Patient

P2B-121

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 · Pennsylvania Hematology Oncology Associates (Philadelphia, PA) (Dr. Tanaka)

consented 2013-06-04

Pennsylvania Hematology Oncology Associates (Philadelphia, PA)

Adverse events

Serious AEs

Open data queries

Luna dropout signal

—

not on Luna

Adverse events 4

mild assessed 2013-09-16

Grade 1 diarrhoea with onset in cycle 5 (2013-09-16); assessed as related to study drug (possible); resolved 2013-09-18.

mild assessed 2013-07-17

Grade 1 hypoalbuminaemia with onset in cycle 2 (2013-07-17); assessed as not related to study drug (unlikely); resolved 2013-08-18.

moderate assessed 2013-07-10

Grade 2 fatigue with onset in cycle 2 (2013-07-10); assessed as not related to study drug (not related); resolved 2013-07-22.

mild assessed 2013-06-21

Grade 1 hypocalcaemia with onset in cycle 1 (2013-06-21); assessed as not related to study drug (unlikely); resolved 2013-07-12.

Data queries 0

No data queries

The CDM sweep raises queries on inconsistent fields.

Luna engagement

This participant doesn't use Luna

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