The one participant who withdrew is low in the scheme of things (3.7%). A single arm trial of DTG/ TDF/FTC published earlier this year had a 17.6% overall withdrawal rate. For BIT225 -010, it doesn't say that one withdrew from the study due to adverse event and the other was an unrelated withdrawl (could have been hit by bus or perhaps relocated). The specific reasons for withdrawal inquestion could be any of adverse events, personal reasons, protocol violations, or other factors not directly related to the treatment being studied. It is such a small trial if it were an adverse event, it may be related to the cART and not the BIT225. Hopefully, we get a better picture when we see the published journal.
Control data from other study:
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- Ann: POSITIVE OUTCOMES IN BIT225 PHASE 2 CLINICAL TRIAL IN HIV
Ann: POSITIVE OUTCOMES IN BIT225 PHASE 2 CLINICAL TRIAL IN HIV, page-174
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