P2B-100

Tata Memorial Hospital, Department of Medical Oncology (Mumbai, India) › P2B-100

P2B-100

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
Tata Memorial Hospital, Department of Medical Oncology (Mumbai, India) · Dr. Kim
consented 2013-04-09

completed

AEs

8

Serious

0

Dropout signal

–

Adverse events

8

Grade 3 anaemia with onset in cycle 6 (2013-08-22); assessed as related to study drug (probable); resolved 2013-09-23.

severe assessed

Grade 2 nausea with onset in cycle 6 (2013-08-09); assessed as not related to study drug (not related); resolved 2013-08-13.

moderate assessed

Grade 2 alopecia with onset in cycle 5 (2013-08-04); assessed as related to study drug (probable); not resolved at last follow-up.

moderate assessed

Grade 2 leukopenia with onset in cycle 5 (2013-07-27); assessed as related to study drug (probable); resolved 2013-08-05.

moderate assessed

Grade 1 decreased appetite with onset in cycle 4 (2013-07-11); assessed as not related to study drug (unlikely); resolved 2013-07-28.

mild assessed

Grade 1 weight decreased with onset in cycle 2 (2013-05-22); assessed as not related to study drug (unlikely); resolved 2013-06-17.

mild assessed

Grade 1 cough with onset in cycle 1 (2013-05-02); assessed as not related to study drug (unlikely); resolved 2013-05-31.

mild assessed

Grade 1 fatigue with onset in cycle 1 (2013-04-27); assessed as not related to study drug (unlikely); resolved 2013-05-24.

mild assessed

Data queries

0

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