P2B-002

Sarcoma Oncology Center (Santa Monica, CA) › P2B-002

P2B-002

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
Sarcoma Oncology Center (Santa Monica, CA) · Dr. Reyes
consented 2012-02-09

withdrawn

AEs

1

Serious

0

Dropout signal

–

Adverse events

1

Grade 3 alanine aminotransferase increased with onset in cycle 2 (2012-03-18); assessed as related to study drug (possible); resolved 2012-04-05; action: drug interrupted.

severe assessed

Data queries

1

EDC value 120 differs from the EHR: 102 mmHg (Observation/vs-b9c3c2577d57-8480-6-20120226, 2012-02-26; EHR stated 102 mm[Hg]). Confirm against source and correct or explain.

F.VS.SYSBP (Systolic blood pressure) open