Table 1.
LP-related adverse events at baseline by group.
| Adverse Event | Group |
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|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| PD Subjects | Healthy Controls | SWEDD Subjects | RR (95% CI) | |||||||||||
|
|
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| (N = 421) | (N = 196) | (N = 62) | ||||||||||||
|
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| # of Subjects | % of Subjects | # of Events | Rate | # of Subjects | % of Subjects | # of Events | Rate | # of Subjects | % of Subjects | # of Events | Rate | PD vs. HC | PD vs. SWEDD | |
| Total | 85 | 20.2% | 100 | 0.238 | 51 | 26.0% | 59 | 0.301 | 17 | 27.4% | 21 | 0.339 | 0.78 (0.58, 1.06) | 0.74 (0.47, 1.16) |
| Most Common | ||||||||||||||
| Post-LP Headache | 49 | 11.6% | 49 | 0.116 | 28 | 14.3% | 28 | 0.143 | 12 | 19.4% | 12 | 0.194 | 0.81 (0.53, 1.25) | 0.60 (0.34, 1.06) |
| Post-LP Back Pain | 22 | 5.2% | 23 | 0.055 | 15 | 7.7% | 15 | 0.077 | 7 | 11.3% | 7 | 0.113 | 0.68 (0.36, 1.28) | 0.46 (0.21, 1.03) |
| Ear | ||||||||||||||
| Tinnitus | 1 | 0.2% | 1 | 0.002 | 0 | 0.0% | 0 | 0.000 | 0 | 0.0% | 0 | 0.000 | . | . |
| Gastrointestinal | ||||||||||||||
| Abdominal pain | 0 | 0.0% | 0 | 0.000 | 1 | 0.5% | 1 | 0.005 | 0 | 0.0% | 0 | 0.000 | . | . |
| Nausea | 4 | 1.0% | 4 | 0.010 | 1 | 0.5% | 1 | 0.005 | 0 | 0.0% | 0 | 0.000 | 1.86 (0.21, 16.53) | . |
| Vomiting | 1 | 0.2% | 1 | 0.002 | 0 | 0.0% | 0 | 0.000 | 0 | 0.0% | 0 | 0.000 | . | . |
| General | ||||||||||||||
| Fatigue | 1 | 0.2% | 1 | 0.002 | 1 | 0.5% | 1 | 0.005 | 0 | 0.0% | 0 | 0.000 | 0.47 (0.03, 7.48) | . |
| Pain | 1 | 0.2% | 1 | 0.002 | 0 | 0.0% | 0 | 0.000 | 0 | 0.0% | 0 | 0.000 | . | . |
| Musculoskeletal | ||||||||||||||
| Musculoskeletal pain | 0 | 0.0% | 0 | 0.000 | 1 | 0.5% | 1 | 0.005 | 0 | 0.0% | 0 | 0.000 | . | . |
| Musculoskeletal stiffness | 2 | 0.5% | 2 | 0.005 | 1 | 0.5% | 1 | 0.005 | 0 | 0.0% | 0 | 0.000 | 0.93 (0.08, 10.20) | . |
| Pain in extremity | 1 | 0.2% | 1 | 0.002 | 0 | 0.0% | 0 | 0.000 | 0 | 0.0% | 0 | 0.000 | . | . |
| Post-LP Back Pain | 22 | 5.2% | 23 | 0.055 | 15 | 7.7% | 15 | 0.077 | 7 | 11.3% | 7 | 0.113 | 0.68 (0.36, 1.28) | 0.46 (0.21, 1.03) |
| Post-LP Injection Site Pain | 4 | 1.0% | 4 | 0.010 | 1 | 0.5% | 1 | 0.005 | 2 | 3.2% | 2 | 0.032 | 1.86 (0.21, 16.53) | 0.29 (0.05, 1.55) |
| Nervous System | ||||||||||||||
| Dizziness | 3 | 0.7% | 3 | 0.007 | 2 | 1.0% | 2 | 0.010 | 0 | 0.0% | 0 | 0.000 | 0.70 (0.12, 4.16) | . |
| Intracranial hypotension | 0 | 0.0% | 0 | 0.000 | 1 | 0.5% | 1 | 0.005 | 0 | 0.0% | 0 | 0.000 | . | . |
| Loss of consciousness | 1 | 0.2% | 1 | 0.002 | 0 | 0.0% | 0 | 0.000 | 0 | 0.0% | 0 | 0.000 | . | . |
| Migraine | 1 | 0.2% | 1 | 0.002 | 0 | 0.0% | 0 | 0.000 | 0 | 0.0% | 0 | 0.000 | . | . |
| Paraesthesia | 0 | 0.0% | 0 | 0.000 | 1 | 0.5% | 1 | 0.005 | 0 | 0.0% | 0 | 0.000 | . | . |
| Parkinson’s disease | 1 | 0.2% | 1 | 0.002 | 0 | 0.0% | 0 | 0.000 | 0 | 0.0% | 0 | 0.000 | . | . |
| Post-LP Headache | 49 | 11.6% | 49 | 0.116 | 28 | 14.3% | 28 | 0.143 | 12 | 19.4% | 12 | 0.194 | 0.81 (0.53, 1.25) | 0.60 (0.34, 1.06) |
| Presyncope | 0 | 0.0% | 0 | 0.000 | 1 | 0.5% | 1 | 0.005 | 0 | 0.0% | 0 | 0.000 | . | . |
| Radicular pain | 2 | 0.5% | 2 | 0.005 | 0 | 0.0% | 0 | 0.000 | 0 | 0.0% | 0 | 0.000 | . | . |
| Syncope | 1 | 0.2% | 1 | 0.002 | 0 | 0.0% | 0 | 0.000 | 0 | 0.0% | 0 | 0.000 | . | . |
| Procedural Related Injuries | ||||||||||||||
| Contusion | 1 | 0.2% | 1 | 0.002 | 0 | 0.0% | 0 | 0.000 | 0 | 0.0% | 0 | 0.000 | . | . |
| Post-LP Injection Site Pain | 3 | 0.7% | 3 | 0.007 | 5 | 2.6% | 5 | 0.026 | 0 | 0.0% | 0 | 0.000 | 0.28 (0.07, 1.16) | . |
Column definitions.
# of Subjects: Number of subjects who had AE.
% of Subjects: Percentage of subjects who had AE.
# of Events: Total number of AEs; includes multiple AEs of same type per subject.
Rate: Number of AEs per total number of subjects.
RR(95% CI): Relative Risk and 95% Confidence Interval for comparing percentages of subjects who had AE in PD subjects vs. healthy controls or PD subjects vs. SWEDD subjects.