Trial Outcomes & Findings for Dose-Ranging Study of AVI-4658 to Induce Dystrophin Expression in Selected Duchenne Muscular Dystrophy (DMD) Patients (NCT NCT00844597)
NCT ID: NCT00844597
Last Updated: 2015-10-06
Results Overview
Number of subjects with 1 or more Treatment Emergent Adverse Event that are possibly related to the investigational drug
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
19 participants
Primary outcome timeframe
Baseline to 6 months
Results posted on
2015-10-06
Participant Flow
Participant milestones
| Measure |
Cohort 1 - 0.5 mg/kg/wk
Subjects in this group received a 0.5 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60-minute period
|
Cohort 2 - 1.0 mg/kg/wk
Subjects in this group will receive a 1.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60-minute period
|
Cohort 3 - 2.0 mg/kg/wk
Subjects in this group will receive a 2.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60-minute period
|
Cohort 4 - 4.0 mg/kg/wk
Subjects in this group will receive a 4.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60-minute period
|
Cohort 5 - 10.0 mg/kg/wk
Subjects in this group will receive a 10.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60-minute period
|
Cohort 6 - 20.0 mg/kg/wk
Subjects in this group will receive a 20.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60-minute period
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
2
|
2
|
3
|
4
|
4
|
|
Overall Study
COMPLETED
|
4
|
2
|
2
|
2
|
4
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Cohort 1 - 0.5 mg/kg/wk
Subjects in this group received a 0.5 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60-minute period
|
Cohort 2 - 1.0 mg/kg/wk
Subjects in this group will receive a 1.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60-minute period
|
Cohort 3 - 2.0 mg/kg/wk
Subjects in this group will receive a 2.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60-minute period
|
Cohort 4 - 4.0 mg/kg/wk
Subjects in this group will receive a 4.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60-minute period
|
Cohort 5 - 10.0 mg/kg/wk
Subjects in this group will receive a 10.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60-minute period
|
Cohort 6 - 20.0 mg/kg/wk
Subjects in this group will receive a 20.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60-minute period
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Dose-Ranging Study of AVI-4658 to Induce Dystrophin Expression in Selected Duchenne Muscular Dystrophy (DMD) Patients
Baseline characteristics by cohort
| Measure |
Cohort 1 - 0.5mg/kg/wk
n=4 Participants
Subjects in this group received a 0.5 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60-minute period
|
Cohort 2 - 1.0mg/kg/wk
n=2 Participants
Subjects in this group received a 1.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60-minute period
|
Cohort 3 - 2.0mg/kg/wk
n=2 Participants
Subjects in this group received a 2.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60-minute period
|
Cohort 4 - 4.0mg/kg/wk
n=3 Participants
Subjects in this group received a 4.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60-minute period
|
Cohort 5 - 10.0mg/kg/wk
n=4 Participants
Subjects in this group received a 10.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60-minute period
|
Cohort 6 - 20.0mg/kg/wk
n=4 Participants
Subjects in this group received a 20.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60-minute period
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
8.3 years
STANDARD_DEVIATION 0.50 • n=99 Participants
|
6.0 years
STANDARD_DEVIATION 0.0 • n=107 Participants
|
11.0 years
STANDARD_DEVIATION 2.83 • n=206 Participants
|
9.7 years
STANDARD_DEVIATION 0.58 • n=7 Participants
|
8.8 years
STANDARD_DEVIATION 2.75 • n=31 Participants
|
8.8 years
STANDARD_DEVIATION 1.26 • n=30 Participants
|
8.7 years
STANDARD_DEVIATION 1.91 • n=3 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
4 Participants
n=30 Participants
|
19 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
4 Participants
n=30 Participants
|
19 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
4 Participants
n=30 Participants
|
18 Participants
n=3 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Body Weight
|
33 kilograms
STANDARD_DEVIATION 4.09 • n=99 Participants
|
23.7 kilograms
STANDARD_DEVIATION 3.46 • n=107 Participants
|
42.6 kilograms
STANDARD_DEVIATION 6.36 • n=206 Participants
|
40.1 kilograms
STANDARD_DEVIATION 19.00 • n=7 Participants
|
34.6 kilograms
STANDARD_DEVIATION 14.01 • n=31 Participants
|
33.0 kilograms
STANDARD_DEVIATION 8.71 • n=30 Participants
|
34.5 kilograms
STANDARD_DEVIATION 10.84 • n=3 Participants
|
|
Height
|
127.3 centimeters
STANDARD_DEVIATION 5.05 • n=99 Participants
|
110.7 centimeters
STANDARD_DEVIATION 4.45 • n=107 Participants
|
126.9 centimeters
STANDARD_DEVIATION 5.09 • n=206 Participants
|
126.9 centimeters
STANDARD_DEVIATION 14.40 • n=7 Participants
|
123.7 centimeters
STANDARD_DEVIATION 10.04 • n=31 Participants
|
126.5 centimeters
STANDARD_DEVIATION 7.18 • n=30 Participants
|
124.5 centimeters
STANDARD_DEVIATION 8.99 • n=3 Participants
|
PRIMARY outcome
Timeframe: Baseline to 6 monthsPopulation: Safety Population - Any patient who received at least one dose of the study drug.
