Trial Outcomes & Findings for Study to Investigate the Effect of BL-8040 (Motixafortide) on the QTc Interval in Healthy Subjects (NCT NCT05293171)
NCT ID: NCT05293171
Last Updated: 2025-03-21
Results Overview
Assessment of the QTc effects of motixafortide 1.25 mg/kg and 2 mg/kg following a single SC injection relative to placebo in healthy subjects by evaluation of the relationship between the plasma concentration of motixafortide and ΔΔQTcI (change from baseline in QTcI)
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
38 participants
Primary outcome timeframe
Cardiodynamic ECG recordings on Day 1 (day of dosing) at different time points prior to dosing and up to 24 hours post-dose in each period (each period is 24 hours long, a total of 4 periods)
Results posted on
2025-03-21
Participant Flow
38 healthy, adult male and female subjects were enrolled in study. The subjects were randomly assigned to 8 different treatment sequences comprising motixafortide (BL-8040) 1.25 mg/kg, motixafortide 2 mg/kg, placebo for motixafortide and moxifloxacin 400 mg in a crossover design. 3 subjects early discontinued the study and did not receive all four treatments, 35 subjects completed the study per protocol and received all four treatments.
Participant milestones
| Measure |
ABCD: 1.25 mg/kg Motixafortide, 2 mg/kg Motixafortide, Placebo, Moxifloxacin
1.25 mg/kg motixafortide + motixafortide-matching placebo administered via SC injection (A) \>\> 2 mg/kg motixafortide administered via SC injection (B) \>\> motixafortide-matching placebo administered via SC injection (C) \>\> 400 mg moxifloxacin administered orally (D)
|
BDAC: 2 mg/kg Motixafortide, Moxifloxacin, 1.25 mg/kg Motixafortide, Placebo
2 mg/kg motixafortide administered via SC injection (B) \>\> 400 mg moxifloxacin administered orally (D) \>\> 1.25 mg/kg motixafortide + motixafortide-matching placebo administered via SC injection (A) \>\> motixafortide-matching placebo administered via SC injection (C)
|
CADB: Placebo, 1.25 mg/kg Motixafortide, Moxifloxacin, 2 mg/kg Motixafortide
Motixafortide-matching placebo administered via SC injection (C) \>\> 1.25 mg/kg motixafortide + motixafortide-matching placebo administered via SC injection (A) \>\> 400 mg moxifloxacin administered orally (D) \>\> 2 mg/kg motixafortide administered via SC injection (B)
|
DCBA: Moxifloxacin, Placebo, 2 mg/kg Motixafortide, 1.25 mg/kg Motixafortide
400 mg moxifloxacin administered orally (D) \>\> motixafortide-matching placebo administered via SC injection (C) \>\> 2 mg/kg motixafortide administered via SC injection (B), 1.25 mg/kg motixafortide + motixafortide-matching placebo administered via SC injection (A)
|
BCAD: 2 mg/kg Motixafortide, Placebo, 1.25 mg/kg Motixafortide, Moxifloxacin
2 mg/kg motixafortide administered via SC injection (B) \>\> motixafortide-matching placebo administered via SC injection (C) \>\> 1.25 mg/kg motixafortide + motixafortide-matching placebo administered via SC injection (A) \>\> 400 mg moxifloxacin administered orally (D)
|
CDBA: Placebo, Moxifloxacin, 2 mg/kg Motixafortide, 1.25 mg/kg Motixafortide
Motixafortide-matching placebo administered via SC injection (C) \>\> 400 mg moxifloxacin administered orally (D) \>\> 2 mg/kg motixafortide administered via SC injection (B) \>\> 1.25 mg/kg motixafortide + motixafortide-matching placebo administered via SC injection (A)
|
ABDC: 1.25 mg/kg Motixafortide, 2 mg/kg Motixafortide, Moxifloxacin, Placebo
1.25 mg/kg motixafortide + motixafortide-matching placebo administered via SC injection (A) \>\> 2 mg/kg motixafortide administered via SC injection (B) \>\> 400 mg moxifloxacin administered orally (D) \>\> motixafortide-matching placebo administered via SC injection (C)
|
DACB: Moxifloxacin, 1.25 mg/kg Motixafortide, Placebo, 2 mg/kg Motixafortide
400 mg moxifloxacin administered orally (D) \>\> 1.25 mg/kg motixafortide + motixafortide-matching placebo administered via SC injection (A) \>\> motixafortide-matching placebo administered via SC injection (C) \>\> 2 mg/kg motixafortide administered via SC injection (B)
|
CABD: Placebo, 1.25 mg/kg Motixafortide, 2 mg/kg Motixafortide, Moxifloxacin
Motixafortide-matching placebo administered via SC injection (C) \>\> 1.25 mg/kg motixafortide + motixafortide-matching placebo administered via SC injection (A) \>\> 2 mg/kg motixafortide administered via SC injection (B) \>\> 400 mg moxifloxacin administered orally (D)
|
ADCB: 1.25 mg/kg Motixafortide, Moxifloxacin, Placebo, 2 mg/kg Motixafortide
1.25 mg/kg motixafortide + motixafortide-matching placebo administered via SC injection (A) \>\> 400 mg moxifloxacin administered orally (D) \>\> motixafortide-matching placebo administered via SC injection (C) \>\> 2 mg/kg motixafortide administered via SC injection (B)
|
BCDA: 2 mg/kg Motixafortide, Placebo, Moxifloxacin, 1.25 mg/kg Motixafortide
2 mg/kg motixafortide administered via SC injection (B) \>\> motixafortide-matching placebo administered via SC injection (C) \>\> 400 mg moxifloxacin administered orally (D) \>\> 1.25 mg/kg motixafortide + motixafortide-matching placebo administered via SC injection (A)
|
DBAC: Moxifloxacin, 2 mg/kg Motixafortide, 1.25 mg/kg Motixafortide, Placebo
400 mg moxifloxacin administered orally (D) \>\> 2 mg/kg motixafortide administered via SC injection (B) \>\> 1.25 mg/kg motixafortide + motixafortide-matching placebo administered via SC injection (A) \>\> motixafortide-matching placebo administered via SC injection (C)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Washout 5 to 7 Days
COMPLETED
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2
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2
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3
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3
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3
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2
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3
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3
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3
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4
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3
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4
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Washout 5 to 7 Days
NOT COMPLETED
|
0
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0
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0
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0
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0
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1
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0
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0
