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. 2020 Dec 16;6(1):e12107. doi: 10.1002/trc2.12107

TABLE 1.

Adverse events (AE) by treatment cohort. A) Number of participants reporting categorized a AE; B) Number of participants with ARIA; C) Number of AEs distributed by severity

Placebo Allo 2 mg Allo 4 mg Allo 6–18 mg
(N = 6) (N = 6) (N = 6) (N = 6) P‐value c
A) Serious AE, N (%) b
Gastrointestinal disorders 0 1 (17) 0 0 1.0
AE, N (%) b
Cardiac disorders 0 0 0 1 (17) 1.0
Gastrointestinal disorders 0 1 (17) 1 (17) 0 1.0
General disorders and administration site conditions 2 (33) 1 (17) 1 (17) 2 (33) 1.0
Infections and infestations 2 (33) 1 (17) 1 (17) 1 (17) 1.0
Injury, poisoning, and procedural complications 1 (17) 0 0 0 1.0
Metabolism and nutrition disorders 0 0 1 (17) 0 1.0
Musculoskeletal and connective tissue disorders 2 (33) 0 0 0 0.22
Nervous system disorders 0 1 (17) 1 (17) 0 1.0
Respiratory, thoracic, and mediastinal disorders 0 1 (17) 0 2 (33) 0.57
Skin and subcutaneous tissue disorders 0 1 (17) 2 (33) 1 (17) 0.88
Surgical and medical procedures 0 0 1 (17) 0 1.0
B) ARIA, N (%) b 0 (0) 0 (0) 0 (0) 0 (0) 1.0
C) AE severity, N (%) d Placebo Allo 2 mg Allo 4 mg Allo 6‐18 mg P‐value e
Mild 5 (62.5) 6 (75) 8 (53) 6 (60) 0.73
Moderate 3 (37.5) 2 (25) 6 (40) 3 (30)
Severe 0 0 1 (7) 1 (10)
a

MedDRA classifications. Abbreviation: ARIA, amyloid related imaging abnormalities.

b

N (%) = no. of participants; Participants may have reported more than one event within a classification.

c

Fisher's exact test comparing proportion of participants reporting an event across treatment cohort.

d

N (%) = no. of events.

e

Fisher's exact test comparing distribution of the most severe AE reported by a participant across treatment cohorts.