Patient

P2B-007

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 Healthcare Institution "Republican Clinical Oncological Center of the Ministry of Health of Republic of Tatarstan" (Kazan', Russia) (Dr. Clarke)

consented 2012-05-22

State Healthcare Institution "Republican Clinical Oncological Center of the Ministry of Health of Republic of Tatarstan" (Kazan', Russia)

Adverse events

Serious AEs

Open data queries

Luna dropout signal

—

not on Luna

Adverse events 3

mild assessed 2012-08-17

Grade 1 anaemia with onset in cycle 4 (2012-08-17); assessed as related to study drug (probable); resolved 2012-09-09.

moderate assessed 2012-06-10

Grade 2 leukopenia with onset in cycle 1 (2012-06-10); assessed as related to study drug (probable); resolved 2012-06-17.

moderate assessed 2012-06-06

Grade 2 nausea with onset in cycle 1 (2012-06-06); assessed as not related to study drug (unlikely); resolved 2012-06-08.

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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Open Luna users