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Table 5 Synthesis of main results concerning the assessment of clinical and genomic safety of subjects treated with IDN 5933

From: Clinical and genomic safety of treatment with Ginkgo biloba L. leaf extract (IDN 5933/Ginkgoselect®Plus) in elderly: a randomised placebo-controlled clinical trial [GiBiEx]

Safety threat Assessment Marker Results Interpretation
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
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