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Table 2 Change from baseline in efficacy endpoints (full-analysis set)

From: Adjunct rasagiline to treat Parkinson’s disease with motor fluctuations: a randomized, double-blind study in China

  Adjusted mean change from baseline (SE) Difference vs placebo (95% CI) p-values
Placebo (n = 152) Rasagiline 1 mg/day (n = 158)
Primary endpoint (mean change over Weeks 4, 8, 12, and 16; ANCOVA, OC)
Total daily OFF time, hoursa − 0.76 (0.16) −1.25 (0.16) −0.50 (− 0.92, − 0.07) 0.023
Secondary endpoints (Week 16; ANCOVA, LOCF)
 CGI-Ib 3.56 (0.07) 3.15 (0.07) −0.41 (− 0.61, − 0.22) < 0.001
 UPDRS-ADL OFF −1.20 (0.28) − 2.21 (0.28) − 1.01 (− 1.75, − 0.27) 0.008
 UPDRS-Motor ON −1.75 (0.55) − 3.34 (0.55) − 1.60 (− 3.05, − 0.14) 0.032
Exploratory analyses (mean change from baseline to Week 16 in total daily OFF time)
 ANCOVA, OC −0.87 (0.21) (n = 147) − 1.39 (0.21) (n = 151) − 0.52 (− 1.06, 0.02) 0.0602
 ANCOVA, LOCF −0.81 (0.20) − 1.36 (0.20) −0.55 (− 1.08, − 0.02) 0.0412
 MMRM, OC −0.81 (0.20) −1.34 (0.20) − 0.53 (− 1.07, 0.00) 0.0514
PDQ-39 summary index and dimension scores (mean change, SE at Week 16; ANCOVA, OC)
 Summary index −0.1 (0.8) −1.9 (0.8) −1.8 (−3.96, 0.42) 0.1122
 Activities of daily living 2.0 (1.3) −4.0 (1.3) −6.1 (−9.52, − 2.64) < 0.001
 Bodily discomfort 1.7 (1.4) − 2.2 (1.4) −3.9 (− 7.65, − 0.12) 0.043
 Cognition 0.9 (1.2) 0.4 (1.2) −0.6 (−3.77, 2.67) 0.737
 Communication −1.0 (1.2) 0.1 (1.2) 1.1 (−2.09, 4.23) 0.506
 Emotional well-being −0.6 (1.5) −3.0 (1.5) −2.4 (−6.35, 1.49) 0.224
 Mobility −1.6 (1.2) −4.1 (1.2) −2.5 (−5.59, 0.53) 0.104
 Social support −1.2 (1.1) 0.4 (1.1) 1.6 (−1.35, 4.53) 0.288
Stigma −2.2 (1.4) −4.7 (1.4) −2.5 (−6.22, 1.32) 0.202
EQ-5D (mean change, SE at Week 16; ANCOVA, OC)
 Utility index 0.00 (0.02) 0.05 (0.02) 0.05 (0.01, 0.09) 0.024
 Health statec 0.77 (1.18) 5.09 (1.20) 4.31 (1.18, 7.45) 0.007
  1. an = 150 for placebo group
  2. babsolute value at Week 16
  3. cmeasured using visual analogue scale