Patient

P2B-043

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 Healthcare Institution "Republican Clinical Oncological Center of the Ministry of Health of Republic of Tatarstan" (Kazan', Russia) (Dr. Clarke)

consented 2012-10-23

State Healthcare Institution "Republican Clinical Oncological Center of the Ministry of Health of Republic of Tatarstan" (Kazan', Russia)

Adverse events

Serious AEs

Open data queries

Luna dropout signal

—

not on Luna

Adverse events 4

mild assessed 2013-02-12

Grade 1 nausea with onset in cycle 5 (2013-02-12); assessed as not related to study drug (unlikely); resolved 2013-02-17.

moderate assessed 2013-02-10

Grade 2 aspartate aminotransferase increased with onset in cycle 5 (2013-02-10); assessed as not related to study drug (not related); resolved 2013-02-20.

severe assessed 2012-12-07

Grade 3 anaemia with onset in cycle 2 (2012-12-07); assessed as related to study drug (probable); resolved 2013-01-06; action: drug interrupted.

mild assessed 2012-11-16

Grade 1 neutropenia with onset in cycle 1 (2012-11-16); assessed as related to study drug (probable); resolved 2012-11-24.

Data queries 5

SV.occurred_on[V7] open

Visit Cycle 6 Day 1: infusion (last planned cycle) (V7) for P2B-043 occurred on 2013-03-01, 12 d late against planned day 106 (2013-02-17 ± 3 d, anchored on first dose 2012-11-04). 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-043 occurred on 2013-02-08, 12 d late against planned day 85 (2013-01-27 ± 3 d, anchored on first dose 2012-11-04). Confirm the visit date or record a protocol deviation.

SV.occurred_on[V5] open

Visit Cycle 4 Day 1: infusion (V5) for P2B-043 occurred on 2013-01-19, 13 d late against planned day 64 (2013-01-06 ± 3 d, anchored on first dose 2012-11-04). Confirm the visit date or record a protocol deviation.

SV.occurred_on[V4] open

Visit Cycle 3 Day 1: infusion; week-6 CT/MRI and ECHO/MUGA before dosing (V4) for P2B-043 occurred on 2012-12-22, 6 d late against planned day 43 (2012-12-16 ± 3 d, anchored on first dose 2012-11-04). Confirm the visit date or record a protocol deviation.

SV.occurred_on[V3] open

Visit Cycle 2 Day 1: infusion (V3) for P2B-043 occurred on 2012-11-30, 5 d late against planned day 22 (2012-11-25 ± 3 d, anchored on first dose 2012-11-04). Confirm the visit date or record a protocol deviation.

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