Table 1. Patient characteristics at enrolment (ITT population).
| Study H2201 | Study H2202 | All patients | ||
|---|---|---|---|---|
| Variable | Statistic/category | N=131 | N=100 | N=231 |
| Age (years) | Median | 55.0 | 56.5 | 56.0 |
| Range | 18–80 | 21–75 | 18–80 | |
| Age group, n (%) | 18–34 years | 10 (7.6) | 6 (6.0) | 16 (6.9) |
| 35–49 years | 31 (23.7) | 32 (32) | 63 (27.3) | |
| 50–64 years | 71 (54.2) | 47 (47.0) | 118 (51.1) | |
| ⩾65 years | 19 (14.5) | 15 (15.0) | 34 (14.7) | |
| Sex, n (%) | Male | 79 (60.3) | 65 (65.0) | 144 (62.3) |
| Female | 52 (39.7) | 35 (35.0) | 87 (37.7) | |
| Performance status | ||||
| ECOG 0–1 | 107 (81.6) | 86 (86.0) | 193 (83.5) | |
| ECOG 2 | 24 (18.3) | 14 (14.0) | 38 (16.5) | |
| Time since initial diagnosis (months) | Median | 9.0 | 10.0 | 9.0 |
| Range | 3–45 | 2–63 | 3–63 | |
| Initial tumour histology, n (%)a | AA | 6 (24.6) | 6 (16.0) | 12 (5.2) |
| GBM | 124 (94.7) | 94 (94.0) | 218 (94.4) | |
| Gliosarcoma | 1 (0.8) | 0 | 1 (0.4) | |
| Time since last recurrence (days) | Median | 27.0 | 26.0 | 26.0 |
| Range | 1–165 | 0–222 | 0–222 | |
| Measurable lesions, n (%)b,c | 0 | 5 (6.8) | 2 (7.1) | 7 (6.9) |
| 1 | 65 (89.0) | 25 (89.3) | 90 (89.1) | |
| 2 | 2 (2.7) | 1 (3.6) | 3 (3.0) | |
| >2 | 1 (1.4) | 0 (0.0) | 1 (1.0) |
a
All patients must have independent histological confirmation of their diagnosis as part of their inclusion. This review is still ongoing at the time of the interim analysis.
b
Tumour burden measurements are based on central independent review (CIR) data.
c
Tumour assessment information was assigned at baseline assessment (first MRI scan). All other data were collected at screening (in some cases this equalled baseline).