Table 3. Sensitivity analyses for the effect of availability of companion diagnostics on adverse events.
AEs, adverse events; CI, confidence interval; N, number; OR, odds ratio. NE, not estimatable
| Group | N | Companion Diagnostic | Non-Companion Diagnostic | P for difference | ||
|---|---|---|---|---|---|---|
| OR | 95% CI | OR | 95% CI | |||
| Toxic death | ||||||
| Blinded companion [8-10, 24] vs non-Companion [25-38] |
18 | 1.12 | 0.59 - 2.14 | 1.29 | 0.97 - 1.72 | 0.69 |
| Open-label companion [39-45] vs non-Companion [46-52] |
14 | 1.57 | 0.98 - 2.51 | 1.24 | 0.82 - 1.86 | 0.46 |
| Best supportive care companion vs non-Companion [46, 47] |
2 | NE | NE | 1.02 | 0.45 - 2.31 | NE |
| Placebo-control only control group companion [8-10] vs non-Companion [26-28, 30, 32, 33] [34-37] |
13 | 1.58 | 0.64 - 3.9 | 1.25 | 0.89 - 1.74 | 0.63 |
| Active Treatment control group companion [24, 39-45] vs non-Companion [25-26, 29, 31, 48-52] |
17 | 1.36 | 0.9 - 2.07 | 1.36 | 0.95 - 1.96 | 0.99 |
| Active Treatment + Placebo control group companion [24] vs non-Companion [25-26, 29, 31] |
4 | 0.78 | 0.31 - 1.98 | 1.3 | 0.7 - 2.39 | 0.37 |
| Treatment discontinuation | ||||||
| Blinded companion [7-10, 24] vs non-Companion [25-38, 53] |
20 | 1.57 | 1.09 - 2.26 | 1.97 | 1.71 - 2.28 | 0.25 |
| Open-label companion[40-45, 54-56] vs non-Companion[46-51, 57-58] |
17 | 1.04 | 0.87 - 1.23 | 1.22 | 1.02 - 1.47 | 0.19 |
| Best supportive care companion vs non-Companion [46-47, 58] | 3 | NE | NE | 18.18 | 3.51 - 94.19 | NE |
| Placebo-control only control group companion [8-10], vs non-Companion [26-28, 30, 32-37] |
14 | 1.85 | 1.16 - 2.94 | 1.90 | 1.56 - 2.32 | 0.91 |
| Active Treatment control group companion [24, 40-45, 54-56] vs non-Companion [25, 29, 31, 38, 48-51, 53, 57] |
20 | 1.04 | 0.88 - 1.23 | 1.46 | 1.27 - 1.68 | 0.002 |
| Active Treatment + Placebo control group companion [24] vs non-Companion [25-26, 29, 31] |
6 | 1.13 | 0.61 - 2.09 | 2.06 | 1.67 - 2.54 | 0.07 |
| Any G3/4 AEs | ||||||
| Blinded companion [7-9] vs non-Companion [26-33, 35, 53] |
13 | 3.05 | 2.26 - 4.12 | 2.26 | 1.99 - 2.57 | 0.07 |
| Open-label companion [42-43, 45] vs non-Companion [49, 57] |
5 | 0.68 | 0.56 - 0.83 | 1.57 | 1.21 - 2.03 | <0.001 |
| Best supportive care companion vs non-Companion | 0 | NE | NE | NE | NE | NE |
| Placebo-control only control group companion [7-9] vs non-Companion [26-28, 30, 32-33, 35] |
10 | 3.05 | 2.26 - 4.12 | 2.26 | 1.9 - 2.69 | 0.09 |
| Active Treatment control group companion [42-43, 45] vs non-Companion [29, 31, 49, 53, 57] |
8 | 0.68 | 0.56 - 0.83 | 1.99 | 1.71 - 2.32 | <0.001 |
| Active Treatment + Placebo control group companion vs non-Companion [29, 31] | 3 | NE | NE | 2.26 | 1.87 - 2.73 | NE |