Patient

P2B-024

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 2012-08-07

State Health Centre Oncology Department (Budapest, Hungary)

Adverse events

Serious AEs

Open data queries

Luna dropout signal

—

not on Luna

Adverse events 5

mild assessed 2012-12-16

Grade 1 pyrexia with onset in cycle 6 (2012-12-16); assessed as not related to study drug (not related); resolved 2012-12-18.

moderate assessed 2012-11-19

Grade 2 anaemia with onset in cycle 5 (2012-11-19); assessed as related to study drug (probable); resolved 2012-12-17.

moderate assessed 2012-11-03

Grade 2 decreased appetite with onset in cycle 4 (2012-11-03); assessed as not related to study drug (not related); resolved 2012-12-01.

severe assessed 2012-09-19

Grade 4 neutropenia with onset in cycle 2 (2012-09-19); assessed as related to study drug (probable); resolved 2012-09-26; action: drug interrupted.

moderate serious assessed 2012-08-25

Grade 2 oral herpes with onset in cycle 1 (2012-08-25); serious (hospitalization); assessed as related to study drug (possible); resolved 2012-09-02.

Data queries 1

serious[Neutropenia 2012-09-19] open

AE Neutropenia (grade 4) for P2B-024 (onset 2012-09-19) 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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