| |
Cohort 1
|
Cohort 2
|
Cohort 3
|
Cohort 4
|
Total
|
|---|
|
(n = 6)
|
(n = 6)
|
(n = 6)
|
(n = 6)
|
(N = 24)
|
|---|
|
Participants with one or more adverse event
|
6 (100.0)
|
6 (100.0)
|
3 (50.0)
|
4 (66.7)
|
19 (79.2)
|
|
Headache
|
3 (50.0)
|
5 (83.3)
|
2 (33.3)
|
2 (33.3)
|
12 (50.0)
|
|
Back pain
|
1 (16.7)
|
2 (33.3)
|
1 (16.7)
|
3 (50.0)
|
7 (29.2)
|
|
Catheter site pain
|
2 (33.3)
|
0
|
1 (16.7)
|
0
|
3 (12.5)
|
|
Dizziness postural
|
0
|
1 (16.7)
|
0
|
1 (16.7)
|
2 (8.3)
|
|
Hypoesthesia
|
1 (16.7)
|
0
|
1 (16.7)
|
0
|
2 (8.3)
|
|
Pain in extremity
|
1 (16.7)
|
0
|
1 (16.7)
|
0
|
2 (8.3)
|
|
Nausea
|
0
|
1 (16.7)
|
1 (16.7)
|
0
|
2 (8.3)
|
|
Musculoskeletal stiffness
|
0
|
1 (16.7)
|
0
|
0
|
1 (4.2)
|
|
Neck pain
|
0
|
0
|
1 (16.7)
|
0
|
1 (4.2)
|
|
Gastroesophageal reflux disease
|
0
|
0
|
1 (16.7)
|
0
|
1 (4.2)
|
|
Regurgitation
|
0
|
0
|
0
|
1 (16.7)
|
1 (4.2)
|
|
Toothache
|
0
|
0
|
0
|
1 (16.7)
|
1 (4.2)
|
|
Dermatophytosis
|
0
|
0
|
1 (16.7)
|
0
|
1 (4.2)
|
|
Sinusitis
|
0
|
0
|
0
|
1 (16.7)
|
1 (4.2)
|
|
Post lumbar puncture syndrome
|
0
|
1 (16.7)
|
0
|
0
|
1 (4.2)
|
|
Pruritus
|
1 (16.7)
|
0
|
0
|
0
|
1 (4.2)
|
|
Flushing
|
0
|
1 (16.7)
|
0
|
0
|
1 (4.2)
|
- Data shown as n (%). Cohort 1: immediate sampling, high frequency; cohort 2: delayed sampling, high frequency, procedure effect; cohort 3: ibuprofen, high frequency, inflammation effect; cohort 4: immediate sampling, low frequency
- The laboratory parameters (clinical chemistry, hematology, urinalysis) were evaluated at screening, on days –1 and 2, and during follow-up (days 7–14 after removal of the spinal catheter). The vital signs and resting 12-lead ECGs were evaluated at screening, on days –1, 1, and 2, and during follow-up. The participants were physically and neurologically examined at screening, on days 1 and 3, and in follow-up. Fundoscopy was performed at screening to exclude intracranial pressure
