Table 5.
Total injection-site reactions by treatment group
| Aripiprazole lauroxil regimen | All patients (n = 104) | |||
|---|---|---|---|---|
| 1064 mg q8wk (n = 35) | 882 mg q6wk (n = 34) | 441 mg q4wk (n = 35) | ||
| ISRs by injection number | ||||
| First injection | ||||
| Any ISR | 2/35 (5.7)a | 2/34 (5.9)b | 3/35 (8.6)c | 7/104 (6.7) |
| Second injectiond | ||||
| Any ISR | 2/31 (6.5) | 1/32 (3.1) | 1/33 (3) | 4/96 (4.2) |
| Third injection | ||||
| Any ISR | 1/29 (3.4) | 1/31 (3.2) | 0/33 (0) | 2/94 (2.1) |
| Any ISR reported | 5/35 (14.3)e | 3/34 (8.8) | 4/35 (11.4) | 12/104 (11.5) |
| Injection-site painf | 4/5 (80) | 3/3 (100) | 3/4 (75) | 10/12 (83.3) |
Data shown as n/m (%), where m is number of evaluable patients, unless otherwise stated
ISR injection-site reaction, q4wk every 4 weeks, q6wk every 6 weeks, q8wk every 8 weeks
aThe 1064-mg q8wk group includes any report of ISR at study visits for weeks 2, 4, 6, and 8 (if reported prior to second injection at week 8)
bThe 882-mg q6wk group includes any report of ISR at study visits for weeks 2, 4, and 6 (if reported prior to second injection at week 6)
cThe 441-mg q4wk group includes any report of ISR at study visits for weeks 2 and 4 (if reported prior to second injection at week 4)
dSee ISR first injection footnotes for information on differences in ISR assessments according to dose/dose interval assignment
eUsing report of ISR at any safety visit
fOther reports of induration (1064 mg q8wk, n = 1; 441 mg q4wk, n = 1)