P2B-135

Christian Medical College (Vellore, India) › P2B-135

P2B-135

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
Christian Medical College (Vellore, India) · Dr. Dubois
consented 2013-07-16

completed

AEs

6

Serious

0

Dropout signal

–

Adverse events

6

Grade 2 mucosal inflammation with onset in cycle 6 (2013-11-20); assessed as related to study drug (probable); resolved 2013-12-02.

moderate assessed

Grade 2 pyrexia with onset in cycle 4 (2013-10-16); assessed as not related to study drug (not related); resolved 2013-10-19.

moderate assessed

Grade 2 decreased appetite with onset in cycle 3 (2013-09-26); assessed as not related to study drug (not related); resolved 2013-10-04.

moderate assessed

Grade 1 alanine aminotransferase increased with onset in cycle 3 (2013-09-21); assessed as not related to study drug (not related); resolved 2013-09-28.

mild assessed

Grade 4 thrombocytopenia with onset in cycle 1 (2013-08-15); assessed as related to study drug (probable); resolved 2013-08-26.

severe assessed

Grade 1 nausea with onset in cycle 1 (2013-08-05); assessed as not related to study drug (unlikely); resolved 2013-08-07.

mild assessed

Data queries

1

AE Thrombocytopenia (grade 4) for P2B-135 (onset 2013-08-15) is CTCAE grade 4 but not flagged serious. Confirm seriousness assessment — grade 4/5 events are life-threatening or fatal by definition.

serious[Thrombocytopenia 2013-08-15] open