Patient

P2B-130

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 · Blokhin Cancer Research Center (Moscow, Russia) (Dr. Moreau)

consented 2013-07-09

Blokhin Cancer Research Center (Moscow, Russia)

Adverse events

Serious AEs

Open data queries

Luna dropout signal

—

not on Luna

Adverse events 7

mild assessed 2013-12-05

Grade 1 blood alkaline phosphatase increased with onset in cycle 6 (2013-12-05); assessed as not related to study drug (not related); resolved 2013-12-26.

severe assessed 2013-11-26

Grade 3 abdominal pain with onset in cycle 6 (2013-11-26); assessed as not related to study drug (not related); resolved 2013-12-06; action: drug interrupted.

severe assessed 2013-11-02

Grade 3 leukopenia with onset in cycle 5 (2013-11-02); assessed as related to study drug (probable); resolved 2013-11-09.

severe serious under_review 2013-10-17

Grade 3 anaemia with onset in cycle 4 (2013-10-17); serious (hospitalization); assessed as related to study drug (probable); resolved 2013-11-10; action: drug interrupted.

moderate assessed 2013-09-09

Grade 2 anaemia with onset in cycle 3 (2013-09-09); assessed as related to study drug (probable); resolved 2013-10-08.

moderate assessed 2013-08-19

Grade 2 constipation with onset in cycle 2 (2013-08-19); assessed as not related to study drug (not related); resolved 2013-08-24.

mild assessed 2013-07-28

Grade 1 nausea with onset in cycle 1 (2013-07-28); assessed as not related to study drug (not related); resolved 2013-07-29.

Data queries 3

SV.occurred_on[V7] open

Visit Cycle 6 Day 1: infusion (last planned cycle) (V7) for P2B-130 occurred on 2013-11-17, 9 d late against planned day 106 (2013-11-08 ± 3 d, anchored on first dose 2013-07-26). 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-130 occurred on 2013-10-26, 8 d late against planned day 85 (2013-10-18 ± 3 d, anchored on first dose 2013-07-26). Confirm the visit date or record a protocol deviation.

SV.occurred_on[V5] open

Visit Cycle 4 Day 1: infusion (V5) for P2B-130 occurred on 2013-10-05, 8 d late against planned day 64 (2013-09-27 ± 3 d, anchored on first dose 2013-07-26). Confirm the visit date or record a protocol deviation.

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