Overview of safety
| Characteristic . | Patients (n = 41) . |
|---|---|
| Patients with ≥1 AE, n (%) | 41 (100.0) |
| Total number of AEs, n | 528 |
| Patients with ≥1 AE grade 3-5, n (%) | 32 (78.0) |
| CTC grade for all AEs | |
| 1 | 229 (43.4) |
| 2 | 173 (32.8) |
| 3 | 102 (19.3) |
| 4 | 22 (4.2) |
| 5 | 2 (0.4) |
| Outcome for all AEs, n (%) | |
| Resolved | 454 (86.0) |
| Resolved with sequelae | 8 (1.5) |
| Persisting | 63 (11.9) |
| Death | 2 (0.4) |
| Missing | 1 (0.2) |
| Patients with ≥1 related SAEs, n (%) | 25 (61.0) |
| Total number of SAEs, n | 56 |
| CTC grade for all SAEs, n (%) | |
| 1 | 1 (1.8) |
| 2 | 6 (10.7) |
| 3 | 45 (80.4) |
| 4 | 2 (3.6) |
| 5 | 2 (3.6) |
| Total number of treatment-related SAEs, n (%) | 33 (58.9) |
| Patients who discontinued due to AE, n (%) | 5 (12.2) |
| Total number of AEs leading to permanent discontinuation, n (%) | 5 (0.9) |
| AEs leading to permanent treatment discontinuation by term, max. cycles of treatment (CTCAE Grade)* | |
| Progressive multifocal leukencephalopathy | C9 (2) |
| Ovarian cancer | C3 (5) |
| Cerebral aspergillosis | C12 (4) |
| Atrial fibrilliation | C12 (1) |
| Arthralgia | C15 (1) |
| Patients with ≥1 AE leading to dose modifications, n (%) | 31 (75.6) |
| Total number of AEs leading to dose modifications, n (%) | |
| Reductions | 25 (4.7) |
| Interruptions | 73 (13.8) |
| Category (SOC) with total number of AEs >5%, n (%) | |
| Blood and lymphatic system disorders | 93 (17.6) |
| Gastrointestinal disorders | 91 (17.2) |
| Infections and infestations | 90 (17.0) |
| General disorders and administration site conditions | 39 (7.4) |
| Musculoskeletal and connective tissue disorders | 30 (5.7) |
| Characteristic . | Patients (n = 41) . |
|---|---|
| Patients with ≥1 AE, n (%) | 41 (100.0) |
| Total number of AEs, n | 528 |
| Patients with ≥1 AE grade 3-5, n (%) | 32 (78.0) |
| CTC grade for all AEs | |
| 1 | 229 (43.4) |
| 2 | 173 (32.8) |
| 3 | 102 (19.3) |
| 4 | 22 (4.2) |
| 5 | 2 (0.4) |
| Outcome for all AEs, n (%) | |
| Resolved | 454 (86.0) |
| Resolved with sequelae | 8 (1.5) |
| Persisting | 63 (11.9) |
| Death | 2 (0.4) |
| Missing | 1 (0.2) |
| Patients with ≥1 related SAEs, n (%) | 25 (61.0) |
| Total number of SAEs, n | 56 |
| CTC grade for all SAEs, n (%) | |
| 1 | 1 (1.8) |
| 2 | 6 (10.7) |
| 3 | 45 (80.4) |
| 4 | 2 (3.6) |
| 5 | 2 (3.6) |
| Total number of treatment-related SAEs, n (%) | 33 (58.9) |
| Patients who discontinued due to AE, n (%) | 5 (12.2) |
| Total number of AEs leading to permanent discontinuation, n (%) | 5 (0.9) |
| AEs leading to permanent treatment discontinuation by term, max. cycles of treatment (CTCAE Grade)* | |
| Progressive multifocal leukencephalopathy | C9 (2) |
| Ovarian cancer | C3 (5) |
| Cerebral aspergillosis | C12 (4) |
| Atrial fibrilliation | C12 (1) |
| Arthralgia | C15 (1) |
| Patients with ≥1 AE leading to dose modifications, n (%) | 31 (75.6) |
| Total number of AEs leading to dose modifications, n (%) | |
| Reductions | 25 (4.7) |
| Interruptions | 73 (13.8) |
| Category (SOC) with total number of AEs >5%, n (%) | |
| Blood and lymphatic system disorders | 93 (17.6) |
| Gastrointestinal disorders | 91 (17.2) |
| Infections and infestations | 90 (17.0) |
| General disorders and administration site conditions | 39 (7.4) |
| Musculoskeletal and connective tissue disorders | 30 (5.7) |
CTC, common terminology criteria; SOC, system organ class; C, cycle.
AEs (and their CTCAE grades in brackets) listed by term and number of maximally reached cycles (C) of treatment, detailed and described in the paragraph “Efficacy.”