P2B-118

Blokhin Cancer Research Center (Moscow, Russia) › P2B-118

P2B-118

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
Blokhin Cancer Research Center (Moscow, Russia) · Dr. Moreau
consented 2013-05-25

completed

AEs

7

Serious

0

Dropout signal

–

Adverse events

7

Grade 3 anaemia with onset in cycle 6 (2013-10-07); assessed as related to study drug (probable); resolved 2013-10-21; action: drug interrupted.

severe assessed

Grade 2 alopecia with onset in cycle 6 (2013-10-06); assessed as related to study drug (probable); not resolved at last follow-up.

moderate assessed

Grade 3 leukopenia with onset in cycle 5 (2013-09-10); assessed as related to study drug (probable); resolved 2013-09-16.

severe assessed

Grade 1 pyrexia with onset in cycle 5 (2013-09-07); assessed as not related to study drug (unlikely); resolved 2013-09-09.

mild assessed

Grade 2 vomiting with onset in cycle 5 (2013-08-31); assessed as not related to study drug (not related); resolved 2013-09-02.

moderate assessed

Grade 1 diarrhoea with onset in cycle 4 (2013-08-20); assessed as not related to study drug (not related); resolved 2013-08-24.

mild assessed

Grade 2 stomatitis with onset in cycle 2 (2013-07-07); assessed as related to study drug (probable); resolved 2013-07-13.

moderate assessed

Data queries

0

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