard Deviation 0.456
|
2.65 ng/mL
Standard Deviation 1.44
|
—
|
2.22 ng/mL
Standard Deviation 0.924
|
|
Cerebrospinal Fluid (CSF) Pharmacokinetics: Predose CSF Drug Concentrations
Day 85
|
2.12 ng/mL
Standard Deviation 0.573
|
3.76 ng/mL
Standard Deviation 2.05
|
1.50 ng/mL
Standard Deviation 0.447
|
3.36 ng/mL
Standard Deviation 1.04
|
SECONDARY outcome
Timeframe: Day 1 and Day 85Population: Pharmacokinetic (PK) Population, defined as all enrolled participants who have evaluable PK data
Renal clearance of nusinersen for participants was assessed in the 12 mg reporting group only, per protocol.
Outcome measures
| Measure |
Nusinersen 3 mg
n=6 Participants
3 mg nusinersen on Days 1, 29, 85, IT injection
|
Nusinersen 6 mg
6 mg nusinersen on Days 1, 29, 85, IT injection
|
Nusinersen 9 mg
9 mg nusinersen on Days 1 and 85, IT injection
|
Nusinersen 12 mg
12 mg nusinersen on Days 1, 29, 85, IT injection
|
|---|---|---|---|---|
|
Urine Pharmacokinetics: Renal Clearance, Cohort 4
Day 1
|
0.674 mL/hr
Standard Deviation 0.602
|
—
|
—
|
—
|
|
Urine Pharmacokinetics: Renal Clearance, Cohort 4
Day 85
|
77.5 mL/hr
Standard Deviation 92.5
|
—
|
—
|
—
|
Adverse Events
Nusinersen 3 mg
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
Nusinersen 6 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Nusinersen 9 mg
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Nusinersen 12 mg
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Nusinersen 3 mg
n=8 participants at risk
3 mg nusinersen on Days 1, 29, 85, IT injection
|
Nusinersen 6 mg
n=8 participants at risk
6 mg nusinersen on Days 1, 29, 85, IT injection
|
Nusinersen 9 mg
n=9 participants at risk
9 mg nusinersen on Days 1 and 85, IT injection
|
Nusinersen 12 mg
n=9 participants at risk
12 mg nusinersen on Days 1, 29, 85, IT injection
|
|---|---|---|---|---|
|
Immune system disorders
Drug hypersensitivity
|
12.5%
1/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
|
Infections and infestations
Pneumonia
|
12.5%
1/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
|
Injury, poisoning and procedural complications
Post lumbar puncture syndrome
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
11.1%
1/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
Other adverse events
| Measure |
Nusinersen 3 mg
n=8 participants at risk
3 mg nusinersen on Days 1, 29, 85, IT injection
|
Nusinersen 6 mg
n=8 participants at risk
6 mg nusinersen on Days 1, 29, 85, IT injection
|
Nusinersen 9 mg
n=9 participants at risk
9 mg nusinersen on Days 1 and 85, IT injection
|
Nusinersen 12 mg
n=9 participants at risk
12 mg nusinersen on Days 1, 29, 85, IT injection
|
|---|---|---|---|---|
|
Cardiac disorders
Palpitations
|
12.5%
1/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
|
Ear and labyrinth disorders
Ear pain
|
12.5%
1/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
11.1%
1/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
|
Eye disorders
Strabismus
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
11.1%
1/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
1/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
12.5%
1/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
22.2%
2/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
22.2%
2/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
22.2%
2/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
22.2%
2/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
|
Gastrointestinal disorders
Nausea
|
25.0%
2/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
22.2%
2/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
11.1%
1/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
|
Gastrointestinal disorders
Diarrhoea
|
12.5%
1/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
11.1%
1/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
11.1%
1/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
|
Gastrointestinal disorders
Lip pain
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
11.1%
1/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
12.5%
1/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
|
General disorders
Puncture site pain
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
37.5%
3/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
33.3%
3/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
22.2%
2/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
|
General disorders
Pyrexia
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
33.3%
3/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
|
General disorders
Fatigue
|
12.5%
1/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
11.1%
1/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
|
General disorders
Catheter site haemorrhage
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
12.5%
1/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
|
General disorders
Catheter site pain
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
11.1%
1/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
|
General disorders
Catheter site related reaction
|
12.5%
1/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
|
General disorders
Chest discomfort
|
12.5%
1/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
|
General disorders
Chills
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
12.5%
1/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
|
General disorders
Feeling cold
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
11.1%
1/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
|
General disorders
Gravitational oedema
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
12.5%
1/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
|
General disorders
Oedema peripheral
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
11.1%
1/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
|
General disorders
Pain
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
12.5%
1/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
|
General disorders
Vessel puncture site haematoma
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
12.5%
1/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
|
Immune system disorders
Hypersensitivity
|
12.5%
1/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
11.1%
1/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
11.1%
1/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
12.5%
1/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
44.4%
4/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
33.3%
3/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
|
Infections and infestations
Upper respiratory tract infection
|
25.0%
2/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
12.5%
1/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
22.2%
2/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
11.1%
1/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
|
Infections and infestations
Pharyngitis streptococcal
|
37.5%
3/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
12.5%
1/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
22.2%
2/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
|
Infections and infestations
Localised infection
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
22.2%
2/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
|
Infections and infestations
Otitis media
|
25.0%
2/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
|
Infections and infestations
Pneumonia
|
12.5%
1/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
12.5%
1/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
11.1%
