Table 2.
Cases with unresolved disagreements between central and site assessments following independent radiologist review
| Participant | Site-assessed progression date | Radiology review (1) | Radiology review (2) | Reason for disagreement | Significance |
|---|---|---|---|---|---|
| 013 | 18 Mar 2013 | SD at 18 Mar 13* | PD at 5 Mar 13* | Significance of new ascites | Disagreement in interpretation of RECIST |
| 062 | 4 Sep 2013 | SD at 4 Sep 13 | PD at 4 Sep 13 | Different choice of TLs; subsequent review against site chosen lesions agreed with site | Issue with application of RECIST/choice of target lesions |
*An ad hoc scan was performed on 5 March prior to scheduled assessment on 18 March. This identified new ascites. This was considered a new lesion consistent with PD by one of the radiologists