Long-term safety including prolonged neutropenia and secondary malignancies
| Long-term safety . | Total . | FC . | FCR . | |||
|---|---|---|---|---|---|---|
| Cases N (%) . | Patients N (%) . | Cases N (%) . | Patients N (%) . | Cases N (%) . | Patients N (%) . | |
| Total patients (safety population), N | 800 | 396 | 404 | |||
| Total cases [N (%)] and patients [N (%)] with ≥1 SPM | 136 (100) | 122 (15) | 77 (57) | 69 (17) | 59 (43) | 53 (13) |
| Secondary malignancies | ||||||
| Richter’s transformation | 38 (28) | 38 (5) | 25 (33) | 25 (6) | 13 (22) | 13 (3) |
| Solid tumors | 55 (40) | 52 (7) | 29 (38) | 28 (7) | 26 (44) | 24 (6) |
| Lung | 18/55 (33) | 18 (2) | 13/29 (45) | 13 (3) | 5/26 (20) | 5 (1) |
| Prostate | 8/55 (15) | 8 (1) | 2/29 (7) | 2 (1) | 6/26 (23) | 6 (2) |
| Renal/bladder | 7/55 (13) | 6 (1) | 3/29 (10) | 3 (1) | 4/26 (15) | 3 (1) |
| Colorectal | 2/55 (4) | 2 (<1) | 0/29 (0) | 0 (0) | 2/26 (8) | 2 (<1) |
| Melanoma | 8/55 (15) | 8 (1) | 3/29 (10) | 3 (1) | 5/26 (20) | 5 (1) |
| Breast | 3/55 (6) | 3 (<1) | 1/29 (3) | 1 (<1) | 2/26 (8) | 2 (<1) |
| Pancreatic | 2/55 (4) | 2 (<1) | 1/29 (3) | 1 (<1) | 1/26 (4) | 1 (<1) |
| Ovarian/uterine/cervical | 1/55 (2) | 1 (<1) | 0/29 (0) | 0 (0) | 1/26 (4) | 1 (<1) |
| Liver/gall bladder | 1/55 (2) | 1 (<1) | 1/29 (3) | 1 (<1) | 0/26 (0) | 0 (0) |
| Thyroid | 2/55 (4) | 2 (<1) | 2/29 (7) | 2 (1) | 0/26 (0) | 0 (0) |
| Pharyngeal/laryngeal | 1/55 (2) | 1 (<1) | 1/29 (3) | 1 (<1) | 0/26 (0) | 0 (0) |
| Other | 2/55 (4) | 2 (<1) | 2/29 (7) | 2 (1) | 0/26 (0) | 0 (0) |
| Hematologic neoplasia | 24 (18) | 23 (3) | 11 (14) | 11 (3) | 13 (22) | 12 (3) |
| AML/MDS | 14/24 (58) | 13 (2) | 7/11 (64) | 7 (2) | 7/13 (54) | 6 (2) |
| Indolent B-non-Hodgkin lymphoma | 3/24 (13) | 3 (<1) | 1/11 (9) | 1 (<1) | 2/13 (16) | 2 (<1) |
| Aggressive B-non-Hodgkin lymphoma | 2/24 (8) | 2 (<1) | 1/11 (9) | 1 (<1) | 1/13 (8) | 1 (<1) |
| ALL | 1/24 (4) | 1 (<1) | 0/11 (0) | 0 (0) | 1/13 (8) | 1 (<1) |
| CML | 1/24 (4) | 1 (<1) | 0/11 (0) | 0 (0) | 1/13 (8) | 1 (<1) |
| Other | 3/24 (13) | 3 (<1) | 2/11 (18) | 2 (<1) | 1/13 (8) | 1 (<1) |
| Basalioma, squamous cell | 19 (14) | 17 (2) | 12 (16) | 11 (3) | 7 (12) | 6 (2) |
| Prolonged neutropenia | ||||||
| 2 months after end of treatment | 101 (13) | 34 (9) | 67 (17) | |||
