Patient

P2B-069

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 · CTRC Institute for Drug Development, University of Texas (San Antonio, TX) (Dr. Muller)

consented 2013-01-15

CTRC Institute for Drug Development, University of Texas (San Antonio, TX)

Adverse events

Serious AEs

Open data queries

Luna dropout signal

—

not on Luna

Adverse events 11

severe assessed 2013-06-04

Grade 3 pain in extremity with onset in cycle 6 (2013-06-04); assessed as not related to study drug (not related); resolved 2013-06-24.

mild assessed 2013-06-02

Grade 1 abdominal pain with onset in cycle 6 (2013-06-02); assessed as not related to study drug (not related); resolved 2013-06-07.

mild assessed 2013-05-02

Grade 1 nausea with onset in cycle 5 (2013-05-02); assessed as not related to study drug (not related); resolved 2013-05-07.

mild assessed 2013-04-24

Grade 1 fatigue with onset in cycle 4 (2013-04-24); assessed as not related to study drug (not related); resolved 2013-05-22.

mild assessed 2013-04-08

Grade 1 constipation with onset in cycle 4 (2013-04-08); assessed as not related to study drug (unlikely); resolved 2013-04-12.

mild assessed 2013-04-07

Grade 1 dyspnoea with onset in cycle 3 (2013-04-07); assessed as not related to study drug (not related); resolved 2013-05-02.

mild assessed 2013-03-22

Grade 1 vomiting with onset in cycle 3 (2013-03-22); assessed as not related to study drug (unlikely); resolved 2013-03-23.

moderate assessed 2013-03-06

Grade 2 stomatitis with onset in cycle 2 (2013-03-06); assessed as related to study drug (probable); resolved 2013-03-11.

mild assessed 2013-03-04

Grade 1 diarrhoea with onset in cycle 2 (2013-03-04); assessed as not related to study drug (not related); resolved 2013-03-08.

moderate assessed 2013-03-03

Grade 2 neutropenia with onset in cycle 2 (2013-03-03); assessed as related to study drug (probable); resolved 2013-03-12.

moderate assessed 2013-02-15

Grade 2 alopecia with onset in cycle 1 (2013-02-15); assessed as related to study drug (probable); not resolved at last follow-up.

Data queries 0

No data queries

The CDM sweep raises queries on inconsistent fields.

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