P2B-116

Royal Perth Hospital (Perth, Australia) › P2B-116

P2B-116

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 Perth Hospital (Perth, Australia) · Dr. Silva
consented 2013-05-24

withdrawn

AEs

7

Serious

0

Dropout signal

–

Adverse events

7

Grade 3 fatigue with onset in cycle 4 (2013-08-23); assessed as not related to study drug (unlikely); resolved 2013-09-16.

severe assessed

Grade 1 anaemia with onset in cycle 4 (2013-08-07); assessed as related to study drug (probable); resolved 2013-08-28.

mild assessed

Grade 1 nausea with onset in cycle 4 (2013-08-06); assessed as not related to study drug (not related); resolved 2013-08-07.

mild assessed

Grade 1 asthenia with onset in cycle 3 (2013-07-31); assessed as not related to study drug (unlikely); resolved 2013-08-23.

mild assessed

Grade 1 leukopenia with onset in cycle 2 (2013-07-02); assessed as related to study drug (probable); resolved 2013-07-07.

mild assessed

Grade 2 vomiting with onset in cycle 2 (2013-06-22); assessed as not related to study drug (unlikely); resolved 2013-06-24.

moderate assessed

Grade 1 alopecia with onset in cycle 1 (2013-06-18); assessed as related to study drug (probable); not resolved at last follow-up.

mild assessed

Data queries

0

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