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Table 3 Ratio of risks, odds, difference or means of secondary efficacy outcomes and harm outcomes across the three sources of data (clinical study report, journal publication and registry report)

From: Benefits and harms of Risperidone and Paliperidone for treatment of patients with schizophrenia or bipolar disorder: a meta-analysis involving individual participant data and clinical study reports

Outcomes

CSR vs. journal publication

CSR vs. registry report

Journal publication vs. registry report

Risperidone

 Efficacy

  Time to relapse

ROR = 1.43 (0.31, 6.48)

ROR = 1.73 (0.39, 7.65)

ROR = 1.21 (0.56, 2.61)

  YMRS

ROM = − 1.83 (− 4.76, 1.10)

ROM = − 2.38 (− 4.64, 0.12)

ROM = − 2.38 (− 4.64, 0.12)

  CGI-S

ROM = − 0.56 (− 3.38, 2.26)

NA

NA

 Safety

  TEAEs

RRR = 0.97 (0.83, 1.14)

RRR = 1.03 (0.86, 1.23)

RRR = 1.06 (0.84, 1.33)

  SAEs

RRR = 0.70 (0.14, 3.42)

RRR = 1.48 (0.64, 3.45)

RRR = 2.13 (0.37, 12.3)

  Discontinuation due to AEs

RRR = 1.14 (0.63, 2.05)

RRR = 0.65 (0.16, 2.67)

RRR = 0.57 (0.14, 2.42)

  Death

NA

NA

NA

Paliperidone

 Efficacy

  Time to relapse

ROR = 3.63 (0.33, 39.44)

ROR = 0.31 (0.03, 3.84)

ROR = 0.09 (0.03, 0.27)

  YMRS

ROM = 0.96 (− 1.73, 3.65)

ROM = − 0.28 (− 1.93, 1.37)

ROM = − 1.24 (− 4.16, 1.68)

  CGI-S

ROM = 2 (− 1.13, 5.13)

ROM = − 0.46 (− 1.83, 0.91)

ROM = − 2.46 (− 5.52, 0.60)

 Safety

  TEAEs

RRR = 1 (0.91, 1.10)

RRR = 0.86 (0.71, 1.03)

RRR = 0.86 (0.71, 1.04)

  SAEs

RRR = 1 (0.61, 1.64)

RRR = 1.38 (0.40, 4.84)

RRR = 1.38 (0.37, 5.17)

  Discontinuation due to AEs

RRR = 1 (0.55, 1.80)

RRR = 1.04 (0.36, 3.00)

RRR = 1.04 (0.37, 2.89)

  Death

NA

NA

NA

Paliperidone palmitate

 Efficacy

  Time to relapse

ROR = 1.25 (0.03, 60.54)

ROR = 0.17 (0.003, 8.75)

ROR = 0.14 (0.06, 0.30)

  YMRS

NA

NA

NA

  CGI-S

NA

ROM = 0 (− 0.32, 0.32)

NA

 Safety

  TEAEs

RRR = 0.95 (0.79, 1.15)

RRR = 0.90 (0.76, 1.07)

RRR = 0.95 (0.74, 1.21)

  SAEs

RRR = 2.54 (0.81, 7.98)

RRR = 1.13 (0.62, 2.05)

RRR = 0.44 (0.13, 1.47)

  Discontinuation due to AEs

RRR = 0.88 (0.24, 3.20)

RRR = 0.96 (0.47, 1.99)

RRR = 1.09 (0.34, 3.45)

  Death

NA

NA

NA

  1. ROM ratio of means, RRR ratio of relative risks, ROR ratio of odds ratio, NA not applicable, CSR clinical study report, PANSS Positive and Negative Syndrome Scale, YMRS Young Mania Rating Scale, CGI-S Clinical Global Impression rating scales, TEAEs treatment-emergent adverse events, SAEs serious adverse events