Patient

P2B-028

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 · CTRC Institute for Drug Development, University of Texas (San Antonio, TX) (Dr. Muller)

consented 2012-08-11

CTRC Institute for Drug Development, University of Texas (San Antonio, TX)

Adverse events

Serious AEs

Open data queries

Luna dropout signal

—

not on Luna

Adverse events 13

severe assessed 2012-12-13

Grade 3 neutropenia with onset in cycle 6 (2012-12-13); assessed as related to study drug (probable); resolved 2012-12-23; action: drug interrupted.

mild assessed 2012-12-10

Grade 1 aspartate aminotransferase increased with onset in cycle 6 (2012-12-10); assessed as not related to study drug (unlikely); resolved 2012-12-31.

moderate serious assessed 2012-12-07

Grade 2 pertussis with onset in cycle 6 (2012-12-07); serious (hospitalization); assessed as not related to study drug (unlikely); resolved 2012-12-18.

severe serious assessed 2012-12-02

Grade 3 cholecystitis acute with onset in cycle 5 (2012-12-02); serious (hospitalization); assessed as not related to study drug (unlikely); resolved 2012-12-14; action: drug interrupted.

mild assessed 2012-11-24

Grade 1 asthenia with onset in cycle 5 (2012-11-24); assessed as not related to study drug (not related); resolved 2012-12-23.

moderate assessed 2012-11-15

Grade 2 constipation with onset in cycle 5 (2012-11-15); assessed as not related to study drug (not related); resolved 2012-11-19.

severe serious assessed 2012-11-05

Grade 3 anaemia with onset in cycle 4 (2012-11-05); serious (hospitalization); assessed as related to study drug (probable); resolved 2012-12-02.

mild assessed 2012-11-05

Grade 1 hypocalcaemia with onset in cycle 4 (2012-11-05); assessed as not related to study drug (not related); resolved 2012-11-12.

moderate assessed 2012-10-27

Grade 2 nausea with onset in cycle 4 (2012-10-27); assessed as not related to study drug (unlikely); resolved 2012-10-29.

moderate assessed 2012-09-27

Grade 2 anaemia with onset in cycle 2 (2012-09-27); assessed as related to study drug (probable); resolved 2012-10-27.

moderate assessed 2012-09-23

Grade 2 pyrexia with onset in cycle 2 (2012-09-23); assessed as not related to study drug (unlikely); resolved 2012-09-26.

severe serious assessed 2012-08-28

Grade 3 pneumonia with onset in cycle 1 (2012-08-28); serious (hospitalization); assessed as not related to study drug (not related); resolved 2012-09-07.

moderate serious assessed 2012-08-24

Grade 2 constipation with onset in cycle 1 (2012-08-24); serious (hospitalization); assessed as not related to study drug (unlikely); resolved 2012-08-31.

Data queries 0

No data queries

The CDM sweep raises queries on inconsistent fields.

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