P2B-120

University of Iowa (Iowa City, IA) › P2B-120

P2B-120

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
University of Iowa (Iowa City, IA) · Dr. Okafor
consented 2013-06-02

completed

AEs

5

Serious

0

Dropout signal

–

Adverse events

5

Grade 2 decreased appetite with onset in cycle 5 (2013-09-20); assessed as not related to study drug (not related); resolved 2013-10-09.

moderate assessed

Grade 1 alopecia with onset in cycle 3 (2013-08-04); assessed as related to study drug (probable); not resolved at last follow-up.

mild assessed

Grade 1 hypocalcaemia with onset in cycle 1 (2013-06-22); assessed as not related to study drug (not related); resolved 2013-07-02.

mild assessed

Grade 1 cough with onset in cycle 1 (2013-06-17); assessed as not related to study drug (unlikely); resolved 2013-07-06.

mild assessed

Grade 3 hypokalaemia with onset in cycle 1 (2013-06-13); assessed as not related to study drug (not related); resolved 2013-06-23.

severe assessed

Data queries

0

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