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0
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0
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0
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0
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Period 2 - Second Dosing
STARTED
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3
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3
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3
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3
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3
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3
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4
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3
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4
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Period 1 - First Dosing
STARTED
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3
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3
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3
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3
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3
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3
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3
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3
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3
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4
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3
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4
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Period 1 - First Dosing
COMPLETED
|
3
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3
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3
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3
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3
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3
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3
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3
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3
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4
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3
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4
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Period 1 - First Dosing
NOT COMPLETED
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Washout 5 to 7 Days
STARTED
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2
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2
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3
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3
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3
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3
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3
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3
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3
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4
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4
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Period 2 - Second Dosing
COMPLETED
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2
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2
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3
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3
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3
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3
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3
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3
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3
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4
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3
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4
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Period 2 - Second Dosing
NOT COMPLETED
|
0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Period 3 - Third Dosing
STARTED
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2
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2
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3
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3
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3
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3
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3
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3
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3
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4
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3
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4
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Period 3 - Third Dosing
COMPLETED
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2
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2
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3
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3
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3
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3
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3
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3
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3
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4
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3
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4
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Period 3 - Third Dosing
NOT COMPLETED
|
0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Period 4 - Forth Dosing
STARTED
|
2
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2
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3
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3
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3
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2
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3
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3
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3
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4
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3
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4
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Period 4 - Forth Dosing
COMPLETED
|
2
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2
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3
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3
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3
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2
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3
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3
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3
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4
