Spitalul Judetean de Urgenta "Dr. Constantin Opris" Baia-Mare, Sectia Oncologie (Baia Mare, Romania)

Sites / ROU

Spitalul Judetean de Urgenta "Dr. Constantin Opris" Baia-Mare, Sectia Oncologie (Baia Mare, Romania)

ROU · PI Dr. Jansen · activated

KRI 0.0

Patients

2

Active

0

Serious AEs

4

Open QA

0

Aged queries

3

Luna users

0

Studies & contracts

1

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

Phase II · study completed · 64000 USD

executed

Patients

2

P2B-063

completed

P2B-132

completed

Safety

11 AEs · 4 serious

Grade 3 cholecystitis with onset in cycle 4 (2013-09-29); serious (hospitalization); assessed as not related to study drug (unlikely); resolved 2013-10-13.

serious P2B-132

Grade 3 febrile neutropenia with onset in cycle 1 (2013-08-03); serious (hospitalization); assessed as related to study drug (probable); resolved 2013-08-10.

serious P2B-132

Grade 3 mucosal inflammation with onset in cycle 1 (2013-08-03); serious (hospitalization); assessed as related to study drug (probable); resolved 2013-08-13.

serious P2B-132

Grade 3 febrile neutropenia with onset in cycle 5 (2013-04-06); serious (hospitalization); assessed as related to study drug (probable); resolved 2013-04-15.

serious P2B-063

QA findings

0 open

TUMOUR ASSESSMENT OUT OF WINDOW: CT/MRI tumour assessment performed outside the +/-7-day window of the 6-weekly schedule (subject P2B-132, 2013-07-27)

resolved minor

Visits & payments

0

Nothing scheduled. Re-score risk to let the pipeline propose a visit.

Luna participants

0

No Luna participants here yet. Participants join once invited by the site.

Open Luna