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Table 2 Incidence of adverse events occurring during study (starting after catheter insertion)

From: Impact of frequent cerebrospinal fluid sampling on Aβ levels: systematic approach to elucidate influencing factors

 

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)

  1. 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
  2. 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