the CLEOPATRA (WO20698) study is therefore likely to provide an indication of the potential medium-term side effects of pertuzumab given in combination with trastuzumab and docetaxel. Adverse events 40: Key safety data for the NEOSPHERE (WO20697), TRYPHAENA (BO22280) and CLEOPATRA (WO20698) Studies. Data have been reconciled with that found in Module 5 Safety Patients experiencing event Neoadjuvant setting MBC setting NEOSPHERE (WO20697) TRYPHAENA (BO22280) CLEOPATRA (WO20698) Overall Neoadjuvant treatment Neoadjuvant treatment treatment period period period T+D Ptz Ptz Ptz Ptz + Ptz Pla +T + Ptz + + + T + D T + +TCH D T + N= T+D FEC/ D N=76 N=396 107 + 08 T+D Arm C Arm 07 Arm Arm A N=72 Arm C D B Arm Arm A B Any AE 100% 98.7% 2% 9% 0% Grade > 73.7% 73.5% 3 Related 96.2% AE 2% AE disc 0 1.9 2.1 5.6% 7.9% 28.8% % AE i/m 50.0% 54.3% 6% SAE 35.5% 29.0% AE 0 0.9 0 0 0 0 0 3.0% death Death, 0 0 0 0 0 0 0 34.3% PD Death, 0 0 0 0 0 0 4.0% other
the CLEOPATRA (WO20698) study is therefore likely to provide an indication of the potential medium-term side effects of pertuzumab given in combination with trastuzumab and docetaxel. Adverse events 40: Key safety data for the NEOSPHERE (WO20697), TRYPHAENA (BO22280) and CLEOPATRA (WO20698) Studies. Data have been reconciled with that found in Module 5 Safety Patients experiencing event Neoadjuvant setting MBC setting NEOSPHERE (WO20697) Neoadjuvant treatment period TRYPHAENA (BO22280) Neoadjuvant treatment period CLEOPATRA (WO20698) Overall treatment period T+D N= 107 Arm A Ptz + T+D Arm B Ptz + T Arm C Ptz + D Arm D Ptz + T + + T+D N=72 Arm A Arm B Ptz +TCH N=76 Arm C Pla +T + D N=396 Ptz + T + D Any AE 100% 98.7% Grade > 3 73.7% 73.5% Related AE 96.2% AE disc 0 5.6% 7.9% 28.8% AE i/m 50.0% 54.3% SAE 35.5% 29.0% AE death 0 0 0 0 0 0 3.0% Death, PD 0 0 0 0 0 0 0 34.3% Death, other 0 0 0 0 0 0 4.0% 0% 6% 2.1 % 2% 2% 9% FEC/ 1.9 0.9 08 07
auspar-pertuzumab-160616-cer.docx