| 12 months after end of treatment | 30 (4) | 14 (4) | 16 (4) | |||
| Long-term safety . | Total . | FC . | FCR . | |||
|---|---|---|---|---|---|---|
| Cases N (%) . | Patients N (%) . | Cases N (%) . | Patients N (%) . | Cases N (%) . | Patients N (%) . | |
| Total patients (safety population), N | 800 | 396 | 404 | |||
| Total cases [N (%)] and patients [N (%)] with ≥1 SPM | 136 (100) | 122 (15) | 77 (57) | 69 (17) | 59 (43) | 53 (13) |
| Secondary malignancies | ||||||
| Richter’s transformation | 38 (28) | 38 (5) | 25 (33) | 25 (6) | 13 (22) | 13 (3) |
| Solid tumors | 55 (40) | 52 (7) | 29 (38) | 28 (7) | 26 (44) | 24 (6) |
| Lung | 18/55 (33) | 18 (2) | 13/29 (45) | 13 (3) | 5/26 (20) | 5 (1) |
| Prostate | 8/55 (15) | 8 (1) | 2/29 (7) | 2 (1) | 6/26 (23) | 6 (2) |
| Renal/bladder | 7/55 (13) | 6 (1) | 3/29 (10) | 3 (1) | 4/26 (15) | 3 (1) |
| Colorectal | 2/55 (4) | 2 (<1) | 0/29 (0) | 0 (0) | 2/26 (8) | 2 (<1) |
| Melanoma | 8/55 (15) | 8 (1) | 3/29 (10) | 3 (1) | 5/26 (20) | 5 (1) |
| Breast | 3/55 (6) | 3 (<1) | 1/29 (3) | 1 (<1) | 2/26 (8) | 2 (<1) |
| Pancreatic | 2/55 (4) | 2 (<1) | 1/29 (3) | 1 (<1) | 1/26 (4) | 1 (<1) |
| Ovarian/uterine/cervical | 1/55 (2) | 1 (<1) | 0/29 (0) | 0 (0) | 1/26 (4) | 1 (<1) |
| Liver/gall bladder | 1/55 (2) | 1 (<1) | 1/29 (3) | 1 (<1) | 0/26 (0) | 0 (0) |
| Thyroid | 2/55 (4) | 2 (<1) | 2/29 (7) | 2 (1) | 0/26 (0) | 0 (0) |
| Pharyngeal/laryngeal | 1/55 (2) | 1 (<1) | 1/29 (3) | 1 (<1) | 0/26 (0) | 0 (0) |
| Other | 2/55 (4) | 2 (<1) | 2/29 (7) | 2 (1) | 0/26 (0) | 0 (0) |
| Hematologic neoplasia | 24 (18) | 23 (3) | 11 (14) | 11 (3) | 13 (22) | 12 (3) |
| AML/MDS | 14/24 (58) | 13 (2) | 7/11 (64) | 7 (2) | 7/13 (54) | 6 (2) |
| Indolent B-non-Hodgkin lymphoma | 3/24 (13) | 3 (<1) | 1/11 (9) | 1 (<1) | 2/13 (16) | 2 (<1) |
| Aggressive B-non-Hodgkin lymphoma | 2/24 (8) | 2 (<1) | 1/11 (9) | 1 (<1) | 1/13 (8) | 1 (<1) |
| ALL | 1/24 (4) | 1 (<1) | 0/11 (0) | 0 (0) | 1/13 (8) | 1 (<1) |
| CML | 1/24 (4) | 1 (<1) | 0/11 (0) | 0 (0) | 1/13 (8) | 1 (<1) |
| Other | 3/24 (13) | 3 (<1) | 2/11 (18) | 2 (<1) | 1/13 (8) | 1 (<1) |
| Basalioma, squamous cell | 19 (14) | 17 (2) | 12 (16) | 11 (3) | 7 (12) | 6 (2) |
| Prolonged neutropenia | ||||||
| 2 months after end of treatment | 101 (13) | 34 (9) | 67 (17) | |||
| 12 months after end of treatment | 30 (4) | 14 (4) | 16 (4) | |||