Patient

P2B-019

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 · Stanford University (Stanford, CA) (Dr. Nolan)

consented 2012-07-13

Stanford University (Stanford, CA)

Adverse events

Serious AEs

Open data queries

Luna dropout signal

—

not on Luna

Adverse events 12

severe assessed 2012-08-05

Grade 3 decreased appetite with onset in cycle 1 (2012-08-05); assessed as not related to study drug (unlikely); resolved 2012-08-27; action: drug interrupted.

moderate assessed 2012-08-03

Grade 2 febrile neutropenia with onset in cycle 1 (2012-08-03); assessed as related to study drug (probable); resolved 2012-08-10.

moderate assessed 2012-08-02

Grade 2 anaemia with onset in cycle 1 (2012-08-02); assessed as related to study drug (probable); resolved 2012-08-14.

severe serious assessed 2012-08-01

Grade 3 pulmonary embolism with onset in cycle 1 (2012-08-01); serious (hospitalization); assessed as not related to study drug (unlikely); resolved 2012-08-21.

severe assessed 2012-07-31

Grade 3 mucosal inflammation with onset in cycle 1 (2012-07-31); assessed as related to study drug (probable); resolved 2012-08-08; action: drug interrupted.

severe assessed 2012-07-31

Grade 4 neutropenia with onset in cycle 1 (2012-07-31); assessed as related to study drug (probable); resolved 2012-08-11; action: drug withdrawn.

severe serious assessed 2012-07-29

Grade 3 febrile neutropenia with onset in cycle 1 (2012-07-29); serious (hospitalization); assessed as related to study drug (probable); resolved 2012-08-02.

severe assessed 2012-07-27

Grade 3 stomatitis with onset in cycle 1 (2012-07-27); assessed as related to study drug (probable); resolved 2012-08-08; action: drug interrupted.

moderate assessed 2012-07-25

Grade 2 fatigue with onset in cycle 1 (2012-07-25); assessed as not related to study drug (not related); resolved 2012-08-05.

moderate assessed 2012-07-25

Grade 2 nausea with onset in cycle 1 (2012-07-25); assessed as not related to study drug (not related); resolved 2012-07-28.

moderate assessed 2012-07-23

Grade 2 alanine aminotransferase increased with onset in cycle 1 (2012-07-23); assessed as not related to study drug (not related); resolved 2012-08-03.

severe serious assessed 2012-07-23

Grade 3 dehydration with onset in cycle 1 (2012-07-23); serious (hospitalization); assessed as not related to study drug (unlikely); resolved 2012-07-26.

Data queries 1

serious[Neutropenia 2012-07-31] open

AE Neutropenia (grade 4) for P2B-019 (onset 2012-07-31) 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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