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. 2023 Apr 24;29(6):1437–1447. doi: 10.1038/s41591-023-02326-3

Table 2.

AEs reported in at least three patients receiving MAPTRx according to severitya

Event Mild (grade 1) Moderate (grade 2) Severe (grade 3)
MAPTRx groups (N = 34) Placebo group (N = 12) MAPTRx groups (N = 34) Placebo group (N = 12) MAPTRx groups (N = 34) Placebo group (N = 12)
Number of patients with event (%)
Any AE (%) 21 (62) 5 (42) 11 (32) 4 (33) 0 0
Any serious AE 0 0 0 2 (16.7) 0 0
Post-LP headacheb 13 (38) 1 (8) 2 (6) 3 (25) 0 0
Procedural pain 4 (12) 1 (8) 3 (9) 0 0 0
Musculoskeletal pain 3 (9) 0 1 (3) 0 0 0
Vomiting 4 (12) 0 0 0 0 0
Back pain 2 (6) 1 (8) 1 (3) 0 0 0
Confusional state 2 (6) 0 1 (3) 0 0 0
Contusion 1 (3) 0 2 (6) 0 0 0
Diarrhea 2 (6) 0 1 (3) 0 0 0
Dizziness 3 (9) 1 (8) 0 0 0 0
Fatigue 3 (9) 0 0 0 0 0
Myalgia 2 (6) 1 (8) 1 (3) 0 0 0
Nasopharyngitis 3 (9) 2 (17) 0 0 0 0
Nausea 3 (9) 0 0 0 0 0
Tinnitus 3 (9) 0 0 0 0 0

aShown are AEs that occurred from the first dose of study drug through the end of MAD part 1 (treatment and post-treatment periods). Each AE was rated as mild, moderate or severe, corresponding to grades of 1, 2 and 3, respectively. In addition, serious AEs were rated as life-threatening (grade 4) or not life-threatening. At each level of summation (overall and according to system organ class or preferred term), patients for whom more than one AE was reported were counted only once for the incidence according to the most severe grade, and if there was a missing severity for the same subject, then the non-missing severity, if available, was chosen for the same subject.

bPost-LP headache indicates both post-LP syndrome and headache that were potentially related to study LP procedure. Related was defined as ‘related’, ‘possible’ or missing relationship to LP procedure.