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3
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4
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|
Period 4 - Forth Dosing
NOT COMPLETED
|
0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Reasons for withdrawal
| Measure |
ABCD: 1.25 mg/kg Motixafortide, 2 mg/kg Motixafortide, Placebo, Moxifloxacin
1.25 mg/kg motixafortide + motixafortide-matching placebo administered via SC injection (A) \>\> 2 mg/kg motixafortide administered via SC injection (B) \>\> motixafortide-matching placebo administered via SC injection (C) \>\> 400 mg moxifloxacin administered orally (D)
|
BDAC: 2 mg/kg Motixafortide, Moxifloxacin, 1.25 mg/kg Motixafortide, Placebo
2 mg/kg motixafortide administered via SC injection (B) \>\> 400 mg moxifloxacin administered orally (D) \>\> 1.25 mg/kg motixafortide + motixafortide-matching placebo administered via SC injection (A) \>\> motixafortide-matching placebo administered via SC injection (C)
|
CADB: Placebo, 1.25 mg/kg Motixafortide, Moxifloxacin, 2 mg/kg Motixafortide
Motixafortide-matching placebo administered via SC injection (C) \>\> 1.25 mg/kg motixafortide + motixafortide-matching placebo administered via SC injection (A) \>\> 400 mg moxifloxacin administered orally (D) \>\> 2 mg/kg motixafortide administered via SC injection (B)
|
DCBA: Moxifloxacin, Placebo, 2 mg/kg Motixafortide, 1.25 mg/kg Motixafortide
400 mg moxifloxacin administered orally (D) \>\> motixafortide-matching placebo administered via SC injection (C) \>\> 2 mg/kg motixafortide administered via SC injection (B), 1.25 mg/kg motixafortide + motixafortide-matching placebo administered via SC injection (A)
|
BCAD: 2 mg/kg Motixafortide, Placebo, 1.25 mg/kg Motixafortide, Moxifloxacin
2 mg/kg motixafortide administered via SC injection (B) \>\> motixafortide-matching placebo administered via SC injection (C) \>\> 1.25 mg/kg motixafortide + motixafortide-matching placebo administered via SC injection (A) \>\> 400 mg moxifloxacin administered orally (D)
|
CDBA: Placebo, Moxifloxacin, 2 mg/kg Motixafortide, 1.25 mg/kg Motixafortide
Motixafortide-matching placebo administered via SC injection (C) \>\> 400 mg moxifloxacin administered orally (D) \>\> 2 mg/kg motixafortide administered via SC injection (B) \>\> 1.25 mg/kg motixafortide + motixafortide-matching placebo administered via SC injection (A)
|
ABDC: 1.25 mg/kg Motixafortide, 2 mg/kg Motixafortide, Moxifloxacin, Placebo
1.25 mg/kg motixafortide + motixafortide-matching placebo administered via SC injection (A) \>\> 2 mg/kg motixafortide administered via SC injection (B) \>\> 400 mg moxifloxacin administered orally (D) \>\> motixafortide-matching placebo administered via SC injection (C)
|
DACB: Moxifloxacin, 1.25 mg/kg Motixafortide, Placebo, 2 mg/kg Motixafortide
400 mg moxifloxacin administered orally (D) \>\> 1.25 mg/kg motixafortide + motixafortide-matching placebo administered via SC injection (A) \>\> motixafortide-matching placebo administered via SC injection (C) \>\> 2 mg/kg motixafortide administered via SC injection (B)
|
CABD: Placebo, 1.25 mg/kg Motixafortide, 2 mg/kg Motixafortide, Moxifloxacin
Motixafortide-matching placebo administered via SC injection (C) \>\> 1.25 mg/kg motixafortide + motixafortide-matching placebo administered via SC injection (A) \>\> 2 mg/kg motixafortide administered via SC injection (B) \>\> 400 mg moxifloxacin administered orally (D)
|
ADCB: 1.25 mg/kg Motixafortide, Moxifloxacin, Placebo, 2 mg/kg Motixafortide
1.25 mg/kg motixafortide + motixafortide-matching placebo administered via SC injection (A) \>\> 400 mg moxifloxacin administered orally (D) \>\> motixafortide-matching placebo administered via SC injection (C) \>\> 2 mg/kg motixafortide administered via SC injection (B)
|
BCDA: 2 mg/kg Motixafortide, Placebo, Moxifloxacin, 1.25 mg/kg Motixafortide
2 mg/kg motixafortide administered via SC injection (B) \>\> motixafortide-matching placebo administered via SC injection (C) \>\> 400 mg moxifloxacin administered orally (D) \>\> 1.25 mg/kg motixafortide + motixafortide-matching placebo administered via SC injection (A)
|
DBAC: Moxifloxacin, 2 mg/kg Motixafortide, 1.25 mg/kg Motixafortide, Placebo
400 mg moxifloxacin administered orally (D) \>\> 2 mg/kg motixafortide administered via SC injection (B) \>\> 1.25 mg/kg motixafortide + motixafortide-matching placebo administered via SC injection (A) \>\> motixafortide-matching placebo administered via SC injection (C)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Washout 5 to 7 Days
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Study to Investigate the Effect of BL-8040 (Motixafortide) on the QTc Interval in Healthy Subjects
Baseline characteristics by cohort
| Measure |
All Subjects
n=38 Participants
All subjects who have received at least one of the four treatments (motixafortide 1.25 mg/kg, motixafortide 2 mg/kg, placebo for motixafortide and moxifloxacin)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
38 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
35.9 years
STANDARD_DEVIATION 7.66 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
35 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
38 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Cardiodynamic ECG recordings on Day 1 (day of dosing) at different time points prior to dosing and up to 24 hours post-dose in each period (each period is 24 hours long, a total of 4 periods)Population: The analysis population is QT/QTc Population
Assessment of the QTc effects of motixafortide 1.25 mg/kg and 2 mg/kg following a single SC injection relative to placebo in healthy subjects by evaluation of the relationship between the plasma concentration of motixafortide and ΔΔQTcI (change from baseline in QTcI)
Outcome measures
| Measure |
1.25 mg/kg Motixafortide (Therapeutic)
n=34 Participants
1.25 mg/kg motixafortide administered via SC injection (Therapeutic)
|
2 mg/kg Motixafortide (Supratherapeutic)
n=36 Participants
2 mg/kg motixafortide administered via SC injection (Supratherapeutic)
|
Placebo
n=34 Participants
Placebo for motixafortide
|
Moxifloxacin
n=36 Participants
Moxifloxacin 400 mg administered Orally
|
400 mg Moxifloxacin
Treatment 400 mg moxifloxacin administered orally 36 subjects out of the 38 enrolled in the study received moxifloxacine 400mg
|
|---|---|---|---|---|---|
|
QTc Effect of Single Subcutaneous (SC) Injections of Motixafortide (BL-8040) 1.25 mg/kg and 2 mg/kg
6 hrs Post-dose
|
-7.2 ms
Interval -10.12 to -4.28
|
-9.0 ms
Interval -11.08 to -6.97
|
-5.5 ms
Interval -7.78 to -3.15
|
2.5 ms
Interval 0.32 to 4.65
|
—
|
|
QTc Effect of Single Subcutaneous (SC) Injections of Motixafortide (BL-8040) 1.25 mg/kg and 2 mg/kg
