Table 2.
Frequently reported (>10% overall and >1 subject in any group) treatment-emergent adverse events and laboratory abnormalities
| |
MEDI-546 |
|||||||||
|---|---|---|---|---|---|---|---|---|---|---|
|
0.1 mg/kg single dose |
0.3 mg/kg single dose |
1.0 mg/kg single dose |
3.0 mg/kg single dose |
10.0 mg/kg single dose |
20.0 mg/kg single dose |
0.3 mg/kg/week multiple dose |
1.0 mg/kg/week multiple dose |
5.0 mg/kg/week multiple dose |
Total |
|
| (n = 1) | (n = 4) | (n = 4) | (n = 4) | (n = 4) | (n = 4) | (n = 4) | (n = 4) | (n = 5) | (N = 34) | |
|
TEAEs | ||||||||||
| Total number of TEAEs |
1 |
10 |
15 |
15 |
18 |
11 |
20 |
20 |
38 |
148 |
| Total subjects reporting ≥1 TEAEs, n (%) |
1 (100.0) |
4 (100.0) |
4 (100.0) |
4 (100.0) |
4 (100.0) |
4 (100.0) |
4 (100.0) |
4 (100.0) |
5 (100.0) |
34 (100.0) |
| Upper respiratory tract infection, n (%)a |
0 (0.0) |
2 (50.0) |
1 (25.0) |
2 (50.0) |
0 (0.0) |
2 (50.0) |
0 (0.0) |
3 (75.0) |
0 (0.0) |
10 (29.4) |
| Headache, n (%)a |
0 (0.0) |
1 (25.0) |
0 (0.0) |
0 (0.0) |
2 (50.0) |
1 (25.0) |
2 (50.0) |
1 (25.0) |
0 (0.0) |
7 (20.6) |
| Diarrhea, n (%)a |
0 (0.0) |
0 (0.0) |
3 (75.0) |
0 (0.0) |
0 (0.0) |
1 (25.0) |
0 (0.0) |
1 (25.0) |
1 (20.0) |
6 (17.6) |
| Nausea, n (%)a |
0 (0.0) |
0 (0.0) |
0 (0.0) |
1 (25.0) |
2 (50.0) |
1 (25.0) |
0 (0.0) |
1 (25.0) |
1 (20.0) |
6 (17.6) |
| Arthralgia, n (%)a |
0 (0.0) |
0 (0.0) |
1 (25.0) |
0 (0.0) |
1 (25.0) |
0 (0.0) |
1 (25.0) |
1 (25.0) |
0 (0.0) |
4 (11.8) |
| Fatigue, n (%)a |
0 (0.0) |
0 (0.0) |
1 (25.0) |
0 (0.0) |
1 (25.0) |
0 (0.0) |
1 (25.0) |
1 (25.0) |
0 (0.0) |
4 (11.8) |
| Pruritus, n (%)a |
0 (0.0) |
0 (0.0) |
1 (25.0) |
0 (0.0) |
1 (25.0) |
0 (0.0) |
0 (0.0) |
1 (25.0) |
1 (20.0) |
4 (11.8) |
| Dizziness, n (%)a |
0 (0.0) |
0 (0.0) |
1 (25.0) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
2 (40.0) |
3 ( 8.8) |
| Musculoskeletal chest pain, n (%)a |
0 (0.0) |
0 (0.0) |
1 (25.0) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
2 (40.0) |
3 ( 8.8) |
| Urticaria, n (%)a |
0 (0.0) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
1 (25.0) |
0 (0.0) |
2 (40.0) |
3 ( 8.8) |
| Constipation, n (%)a |
0 (0.0) |
2 (50.0) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
2 (5.9) |
| Depression, n (%)a |
0 (0.0) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
2 (40.0) |
2 (5.9) |
|
Laboratory abnormalities | ||||||||||
| Anemiab,c, n (%) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
1 (20.0) |
1 (2.9) |
| Decreased hemoglobind, n (%) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
1 (20.0) |
1 (2.9) |
| Decreased absolute lymphocyte countd, n (%) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
1 (20.0) |
1 (2.9) |
| Elevated aspartate aminotransferase valuee, n (%) |
0 (0.0) |
1 (25.0) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
1 (2.9) |
| Hyperglycemiab, n (%) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
1 (25.0) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
1 (2.9) |
| Hematuriab, n (%) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (25.0) | 0 (0.0) | 0 (0.0) | 1 (2.9) |
aPreferred term according to the Medical Dictionary for Regulatory Activities version 14.0.
bLaboratory abnormality reported as a TEAE.
cGrade 1 in severity.
dGrade 3 in severity.
eGrade 2 in severity.
TEAE treatment-emergent adverse event.
Note: Subjects were counted only once for each preferred term, regardless of how many events the subject reported.