Number of subjects with 1 or more Treatment Emergent Adverse Event that are possibly related to the investigational drug
Outcome measures
| Measure |
Open Label Treatment Arm
n=19 Participants
AVI-4658 for Injection: AVI-4658 for Injection, is packaged as 100 mg/mL in phosphate buffered saline with 1 mL per vial. Study dosages will be infused over a 1 hour period with Normal saline as follows:
Cohort 1: 0.5mg/kg once weekly for 12 weeks; Cohort 2: 1.0mg/kg once weekly for 12 weeks; Cohort 3: 2.0mg/kg once weekly for 12 weeks; Cohort 4: 4.0mg/kg once weekly for 12 weeks; Cohort 5: 10.0mg/kg once weekly for 12 weeks; Cohort 6: 20.0mg/kg once weekly for 12 weeks
|
Cohort 2 - 1.0 mg/kg/wk
Subjects in this group received a 1.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period
|
Cohort 3 - 2.0 mg/kg/wk
Subjects in this group received a 2.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period
|
Cohort 4 - 4.0 mg/kg/wk
Subjects in this group received a 4.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period
|
Cohort 5 - 10.0 mg/kg/wk
Subjects in this group received a 10.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period
|
Cohort 6 - 20.0 mg/kg/wk
Subjects in this group received a 20.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period
|
|---|---|---|---|---|---|---|
|
Safety and Tolerability
|
14 participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: from Baseline to Follow up (27 weeks)Population: Safety Population
Number of Patients with Treatment Emergent Adverse Events
Outcome measures
| Measure |
Open Label Treatment Arm
n=19 Participants
AVI-4658 for Injection: AVI-4658 for Injection, is packaged as 100 mg/mL in phosphate buffered saline with 1 mL per vial. Study dosages will be infused over a 1 hour period with Normal saline as follows:
Cohort 1: 0.5mg/kg once weekly for 12 weeks; Cohort 2: 1.0mg/kg once weekly for 12 weeks; Cohort 3: 2.0mg/kg once weekly for 12 weeks; Cohort 4: 4.0mg/kg once weekly for 12 weeks; Cohort 5: 10.0mg/kg once weekly for 12 weeks; Cohort 6: 20.0mg/kg once weekly for 12 weeks
|
Cohort 2 - 1.0 mg/kg/wk
Subjects in this group received a 1.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period
|
Cohort 3 - 2.0 mg/kg/wk
Subjects in this group received a 2.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period
|
Cohort 4 - 4.0 mg/kg/wk
Subjects in this group received a 4.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period
|
Cohort 5 - 10.0 mg/kg/wk
Subjects in this group received a 10.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period
|
Cohort 6 - 20.0 mg/kg/wk
Subjects in this group received a 20.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period
|
|---|---|---|---|---|---|---|
|
Treatment Emergent Adverse Events
|
19 participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Samples were taken: 30 minutes pre dose; and at 5 (±1), 15 (±2), 30 (±5), 60 (±5), and 90 (±5) minutes; and 2, 4, 6, 8, 12, and 24 hours (all ± 15 minutes) post dose at Weeks 1, 6, and 12Population: PK Evaluable Population: Included all patients who provided at least 1 PK sample. The reportable PK population included those patients with at least Cmax, Tmax, and AUC0-24 computed from 1 or more of the 3 sampling days (1st, 6th, 12th dose \[Weeks 1, 6, and 12\]).
