Patient

P2B-115

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 · Royal North Shore (St Leonards, Australia) (Dr. Rossi)

consented 2013-05-20

Royal North Shore (St Leonards, Australia)

Adverse events

Serious AEs

Open data queries

Luna dropout signal

—

not on Luna

Adverse events 7

severe assessed 2013-09-29

Grade 3 decreased appetite with onset in cycle 6 (2013-09-29); assessed as not related to study drug (not related); resolved 2013-10-10; action: drug interrupted.

mild assessed 2013-09-13

Grade 1 abdominal pain with onset in cycle 5 (2013-09-13); assessed as not related to study drug (not related); resolved 2013-09-21.

severe serious assessed 2013-09-08

Grade 3 anaemia with onset in cycle 5 (2013-09-08); serious (hospitalization); assessed as related to study drug (probable); resolved 2013-09-29; action: dose reduced.

mild assessed 2013-08-25

Grade 1 anaemia with onset in cycle 4 (2013-08-25); assessed as related to study drug (probable); resolved 2013-09-21.

mild assessed 2013-07-20

Grade 1 nausea with onset in cycle 3 (2013-07-20); assessed as not related to study drug (not related); resolved 2013-07-23.

moderate assessed 2013-07-08

Grade 2 neutropenia with onset in cycle 2 (2013-07-08); assessed as related to study drug (probable); resolved 2013-07-16.

moderate assessed 2013-06-21

Grade 2 alopecia with onset in cycle 1 (2013-06-21); 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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