Patient

P2B-134

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 · Sarcoma Oncology Center (Santa Monica, CA) (Dr. Reyes)

consented 2013-07-12

Sarcoma Oncology Center (Santa Monica, CA)

Adverse events

Serious AEs

Open data queries

Luna dropout signal

—

not on Luna

Adverse events 12

mild assessed 2013-11-22

Grade 1 anaemia with onset in cycle 6 (2013-11-22); assessed as related to study drug (probable); resolved 2013-12-07.

severe assessed 2013-11-16

Grade 3 thrombocytopenia with onset in cycle 6 (2013-11-16); assessed as related to study drug (probable); resolved 2013-11-27.

severe serious under_review 2013-10-29

Grade 4 febrile neutropenia with onset in cycle 5 (2013-10-29); serious (hospitalization); assessed as related to study drug (probable); resolved 2013-11-04; action: drug interrupted.

severe serious under_review 2013-10-22

Grade 3 anaemia with onset in cycle 5 (2013-10-22); serious (hospitalization); assessed as related to study drug (probable); resolved 2013-11-26; action: dose reduced.

mild assessed 2013-10-20

Grade 1 vomiting with onset in cycle 5 (2013-10-20); assessed as not related to study drug (not related); resolved 2013-10-23.

severe assessed 2013-10-02

Grade 3 neutropenia with onset in cycle 4 (2013-10-02); assessed as related to study drug (probable); resolved 2013-10-12.

severe assessed 2013-09-16

Grade 3 leukopenia with onset in cycle 3 (2013-09-16); assessed as related to study drug (probable); resolved 2013-09-25.

severe assessed 2013-09-14

Grade 3 asthenia with onset in cycle 3 (2013-09-14); assessed as not related to study drug (unlikely); resolved 2013-10-10.

moderate assessed 2013-08-22

Grade 2 febrile neutropenia with onset in cycle 2 (2013-08-22); assessed as related to study drug (probable); resolved 2013-08-27.

moderate assessed 2013-08-05

Grade 2 alopecia with onset in cycle 1 (2013-08-05); assessed as related to study drug (probable); not resolved at last follow-up.

severe assessed 2013-07-29

Grade 3 abdominal pain with onset in cycle 1 (2013-07-29); assessed as not related to study drug (unlikely); resolved 2013-08-06; action: drug interrupted.

severe serious assessed 2013-07-28

Grade 4 neutropenic sepsis with onset in cycle 1 (2013-07-28); serious (life-threatening; hospitalization); assessed as related to study drug (probable); resolved 2013-08-05; action: drug interrupted.

Data queries 2

SV.occurred_on[V7] open

Visit Cycle 6 Day 1: infusion (last planned cycle) (V7) for P2B-134 occurred on 2013-11-08, 5 d late against planned day 106 (2013-11-03 ± 3 d, anchored on first dose 2013-07-21). 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-134 occurred on 2013-10-17, 4 d late against planned day 85 (2013-10-13 ± 3 d, anchored on first dose 2013-07-21). Confirm the visit date or record a protocol deviation.

Luna engagement

This participant doesn't use Luna

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

Open Luna users