Border Medical Oncology (Wodonga, Australia) › P2B-039

P2B-039

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
Border Medical Oncology (Wodonga, Australia) · Dr. Kim
consented 2012-10-10

completed

AEs

Serious

Dropout signal

–

Adverse events

Grade 2 alopecia with onset in cycle 4 (2013-01-15); assessed as related to study drug (probable); not resolved at last follow-up.

moderate assessed

Grade 2 asthenia with onset in cycle 4 (2013-01-04); assessed as not related to study drug (unlikely); resolved 2013-01-12.

moderate assessed

Grade 2 decreased appetite with onset in cycle 4 (2012-12-28); assessed as not related to study drug (unlikely); resolved 2013-01-08.

moderate assessed

Grade 2 alanine aminotransferase increased with onset in cycle 3 (2012-12-14); assessed as not related to study drug (not related); resolved 2012-12-24.

moderate assessed

Grade 1 fatigue with onset in cycle 3 (2012-12-10); assessed as not related to study drug (unlikely); resolved 2012-12-28.

mild assessed

Grade 2 vomiting with onset in cycle 3 (2012-12-07); assessed as not related to study drug (unlikely); resolved 2012-12-08.

moderate assessed

Grade 2 ejection fraction decreased with onset in cycle 2 (2012-12-04); assessed as related to study drug (probable); resolved 2013-01-28.

moderate assessed

Grade 3 pain in extremity with onset in cycle 2 (2012-11-25); assessed as not related to study drug (not related); resolved 2012-12-15.

severe assessed

Grade 1 aspartate aminotransferase increased with onset in cycle 2 (2012-11-23); assessed as not related to study drug (not related); resolved 2012-12-13.

mild assessed

Data queries

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