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Monday, February 19, 2024 5:35:39 AM
Supplement 1.
Trial protocol.
”For purposes of the Secondary Endpoint #2, Confirmed Progressive Disease (cPD) is defined as:
Initial disease progression determined through independent review (unconfirmed PD), AND also either
(i) a new lesion or
(ii) any one of the following criteria (modified iRANO criteria):
* A further 25% increase or greater in the sum of bi-perpendicular diameters of enhancing tumor, occurring at least 4 weeks after the initial event of PD/PSPD;
* Significant increase in T2/FLAIR non-enhancing lesion attributable to tumor growth;
* Death (all deaths are counted as events).
A secondary analysis will, in addition to the MRI findings, take into account the clinical status of the patient, as follows:
* Non-temporary increase in steroid dose >2 mg/day not associated with the unconfirmed PD event;
* Significant clinical decline not attributable to other causes;”
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