Expert radiologists are consulted for all abnormal findings and the management of clinically relevant findings is based on protocols defined by expert panels.
Outcome was assessed by investigators at the end of therapy or at the last visit as success (complete or partial response), stable infection, or failure, based on protocol-defined criteria.
Supplementary treatment was permissible at week 78, based on protocol-defined criteria.
In total, 7 of 30 (23%) patients required dose reductions based on protocol-defined toxicities, with doses reduced to 300 mg per day in three patients (10%).
Four subjects had grade 2 increases in ALT, which resulted in premature discontinuation of the study based on protocol-defined stopping criteria.
In Group C, the irinotecan dose was based on protocol-defined toxicity risk factors identified at baseline: grade 3 4 neutropenia (bilirubin >70% upper limit of normal (UNL), haemoglobin <12 g dl−1, >3 organs involved) and/or grade 3 4 diarrhoea (PS⩾1, creatinine >70% UNL (Freyer et al, 2000)).
Study drug interruption (and reintroduction), dose reduction (and re-escalation), and permanent discontinuation were employed based on protocol-defined criteria, which differed for hematologic AEs, skin toxicities, hypertension, and any other AEs (Supplementary Tables 1, 2, 3 and 4, see section on supplementary data given at the end of this article) (Brose et al. 2014 a ).
Some patients completed their 3, 6 or 12 month visit earlier or later than scheduled (see results) based on the protocol defined visit schedule and visit windows.
Finally, we revised the questionnaire and administered it to the mothers in the children's kindergartens based on a defined protocol.
Therefore, the 'human embryonic stem cell (hESC -derived novel alternative test systems (ESNATS)' European commission researchESC -derivedablished RT tests based onovelined differentialternativecols of hESC and testr progeny.
