P2B-126

Grade 3 deep vein thrombosis with onset in cycle 4 (2013-09-28); serious (hospitalization); assessed as not related to study drug (unlikely); resolved 2013-11-04.

Grade 1 anaemia with onset in cycle 4 (2013-09-15); assessed as related to study drug (probable); resolved 2013-10-17.

Grade 1 abdominal pain with onset in cycle 3 (2013-09-10); assessed as not related to study drug (unlikely); resolved 2013-09-19.

Grade 2 pyrexia with onset in cycle 3 (2013-09-01); assessed as not related to study drug (unlikely); resolved 2013-09-04.

Grade 3 lower respiratory tract infection with onset in cycle 3 (2013-08-30); serious (hospitalization); assessed as related to study drug (possible); resolved 2013-09-10.

Grade 1 nausea with onset in cycle 3 (2013-08-23); assessed as not related to study drug (unlikely); resolved 2013-08-25.

Grade 1 alopecia with onset in cycle 2 (2013-08-10); assessed as related to study drug (probable); not resolved at last follow-up.

Grade 4 neutropenia with onset in cycle 1 (2013-07-19); assessed as related to study drug (probable); resolved 2013-07-27.

Grade 2 pyrexia with onset in cycle 1 (2013-07-17); serious (hospitalization); assessed as not related to study drug (not related); resolved 2013-07-19.

Visit Cycle 4 Day 1: infusion (V5) for P2B-126 occurred on 2013-09-12, 4 d late against planned day 64 (2013-09-08 ± 3 d, anchored on first dose 2013-07-07). Confirm the visit date or record a protocol deviation.

Visit Cycle 3 Day 1: infusion; week-6 CT/MRI and ECHO/MUGA before dosing (V4) for P2B-126 occurred on 2013-08-23, 5 d late against planned day 43 (2013-08-18 ± 3 d, anchored on first dose 2013-07-07). Confirm the visit date or record a protocol deviation.

AE Neutropenia (grade 4) for P2B-126 (onset 2013-07-19) is CTCAE grade 4 but not flagged serious. Confirm seriousness assessment — grade 4/5 events are life-threatening or fatal by definition.