Table 3 Summary risk difference comparison of adverse events

Any AE, %

−20.7

−47.9, 6.4

0.135

−35.3

−72.4, 1.8

0.063

 Moderate to severe

−39.6

−67.1, −12.2

0.005

−46.4

−79.4, −13.3

0.006

 Mild

18.9

−9.6, 47.4

0.194

11.1

−24.4, 46.6

0.540

At least one SAE, %

−7.4

−16.7, 1.9

0.117

−8.2

−17.4, 1.0

0.080

Discontinuation for any reason, %

−8.1

−20.6, 4.3

0.201

−10.1

−23.4, 3.2

0.136

Discontinuation due to AE, %

−9.3

−19.1, 0.6

0.065

−10.4

−20.3, −0.4

0.041

Dose reduction due to AE

−41.1

−59.1, −23.1

<0.001

−40.5

−62.0, −19.0

<0.001

Dose reduction/suspension due to AE

−41.1

−60.0, −22.3

<0.001

−41.6

−63.9, −19.3

<0.001

 Agitation, %

−12.6

−23.0, −2.2

0.018

−14.2

−24.6, −3.8

0.007

 Akathisia (PI), %

−18.5

−30.5, −6.5

0.003

−18.9

−32.0, −5.8

0.005

 Anxiety, %

−11.5

−24.4, 1.5

0.083

−12.0

−25.2, 1.2

0.074

 Coughing, %

2.6

−10.2, 15.4

0.692

2.6

−10.2, 15.4

0.692

 Depression, %

−19.3

−32.0, −6.6

0.003

−20.8

−33.8, −7.8

0.002

 Depression/agitated depression, %

−17.0

−30.4, −3.7

0.013

−20.2

−33.9, −6.5

0.004

 Diarrhea, %

11.5

−3.8, 26.8

0.141

9.7

−9.4, 28.7

0.320

 Drowsiness/somnolence, %

−21.5

−39.2, −3.7

0.018

−22.9

−44.9, −0.8

0.042

 Fall, %

−7.8

−26.5, 11.0

0.417

−10.6

−32.1, 10.9

0.336

 Fatigue, %

−6.7

−25.6, 12.3

0.491

−8.3

−28.3, 11.7

0.416

 Insomnia, %

−23.7

−38.7, −8.7

0.002

−24.3

−40.9, −7.6

0.004

 Nausea, %

−8.5

−23.2, 6.1

0.255

−9.7

−24.7, 5.4

0.207

 Parkinsonism (PI), %

−14.8

−24.3, −5.3

0.002

−14.8

−24.3, −5.3

0.002

 Vomiting, %

−8.9

−20.4, 2.6

0.129

−8.7

−21.1, 3.8

0.173