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Mufaso

02/28/24 3:02 PM

#250817 RE: jbog #250783

Jbog- Viking reported both "Discontinued treatment early" and "Discontinued study early" and clarified what each meant in the cc. As I heard it they said “Discontinued treatment early” meant the participant missed at most 2 doses but stayed in the study while "Discounted study early" meant the participant didn’t finish the study . (The exchange occurred at around the 33 min of the cc if you want to listen for yourself.) So I believe the study discontinuation numbers were the lower numbers (second row) and exceptional.

Here were the raw numbers reported in these two categories:

Placebo VK2735 VK2735 VK2735 VK2735 VK2735
2.5 mg 5 mg 10 mg 15 mg Combined
(n=35) (n=35) (n=35) (n=35) (n=35) (n=140)
Discontinued treatment early 5 (14%) 2 (6%) 4 (11%) 5 (14%) 7 (20%) 18 (13%)
Discontinued study early 2 (6%) 0 (0%) 1 (3%) 2 (6%) 2 (6%) 5 (4%)


Irrespective of the discontinuations, the point is tolerability. In the VKTX cc it was stated that almost all AE’s were mild or moderate (emphasis was on mild/resolving quickly) and occurring most often in the very first week of treatment.

I believe most analysts think that a less aggressive dosing schedule would contribute to a better tolerability profile than even better than these exceptionally good numbers portray.