This SAP would need CHMP approval prior to implementation by Q1-2008 • To submit the clinical study reports of 20030167 and 20030250 studies including the safety-efficacy analysis in relation with KRAS by Q1-2008 • To submit the clinical study report of PACCE study (even if interim) including the safety-efficacy analysis in relation with KRAS by Q1-2008 • To submit the clinical study summary report of 20050181 study to confirm the hypothesis on wild-type KRAS as a biomarker for selecting patients to be treated by Q4-2008 • To provide data on Quality of Life of 20050181 study by Q4-2008 • To submit the clinical study report of STEPP study including the safety-efficacy analysis in relation with KRAS by Q1-2009 • To submit the clinical study summary reports of SPIRITT and PRECEPT studies including the safety-efficacy analysis in relation with KRAS by Q2-2009 • To submit the clinical study report summary of 20050203 study including the safety-efficacy analysis in relation with KRAS by Q4-2009. • To provide additional data on Quality of Life of 20050203 study by Q4-2009 • To submit the final clinical study summary report of • 20050203 study including the safety-efficacy analysis in relation with KRAS by Q1-2010 • To provide additional data on Quality of Life of 20050203 study by Q1-2010 • To submit the final clinical study report of 20050181 study including the safety-efficacy analysis in relation with KRAS by Q1-2010 • To submit the final clinical study report of PACCE study including the safety-efficacy analysis in relation with KRAS by Q2-2011
Questo piano di analisi statistica (SAP) richiederà l’ approvazione del CHMP prima della sua implementazione che dovrà avvenire entro Q1-2008 • Presentare i clinical study report degli studi 20030167 e 20030250 includendo le analisi di sicurezza ed efficacia in relazione con KRAS entro Q1-2008 • Presentare il clinical study report dello studio PACCE (anche se ad interim) includendo le analisi di sicurezza ed efficacia in relazione con KRAS entro Q1-2008 • Presentare il clinical study summary report dello studio 20050181 per confermare l’ ipotesi sul KRAS wild-type come biomarker dei pazienti selezionati da trattare entro Q4-2008 • Fornire dati sulla Qualità di Vita dello studio 20050181 entro Q4-2008 • Presentare il clinical study report dello studio STEPP includendo le analisi di sicurezza ed efficacia in relazione con KRAS entro Q1-2009 • Presentare il clinical study summary reports degli studi SPIRITT e PRECEPT includendo le analisi di sicurezza ed efficacia in relazione con KRAS entro Q2-2009 • Presentare i clinical study report dello studio 20050203 includendo le analisi di sicurezza ed efficacia in relazione con KRAS entro Q4-2009 • Fornire dati sulla Qualità di Vita dello studio 20050203 entro Q4-2009 • Presentare il final clinical study summary report dello studio 20050203 includendo le analisi di sicurezza ed efficacia in relazione con KRAS entro Q1-2010 • Fornire dati addizionali sulla Qualità di Vita dello studio 20050203 entro Q1-2010 • Presentare il final clinical study summary report dello studio 20050181 includendo le analisi di sicurezza ed efficacia in relazione con KRAS entro Q1-2010 • Presentare il final clinical study summary report dello studio PACCE includendo le analisi di sicurezza ed efficacia in relazione con KRAS entro Q2-2011