Table 5.
Trial Characteristics associated with harm reporting quality score (0-16 scale).
| Trial Characteristics | HRQS | Linear Regression | ||||||
|---|---|---|---|---|---|---|---|---|
| Univariate Analysis | Multivariate Analysis | |||||||
| Mean | SE | Estimate | SE | P | Estimate | SE | P | |
| Year of publication, continuous | — | — | -0.004 | 0.055 | 0.937 | |||
| Journal type | ||||||||
| Oncologic journal | 11.1 | 1.826 | Reference | 0.822 | ||||
| Comprehensive journal | 11.03 | 1.264 | -0.064 | 0.284 | ||||
| Journal impact factor | ||||||||
| <30 | 9.67 | 2.06 | Reference | 0.003 | Reference | |||
| 30~60 | 11.35 | 1.647 | 1.679 | 0.479 | 1.192 | 0.508 | 0.021 | |
| >60 | 11.09 | 1.195 | 1.423 | 0.479 | 0.645 | 0.626 | 0.305 | |
| Phase of trial | ||||||||
| Phase II | 10 | 2.303 | Reference | <0.001 | Reference | |||
| Phase III | 11.32 | 1.211 | 1.323 | 0.337 | 1.030 | 0.445 | 0.023 | |
| Sources of trial funding | ||||||||
| Funded by industry | 11.09 | 1.555 | Reference | 0.155 | Reference | |||
| No industry funding | 9.5 | 2.121 | -1.591 | 1.112 | -0.298 | 1.105 | 0.788 | |
| Region in which trial was led | ||||||||
| International | 11.09 | 1.442 | Reference | 0.723 | ||||
| Others | 10.95 | 2.172 | -0.139 | 0.392 | ||||
| Continent where is the principal investigator from | ||||||||
| North America | 10.81 | 1.562 | Reference | 0.032 | Reference | |||
| Europe | 10.94 | 1.713 | 0.127 | 0.328 | 0.077 | 0.309 | 0.805 | |
| Asia | 11.78 | 1.166 | 0.970 | 0.372 | 0.621 | 0.400 | 0.123 | |
| Oceania | 12.33 | 0.577 | 1.521 | 0.903 | 1.170 | 0.866 | 0.180 | |
| Participating centers, No. of centers | ||||||||
| ≤120 | 11.35 | 1.591 | Reference | 0.003 | Reference | |||
| >120 | 11.2 | 1.325 | -0.154 | 0.297 | -0.146 | 0.347 | 0.675 | |
| Unknown | 10 | 1.747 | -1.354 | 0.401 | -0.628 | 0.416 | 0.134 | |
| Sample size, continuous | — | — | 0.000 | 0.000 | 0.067 | 0.000 | 0.000 | 0.891 |
| Tumor type | ||||||||
| Lung cancer | 10.77 | 1.716 | Reference | 0.402 | ||||
| Melanoma | 11.14 | 1.356 | 0.369 | 0.411 | ||||
| Urinary system | 10.94 | 1.305 | 0.177 | 0.440 | ||||
| Digestive system | 11.21 | 1.398 | 0.443 | 0.432 | ||||
| Others | 11.57 | 1.777 | 0.804 | 0.417 | ||||
| Immune checkpoint blocking agent | ||||||||
| Anti-PD-1 | 11.33 | 1.654 | Reference | 0.183 | Reference | |||
| Anti-PD-L1 | 10.58 | 1.455 | -0.753 | 0.344 | -0.580 | 0.340 | 0.091 | |
| Anti-CTLA-4 | 10.94 | 1.611 | -0.396 | 0.437 | -0.456 | 0.460 | 0.324 | |
| Multi-agents | 11.13 | 1.258 | -0.208 | 0.437 | -0.057 | 0.431 | 0.895 | |
| Immunotherapy strategy | ||||||||
| Immunotherapy (monotherapy or combination of two types of ICI) | 11.03 | 1.739 | Reference | 0.590 | ||||
| Combined with chemotherapy | 11.23 | 1.104 | 0.207 | 0.340 | ||||
| Combined with target therapy | 10.8 | 1.398 | -0.226 | 0.532 | ||||
| Combined with others | 11.17 | 1.722 | 0.141 | 0.671 | ||||
| Results of the primary outcome | ||||||||
| Positive | 11.32 | 1.145 | Reference | 0.011 | Reference | |||
| Negative | 10.58 | 2.074 | -0.744 | 0.290 | -0.602 | 0.367 | 0.104 | |
HRQS, harm reporting quality score; SE, standard error; PD-1, programmed cell death protein 1; PD-L1, programmed death-ligand 1; CTLA-4, cytotoxic T-lymphocyte antigen 4; ICI, immune checkpoint inhibitors.