8 hrs Post-dose
|
-3.8 ms
Interval -6.52 to -1.15
|
-6.5 ms
Interval -8.42 to -4.49
|
-3.5 ms
Interval -5.39 to -1.68
|
5.7 ms
Interval 3.65 to 7.75
|
—
|
|
QTc Effect of Single Subcutaneous (SC) Injections of Motixafortide (BL-8040) 1.25 mg/kg and 2 mg/kg
0.25 hr Post-dose
|
-0.6 ms
Interval -2.29 to 1.04
|
1.1 ms
Interval -1.6 to 3.78
|
-3.0 ms
Interval -4.02 to -1.95
|
-1.1 ms
Interval -2.34 to 0.23
|
—
|
|
QTc Effect of Single Subcutaneous (SC) Injections of Motixafortide (BL-8040) 1.25 mg/kg and 2 mg/kg
0.5 hr Post-dose
|
4.0 ms
Interval 1.92 to 6.0
|
7.8 ms
Interval 4.98 to 10.68
|
-1.4 ms
Interval -2.31 to -0.49
|
2.7 ms
Interval 0.65 to 4.74
|
—
|
|
QTc Effect of Single Subcutaneous (SC) Injections of Motixafortide (BL-8040) 1.25 mg/kg and 2 mg/kg
0.75 hr Post-dose
|
7.6 ms
Interval 4.54 to 10.69
|
11.8 ms
Interval 8.32 to 15.2
|
-0.1 ms
Interval -1.23 to 1.06
|
8.5 ms
Interval 6.2 to 10.78
|
—
|
|
QTc Effect of Single Subcutaneous (SC) Injections of Motixafortide (BL-8040) 1.25 mg/kg and 2 mg/kg
1 hr Post-dose
|
8.1 ms
Interval 4.53 to 11.72
|
11.2 ms
Interval 8.02 to 14.41
|
1.2 ms
Interval 0.12 to 2.33
|
10.4 ms
Interval 8.26 to 12.57
|
—
|
|
QTc Effect of Single Subcutaneous (SC) Injections of Motixafortide (BL-8040) 1.25 mg/kg and 2 mg/kg
1.5 hrs Post-dose
|
5.3 ms
Interval 2.64 to 7.89
|
2.9 ms
Interval 0.27 to 5.48
|
1.8 ms
Interval 0.17 to 3.36
|
11.8 ms
Interval 9.71 to 13.82
|
—
|
|
QTc Effect of Single Subcutaneous (SC) Injections of Motixafortide (BL-8040) 1.25 mg/kg and 2 mg/kg
2 hrs Post-done
|
2.4 ms
Interval 0.17 to 4.55
|
0.2 ms
Interval -2.76 to 3.24
|
1.5 ms
Interval 0.0 to 2.95
|
14.7 ms
Interval 12.77 to 16.59
|
—
|
|
QTc Effect of Single Subcutaneous (SC) Injections of Motixafortide (BL-8040) 1.25 mg/kg and 2 mg/kg
3 hrs Post-dose
|
0.3 ms
Interval -1.51 to 2.2
|
-1.9 ms
Interval -4.15 to 0.44
|
2.4 ms
Interval 0.49 to 4.33
|
13.5 ms
Interval 11.44 to 15.47
|
—
|
|
QTc Effect of Single Subcutaneous (SC) Injections of Motixafortide (BL-8040) 1.25 mg/kg and 2 mg/kg
4 hrs Post-dose
|
3.3 ms
Interval 1.67 to 4.85
|
2.3 ms
Interval -0.28 to 4.79
|
3.8 ms
Interval 2.16 to 5.5
|
15.0 ms
Interval 13.28 to 16.73
|
—
|
|
QTc Effect of Single Subcutaneous (SC) Injections of Motixafortide (BL-8040) 1.25 mg/kg and 2 mg/kg
12 hrs Post-dose
|
-1.1 ms
Interval -3.7 to 1.49
|
-2.7 ms
Interval -5.37 to 0.0
|
0.5 ms
Interval -1.44 to 2.4
|
4.7 ms
Interval 2.71 to 6.67
|
—
|
|
QTc Effect of Single Subcutaneous (SC) Injections of Motixafortide (BL-8040) 1.25 mg/kg and 2 mg/kg
16 hrs Post-dose
|
4.3 ms
Interval 1.28 to 7.27
|
3.5 ms
Interval 0.64 to 6.37
|
5.6 ms
Interval 3.36 to 7.8
|
11.6 ms
Interval 9.88 to 13.39
|
—
|
|
QTc Effect of Single Subcutaneous (SC) Injections of Motixafortide (BL-8040) 1.25 mg/kg and 2 mg/kg
24 hrs Post-dose
|
0.2 ms
Interval -1.88 to 2.28
|
0.1 ms
Interval -1.68 to 1.88
|
1.8 ms
Interval -0.07 to 3.66
|
3.7 ms
Interval 2.13 to 5.24
|
—
|
SECONDARY outcome
Timeframe: During the entire study. For each participant starting from Screening until End of Study Visit - approximately 1 month.Evaluation of safety (by assessing adverse events (AEs), ECGs, vital signs, clinical lab tests, physical examination) and tolerability (by assessing AEs) of single therapeutic and supratherapeutic SC injections of motixafortide in healthy subjects as well as of placebo and moxifloxacin.
Outcome measures
| Measure |
1.25 mg/kg Motixafortide (Therapeutic)
n=38 Participants
1.25 mg/kg motixafortide administered via SC injection (Therapeutic)
|
2 mg/kg Motixafortide (Supratherapeutic)
n=36 Participants
2 mg/kg motixafortide administered via SC injection (Supratherapeutic)
|
Placebo
n=37 Participants
Placebo for motixafortide
|
Moxifloxacin
n=36 Participants
Moxifloxacin 400 mg administered Orally
|
400 mg Moxifloxacin
n=36 Participants
Treatment 400 mg moxifloxacin administered orally 36 subjects out of the 38 enrolled in the study received moxifloxacine 400mg
|
|---|---|---|---|---|---|
|
Evaluation of AEs, 12-lead Safety ECGs, Vital Signs, Clinical Laboratory Tests, and Physical Examinations.
All-Cause Mortality
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Evaluation of AEs, 12-lead Safety ECGs, Vital Signs, Clinical Laboratory Tests, and Physical Examinations.
Serious Adverse Events
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Evaluation of AEs, 12-lead Safety ECGs, Vital Signs, Clinical Laboratory Tests, and Physical Examinations.
Non-serious Adverse Events
|
38 Participants
|
36 Participants
|
37 Participants
|
22 Participants
|
12 Participants
|
|
Evaluation of AEs, 12-lead Safety ECGs, Vital Signs, Clinical Laboratory Tests, and Physical Examinations.
Safety ECG (clinically significant changes)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Evaluation of AEs, 12-lead Safety ECGs, Vital Signs, Clinical Laboratory Tests, and Physical Examinations.
Vital Signs (clinically significant changes)
|
3 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Evaluation of AEs, 12-lead Safety ECGs, Vital Signs, Clinical Laboratory Tests, and Physical Examinations.
Clinical Laboratory Tests (clinically significant changes)
|
38 Participants
|
36 Participants
|
36 Participants
|
0 Participants
|
1 Participants
|
|
Evaluation of AEs, 12-lead Safety ECGs, Vital Signs, Clinical Laboratory Tests, and Physical Examinations.
Physical Examination (clinically significant changes)
|
38 Participants
|
35 Participants
|
37 Participants
|
22 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Blood for motixafortide PK is collected prior to dosing and at 13 different timepoints following dosing up to 24 hoursPopulation: PK population
Evaluation of pharmacokinetics (PK) (AUC0-t and AUC0-inf) of single therapeutic and supratherapeutic SC injections of motixafortide in healthy subjects.
Outcome measures
| Measure |
1.25 mg/kg Motixafortide (Therapeutic)
n=35 Participants
1.25 mg/kg motixafortide administered via SC injection (Therapeutic)
|
2 mg/kg Motixafortide (Supratherapeutic)
n=37 Participants
2 mg/kg motixafortide administered via SC injection (Supratherapeutic)
|
Placebo
Placebo for motixafortide
|
Moxifloxacin
Moxifloxacin 400 mg administered Orally
|
400 mg Moxifloxacin
Treatment 400 mg moxifloxacin administered orally 36 subjects out of the 38 enrolled in the study received moxifloxacine 400mg
|
|---|---|---|---|---|---|
|
PK (AUC0-t and AUC0-inf) of Single Therapeutic and Supratherapeutic SC Injections of Motixafortide (BL-8040) in Healthy Subjects.
AUC0-inf
|
3738 ng*h/mL
Standard Deviation 1056.3
|
6329 ng*h/mL
Standard Deviation 1858.1
|
—
|
—
|
—
|
|
PK (AUC0-t and AUC0-inf) of Single Therapeutic and Supratherapeutic SC Injections of Motixafortide (BL-8040) in Healthy Subjects.
