Patient

P2B-116

withdrawn Phase II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 Perth Hospital (Perth, Australia) (Dr. Silva)

consented 2013-05-24

Royal Perth Hospital (Perth, Australia)

Adverse events

Serious AEs

Open data queries

Luna dropout signal

—

not on Luna

Adverse events 7

severe assessed 2013-08-23

Grade 3 fatigue with onset in cycle 4 (2013-08-23); assessed as not related to study drug (unlikely); resolved 2013-09-16.

mild assessed 2013-08-07

Grade 1 anaemia with onset in cycle 4 (2013-08-07); assessed as related to study drug (probable); resolved 2013-08-28.

mild assessed 2013-08-06

Grade 1 nausea with onset in cycle 4 (2013-08-06); assessed as not related to study drug (not related); resolved 2013-08-07.

mild assessed 2013-07-31

Grade 1 asthenia with onset in cycle 3 (2013-07-31); assessed as not related to study drug (unlikely); resolved 2013-08-23.

mild assessed 2013-07-02

Grade 1 leukopenia with onset in cycle 2 (2013-07-02); assessed as related to study drug (probable); resolved 2013-07-07.

moderate assessed 2013-06-22

Grade 2 vomiting with onset in cycle 2 (2013-06-22); assessed as not related to study drug (unlikely); resolved 2013-06-24.

mild assessed 2013-06-18

Grade 1 alopecia with onset in cycle 1 (2013-06-18); 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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