P2B-086

State Health Centre Oncology Department (Budapest, Hungary) › P2B-086

P2B-086

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 Health Centre Oncology Department (Budapest, Hungary) · Dr. Clarke
consented 2013-03-12

completed

AEs

7

Serious

0

Dropout signal

–

Adverse events

7

Grade 1 fatigue with onset in cycle 2 (2013-04-30); assessed as not related to study drug (unlikely); resolved 2013-05-24.

mild assessed

Grade 3 asthenia with onset in cycle 2 (2013-04-25); assessed as not related to study drug (unlikely); resolved 2013-05-09.

severe assessed

Grade 3 febrile neutropenia with onset in cycle 2 (2013-04-17); assessed as related to study drug (probable); resolved 2013-04-21.

severe assessed

Grade 3 neutropenia with onset in cycle 1 (2013-04-01); assessed as related to study drug (probable); resolved 2013-04-11; action: drug interrupted.

severe assessed

Grade 1 stomatitis with onset in cycle 1 (2013-03-27); assessed as related to study drug (probable); resolved 2013-04-04.

mild assessed

Grade 1 nausea with onset in cycle 1 (2013-03-25); assessed as not related to study drug (unlikely); resolved 2013-03-29.

mild assessed

Grade 2 vomiting with onset in cycle 1 (2013-03-25); assessed as not related to study drug (unlikely); resolved 2013-03-28.

moderate assessed

Data queries

0

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