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Table 4 The top 30 signal strength of adverse events of rotigotine ranked by the number of case reports at the PTs level in FAERS database

From: Rotigotine safety in real-world settings: a pharmacovigilance study using FAERS data

Preferred terms (PTs)

Case reports

ROR (95% CI)

PRR (χ²)

EBGM

(EBGM05)

BCPNN (IC025)

Product Adhesion Issue*

1336

115.28 (108.94–121.98)

108.46 (135850.43)

103.57 (98.79)

6.69 (5.03)

Drug Ineffective*

651

1.32 (1.22–1.43)

1.31 (50.04)

1.31 (1.23)

0.39 (-1.27)

Death*

529

1.67 (1.53–1.82)

1.65 (137.14)

1.65 (1.53)

0.72 (-0.94)

Off Label Use*

437

1.46 (1.33–1.6)

1.45 (62.01)

1.45 (1.34)

0.54 (-1.13)

Application Site Pruritus*

417

50.28 (45.59–55.46)

49.37 (19348.15)

48.34 (44.54)

5.6 (3.93)

Application Site Erythema*

409

41.5 (37.6–45.81)

40.77 (15592.76)

40.07 (36.89)

5.32 (3.66)

Device Adhesion Issue*

383

75.95 (68.54–84.16)

74.67 (26959.86)

72.33 (66.38)

6.18 (4.51)

Fall*

361

2.93 (2.64–3.25)

2.9 (451.76)

2.9 (2.66)

1.54 (-0.13)

Parkinson’S Disease*

345

51.57 (46.31–57.42)

50.79 (16476.71)

49.7 (45.43)

5.64 (3.97)

Overdose*

334

4.01 (3.59–4.46)

3.96 (740.61)

3.96 (3.61)

1.98 (0.32)

Tremor*

308

5.01 (4.48–5.61)

4.96 (974)

4.95 (4.51)

2.31 (0.64)

Dizziness*

249

1.35 (1.2–1.53)

1.35 (22.84)

1.35 (1.22)

0.43 (-1.23)

Insomnia*

245

2.46 (2.17–2.79)

2.45 (210.31)

2.45 (2.2)

1.29 (-0.38)

Hallucination*

233

8.7 (7.64–9.9)

8.62 (1564.37)

8.59 (7.71)

3.1 (1.44)

Nausea

224

0.77 (0.67–0.87)

0.77 (15.69)

0.77 (0.69)

-0.38 (-2.04)

Application Site Reaction*

215

98.76 (86.11–113.28)

97.82 (19756.77)

93.83 (83.66)

6.55 (4.89)

Restless Legs Syndrome*

210

30.74 (26.81–35.24)

30.46 (5905.93)

30.07 (26.82)

4.91 (3.24)

Somnolence*

199

2.69 (2.34–3.1)

2.68 (209.82)

2.68 (2.38)

1.42 (-0.25)

Application Site Rash*

191

35 (30.32–40.4)

34.71 (6159.97)

34.2 (30.33)

5.1 (3.43)

Gait Disturbance*

169

2.28 (1.96–2.65)

2.27 (120.64)

2.27 (2)

1.18 (-0.48)

Pneumonia*

164

1.39 (1.19–1.62)

1.38 (17.6)

1.38 (1.22)

0.47 (-1.2)

Wrong Technique In Product Usage Process*

160

2.15 (1.84–2.51)

2.14 (97.65)

2.14 (1.88)

1.1 (-0.57)

Anxiety*

159

1.47 (1.26–1.72)

1.47 (23.73)

1.47 (1.29)

0.55 (-1.11)

Fatigue

152

0.52 (0.44–0.61)

0.52 (66.3)

0.52 (0.46)

-0.93 (-2.6)

Vomiting

140

0.82 (0.69–0.97)

0.82 (5.59)

0.82 (0.71)

-0.29 (-1.95)

Pain

140

0.59 (0.5–0.69)

0.59 (40.4)

0.59 (0.51)

-0.76 (-2.43)

Intentional Product Misuse*

139

4.2 (3.56–4.97)

4.18 (336.66)

4.18 (3.63)

2.06 (0.4)

Asthenia

137

0.99 (0.83–1.17)

0.99 (0.03)

0.99 (0.86)

-0.02 (-1.69)

Pruritus

137

1.05 (0.89–1.24)

1.05 (0.35)

1.05 (0.91)

0.07 (-1.59)

Dysphagia*

128

3.7 (3.11–4.4)

3.68 (249.92)

3.68 (3.18)

1.88 (0.21)

  1. Asterisks (*) indicate statistically significant signals. EBGM and IC are Bayesian-based metrics used to quantify the strength of associations between drugs and adverse events. EBGM represents the geometric mean of the posterior distribution of the reporting ratio, while IC measures the information gained from the association. Both metrics are accompanied by their 95% confidence intervals (EBGM05 and IC025), which indicate statistical significance. Abbreviations: ROR, reporting odds ratio; PRR, proportional reporting ratio; EBGM, empirical Bayesian geometric mean; EBGM05, the lower limit of the 95% confidence interval of EBGM; BCPNN, bayesian confidence propagation neural network, the lower limit of the 95% confidence interval of the IC