TABLE 1.
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) |
MedDRA classifications. Abbreviation: ARIA, amyloid related imaging abnormalities.
N (%) = no. of participants; Participants may have reported more than one event within a classification.
Fisher's exact test comparing proportion of participants reporting an event across treatment cohort.
N (%) = no. of events.
Fisher's exact test comparing distribution of the most severe AE reported by a participant across treatment cohorts.