Patient

P2B-045

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 2012-10-25

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 11

severe serious assessed 2013-02-26

Grade 3 atrial tachycardia with onset in cycle 6 (2013-02-26); serious (hospitalization); assessed as not related to study drug (unlikely); resolved 2013-02-27.

moderate assessed 2013-02-24

Grade 2 thrombocytopenia with onset in cycle 6 (2013-02-24); assessed as related to study drug (probable); resolved 2013-03-01.

mild assessed 2013-02-23

Grade 1 fatigue with onset in cycle 6 (2013-02-23); assessed as not related to study drug (unlikely); resolved 2013-03-13.

mild assessed 2013-02-19

Grade 1 constipation with onset in cycle 6 (2013-02-19); assessed as not related to study drug (not related); resolved 2013-02-23.

mild assessed 2013-02-06

Grade 1 decreased appetite with onset in cycle 5 (2013-02-06); assessed as not related to study drug (unlikely); resolved 2013-02-17.

moderate assessed 2013-01-30

Grade 2 stomatitis with onset in cycle 5 (2013-01-30); assessed as related to study drug (probable); resolved 2013-02-08.

mild assessed 2013-01-14

Grade 1 anaemia with onset in cycle 4 (2013-01-14); assessed as related to study drug (probable); resolved 2013-01-31.

mild assessed 2012-12-31

Grade 1 hypokalaemia with onset in cycle 3 (2012-12-31); assessed as not related to study drug (unlikely); resolved 2013-01-03.

severe serious assessed 2012-12-25

Grade 4 thrombocytopenia with onset in cycle 3 (2012-12-25); serious (hospitalization); assessed as related to study drug (probable); resolved 2013-01-05.

severe serious assessed 2012-12-03

Grade 4 febrile neutropenia with onset in cycle 2 (2012-12-03); serious (hospitalization); assessed as related to study drug (probable); resolved 2012-12-08; action: dose reduced.

moderate assessed 2012-11-16

Grade 2 febrile neutropenia with onset in cycle 1 (2012-11-16); assessed as related to study drug (probable); resolved 2012-11-24.

Data queries 0

No data queries

The CDM sweep raises queries on inconsistent fields.

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