Standard Pharmacokinetic parameters estimated using non-compartmental modeling of plasma concentration data.
Outcome measures
| Measure |
Open Label Treatment Arm
n=19 Participants
AVI-4658 for Injection: AVI-4658 for Injection, is packaged as 100 mg/mL in phosphate buffered saline with 1 mL per vial. Study dosages will be infused over a 1 hour period with Normal saline as follows:
Cohort 1: 0.5mg/kg once weekly for 12 weeks; Cohort 2: 1.0mg/kg once weekly for 12 weeks; Cohort 3: 2.0mg/kg once weekly for 12 weeks; Cohort 4: 4.0mg/kg once weekly for 12 weeks; Cohort 5: 10.0mg/kg once weekly for 12 weeks; Cohort 6: 20.0mg/kg once weekly for 12 weeks
|
Cohort 2 - 1.0 mg/kg/wk
Subjects in this group received a 1.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period
|
Cohort 3 - 2.0 mg/kg/wk
Subjects in this group received a 2.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period
|
Cohort 4 - 4.0 mg/kg/wk
Subjects in this group received a 4.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period
|
Cohort 5 - 10.0 mg/kg/wk
Subjects in this group received a 10.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period
|
Cohort 6 - 20.0 mg/kg/wk
Subjects in this group received a 20.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period
|
|---|---|---|---|---|---|---|
|
Pharmacokinetics - Mean Peak Plasma Concentration of AVI-4658 After Administration
|
39000 ng/mL
Standard Deviation 16900
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Biopsies were taken at Baseline and Week 14Population: Per Protocol Population - Included all patients who received all 12 doses of study treatment.
Efficacy was defined as an estimated change in the percentage of dystrophin positive fibers (assessed by IHC) at Week 14 from Baseline after 12 weekly doses of eterplirsen. This outcome measure represents the number of patients to show an increase in the percentage of dystrophin-positive fibers.
Outcome measures
| Measure |
Open Label Treatment Arm
n=17 Participants
AVI-4658 for Injection: AVI-4658 for Injection, is packaged as 100 mg/mL in phosphate buffered saline with 1 mL per vial. Study dosages will be infused over a 1 hour period with Normal saline as follows:
Cohort 1: 0.5mg/kg once weekly for 12 weeks; Cohort 2: 1.0mg/kg once weekly for 12 weeks; Cohort 3: 2.0mg/kg once weekly for 12 weeks; Cohort 4: 4.0mg/kg once weekly for 12 weeks; Cohort 5: 10.0mg/kg once weekly for 12 weeks; Cohort 6: 20.0mg/kg once weekly for 12 weeks
|
Cohort 2 - 1.0 mg/kg/wk
Subjects in this group received a 1.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period
|
Cohort 3 - 2.0 mg/kg/wk
Subjects in this group received a 2.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period
|
Cohort 4 - 4.0 mg/kg/wk
Subjects in this group received a 4.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period
|
Cohort 5 - 10.0 mg/kg/wk
Subjects in this group received a 10.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period
|
Cohort 6 - 20.0 mg/kg/wk
Subjects in this group received a 20.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period
|
|---|---|---|---|---|---|---|
|
Efficacy of Eteplirsen Over 12 Weeks of Dosing
|
11 participants
|
—
|
—
|
—
|
—
|
—
|
POST_HOC outcome
Timeframe: 27 WeeksPopulation: Safety Population
Adverse events that occurred in \>15% of overall patient population across dose level arms.
