P2B-103

Medisprof SRL (Cluj-Napoca, Romania) › P2B-103

P2B-103

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
Medisprof SRL (Cluj-Napoca, Romania) · Dr. Kowalski
consented 2013-04-23

completed

AEs

8

Serious

0

Dropout signal

–

Adverse events

8

Grade 2 vomiting with onset in cycle 6 (2013-08-17); assessed as not related to study drug (not related); resolved 2013-08-20.

moderate assessed

Grade 2 alopecia with onset in cycle 5 (2013-08-07); assessed as related to study drug (probable); not resolved at last follow-up.

moderate assessed

Grade 2 anaemia with onset in cycle 5 (2013-08-07); assessed as related to study drug (probable); resolved 2013-08-22.

moderate assessed

Grade 1 oedema peripheral with onset in cycle 5 (2013-08-04); assessed as not related to study drug (unlikely); resolved 2013-09-06.

mild assessed

Grade 2 diarrhoea with onset in cycle 5 (2013-08-01); assessed as not related to study drug (not related); resolved 2013-08-05.

moderate assessed

Grade 2 hypocalcaemia with onset in cycle 4 (2013-07-21); assessed as not related to study drug (unlikely); resolved 2013-07-26.

moderate assessed

Grade 1 fatigue with onset in cycle 4 (2013-07-20); assessed as not related to study drug (unlikely); resolved 2013-07-30.

mild assessed

Grade 3 pain in extremity with onset in cycle 2 (2013-06-09); assessed as not related to study drug (not related); resolved 2013-06-28.

severe assessed

Data queries

0

No data queries. Open queries would appear here for this patient.