Table 3.
Subgroup analysis of the relative risk (RR) of all-grade adverse events for the combination of ipi and sargramostim versus ipi alone
| Subgroup | Control
|
Analysis number | All grade, RR | 95% CI | P-value | |
|---|---|---|---|---|---|---|
| Combined therapy | Monotherapy | |||||
| Diarrhea | ||||||
| ipi (10 mg/kg)+GM-CSF (250 μg/m2) versus ipi (10 mg/kg) | 145 | 147 | – | 0.91 | 0.50–1.66 | 0.76 |
| ipi (10 mg/kg)+GM-CSF (125 μg/m2) versus ipi (10 mg/kg) | 9 | 13 | – | 0.87 | 0.27–2.74 | 0.81 |
| Nausea | ||||||
| ipi (10 mg/kg)+GM-CSF (250 μg/m2) versus ipi (10 mg/kg) | 133 | 135 | – | 0.67 | 0.20–2.32 | 0.53 |
| ipi (10 mg/kg)+GM-CSF (125 μg/m2) versus ipi (10 mg/kg) | 9 | 13 | – | 0.72 | 0.17–3.14 | 0.66 |
| Colitis | ||||||
| ipi (10 mg/kg)+GM-CSF (250 μg/m2) versus ipi (10 mg/kg) | 133 | 135 | – | 0.72 | 0.34–1.55 | 0.40 |
| ipi (10 mg/kg)+GM-CSF (125 μg/m2) versus ipi (10 mg/kg) | 9 | 13 | – | 0.16 | 0.01–2.58 | 0.19 |
| ipi (3 mg/kg)+GM-CSF (250 μg/m2) versus ipi (3 mg/kg) | 16 | 16 | – | 1.00 | 0.16–6.25 | 1.00 |
| Fatigue | ||||||
| ipi (10 mg/kg)+GM-CSF (250 μg/m2) versus ipi (10 mg/kg) | 133 | 135 | – | 0.47 | 0.02–11.87 | 0.64 |
| ipi (10 mg/kg)+GM-CSF (125 μg/m2) versus ipi (10 mg/kg) | 9 | 13 | – | 1.44 | 0.68–3.05 | 0.33 |
| Hypophysitis | ||||||
| ipi (10 mg/kg)+GM-CSF (125 μg/m2) versus ipi (10 mg/kg) | 9 | 13 | – | 2.89 | 0.31–27.27 | 0.35 |
| ipi (3 mg/kg)+GM-CSF (250 μg/m2) versus ipi (3 mg/kg) | 16 | 16 | – | 0.20 | 0.01–3.86 | 0.29 |
| Dry skin | ||||||
| ipi (10 mg/kg)+GM-CSF (250 μg/m2) versus ipi (10 mg/kg) | 133 | 135 | – | 1.02 | 0.51–2.02 | 0.96 |
| ipi (10 mg/kg)+GM-CSF (125 μg/m2) versus ipi (10 mg/kg) | 9 | 13 | – | 1.08 | 0.32–3.71 | 0.90 |
Abbreviations: GM-CSF, granulocyte-macrophage colony-stimulating factor; ipi, ipilimumab; RR, relative risk.