Outcome measures
| Measure |
Open Label Treatment Arm
n=4 Participants
AVI-4658 for Injection: AVI-4658 for Injection, is packaged as 100 mg/mL in phosphate buffered saline with 1 mL per vial. Study dosages will be infused over a 1 hour period with Normal saline as follows:
Cohort 1: 0.5mg/kg once weekly for 12 weeks; Cohort 2: 1.0mg/kg once weekly for 12 weeks; Cohort 3: 2.0mg/kg once weekly for 12 weeks; Cohort 4: 4.0mg/kg once weekly for 12 weeks; Cohort 5: 10.0mg/kg once weekly for 12 weeks; Cohort 6: 20.0mg/kg once weekly for 12 weeks
|
Cohort 2 - 1.0 mg/kg/wk
n=2 Participants
Subjects in this group received a 1.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period
|
Cohort 3 - 2.0 mg/kg/wk
n=2 Participants
Subjects in this group received a 2.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period
|
Cohort 4 - 4.0 mg/kg/wk
n=3 Participants
Subjects in this group received a 4.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period
|
Cohort 5 - 10.0 mg/kg/wk
n=4 Participants
Subjects in this group received a 10.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period
|
Cohort 6 - 20.0 mg/kg/wk
n=4 Participants
Subjects in this group received a 20.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period
|
|---|---|---|---|---|---|---|
|
Adverse Events >15%
Nausea
|
0 Events
|
0 Events
|
1 Events
|
1 Events
|
0 Events
|
1 Events
|
|
Adverse Events >15%
Vomiting
|
0 Events
|
0 Events
|
1 Events
|
1 Events
|
1 Events
|
0 Events
|
|
Adverse Events >15%
Upper respiratory tract infection
|
2 Events
|
1 Events
|
0 Events
|
1 Events
|
2 Events
|
2 Events
|
|
Adverse Events >15%
Myalgia
|
1 Events
|
1 Events
|
1 Events
|
0 Events
|
1 Events
|
0 Events
|
|
Adverse Events >15%
Dizziness
|
0 Events
|
0 Events
|
1 Events
|
1 Events
|
0 Events
|
1 Events
|
|
Adverse Events >15%
Headache
|
2 Events
|
1 Events
|
2 Events
|
0 Events
|
2 Events
|
1 Events
|
|
Adverse Events >15%
Cardiomyopathy
|
0 Events
|
0 Events
|
0 Events
|
1 Events
|
0 Events
|
2 Events
|
|
Adverse Events >15%
Tachycardia
|
0 Events
|
0 Events
|
0 Events
|
1 Events
|
0 Events
|
2 Events
|
|
Adverse Events >15%
Abdominal Pain
|
0 Events
|
1 Events
|
0 Events
|
1 Events
|
1 Events
|
0 Events
|
|
Adverse Events >15%
Influenza like illness
|
0 Events
|
0 Events
|
2 Events
|
0 Events
|
1 Events
|
0 Events
|
|
Adverse Events >15%
Rhinitis
|
1 Events
|
0 Events
|
0 Events
|
1 Events
|
4 Events
|
1 Events
|
|
Adverse Events >15%
Fall
|
2 Events
|
0 Events
|
0 Events
|
2 Events
|
0 Events
|
1 Events
|
|
Adverse Events >15%
Arthralgia
|
1 Events
|
0 Events
|
1 Events
|
1 Events
|
0 Events
|
0 Events
|
|
Adverse Events >15%
Back Pain
|
1 Events
|
0 Events
|
1 Events
|
2 Events
|
2 Events
|
1 Events
|
Adverse Events
Cohort 1 - 0.5 mg/kg/wk
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 2 - 1.0 mg/kg/wk
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 3 - 2.0 mg/kg/wk
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 4 - 4.0 mg/kg/wk
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 5 - 10.0 mg/kg/wk
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 6 - 20.0 mg/kg/wk
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1 - 0.5 mg/kg/wk
n=4 participants at risk
Subjects in this group received a 0.5 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period
|
Cohort 2 - 1.0 mg/kg/wk
n=2 participants at risk
Subjects in this group received a 1.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period
|
Cohort 3 - 2.0 mg/kg/wk
n=2 participants at risk
Subjects in this group received a 2.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period
|
Cohort 4 - 4.0 mg/kg/wk
n=3 participants at risk
Subjects in this group received a 4.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period
|
Cohort 5 - 10.0 mg/kg/wk
n=4 participants at risk
Subjects in this group received a 10.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period
|
Cohort 6 - 20.0 mg/kg/wk
n=4 participants at risk
Subjects in this group received a 20.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Post-Operative Nausea and Vomiting
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
50.0%
1/2 • Number of events 1 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/3 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
|
Musculoskeletal and connective tissue disorders
Fracture of Left Medial Malleolus
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
33.3%
1/3 • Number of events 1 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
Other adverse events
| Measure |
Cohort 1 - 0.5 mg/kg/wk
n=4 participants at risk
Subjects in this group received a 0.5 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period
|
Cohort 2 - 1.0 mg/kg/wk
n=2 participants at risk
Subjects in this group received a 1.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period
|
Cohort 3 - 2.0 mg/kg/wk
n=2 participants at risk
Subjects in this group received a 2.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period
|
Cohort 4 - 4.0 mg/kg/wk
n=3 participants at risk
Subjects in this group received a 4.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period
|
Cohort 5 - 10.0 mg/kg/wk
n=4 participants at risk
Subjects in this group received a 10.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period
|
Cohort 6 - 20.0 mg/kg/wk
n=4 participants at risk
Subjects in this group received a 20.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Rhinitis
|
25.0%
1/4 • Number of events 1 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
33.3%
1/3 • Number of events 1 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
100.0%
4/4 • Number of events 4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
25.0%
1/4 • Number of events 1 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
|
Infections and infestations
Upper respiratory tract infection
|
50.0%
2/4 • Number of events 2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
50.0%
1/2 • Number of events 1 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
33.3%
1/3 • Number of events 1 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
50.0%
2/4 • Number of events 2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
50.0%
2/4 • Number of events 2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
|
Injury, poisoning and procedural complications
Fall
|
50.0%
2/4 • Number of events 2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
66.7%
2/3 • Number of events 2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
25.0%
1/4 • Number of events 1 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.0%
1/4 • Number of events 1 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
