Patient

P2B-050

withdrawn Phase II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

consented 2012-11-05

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 10

mild assessed 2012-12-11

Grade 1 abdominal pain with onset in cycle 1 (2012-12-11); assessed as not related to study drug (unlikely); resolved 2012-12-13.

severe assessed 2012-12-05

Grade 4 neutropenia with onset in cycle 1 (2012-12-05); assessed as related to study drug (probable); resolved 2012-12-11.

mild assessed 2012-12-04

Grade 1 leukopenia with onset in cycle 1 (2012-12-04); assessed as related to study drug (probable); resolved 2012-12-14.

severe serious assessed 2012-12-04

Grade 3 pneumonia with onset in cycle 1 (2012-12-04); serious (hospitalization); assessed as not related to study drug (not related); resolved 2012-12-20; action: drug interrupted.

moderate assessed 2012-12-03

Grade 2 anaemia with onset in cycle 1 (2012-12-03); assessed as related to study drug (probable); resolved 2013-01-07.

mild assessed 2012-12-01

Grade 1 oedema peripheral with onset in cycle 1 (2012-12-01); assessed as not related to study drug (not related); resolved 2012-12-21.

severe serious assessed 2012-11-29

Grade 3 anaemia with onset in cycle 1 (2012-11-29); serious (hospitalization); assessed as related to study drug (probable); resolved 2012-12-14.

mild assessed 2012-11-28

Grade 1 constipation with onset in cycle 1 (2012-11-28); assessed as not related to study drug (unlikely); resolved 2012-11-30.

moderate assessed 2012-11-26

Grade 2 dyspnoea with onset in cycle 1 (2012-11-26); assessed as not related to study drug (not related); resolved 2012-12-20.

mild assessed 2012-11-26

Grade 1 nausea with onset in cycle 1 (2012-11-26); assessed as not related to study drug (unlikely); resolved 2012-11-28.

Data queries 1

serious[Neutropenia 2012-12-05] open

AE Neutropenia (grade 4) for P2B-050 (onset 2012-12-05) is CTCAE grade 4 but not flagged serious. Confirm seriousness assessment — grade 4/5 events are life-threatening or fatal by definition.

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