|
Clinical adverse effects
|
Diary of adverse effects / clinical records at T0 and T1
|
Treatment associated symptoms / Unexpected symptoms
|
1 death unrelated to treatment No symptoms associated to treatment
|
No occurrence of clinical symptoms associated to the treatment
|
|
Liver injury
|
Laboratory testing at T0 and T1
|
ALT – AST – γGT
|
No new subjects reported pathological exams at T1
|
No liver injury associated to the treatment
|
|
Genomic instability
|
Laboratory testing at T0 and T1
|
Cytokinesis Block Micronucleus assay
|
No increase of mean MN frequency in subjects treated with IDN 5933 [MR = 0.98; 0.84–1.16]
|
No increase of genomic instability associated to the treatment
|
|
DNA damage
|
Laboratory testing at T0 and T1
|
Comet assay
|
No increase of mean TI% damage in subjects treated with IDN 5933 [MR = 0.96; 0.64–1.40]
|
No increase of DNA damage associate to the treatment
|
|
Modulation of genes involved in liver carcinogenesis
|
Laboratory testing at T0 and T1
|
c-myb – p53 – ctnnb1 expression level [mRNA level]
|
No association with treatment
|
No altered expression of liver cancer genes associated to the treatment
|
