Patient

P2B-041

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 2012-10-13

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 7

mild assessed 2013-02-16

Grade 1 stomatitis with onset in cycle 6 (2013-02-16); assessed as related to study drug (probable); resolved 2013-02-25.

mild assessed 2013-02-11

Grade 1 fatigue with onset in cycle 6 (2013-02-11); assessed as not related to study drug (not related); resolved 2013-03-10.

severe serious assessed 2013-01-24

Grade 3 tumour haemorrhage with onset in cycle 5 (2013-01-24); serious (hospitalization); assessed as not related to study drug (not related); resolved 2013-02-02; action: drug interrupted.

moderate assessed 2013-01-04

Grade 2 pain in extremity with onset in cycle 4 (2013-01-04); assessed as not related to study drug (not related); resolved 2013-01-19.

mild assessed 2013-01-03

Grade 1 cough with onset in cycle 4 (2013-01-03); assessed as not related to study drug (unlikely); resolved 2013-01-10.

severe assessed 2012-12-28

Grade 3 nausea with onset in cycle 4 (2012-12-28); assessed as not related to study drug (unlikely); resolved 2012-12-29.

mild assessed 2012-11-14

Grade 1 hypocalcaemia with onset in cycle 2 (2012-11-14); assessed as not related to study drug (unlikely); resolved 2012-11-19.

Data queries 0

No data queries

The CDM sweep raises queries on inconsistent fields.

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