Investigator-reported and independent review-reported cases of MDS/AML after tositumomab and iodine I131 tositumomab
Study . | No. . | No. MDS/AML . | Crude incidence, % (95% CI) . | After tositumomab and iodine I131 tositumomab, person-years . | Median follow-up, y . | Annualized incidence, %, y (95% CI) . |
|---|---|---|---|---|---|---|
| Investigator-reported | ||||||
| RIT-I-000 | 22 | 5 | 22.7 (7.8-45.3) | 104 | 3.8 | 4.8 (2.0-11.5) |
| RIT-II-001 | 47 | 5 | 10.6 (3.5-23.1) | 167 | 2.8 | 3.0 (1.2-7.2) |
| RIT-II-002 | 61 | 4 | 6.6 (1.8-15.9) | 177 | 3.2 | 2.3 (0.8-6.0) |
| RIT-II-004 | 60 | 4 | 6.7 (1.8-16.2) | 152 | 2.5 | 2.6 (1.0-7.0) |
| CP-97-012 | 40 | 2 | 5.0 (0.6-16.9) | 103 | 3.2 | 1.9 (0.5-7.7) |
| Expanded access | 765 | 15 | 2.0 (1.1-3.2) | 1,440 | 1.9 | 1.0 (0.6-1.7) |
| Subtotal | 995 | 35 | 3.5 (2.5-4.9) | 2144 | 2.0 | 1.6 (1.2-2.3) |
| RIT-II-003 | 76 | 0 | 0.0 (0.0-4.7) | 346 | 4.6 | 0.0 (0.0-0.9) |
| Total | 1071 | 35 | 3.3 (2.3-4.5) | 2490 | 2.1 | 1.4 (1.0-2.0) |
| Independent review-reported | ||||||
| RIT-I-000 | 20 | 3 | 15.0 (3.2-37.9) | 96 | 3.8 | 3.1 (1.0-9.6) |
| RIT-II-001 | 46 | 4 | 8.7 (2.4-20.8) | 166 | 2.9 | 2.4 (0.9-6.4) |
| RIT-II-002 | 60 | 3 | 5.0 (1.0-13.9) | 176 | 3.2 | 1.7 (0.5-5.3) |
| RIT-II-004 | 59 | 2 | 3.4 (0.4-11.7) | 154 | 2.4 | 1.3 (0.3-5.2) |
| CP-97-012 | 40 | 2 | 5.0 (0.6-16.9) | 103 | 3.2 | 1.9 (0.5-7.7) |
| Expanded access | 760 | 9 | 1.2 (0.5-2.2) | 1436 | 1.9 | 0.6 (0.3-1.2) |
| Subtotal | 985 | 23 | 2.3 (1.5-3.5) | 2132 | 2.0 | 1.1 (0.7-1.6) |
| RIT-II-003 | 76 | 0 | 0.0 (0.0-4.7) | 346 | 4.6 | 0.0 (0.0-0.9) |
| Total | 1061 | 23 | 2.2 (1.4-3.2) | 2479 | 2.1 | 0.9 (0.6-1.4) |
Study . | No. . | No. MDS/AML . | Crude incidence, % (95% CI) . | After tositumomab and iodine I131 tositumomab, person-years . | Median follow-up, y . | Annualized incidence, %, y (95% CI) . |
|---|---|---|---|---|---|---|
| Investigator-reported | ||||||
| RIT-I-000 | 22 | 5 | 22.7 (7.8-45.3) | 104 | 3.8 | 4.8 (2.0-11.5) |
| RIT-II-001 | 47 | 5 | 10.6 (3.5-23.1) | 167 | 2.8 | 3.0 (1.2-7.2) |
| RIT-II-002 | 61 | 4 | 6.6 (1.8-15.9) | 177 | 3.2 | 2.3 (0.8-6.0) |
| RIT-II-004 | 60 | 4 | 6.7 (1.8-16.2) | 152 | 2.5 | 2.6 (1.0-7.0) |
| CP-97-012 | 40 | 2 | 5.0 (0.6-16.9) | 103 | 3.2 | 1.9 (0.5-7.7) |
| Expanded access | 765 | 15 | 2.0 (1.1-3.2) | 1,440 | 1.9 | 1.0 (0.6-1.7) |
| Subtotal | 995 | 35 | 3.5 (2.5-4.9) | 2144 | 2.0 | 1.6 (1.2-2.3) |
| RIT-II-003 | 76 | 0 | 0.0 (0.0-4.7) | 346 | 4.6 | 0.0 (0.0-0.9) |
| Total | 1071 | 35 | 3.3 (2.3-4.5) | 2490 | 2.1 | 1.4 (1.0-2.0) |
| Independent review-reported | ||||||
| RIT-I-000 | 20 | 3 | 15.0 (3.2-37.9) | 96 | 3.8 | 3.1 (1.0-9.6) |
| RIT-II-001 | 46 | 4 | 8.7 (2.4-20.8) | 166 | 2.9 | 2.4 (0.9-6.4) |
| RIT-II-002 | 60 | 3 | 5.0 (1.0-13.9) | 176 | 3.2 | 1.7 (0.5-5.3) |
| RIT-II-004 | 59 | 2 | 3.4 (0.4-11.7) | 154 | 2.4 | 1.3 (0.3-5.2) |
| CP-97-012 | 40 | 2 | 5.0 (0.6-16.9) | 103 | 3.2 | 1.9 (0.5-7.7) |
| Expanded access | 760 | 9 | 1.2 (0.5-2.2) | 1436 | 1.9 | 0.6 (0.3-1.2) |
| Subtotal | 985 | 23 | 2.3 (1.5-3.5) | 2132 | 2.0 | 1.1 (0.7-1.6) |
| RIT-II-003 | 76 | 0 | 0.0 (0.0-4.7) | 346 | 4.6 | 0.0 (0.0-0.9) |
| Total | 1061 | 23 | 2.2 (1.4-3.2) | 2479 | 2.1 | 0.9 (0.6-1.4) |