P2B-124

State Healthcare Institution "Republican Clinical Oncological Center of the Ministry of Health of Republic of Tatarstan" (Kazan', Russia) › P2B-124

P2B-124

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 · Phase II
State Healthcare Institution "Republican Clinical Oncological Center of the Ministry of Health of Republic of Tatarstan" (Kazan', Russia) · Dr. Clarke
consented 2013-06-14

withdrawn

AEs

6

Serious

0

Dropout signal

–

Adverse events

6

Grade 2 mucosal inflammation with onset in cycle 2 (2013-07-21); assessed as related to study drug (probable); resolved 2013-07-29.

moderate assessed

Grade 2 asthenia with onset in cycle 2 (2013-07-20); assessed as not related to study drug (not related); resolved 2013-08-19.

moderate assessed

Grade 3 fatigue with onset in cycle 2 (2013-07-16); assessed as not related to study drug (unlikely); resolved 2013-07-26; action: drug interrupted.

severe assessed

Grade 1 alopecia with onset in cycle 1 (2013-07-12); assessed as related to study drug (probable); not resolved at last follow-up.

mild assessed

Grade 2 diarrhoea with onset in cycle 1 (2013-07-04); assessed as not related to study drug (unlikely); resolved 2013-07-09.

moderate assessed

Grade 1 nausea with onset in cycle 1 (2013-06-24); assessed as not related to study drug (unlikely); resolved 2013-06-29.

mild assessed

Data queries

0

No data queries. Open queries would appear here for this patient.