P2B-121

Pennsylvania Hematology Oncology Associates (Philadelphia, PA) › P2B-121

P2B-121

A Multicenter, Randomized, Open-Label Phase 2b Study to Investigate the Preliminary Efficacy and Safety of INNO-206 (Doxorubicin-EMCH) Compared to Doxorubicin in Subjects With Metastatic, Locally Advanced, or Unresectable Soft Tissue Sarcoma · Phase II
Pennsylvania Hematology Oncology Associates (Philadelphia, PA) · Dr. Tanaka
consented 2013-06-04

completed

AEs

4

Serious

0

Dropout signal

–

Adverse events

4

Grade 1 diarrhoea with onset in cycle 5 (2013-09-16); assessed as related to study drug (possible); resolved 2013-09-18.

mild assessed

Grade 1 hypoalbuminaemia with onset in cycle 2 (2013-07-17); assessed as not related to study drug (unlikely); resolved 2013-08-18.

mild assessed

Grade 2 fatigue with onset in cycle 2 (2013-07-10); assessed as not related to study drug (not related); resolved 2013-07-22.

moderate assessed

Grade 1 hypocalcaemia with onset in cycle 1 (2013-06-21); assessed as not related to study drug (unlikely); resolved 2013-07-12.

mild assessed

Data queries

0

No data queries. Open queries would appear here for this patient.