Patient

P2B-070

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 · State Health Centre Oncology Department (Budapest, Hungary) (Dr. Clarke)

consented 2013-01-18

State Health Centre Oncology Department (Budapest, Hungary)

Adverse events

Serious AEs

Open data queries

Luna dropout signal

—

not on Luna

Adverse events 11

moderate assessed 2013-05-08

Grade 2 dyspnoea with onset in cycle 5 (2013-05-08); assessed as not related to study drug (not related); resolved 2013-05-22.

mild assessed 2013-04-28

Grade 1 asthenia with onset in cycle 4 (2013-04-28); assessed as not related to study drug (not related); resolved 2013-05-12.

moderate assessed 2013-04-23

Grade 2 hypoalbuminaemia with onset in cycle 4 (2013-04-23); assessed as not related to study drug (unlikely); resolved 2013-06-03.

moderate assessed 2013-04-20

Grade 2 febrile neutropenia with onset in cycle 4 (2013-04-20); assessed as related to study drug (probable); resolved 2013-04-28.

mild assessed 2013-03-24

Grade 1 stomatitis with onset in cycle 3 (2013-03-24); assessed as related to study drug (probable); resolved 2013-04-03.

severe assessed 2013-03-04

Grade 3 neutropenia with onset in cycle 2 (2013-03-04); assessed as related to study drug (probable); resolved 2013-03-11; action: drug interrupted.

mild assessed 2013-02-27

Grade 1 vomiting with onset in cycle 2 (2013-02-27); assessed as not related to study drug (not related); resolved 2013-03-01.

mild assessed 2013-02-21

Grade 1 blood alkaline phosphatase increased with onset in cycle 1 (2013-02-21); assessed as not related to study drug (unlikely); resolved 2013-03-12.

mild assessed 2013-02-18

Grade 1 hypokalaemia with onset in cycle 1 (2013-02-18); assessed as not related to study drug (not related); resolved 2013-02-26.

severe serious assessed 2013-02-11

Grade 4 febrile neutropenia with onset in cycle 1 (2013-02-11); serious (hospitalization); assessed as related to study drug (probable); resolved 2013-02-17; action: dose reduced.

mild assessed 2013-02-05

Grade 1 nausea with onset in cycle 1 (2013-02-05); assessed as not related to study drug (unlikely); resolved 2013-02-10.

Data queries 0

No data queries

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