AUC0-t
|
3678 ng*h/mL
Standard Deviation 1052.0
|
6544 ng*h/mL
Standard Deviation 2543.1
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Blood for motixafortide PK is collected prior to dosing and at 13 different timepoints following dosing up to 24 hoursPopulation: PK population
Evaluation of PK (AUC%extrap) of single therapeutic and supratherapeutic SC injections of motixafortide in healthy subjects. AUC%extrap = (1 - AUC0-t/AUC0-inf) x 100
Outcome measures
| Measure |
1.25 mg/kg Motixafortide (Therapeutic)
n=35 Participants
1.25 mg/kg motixafortide administered via SC injection (Therapeutic)
|
2 mg/kg Motixafortide (Supratherapeutic)
n=36 Participants
2 mg/kg motixafortide administered via SC injection (Supratherapeutic)
|
Placebo
Placebo for motixafortide
|
Moxifloxacin
Moxifloxacin 400 mg administered Orally
|
400 mg Moxifloxacin
Treatment 400 mg moxifloxacin administered orally 36 subjects out of the 38 enrolled in the study received moxifloxacine 400mg
|
|---|---|---|---|---|---|
|
PK (AUC%Extrap) of Single Therapeutic and Supratherapeutic SC Injections of Motixafortide (BL-8040) in Healthy Subjects.
|
1.717 % AUC0-inf
Standard Deviation 0.70009
|
1.302 % AUC0-inf
Standard Deviation 0.59016
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Blood for motixafortide PK is collected prior to dosing and at 13 different timepoints following dosing up to 24 hoursPopulation: PK Population
Evaluation of PK (Cmax) of single therapeutic and supratherapeutic SC injections of motixafortide in healthy subjects.
Outcome measures
| Measure |
1.25 mg/kg Motixafortide (Therapeutic)
n=35 Participants
1.25 mg/kg motixafortide administered via SC injection (Therapeutic)
|
2 mg/kg Motixafortide (Supratherapeutic)
n=37 Participants
2 mg/kg motixafortide administered via SC injection (Supratherapeutic)
|
Placebo
Placebo for motixafortide
|
Moxifloxacin
Moxifloxacin 400 mg administered Orally
|
400 mg Moxifloxacin
Treatment 400 mg moxifloxacin administered orally 36 subjects out of the 38 enrolled in the study received moxifloxacine 400mg
|
|---|---|---|---|---|---|
|
PK (Cmax) of Single Therapeutic and Supratherapeutic SC Injections of Motixafortide (BL-8040) in Healthy Subjects.
|
2245 ng/mL
Standard Deviation 791.11
|
3198 ng/mL
Standard Deviation 1192.4
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Blood for motixafortide PK is collected prior to dosing and at 13 different time points following dosing up to 24 hoursPopulation: PK Population
Evaluation of PK (Tmax) of single therapeutic and supratherapeutic SC injections of motixafortide in healthy subjects.
Outcome measures
| Measure |
1.25 mg/kg Motixafortide (Therapeutic)
n=35 Participants
1.25 mg/kg motixafortide administered via SC injection (Therapeutic)
|
2 mg/kg Motixafortide (Supratherapeutic)
n=37 Participants
2 mg/kg motixafortide administered via SC injection (Supratherapeutic)
|
Placebo
Placebo for motixafortide
|
Moxifloxacin
Moxifloxacin 400 mg administered Orally
|
400 mg Moxifloxacin
Treatment 400 mg moxifloxacin administered orally 36 subjects out of the 38 enrolled in the study received moxifloxacine 400mg
|
|---|---|---|---|---|---|
|
PK (Tmax) of Single Therapeutic and Supratherapeutic SC Injections of Motixafortide (BL-8040) in Healthy Subjects.
|
0.754 hr
Standard Deviation 0.1754
|
0.690 hr
Standard Deviation 0.2239
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: ECG recording from prior to dosing (3 timepoints) until 24 hours following administration (13 timepoints after dosing)Population: QT/QTc Population
Assessment of the effect of single therapeutic and supratherapeutic SC injections of motixafortide on Heart Rate (a non-QT interval ECG parameter) by change from baseline (in bpm). "Change from Baseline" at the Baseline timepoint (predosing) is defined as zero. Baseline was the average of the derived ECG intervals from the 3 ECG timepoints prior to dosing (-0.75, -0.5, and -0.25 hours) on Day 1. Descriptive statistics of ECG parameters (HR) by-timepoint analysis of Change-from-Baseline values was done.
Outcome measures
| Measure |
1.25 mg/kg Motixafortide (Therapeutic)
n=34 Participants
1.25 mg/kg motixafortide administered via SC injection (Therapeutic)
|
2 mg/kg Motixafortide (Supratherapeutic)
n=36 Participants
2 mg/kg motixafortide administered via SC injection (Supratherapeutic)
