Patient

P2B-091

completed Phase II

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 · Municipal institution "Chernivtsi Regional Clinical Oncologic Dispensary" (Chernivtsi, Ukraine) (Dr. Ito)

consented 2013-03-21

Municipal institution "Chernivtsi Regional Clinical Oncologic Dispensary" (Chernivtsi, Ukraine)

Adverse events

Serious AEs

Open data queries

Luna dropout signal

—

not on Luna

Adverse events 4

moderate assessed 2013-08-01

Grade 2 pyrexia with onset in cycle 6 (2013-08-01); assessed as not related to study drug (not related); resolved 2013-08-03.

mild assessed 2013-07-21

Grade 1 nausea with onset in cycle 6 (2013-07-21); assessed as not related to study drug (not related); resolved 2013-07-26.

moderate assessed 2013-06-24

Grade 2 alopecia with onset in cycle 4 (2013-06-24); assessed as related to study drug (probable); not resolved at last follow-up.

mild assessed 2013-06-19

Grade 1 asthenia with onset in cycle 4 (2013-06-19); assessed as not related to study drug (not related); resolved 2013-07-11.

Data queries 0

No data queries

The CDM sweep raises queries on inconsistent fields.

Luna engagement

This participant doesn't use Luna

Invite them from the site to track mood, adherence and check-ins.

Open Luna users