50.0%
1/2 • Number of events 1 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
66.7%
2/3 • Number of events 2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
50.0%
2/4 • Number of events 2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
25.0%
1/4 • Number of events 1 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
25.0%
1/4 • Number of events 1 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
50.0%
1/2 • Number of events 1 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
50.0%
1/2 • Number of events 1 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/3 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
25.0%
1/4 • Number of events 1 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
|
Nervous system disorders
Headache
|
50.0%
2/4 • Number of events 2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
50.0%
1/2 • Number of events 1 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
100.0%
2/2 • Number of events 2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/3 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
50.0%
2/4 • Number of events 2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
25.0%
1/4 • Number of events 1 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
33.3%
1/3 • Number of events 1 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
50.0%
2/4 • Number of events 2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
50.0%
1/2 • Number of events 1 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
33.3%
1/3 • Number of events 1 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
25.0%
1/4 • Number of events 1 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
50.0%
1/2 • Number of events 1 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
33.3%
1/3 • Number of events 1 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
25.0%
1/4 • Number of events 1 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
|
General disorders
Influenza like illness
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
100.0%
2/2 • Number of events 2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/3 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
25.0%
1/4 • Number of events 1 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
25.0%
1/4 • Number of events 1 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
50.0%
1/2 • Number of events 1 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
33.3%
1/3 • Number of events 1 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
50.0%
1/2 • Number of events 1 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
33.3%
1/3 • Number of events 1 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
25.0%
1/4 • Number of events 1 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
|
Blood and lymphatic system disorders
Platelet anisocytosis
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
33.3%
1/3 • Number of events 1 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
33.3%
1/3 • Number of events 1 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
33.3%
1/3 • Number of events 1 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
|
Ear and labyrinth disorders
Ear Pain
|
25.0%
1/4 • Number of events 1 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/3 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
50.0%
1/2 • Number of events 1 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
33.3%
1/3 • Number of events 1 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
25.0%
1/4 • Number of events 1 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
|
Gastrointestinal disorders
Abdominal pain - Upper
|
25.0%
1/4 • Number of events 1 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
50.0%
1/2 • Number of events 1 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/3 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
|
Gastrointestinal disorders
Constipation
|
25.0%
1/4 • Number of events 1 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/3 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
33.3%
1/3 • Number of events 1 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
50.0%
1/2 • Number of events 1 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/3 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
|
Gastrointestinal disorders
Lip dry
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/3 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
25.0%
1/4 • Number of events 1 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
|
General disorders
Abasia
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/3 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
25.0%
1/4 • Number of events 1 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
|
General disorders
Application site rash
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/3 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
25.0%
1/4 • Number of events 1 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
|
General disorders
Catheter Site Pain
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/3 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
25.0%
1/4 • Number of events 1 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
|
General disorders
Disease progression
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/3 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
25.0%
1/4 • Number of events 1 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
25.0%
1/4 • Number of events 1 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
|
General disorders
Fatigue
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
50.0%
1/2 • Number of events 1 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/3 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
25.0%
1/4 • Number of events 1 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
|
General disorders
Infusion related reaction
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/3 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
25.0%
1/4 • Number of events 1 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
|
General disorders
Pyrexia
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
33.3%
1/3 • Number of events 1 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
|
General disorders
Vaccination site pain
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/3 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
25.0%
1/4 • Number of events 1 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
|
General disorders
Vessel puncture site haematoma
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
50.0%
