Table 2.
All (N = 38) n (%) | Discontinueda | |||
---|---|---|---|---|
No (N = 23) n (%) | Yes (N = 15) n (%) | P valueb | ||
Patients with at least 1 AE | 29 (76.3) | 15 (65.2) | 14 (93.3) | 0.0501 |
Local AEs | 23 (60.5) | 13 (56.5) | 10 (66.7) | 0.3897 |
Erythema | 16 (42.1) | 12 (52.2) | 4 (26.7) | |
Pain/burning during max rate infusion | 7 (18.4) | 5 (21.7) | 2 (13.3) | |
Itching | 6 (15.8) | 2 (8.7) | 4 (26.7) | |
Excessive swelling | 5 (13.2) | 2 (8.7) | 3 (20.0) | |
Pain at site | 5 (13.2) | 3 (13.0) | 2 (13.3) | |
Discomfort | 3 (7.9) | 2 (8.7) | 1 (6.7) | |
Pain/burning during rate ramp-up | 2 (5.3) | 0 (0.0) | 2 (13.3) | |
Pain/burning during hyaluronidase infusion | 2 (5.3) | 0 (0.0) | 2 (13.3) | |
Continual burning | 2 (5.3) | 2 (8.7) | 0 (0.0) | |
Leakage | 1 (2.6) | 0 (0.0) | 1 (6.7) | |
Rash | 1 (2.6) | 0 (0.0) | 1 (6.7) | |
Systemic AEs | 24 (63.2) | 11 (47.9) | 13 (86.7) | 0.0165 |
Headache | 18 (47.4) | 9 (39.1) | 9 (60.0) | |
Malaise | 10 (26.3) | 5 (21.7) | 5 (33.3) | |
GI disorderc | 6 (15.8) | 3 (13.0) | 3 (20.0) | |
Migraine | 3 (7.9) | 0 (0.0) | 3 (20.0) | |
Fever | 5 (13.2) | 1 (4.3) | 4 (26.7) | |
Body aches | 3 (7.9) | 2 (8.7) | 1 (6.7) | |
Cough/sore throat/sinus infection | 2 (5.3) | 0 (0.0) | 2 (13.3) | |
Rash (not infusion site) | 2 (5.3) | 1 (4.3) | 1 (6.7) | |
Joint pain | 2 (5.3) | 1 (4.3) | 1 (6.7) | |
Itch | 2 (5.3) | 1 (4.3) | 1 (6.7) | |
Muscle weakness | 2 (5.3) | 0 (0.0) | 2 (13.3) | |
Light sensitivity | 1 (2.6) | 0 (0.0) | 1 (6.7) | |
Myalgias | 1 (2.6) | 0 (0.0) | 1 (6.7) | |
Wheezing/chest tightness | 1 (2.6) | 0 (0.0) | 1 (6.7) | |
Dehydration | 1 (2.6) | 0 (0.0) | 1 (6.7) | |
Leakage | 1 (2.6) | 0 (0.0) | 1 (6.7) |
AE adverse event, GI gastrointestinal
a Includes all reported AEs and does not imply that the listed AE was the reason for discontinuation in each row
b Within each row, comparison of percentage of patients in a given row who did not discontinue versus the percentage of patients who did discontinue (not the same as column percentages shown in the table; see text for relevant percentages). P values reflect one-tailed Fisher’s exact test
c For example, nausea, vomiting, diarrhea