Patient

P2B-063

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 · Spitalul Judetean de Urgenta "Dr. Constantin Opris" Baia-Mare, Sectia Oncologie (Baia Mare, Romania) (Dr. Jansen)

consented 2012-12-21

Spitalul Judetean de Urgenta "Dr. Constantin Opris" Baia-Mare, Sectia Oncologie (Baia Mare, Romania)

Adverse events

Serious AEs

Open data queries

Luna dropout signal

—

not on Luna

Adverse events 4

severe serious assessed 2013-04-06

Grade 3 febrile neutropenia with onset in cycle 5 (2013-04-06); serious (hospitalization); assessed as related to study drug (probable); resolved 2013-04-15.

mild assessed 2013-03-29

Grade 1 diarrhoea with onset in cycle 5 (2013-03-29); assessed as not related to study drug (unlikely); resolved 2013-04-03.

moderate assessed 2013-01-12

Grade 2 febrile neutropenia with onset in cycle 1 (2013-01-12); assessed as related to study drug (probable); resolved 2013-01-21.

moderate assessed 2013-01-12

Grade 2 neutropenia with onset in cycle 1 (2013-01-12); assessed as related to study drug (probable); resolved 2013-01-21.

Data queries 0

No data queries

The CDM sweep raises queries on inconsistent fields.

Luna engagement

This participant doesn't use Luna

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