|
Placebo
n=34 Participants
Placebo for motixafortide
|
Moxifloxacin
n=36 Participants
Moxifloxacin 400 mg administered Orally
|
400 mg Moxifloxacin
Treatment 400 mg moxifloxacin administered orally 36 subjects out of the 38 enrolled in the study received moxifloxacine 400mg
|
|---|---|---|---|---|---|
|
Effect of Single Therapeutic and Supratherapeutic SC Injections of Motixafortide (BL-8040) on Heart Rate
24 hrs Post-dose
|
4.2 bpm
Interval 2.28 to 6.14
|
6.2 bpm
Interval 4.3 to 8.06
|
-0.2 bpm
Interval -2.37 to 1.88
|
0.5 bpm
Interval -0.55 to 1.51
|
—
|
|
Effect of Single Therapeutic and Supratherapeutic SC Injections of Motixafortide (BL-8040) on Heart Rate
0.25 hr Post-dose
|
3.1 bpm
Interval 1.9 to 4.31
|
7.7 bpm
Interval 5.05 to 10.38
|
-0.8 bpm
Interval -1.79 to 0.14
|
-0.7 bpm
Interval -1.44 to 0.11
|
—
|
|
Effect of Single Therapeutic and Supratherapeutic SC Injections of Motixafortide (BL-8040) on Heart Rate
0.5 hr Post-dose
|
9.3 bpm
Interval 7.2 to 11.37
|
15.5 bpm
Interval 12.63 to 18.47
|
-1.0 bpm
Interval -2.02 to 0.0
|
0.1 bpm
Interval -1.01 to 1.16
|
—
|
|
Effect of Single Therapeutic and Supratherapeutic SC Injections of Motixafortide (BL-8040) on Heart Rate
0.75 hr Post-dose
|
10.6 bpm
Interval 7.54 to 13.7
|
12.8 bpm
Interval 9.88 to 15.73
|
-2.2 bpm
Interval -3.28 to -1.05
|
0.8 bpm
Interval -0.55 to 2.12
|
—
|
|
Effect of Single Therapeutic and Supratherapeutic SC Injections of Motixafortide (BL-8040) on Heart Rate
1 hr Post-dose
|
6.3 bpm
Interval 3.44 to 9.23
|
7.2 bpm
Interval 4.57 to 9.88
|
-2.8 bpm
Interval -3.99 to -1.66
|
0.9 bpm
Interval -0.48 to 2.3
|
—
|
|
Effect of Single Therapeutic and Supratherapeutic SC Injections of Motixafortide (BL-8040) on Heart Rate
1.5 hrs Post-dose
|
-1.5 bpm
Interval -3.49 to 0.56
|
0.9 bpm
Interval -1.43 to 3.26
|
-4.1 bpm
Interval -5.42 to -2.75
|
-1.9 bpm
Interval -2.86 to -0.87
|
—
|
|
Effect of Single Therapeutic and Supratherapeutic SC Injections of Motixafortide (BL-8040) on Heart Rate
2 hrs Post-dose
|
-1.6 bpm
Interval -3.58 to 0.39
|
1.0 bpm
Interval -0.74 to 2.77
|
-5.9 bpm
Interval -7.4 to -4.37
|
-1.2 bpm
Interval -2.31 to -0.15
|
—
|
|
Effect of Single Therapeutic and Supratherapeutic SC Injections of Motixafortide (BL-8040) on Heart Rate
3 hrs Post-dose
|
-1.1 bpm
Interval -3.03 to 0.88
|
2.7 bpm
Interval 0.74 to 4.69
|
-5.5 bpm
Interval -6.9 to -4.0
|
-2.6 bpm
Interval -3.74 to -1.52
|
—
|
|
Effect of Single Therapeutic and Supratherapeutic SC Injections of Motixafortide (BL-8040) on Heart Rate
4 hrs Post-dose
|
1.1 bpm
Interval -1.09 to 3.27
|
5.7 bpm
Interval 3.74 to 7.71
|
-4.6 bpm
Interval -6.1 to -3.13
|
-1.3 bpm
Interval -2.6 to -0.09
|
—
|
|
Effect of Single Therapeutic and Supratherapeutic SC Injections of Motixafortide (BL-8040) on Heart Rate
6 hrs Post-dose
|
9.8 bpm
Interval 6.86 to 12.81
|
15.6 bpm
Interval 13.14 to 17.99
|
2.0 bpm
Interval 0.3 to 3.73
|
5.3 bpm
Interval 3.65 to 7.02
|
—
|
|
Effect of Single Therapeutic and Supratherapeutic SC Injections of Motixafortide (BL-8040) on Heart Rate
8 hrs Post-dose
|
5.9 bpm
Interval 2.8 to 9.09
|
11.4 bpm
Interval 8.93 to 13.88
|
-1.6 bpm
Interval -3.35 to 0.17
|
2.4 bpm
Interval 0.92 to 3.91
|
—
|
|
Effect of Single Therapeutic and Supratherapeutic SC Injections of Motixafortide (BL-8040) on Heart Rate
12 hrs Post-dose
|
10.8 bpm
Interval 8.21 to 13.41
|
15.4 bpm
Interval 12.57 to 18.18
|
2.8 bpm
Interval 1.0 to 4.63
|
6.2 bpm
Interval 4.48 to 7.86
|
—
|
|
Effect of Single Therapeutic and Supratherapeutic SC Injections of Motixafortide (BL-8040) on Heart Rate
16 hrs Post-dose
|
6.0 bpm
Interval 2.65 to 9.35
|
8.9 bpm
Interval 6.24 to 11.5
|
-3.0 bpm
Interval -4.78 to -1.13
|
1.1 bpm
Interval -0.41 to 2.57
|
—
|
Adverse Events
All Subjects
Serious events: 0 serious events
Other events: 38 other events
Deaths: 0 deaths
1.25 mg/kg Motixafortide
Serious events: 0 serious events
Other events: 36 other events
Deaths: 0 deaths
2 mg/kg Motixafortide
Serious events: 0 serious events
Other events: 37 other events
Deaths: 0 deaths
Placebo SC
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
400 mg Moxifloxacin
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
All Subjects
n=38 participants at risk
All Subjects enrolled, randomized and to the study and received at least one dose of any of the study treatments.
