Table 3:
Concordance between investigator-assessed and BICR-assessed response
| Investigator-assessed |
Concordance rate of responders, n/N (%)* | |||
|---|---|---|---|---|
| Responders (CR or PR) | Non-responders | Not evaluable | ||
| BICR-assessed | ||||
| Asymptomatic intracranial | 81/95 (85%) | |||
| Responders (CR or PR) | 45 (47%) | 5 (5%) | 0 | |
| Non-responders | 8 (8%) | 25 (26%) | 1 (1%) | |
| Not evaluable | 1 (1%) | 4 (4%) | 6 (6%) | |
| Asymptomatic extracranial | 84/95 (88%) | |||
| Responders (CR or PR) | 44 (46%) | 3 (3%) | 3 (3%) | |
| Non-responders | 1 (1%) | 14 (15%) | 4 (4%) | |
| Not evaluable | 4 (4%) | 5 (5%) | 17 (18%) | |
| Asymptomatic global | 88/95 (93%) | |||
| Responders (CR or PR) | 47 (49%) | 2 (2%) | 0 | |
| Non-responders | 4 (4%) | 25 (26%) | 5 (5%) | |
| Not evaluable | 1 (1%) | 3 (3%) | 8 (8%) | |
| Symptomatic intracranial | 16/17 (94%) | |||
| Responders (CR or PR) | 3 (18%) | 1 (6%) | 0 | |
| Non-responders | 0 | 9 (53%) | 1 (6%) | |
| Not evaluable | 0 | 1 (6%) | 2 (12%) | |
| Symptomatic extracranial | 17/17 (100%) | |||
| Responders (CR or PR) | 4 (24%) | 0 | 0 | |
| Non-responders | 0 | 4 (24%) | 2 (12%) | |
| Not evaluable | 0 | 3 (18%) | 4 (24%) | |
| Symptomatic global | 17/17 (100%) | |||
| Responders (CR or PR) | 4 (24%) | 0 | 0 | 17/17 (100%) |
| Non-responders | 0 | 7 (41%) | 3 (18%) | |
| Not evaluable | 0 | 3 (18%) | 0 | |
BICR=blinded independent central review. CR=complete response. PR=partial response.
*
Quantifies the frequency with which investigator-assessed and BICR-assessed response agreed on classification of a patient as responder versus non-responder or not-evaluable (ie, matches included responder to responder, non-responder to non-responder, not evaluable to not evaluable, and not evaluable to non-responder) as a proportion of the total number of patients with assessments by both the investigator and BICR (n=95 for asymptomatic and n=17 for symptomatic).