Tom3 schreef op 24 september 2018 13:47:
In het prospectus staat dat de bloedingen niet drug gerelateerd waren. Waarom twijfelt men aan die uitspraak? Waarom kon dit niet opgenomen worden in de PP sheets? Het zou de koers goed doen als Argenx haar woorden hard kan maken.
"The frequency of bleeding related events, as defined in the protocol, was evaluated separately. This was done due to the nature of the disease, as
low platelet levels in ITP patients may induce bleeding events in a proportion of patients, and signs and symptoms vary widely. Twenty-eight bleeding
events were reported in 12 patients (31.6%) across the treatment cohorts. Five patients (38.5%) in each the efgartigimod 5 mg/kg arm and 10 mg/kg
arm, experienced at least one bleeding TEAE, compared to two (16.7%) in the placebo cohort. Bleeding was measured according to the SMOG Index of
the ITP-BAT scale, a bleeding scale specific for ITP. Severity is graded from 0 to 4. No grade 4 bleeding events were observed in the study. Grade 2 and
3 events were observed, including events recorded on the day of rescue, in six patients (23.1%) in the efgartigimod arms, compared to one patient
(8.3%) in the placebo arm. Our analysis of this data regarding bleeding related events is ongoing, but, to date, no bleeding events were considered
related to the study drug. Further analysis of this data includes the relation with each patient's bleeding history and demographics of the patients, and
the relation with response to efgartigimod. We expect to report our conclusions in our full data release in December 2018."