|
1.25 mg/kg Motixafortide
n=36 participants at risk
Treatment 1.25 mg/kg motixafortide administered SC 36 subjects out of the 38 enrolled in the study received motixafortide (BL-8040) 1.25mg/kg
|
2 mg/kg Motixafortide
n=37 participants at risk
Treatment 2 mg/kg motixafortide administered SC 37 subjects out of the 38 enrolled in the study received motixafortide (BL-8040) 2mg/kg
|
Placebo SC
n=36 participants at risk
Placebo administered SC 36 subjects out of the 38 enrolled in the study received placebo for motixafortide (BL-8040)
|
400 mg Moxifloxacin
n=36 participants at risk
Treatment 400 mg moxifloxacin administered orally 36 subjects out of the 38 enrolled in the study received moxifloxacine 400mg
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Leukocytosis
|
100.0%
38/38 • Number of events 72 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
100.0%
36/36 • Number of events 36 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
97.3%
36/37 • Number of events 36 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/36 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/36 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.3%
2/38 • Number of events 2 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
5.6%
2/36 • Number of events 2 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/37 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/36 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/36 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
|
Gastrointestinal disorders
Haematochezia
|
5.3%
2/38 • Number of events 3 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
2.8%
1/36 • Number of events 1 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/37 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
2.8%
1/36 • Number of events 2 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/36 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
|
Gastrointestinal disorders
Nausea
|
28.9%
11/38 • Number of events 14 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
13.9%
5/36 • Number of events 5 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
16.2%
6/37 • Number of events 6 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
5.6%
2/36 • Number of events 2 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
2.8%
1/36 • Number of events 1 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
|
Gastrointestinal disorders
Vomiting
|
15.8%
6/38 • Number of events 7 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
11.1%
4/36 • Number of events 4 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
8.1%
3/37 • Number of events 3 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/36 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/36 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
|
General disorders
Chills
|
34.2%
13/38 • Number of events 19 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
22.2%
8/36 • Number of events 8 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
27.0%
10/37 • Number of events 10 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
2.8%
1/36 • Number of events 1 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/36 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
|
General disorders
Feeling hot
|
60.5%
23/38 • Number of events 30 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
25.0%
9/36 • Number of events 11 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
45.9%
17/37 • Number of events 17 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/36 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
2.8%
1/36 • Number of events 2 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
|
General disorders
Injection site erythema
|
97.4%
37/38 • Number of events 69 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
80.6%
29/36 • Number of events 33 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
75.7%
28/37 • Number of events 32 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
11.1%
4/36 • Number of events 4 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/36 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
|
General disorders
Injection site hypoaesthesia
|
7.9%
3/38 • Number of events 3 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
5.6%
2/36 • Number of events 2 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/37 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
2.8%
1/36 • Number of events 1 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/36 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
|
General disorders
Injection site induration
|
68.4%
26/38 • Number of events 34 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
41.7%
15/36 • Number of events 16 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
32.4%
12/37 • Number of events 13 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
13.9%
5/36 • Number of events 5 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/36 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
|
General disorders
Injection site mass
|
15.8%
6/38 • Number of events 6 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
11.1%
4/36 • Number of events 4 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
5.4%
2/37 • Number of events 2 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/36 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/36 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
|
General disorders
Injection site pain
|
97.4%
37/38 • Number of events 159 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
88.9%
32/36 • Number of events 66 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
97.3%
36/37 • Number of events 82 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
27.8%
10/36 • Number of events 11 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/36 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
|
General disorders
Injection site pruritus
|
63.2%
24/38 • Number of events 42 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
47.2%
17/36 • Number of events 20 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
45.9%
17/37 • Number of events 19 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
8.3%
3/36 • Number of events 3 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/36 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
|
General disorders
Injection site swelling
|
7.9%
3/38 • Number of events 3 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
5.6%
2/36 • Number of events 2 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
2.7%
1/37 • Number of events 1 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/36 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/36 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
13.2%
5/38 • Number of events 7 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/36 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
10.8%
4/37 • Number of events 6 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/36 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
2.8%
1/36 • Number of events 1 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.5%
4/38 • Number of events 5 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
5.6%
2/36 • Number of events 3 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
5.4%
2/37 • Number of events 2 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/36 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/36 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.3%
2/38 • Number of events 3 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
5.6%
2/36 • Number of events 3 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/37 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/36 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/36 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
|
Nervous system disorders
Headache
|
42.1%
16/38 • Number of events 19 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
25.0%
9/36 • Number of events 9 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
18.9%
7/37 • Number of events 8 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
2.8%
1/36 • Number of events 1 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
2.8%
1/36 • Number of events 1 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
|
Nervous system disorders
Paraesthesia
|
42.1%
16/38 • Number of events 23 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
30.6%
11/36 • Number of events 13 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
24.3%
9/37 • Number of events 10 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/36 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/36 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
|
Nervous system disorders
Somnolence
|
5.3%
2/38 • Number of events 2 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
2.8%
1/36 • Number of events 1 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/37 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/36 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
2.8%
1/36 • Number of events 1 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
|
Nervous system disorders
Tremor
|
39.5%
15/38 • Number of events 19 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
19.4%
7/36 • Number of events 7 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
29.7%
11/37 • Number of events 11 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
2.8%
1/36 • Number of events 1 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/36 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
|
Renal and urinary disorders
Urinary incontinence
|
5.3%
2/38 • Number of events 2 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
5.6%
2/36 • Number of events 2 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/37 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/36 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/36 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
7.9%
3/38 • Number of events 3 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
5.6%
2/36 • Number of events 2 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
2.7%
1/37 • Number of events 1 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/36 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/36 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
|
Skin and subcutaneous tissue disorders
Acne
|
5.3%
2/38 • Number of events 3 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/36 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/37 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
2.8%
1/36 • Number of events 1 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
2.8%
1/36 • Number of events 2 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
26.3%
10/38 • Number of events 10 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
13.9%
5/36 • Number of events 5 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
10.8%
4/37 • Number of events 4 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
2.8%
1/36 • Number of events 1 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/36 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
7.9%
3/38 • Number of events 3 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
8.3%
3/36 • Number of events 3 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/37 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/36 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/36 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
|
Skin and subcutaneous tissue disorders
Piloerection
|
5.3%
2/38 • Number of events 3 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
2.8%
1/36 • Number of events 2 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
2.7%
1/37 • Number of events 1 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/36 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/36 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
73.7%
28/38 • Number of events 53 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
58.3%
21/36 • Number of events 26 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
64.9%
24/37 • Number of events 26 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/36 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
2.8%
1/36 • Number of events 1 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.9%
3/38 • Number of events 3 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/36 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
5.4%
2/37 • Number of events 2 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/36 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
2.8%
1/36 • Number of events 1 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
5.3%
2/38 • Number of events 2 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
2.8%
1/36 • Number of events 1 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
2.7%
1/37 • Number of events 1 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/36 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/36 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
68.4%
26/38 • Number of events 37 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
38.9%
14/36 • Number of events 14 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
59.5%
22/37 • Number of events 23 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/36 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/36 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
