P2B-077

Municipal Institution "Dnipropetrovsk City Multi-Field Clinical Hospital #4" of Dnipropetrovsk Regional Councel (Dnipropetrovsk, Ukraine) › P2B-077

P2B-077

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
Municipal Institution "Dnipropetrovsk City Multi-Field Clinical Hospital #4" of Dnipropetrovsk Regional Councel (Dnipropetrovsk, Ukraine) · Dr. Reyes
consented 2013-02-17

withdrawn

AEs

5

Serious

0

Dropout signal

–

Adverse events

5

Grade 1 fatigue with onset in cycle 4 (2013-05-24); assessed as not related to study drug (not related); resolved 2013-06-09.

mild assessed

Grade 2 anaemia with onset in cycle 3 (2013-04-29); assessed as related to study drug (probable); resolved 2013-05-21.

moderate assessed

Grade 1 mucosal inflammation with onset in cycle 2 (2013-04-10); assessed as related to study drug (probable); resolved 2013-04-17.

mild assessed

Grade 2 thrombocytopenia with onset in cycle 2 (2013-04-06); assessed as related to study drug (probable); resolved 2013-04-18.

moderate assessed

Grade 3 neutropenia with onset in cycle 1 (2013-03-18); assessed as related to study drug (probable); resolved 2013-03-24.

severe assessed

Data queries

1

Visit Cycle 4 Day 1: infusion (V5) for P2B-077 occurred on 2013-05-17, 5 d late against planned day 64 (2013-05-12 ± 3 d, anchored on first dose 2013-03-10). Confirm the visit date or record a protocol deviation.

SV.occurred_on[V5] open