Patient

P2B-066

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 · Hemato Oncology Clinic, Vedanta Institute of Medical Science (Ahmedabad, India) (Dr. Ito)

consented 2013-01-05

Hemato Oncology Clinic, Vedanta Institute of Medical Science (Ahmedabad, India)

Adverse events

Serious AEs

Open data queries

Luna dropout signal

—

not on Luna

Adverse events 5

moderate assessed 2013-03-20

Grade 2 nausea with onset in cycle 4 (2013-03-20); assessed as not related to study drug (not related); resolved 2013-03-25.

mild assessed 2013-03-18

Grade 1 fatigue with onset in cycle 4 (2013-03-18); assessed as not related to study drug (unlikely); resolved 2013-03-29.

severe assessed 2013-02-13

Grade 3 neutropenia with onset in cycle 2 (2013-02-13); assessed as related to study drug (probable); resolved 2013-02-19.

mild assessed 2013-02-12

Grade 1 oedema peripheral with onset in cycle 2 (2013-02-12); assessed as not related to study drug (not related); resolved 2013-03-13.

moderate assessed 2013-02-12

Grade 2 pyrexia with onset in cycle 2 (2013-02-12); assessed as not related to study drug (not related); resolved 2013-02-14.

Data queries 0

No data queries

The CDM sweep raises queries on inconsistent fields.

Luna engagement

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