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)
| 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 |
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