Patient

P2B-035

completed Phase II

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 · Vinnytsya Regional Clinical Oncologic Dispensary, Surgical Department (Vinnytsia, Ukraine) (Dr. Tanaka)

consented 2012-09-11

Vinnytsya Regional Clinical Oncologic Dispensary, Surgical Department (Vinnytsia, Ukraine)

Adverse events

Serious AEs

Open data queries

Luna dropout signal

—

not on Luna

Adverse events 6

mild assessed 2013-01-18

Grade 1 mucosal inflammation with onset in cycle 6 (2013-01-18); assessed as related to study drug (probable); resolved 2013-01-25.

mild assessed 2013-01-07

Grade 1 nausea with onset in cycle 6 (2013-01-07); assessed as not related to study drug (unlikely); resolved 2013-01-10.

moderate serious assessed 2012-12-27

Grade 2 mucosal inflammation with onset in cycle 5 (2012-12-27); serious (hospitalization); assessed as related to study drug (probable); resolved 2013-01-05.

moderate assessed 2012-12-08

Grade 2 febrile neutropenia with onset in cycle 4 (2012-12-08); assessed as related to study drug (probable); resolved 2012-12-17.

mild assessed 2012-11-13

Grade 1 hypoalbuminaemia with onset in cycle 3 (2012-11-13); assessed as not related to study drug (unlikely); resolved 2012-12-17.

severe serious assessed 2012-10-07

Grade 3 febrile neutropenia with onset in cycle 1 (2012-10-07); serious (hospitalization); assessed as related to study drug (probable); resolved 2012-10-13.

Data queries 0

No data queries

The CDM sweep raises queries on inconsistent fields.

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