Royal Hobart Hospital (Hobart, Australia) › P2B-110

P2B-110

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
Royal Hobart Hospital (Hobart, Australia) · Dr. Novak
consented 2013-05-09

completed

AEs

Serious

Dropout signal

–

Adverse events

Grade 3 leukopenia with onset in cycle 6 (2013-09-22); serious (hospitalization); assessed as related to study drug (probable); resolved 2013-09-30.

severe serious assessed

Grade 2 febrile neutropenia with onset in cycle 6 (2013-09-20); assessed as related to study drug (probable); resolved 2013-09-27.

moderate assessed

Grade 2 anaemia with onset in cycle 4 (2013-08-17); assessed as related to study drug (probable); resolved 2013-08-28.

moderate assessed

Grade 3 pulmonary embolism with onset in cycle 4 (2013-08-16); serious (hospitalization); assessed as not related to study drug (unlikely); resolved 2013-09-04; action: drug interrupted.

severe serious assessed

Grade 1 fatigue with onset in cycle 4 (2013-08-11); assessed as not related to study drug (not related); resolved 2013-09-04.

mild assessed

Grade 3 neutropenia with onset in cycle 1 (2013-06-05); assessed as related to study drug (probable); resolved 2013-06-13; action: drug interrupted.

severe assessed

Grade 3 febrile neutropenia with onset in cycle 1 (2013-06-03); serious (hospitalization); assessed as related to study drug (probable); resolved 2013-06-12; action: dose reduced.

severe serious assessed

Grade 2 leukopenia with onset in cycle 1 (2013-06-02); assessed as related to study drug (probable); resolved 2013-06-10.

moderate assessed

Grade 3 stomatitis with onset in cycle 1 (2013-06-02); assessed as related to study drug (probable); resolved 2013-06-07; action: drug interrupted.

severe assessed

Data queries

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