Patient

P2B-040

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 · State Health Centre Oncology Department (Budapest, Hungary) (Dr. Clarke)

consented 2012-10-11

State Health Centre Oncology Department (Budapest, Hungary)

Adverse events

Serious AEs

Open data queries

Luna dropout signal

—

not on Luna

Adverse events 7

mild assessed 2013-02-09

Grade 1 asthenia with onset in cycle 5 (2013-02-09); assessed as not related to study drug (not related); resolved 2013-02-18.

severe serious assessed 2013-01-16

Grade 3 gastroenteritis with onset in cycle 4 (2013-01-16); serious (hospitalization); assessed as related to study drug (possible); resolved 2013-01-20; action: drug interrupted.

moderate assessed 2013-01-13

Grade 2 pain in extremity with onset in cycle 4 (2013-01-13); assessed as not related to study drug (not related); resolved 2013-01-25.

mild assessed 2013-01-11

Grade 1 vomiting with onset in cycle 4 (2013-01-11); assessed as not related to study drug (not related); resolved 2013-01-13.

mild assessed 2012-11-24

Grade 1 pyrexia with onset in cycle 2 (2012-11-24); assessed as not related to study drug (unlikely); resolved 2012-11-28.

moderate assessed 2012-11-19

Grade 2 decreased appetite with onset in cycle 2 (2012-11-19); assessed as not related to study drug (not related); resolved 2012-12-16.

moderate assessed 2012-10-28

Grade 2 nausea with onset in cycle 1 (2012-10-28); assessed as not related to study drug (unlikely); resolved 2012-11-02.

Data queries 3

SV.occurred_on[V7] open

Visit Cycle 6 Day 1: infusion (last planned cycle) (V7) for P2B-040 occurred on 2013-02-26, 16 d late against planned day 106 (2013-02-10 ± 3 d, anchored on first dose 2012-10-28). Confirm the visit date or record a protocol deviation.

SV.occurred_on[V6] open

Visit Cycle 5 Day 1: infusion; week-12 CT/MRI and ECHO/MUGA before dosing (V6) for P2B-040 occurred on 2013-02-04, 15 d late against planned day 85 (2013-01-20 ± 3 d, anchored on first dose 2012-10-28). Confirm the visit date or record a protocol deviation.

SV.occurred_on[V5] open

Visit Cycle 4 Day 1: infusion (V5) for P2B-040 occurred on 2013-01-08, 9 d late against planned day 64 (2012-12-30 ± 3 d, anchored on first dose 2012-10-28). Confirm the visit date or record a protocol deviation.

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