1/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
|
Infections and infestations
Viral infection
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
12.5%
1/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
11.1%
1/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
|
Infections and infestations
Ear infection
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
11.1%
1/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
|
Infections and infestations
Eye infection staphylococcal
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
11.1%
1/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
11.1%
1/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
|
Infections and infestations
Gastrointestinal viral infection
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
11.1%
1/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
|
Infections and infestations
Impetigo
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
11.1%
1/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
|
Infections and infestations
Influenza
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
11.1%
1/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
12.5%
1/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
|
Infections and infestations
Rhinitis
|
12.5%
1/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
|
Infections and infestations
Skin bacterial infection
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
11.1%
1/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
11.1%
1/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
|
Injury, poisoning and procedural complications
Post lumbar puncture syndrome
|
37.5%
3/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
12.5%
1/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
33.3%
3/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
55.6%
5/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
12.5%
1/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
22.2%
2/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
|
Injury, poisoning and procedural complications
Laceration
|
12.5%
1/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
11.1%
1/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
11.1%
1/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
12.5%
1/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
12.5%
1/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
|
Injury, poisoning and procedural complications
Sunburn
|
12.5%
1/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
11.1%
1/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
|
Injury, poisoning and procedural complications
Torus fracture
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
12.5%
1/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
11.1%
1/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
|
Injury, poisoning and procedural complications
Agitation postoperative
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
11.1%
1/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
11.1%
1/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
|
Injury, poisoning and procedural complications
Limb injury
|
12.5%
1/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
12.5%
1/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
11.1%
1/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
11.1%
1/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
|
Investigations
Blood bicarbonate decreased
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
11.1%
1/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
|
Investigations
Weight decreased
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
11.1%
1/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
11.1%
1/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.5%
1/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
25.0%
2/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
22.2%
2/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
44.4%
4/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
|
Musculoskeletal and connective tissue disorders
Joint contracture
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
12.5%
1/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
11.1%
1/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
11.1%
1/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
12.5%
1/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
11.1%
1/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
11.1%
1/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
12.5%
1/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
11.1%
1/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
12.5%
1/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
11.1%
1/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
11.1%
1/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
|
Musculoskeletal and connective tissue disorders
Pelvic deformity
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
12.5%
1/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
12.5%
1/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
|
Nervous system disorders
Headache
|
50.0%
4/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
25.0%
2/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
11.1%
1/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
11.1%
1/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
|
Nervous system disorders
Dyslexia
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
11.1%
1/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
12.5%
1/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
12.5%
1/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
|
Psychiatric disorders
Agitation
|
12.5%
1/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
11.1%
1/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
|
Psychiatric disorders
Attention deficit/hyperactivity disorder
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
11.1%
1/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
|
Psychiatric disorders
Dysphoria
|
12.5%
1/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
|
Psychiatric disorders
Parasomnia
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
11.1%
1/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
12.5%
1/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
11.1%
1/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
11.1%
1/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
12.5%
1/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
11.1%
1/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
11.1%
1/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
12.5%
1/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
11.1%
1/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
12.5%
1/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
11.1%
1/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
12.5%
1/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Restrictive pulmonary disease
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
12.5%
1/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
12.5%
1/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/8 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
11.1%
1/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
0.00%
0/9 • Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days.
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Our agreement is subject to confidentiality but generally the PI can publish, for noncommercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication.
- Publication restrictions are in place
Restriction type: OTHER