P2B-137

CTRC Institute for Drug Development, University of Texas (San Antonio, TX) › P2B-137

P2B-137

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
CTRC Institute for Drug Development, University of Texas (San Antonio, TX) · Dr. Muller
consented 2013-07-17

completed

AEs

3

Serious

0

Dropout signal

–

Adverse events

3

Grade 3 hypokalaemia with onset in cycle 4 (2013-10-24); assessed as not related to study drug (not related); resolved 2013-11-02; action: drug interrupted.

severe assessed

Grade 2 anaemia with onset in cycle 3 (2013-10-02); assessed as related to study drug (probable); resolved 2013-10-23.

moderate assessed

Grade 1 nausea with onset in cycle 2 (2013-08-23); assessed as not related to study drug (not related); resolved 2013-08-25.

mild assessed

Data queries

0

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