Sarcoma Oncology Center (Santa Monica, CA)

Grade 4 febrile neutropenia with onset in cycle 5 (2013-10-29); serious (hospitalization); assessed as related to study drug (probable); resolved 2013-11-04; action: drug interrupted.

Grade 3 anaemia with onset in cycle 5 (2013-10-22); serious (hospitalization); assessed as related to study drug (probable); resolved 2013-11-26; action: dose reduced.

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 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 3 vomiting with onset in cycle 5 (2013-08-10); serious (hospitalization); assessed as related to study drug (possible); resolved 2013-08-13; action: drug interrupted.

Grade 4 neutropenic sepsis with onset in cycle 1 (2013-07-28); serious (life-threatening; hospitalization); assessed as related to study drug (probable); resolved 2013-08-05; action: drug interrupted.

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.

Grade 3 atrial fibrillation with onset in cycle 6 (2013-05-16); serious (hospitalization); assessed as not related to study drug (not related); resolved 2013-05-19.

TUMOUR ASSESSMENT OUT OF WINDOW: CT/MRI tumour assessment performed outside the +/-7-day window of the 6-weekly schedule (subject P2B-139, 2013-09-19)

INFORMED CONSENT PROCESS DEVIATION: Re-consent to the amended ICF (Amendment 2) obtained after the next study procedure (subject P2B-139, 2013-07-28)

TUMOUR ASSESSMENT OUT OF WINDOW: CT/MRI tumour assessment performed outside the +/-7-day window of the 6-weekly schedule (subject P2B-068, 2013-03-25)

TUMOUR ASSESSMENT OUT OF WINDOW: CT/MRI tumour assessment performed outside the +/-7-day window of the 6-weekly schedule (subject P2B-078, 2013-03-06)

INFORMED CONSENT PROCESS DEVIATION: Re-consent to the amended ICF (Amendment 2) obtained after the next study procedure (subject P2B-078, 2013-02-22)

LABORATORY ASSESSMENT NOT DONE: Pre-dose haematology or chemistry panel not performed within 72 h of Day 1 (subject P2B-062, 2013-01-12)

STUDY DRUG ADMINISTRATION DEVIATION: Infusion duration outside protocol (aldoxorubicin 30 min / doxorubicin per label) or incorrect BSA used for dose calculation (subject P2B-005, 2012-08-10)

STUDY DRUG ADMINISTRATION DEVIATION: Infusion duration outside protocol (aldoxorubicin 30 min / doxorubicin per label) or incorrect BSA used for dose calculation (subject P2B-011, 2012-07-26)

VISIT OUT OF WINDOW: Cycle Day 1 visit outside the +/-3-day window without a documented toxicity delay (subject P2B-002, 2012-02-28)