Patient

P2B-020

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 2012-07-23

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 13

moderate serious assessed 2012-10-18

Grade 2 pyrexia with onset in cycle 4 (2012-10-18); serious (hospitalization); assessed as not related to study drug (not related); resolved 2012-10-20.

severe assessed 2012-10-17

Grade 4 neutropenia with onset in cycle 4 (2012-10-17); assessed as related to study drug (probable); resolved 2012-10-22; action: drug interrupted.

mild assessed 2012-10-14

Grade 1 thrombocytopenia with onset in cycle 4 (2012-10-14); assessed as related to study drug (probable); resolved 2012-10-23.

severe serious assessed 2012-10-08

Grade 3 vomiting with onset in cycle 4 (2012-10-08); serious (hospitalization); assessed as not related to study drug (unlikely); resolved 2012-10-09.

severe serious assessed 2012-09-26

Grade 4 febrile neutropenia with onset in cycle 3 (2012-09-26); serious (hospitalization); assessed as related to study drug (probable); resolved 2012-10-05; action: dose reduced.

severe serious assessed 2012-09-25

Grade 3 thrombocytopenia with onset in cycle 3 (2012-09-25); serious (hospitalization); assessed as related to study drug (probable); resolved 2012-10-07.

moderate assessed 2012-09-02

Grade 2 anaemia with onset in cycle 2 (2012-09-02); assessed as related to study drug (probable); resolved 2012-09-20.

mild assessed 2012-08-28

Grade 1 weight decreased with onset in cycle 2 (2012-08-28); assessed as not related to study drug (unlikely); resolved 2012-09-24.

moderate assessed 2012-08-26

Grade 2 vomiting with onset in cycle 2 (2012-08-26); assessed as not related to study drug (unlikely); resolved 2012-08-28.

moderate assessed 2012-08-15

Grade 2 febrile neutropenia with onset in cycle 1 (2012-08-15); assessed as related to study drug (probable); resolved 2012-08-20.

mild assessed 2012-08-13

Grade 1 pyrexia with onset in cycle 1 (2012-08-13); assessed as not related to study drug (not related); resolved 2012-08-15.

moderate assessed 2012-08-10

Grade 2 asthenia with onset in cycle 1 (2012-08-10); assessed as not related to study drug (not related); resolved 2012-09-08.

severe serious assessed 2012-08-07

Grade 4 hypovolaemic shock with onset in cycle 1 (2012-08-07); serious (life-threatening; hospitalization); assessed as not related to study drug (not related); resolved 2012-08-09; action: drug interrupted.

Data queries 1

serious[Neutropenia 2012-10-17] open

AE Neutropenia (grade 4) for P2B-020 (onset 2012-10-17) 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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