|
Vascular disorders
Flushing
|
65.8%
25/38 • Number of events 32 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
27.8%
10/36 • Number of events 11 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
56.8%
21/37 • Number of events 21 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/36 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/36 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
|
Gastrointestinal disorders
Constipation
|
13.2%
5/38 • Number of events 6 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
2.8%
1/36 • Number of events 1 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
2.7%
1/37 • Number of events 1 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
5.6%
2/36 • Number of events 2 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
5.6%
2/36 • Number of events 2 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
|
General disorders
Injection site bruising
|
18.4%
7/38 • Number of events 7 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
11.1%
4/36 • Number of events 4 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
8.1%
3/37 • Number of events 3 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/36 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/36 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
|
General disorders
Injection site discolouration
|
36.8%
14/38 • Number of events 14 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
22.2%
8/36 • Number of events 8 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
10.8%
4/37 • Number of events 4 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
5.6%
2/36 • Number of events 2 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/36 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
|
General disorders
Injection site haemorrhage
|
5.3%
2/38 • Number of events 2 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
2.8%
1/36 • Number of events 1 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
2.7%
1/37 • Number of events 1 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/36 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/36 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
|
General disorders
Injection site oedema
|
15.8%
6/38 • Number of events 6 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
8.3%
3/36 • Number of events 3 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
5.4%
2/37 • Number of events 2 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
2.8%
1/36 • Number of events 1 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/36 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.3%
2/38 • Number of events 2 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/36 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
5.4%
2/37 • Number of events 2 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/36 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/36 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
|
Nervous system disorders
Dizziness
|
28.9%
11/38 • Number of events 15 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
16.7%
6/36 • Number of events 6 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
10.8%
4/37 • Number of events 5 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
8.3%
3/36 • Number of events 3 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
2.8%
1/36 • Number of events 1 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
|
Nervous system disorders
Hypoaesthesia
|
10.5%
4/38 • Number of events 7 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
5.6%
2/36 • Number of events 3 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
10.8%
4/37 • Number of events 4 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/36 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/36 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
|
Nervous system disorders
Presyncope
|
5.3%
2/38 • Number of events 2 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
2.8%
1/36 • Number of events 1 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
2.7%
1/37 • Number of events 1 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/36 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/36 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
|
Renal and urinary disorders
Micturition urgency
|
5.3%
2/38 • Number of events 3 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
5.6%
2/36 • Number of events 2 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
2.7%
1/37 • Number of events 1 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/36 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/36 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
13.2%
5/38 • Number of events 6 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/36 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
5.4%
2/37 • Number of events 3 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
5.6%
2/36 • Number of events 2 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
2.8%
1/36 • Number of events 1 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
|
Ear and labyrinth disorders
Ear discomfort
|
5.3%
2/38 • Number of events 2 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/36 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
5.4%
2/37 • Number of events 2 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/36 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/36 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
|
General disorders
Injection site warmth
|
10.5%
4/38 • Number of events 6 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
2.8%
1/36 • Number of events 1 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
8.1%
3/37 • Number of events 4 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
2.8%
1/36 • Number of events 1 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/36 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
|
General disorders
Peripheral swelling
|
21.1%
8/38 • Number of events 12 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
8.3%
3/36 • Number of events 3 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
16.2%
6/37 • Number of events 8 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
2.8%
1/36 • Number of events 1 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/36 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
|
General disorders
Pain
|
15.8%
6/38 • Number of events 7 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
5.6%
2/36 • Number of events 2 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
10.8%
4/37 • Number of events 4 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/36 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
2.8%
1/36 • Number of events 1 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
21.1%
8/38 • Number of events 9 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
13.9%
5/36 • Number of events 5 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
10.8%
4/37 • Number of events 4 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/36 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/36 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.3%
2/38 • Number of events 2 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
2.8%
1/36 • Number of events 1 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
2.7%
1/37 • Number of events 1 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/36 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/36 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
|
Nervous system disorders
Taste disorder
|
7.9%
3/38 • Number of events 4 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
2.8%
1/36 • Number of events 1 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
8.1%
3/37 • Number of events 3 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/36 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/36 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
|
Psychiatric disorders
Insomnia
|
7.9%
3/38 • Number of events 3 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
2.8%
1/36 • Number of events 1 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
5.4%
2/37 • Number of events 2 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/36 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/36 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.9%
3/38 • Number of events 4 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
2.8%
1/36 • Number of events 1 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
2.7%
1/37 • Number of events 1 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
5.6%
2/36 • Number of events 2 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/36 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
|
Cardiac disorders
Palpitations
|
7.9%
3/38 • Number of events 3 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
2.8%
1/36 • Number of events 1 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
5.4%
2/37 • Number of events 2 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/36 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/36 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
|
Investigations
Weight decreased
|
7.9%
3/38 • Number of events 3 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
2.8%
1/36 • Number of events 1 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/37 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
5.6%
2/36 • Number of events 2 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/36 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.3%
2/38 • Number of events 2 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
2.8%
1/36 • Number of events 1 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
2.7%
1/37 • Number of events 1 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/36 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/36 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
|
General disorders
Fatigue
|
5.3%
2/38 • Number of events 2 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
5.6%
2/36 • Number of events 2 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/37 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/36 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/36 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.9%
3/38 • Number of events 4 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
8.3%
3/36 • Number of events 3 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/37 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
2.8%
1/36 • Number of events 1 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/36 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
|
Nervous system disorders
Burning sensation
|
15.8%
6/38 • Number of events 10 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
11.1%
4/36 • Number of events 5 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
10.8%
4/37 • Number of events 5 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/36 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/36 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
5.3%
2/38 • Number of events 4 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
5.6%
2/36 • Number of events 2 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
5.4%
2/37 • Number of events 2 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/36 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/36 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
|
General disorders
Asthenia
|
5.3%
2/38 • Number of events 2 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
2.8%
1/36 • Number of events 1 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/37 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
2.8%
1/36 • Number of events 1 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/36 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.3%
2/38 • Number of events 2 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
2.8%
1/36 • Number of events 1 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
2.7%
1/37 • Number of events 1 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/36 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/36 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
5.3%
2/38 • Number of events 2 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
2.8%
1/36 • Number of events 1 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/37 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
2.8%
1/36 • Number of events 1 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/36 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
|
General disorders
Injection site necrosis
|
5.3%
2/38 • Number of events 2 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
2.8%
1/36 • Number of events 1 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
2.7%
1/37 • Number of events 1 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/36 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
0.00%
0/36 • AE are collected during the entire study for each subject. From the Informed Consent Form (ICF) signature until end of study for each participant. The duration of each participant in the study was approximately 1 month. AE were followed until resolution or stabilization in case the event was ongoing at the end of study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place