CTRC Institute for Drug Development, University of Texas (San Antonio, TX)

Grade 3 anaemia with onset in cycle 4 (2013-07-16); serious (hospitalization); assessed as related to study drug (probable); resolved 2013-07-23; action: drug withdrawn.

Grade 3 vomiting with onset in cycle 1 (2013-06-17); serious (hospitalization); assessed as not related to study drug (unlikely); resolved 2013-06-24; action: drug withdrawn.

Grade 3 gastrointestinal haemorrhage with onset in cycle 1 (2013-06-09); serious (hospitalization); assessed as not related to study drug (unlikely); resolved 2013-06-14; action: drug interrupted.

Grade 3 leukopenia with onset in cycle 1 (2013-06-09); serious (hospitalization); assessed as related to study drug (probable); resolved 2013-06-18; action: dose reduced.

Grade 3 febrile neutropenia with onset in cycle 1 (2013-05-22); serious (hospitalization); assessed as related to study drug (probable); resolved 2013-05-28; action: drug interrupted.

Grade 2 pertussis with onset in cycle 6 (2012-12-07); serious (hospitalization); assessed as not related to study drug (unlikely); resolved 2012-12-18.

Grade 3 pneumonia with onset in cycle 1 (2012-12-04); serious (hospitalization); assessed as not related to study drug (not related); resolved 2012-12-20; action: drug interrupted.

Grade 3 cholecystitis acute with onset in cycle 5 (2012-12-02); serious (hospitalization); assessed as not related to study drug (unlikely); resolved 2012-12-14; action: drug interrupted.

VISIT OUT OF WINDOW: Cycle Day 1 visit outside the +/-3-day window without a documented toxicity delay (subject P2B-028, 2012-12-05)

LABORATORY ASSESSMENT NOT DONE: Pre-dose haematology or chemistry panel not performed within 72 h of Day 1 (subject P2B-050, 2012-11-27)

INFORMED CONSENT PROCESS DEVIATION: Re-consent to the amended ICF (Amendment 2) obtained after the next study procedure (subject P2B-050, 2012-11-08)