P2B-097

Royal Hobart Hospital (Hobart, Australia) › P2B-097

P2B-097

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
Royal Hobart Hospital (Hobart, Australia) · Dr. Novak
consented 2013-04-01

completed

AEs

5

Serious

0

Dropout signal

–

Adverse events

5

Grade 1 hypoalbuminaemia with onset in cycle 4 (2013-07-03); assessed as not related to study drug (unlikely); resolved 2013-08-04.

mild assessed

Grade 2 oedema peripheral with onset in cycle 4 (2013-06-27); assessed as not related to study drug (unlikely); resolved 2013-08-09.

moderate assessed

Grade 3 fatigue with onset in cycle 3 (2013-06-03); assessed as not related to study drug (unlikely); resolved 2013-06-12; action: drug interrupted.

severe assessed

Grade 1 pyrexia with onset in cycle 1 (2013-05-04); assessed as not related to study drug (not related); resolved 2013-05-07.

mild assessed

Grade 2 nausea with onset in cycle 1 (2013-04-24); assessed as not related to study drug (unlikely); resolved 2013-04-25.

moderate assessed

Data queries

0

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