Disease activity indices do not necessarily reflect disease outcome in the generally short timeframes of protocol treatment.
These deaths, judged as the result of serious shortcomings when coroners issue a "prevention of future death notice", are attributed to factors such as not following protocol, treatment delays, medication mistakes and insufficient risk assessments.
Early protocol treatment cessation was also more frequent in those age ≥ 65 years (50%) versus < 65 years (35.9%) across trials.
The maximum response achieved using all protocol treatment was 27 (66%) CRs, seven (17%) PRs or regression, six (15%) SDs, and one (2%) PD.
There was 98% protocol treatment compliance.
Six patients (15.4%) did not complete the protocol treatment.
All patients have discontinued protocol treatment as of August 2008.
The end of the protocol treatment period was not prescribed.
All patients who started protocol treatment are evaluable for toxicity.
During the course of protocol treatment, three patient deaths occurred.
Forty patients (72.7%) received subsequent therapy after protocol treatment.