1/2 • Number of events 1 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
33.3%
1/3 • Number of events 1 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
|
Infections and infestations
Bronchitis
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
50.0%
1/2 • Number of events 1 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/3 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
25.0%
1/4 • Number of events 1 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
|
Infections and infestations
Hordeolum
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
50.0%
1/2 • Number of events 1 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/3 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
|
Infections and infestations
Incision site infection
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/3 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
25.0%
1/4 • Number of events 1 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/3 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
25.0%
1/4 • Number of events 1 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
50.0%
1/2 • Number of events 1 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/3 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
|
Infections and infestations
Tinea infection
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
50.0%
1/2 • Number of events 1 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/3 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
|
Infections and infestations
Viral Infection
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
50.0%
1/2 • Number of events 1 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/3 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
25.0%
1/4 • Number of events 1 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
|
Injury, poisoning and procedural complications
Ankle Fracture
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
33.3%
1/3 • Number of events 1 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
50.0%
1/2 • Number of events 1 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/3 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
25.0%
1/4 • Number of events 1 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/3 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
33.3%
1/3 • Number of events 1 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/3 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
25.0%
1/4 • Number of events 1 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
|
Injury, poisoning and procedural complications
Head Injury
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
33.3%
1/3 • Number of events 1 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
|
Injury, poisoning and procedural complications
Heat Stroke
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
50.0%
1/2 • Number of events 1 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/3 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
33.3%
1/3 • Number of events 1 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
25.0%
1/4 • Number of events 1 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
33.3%
1/3 • Number of events 1 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
50.0%
2/4 • Number of events 2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/3 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
|
Injury, poisoning and procedural complications
Vaccination complication
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
33.3%
1/3 • Number of events 1 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
|
Metabolism and nutrition disorders
Decreased appetitie
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
33.3%
1/3 • Number of events 1 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
|
Musculoskeletal and connective tissue disorders
Coccydynia
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
33.3%
1/3 • Number of events 1 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
25.0%
1/4 • Number of events 1 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/3 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
25.0%
1/4 • Number of events 1 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/3 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
25.0%
1/4 • Number of events 1 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/3 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
25.0%
1/4 • Number of events 1 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
|
Renal and urinary disorders
Enuresis
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/3 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
25.0%
1/4 • Number of events 1 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
50.0%
1/2 • Number of events 1 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/3 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
50.0%
2/4 • Number of events 2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/3 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/3 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
25.0%
1/4 • Number of events 1 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/3 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
25.0%
1/4 • Number of events 1 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/3 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
25.0%
1/4 • Number of events 1 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
25.0%
1/4 • Number of events 1 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/3 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
|
Vascular disorders
Haematoma
|
25.0%
1/4 • Number of events 1 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/3 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
25.0%
1/4 • Number of events 1 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
|
Vascular disorders
Pallor
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/2 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
50.0%
1/2 • Number of events 1 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/3 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
0.00%
0/4 • Adverse Event data for this study was collected from Baseline to Follow-up (27 Weeks)
|
Additional Information
Edward M. Kaye, MD, Interim CEO, SVP & Chief Medical Officer
Sarepta Therapeutics
Phone: 617-274-4003
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The PI required written permission to publish any information relating to the trial and if given permission to acknowledge the sponsor's contribution and ownership of the materials.
- Publication restrictions are in place
Restriction type: OTHER