AEs occurring in more than 1 patient treated on the 6 and 10 μg/kg dose levels
| AE . | IV or SQ (n = 24) . | IV (n = 7) . | SQ (n = 17) . | ||
|---|---|---|---|---|---|
| Grade 1-3 | Grade 1-2 | Grade 3 | Grade 1-2 | Grade 3 | |
| Hypertension | 20 (83) | 3 (43) | 2 (29) | 11 (65) | 4 (24) |
| Injection site reaction* | 19 (79) | 2 (29) | 1 (14) | 14 (82) | 2 (12) |
| Fever* | 18 (75) | 5 (71) | 2 (29) | 2 (12) | 9 (53) |
| Chills | 15 (63) | 7 (100) | 8 (47) | ||
| Hypotension | 15 (63) | 3 (43) | 1 (14) | 10 (59) | 1 (6) |
| GI symptoms | 13 (54) | 2 (29) | 11 (65) | ||
| Fatigue | 12 (50) | 6 (86) | 4 (24) | 2 (12) | |
| Electrolyte abnormalities | 10 (42) | 3 (43) | 5 (29) | 2 (12) | |
| Edema | 9 (38) | 3 (43) | 6 (35) | ||
| Headache | 8 (33) | 4 (57) | 3 (18) | 1 (6) | |
| Dyspnea | 8 (33) | 2 (29) | 5 (29) | 1 (6) | |
| Hypoxia* | 7 (29) | 2 (29) | 3 (43) | 2 (12) | |
| Achiness | 7 (29) | 4 (57) | 3 (18) | ||
| Renal insufficiency | 7 (29) | 2 (29) | 5 (29) | ||
| Hypoalbuminemia | 6 (25) | 1 (14) | 5 (29) | ||
| Abdominal pain | 4 (17) | 3 (18) | 1 (6) | ||
| Abnormal LFT result | 3 (13) | 2 (29) | 1 (6) | ||
| Anorexia | 3 (13) | 1 (14) | 2 (12) | ||
| Confusion | 3 (13) | 1 (14) | 2 (12) | ||
| Mouth sores | 3 (13) | 1 (14) | 2 (12) | ||
| Minor bleeding | 3 (13) | 1 (14) | 2 (12) | ||
| Infections | 3 (13) | 1 (14) | 1 (6) | 1 (6) | |
| Cytopenias | 3 (13) | 1 (14) | 2 (12) | ||
| Bacteremia | 2 (8) | 2 (12) | |||
| Allergic rhinitis | 2 (8) | 2 (29) | |||
| Pemphigus rash | 1 (4) | 1 (6) | |||
| AE . | IV or SQ (n = 24) . | IV (n = 7) . | SQ (n = 17) . | ||
|---|---|---|---|---|---|
| Grade 1-3 | Grade 1-2 | Grade 3 | Grade 1-2 | Grade 3 | |
| Hypertension | 20 (83) | 3 (43) | 2 (29) | 11 (65) | 4 (24) |
| Injection site reaction* | 19 (79) | 2 (29) | 1 (14) | 14 (82) | 2 (12) |
| Fever* | 18 (75) | 5 (71) | 2 (29) | 2 (12) | 9 (53) |
| Chills | 15 (63) | 7 (100) | 8 (47) | ||
| Hypotension | 15 (63) | 3 (43) | 1 (14) | 10 (59) | 1 (6) |
| GI symptoms | 13 (54) | 2 (29) | 11 (65) | ||
| Fatigue | 12 (50) | 6 (86) | 4 (24) | 2 (12) | |
| Electrolyte abnormalities | 10 (42) | 3 (43) | 5 (29) | 2 (12) | |
| Edema | 9 (38) | 3 (43) | 6 (35) | ||
| Headache | 8 (33) | 4 (57) | 3 (18) | 1 (6) | |
| Dyspnea | 8 (33) | 2 (29) | 5 (29) | 1 (6) | |
| Hypoxia* | 7 (29) | 2 (29) | 3 (43) | 2 (12) | |
| Achiness | 7 (29) | 4 (57) | 3 (18) | ||
| Renal insufficiency | 7 (29) | 2 (29) | 5 (29) | ||
| Hypoalbuminemia | 6 (25) | 1 (14) | 5 (29) | ||
| Abdominal pain | 4 (17) | 3 (18) | 1 (6) | ||
| Abnormal LFT result | 3 (13) | 2 (29) | 1 (6) | ||
| Anorexia | 3 (13) | 1 (14) | 2 (12) | ||
| Confusion | 3 (13) | 1 (14) | 2 (12) | ||
| Mouth sores | 3 (13) | 1 (14) | 2 (12) | ||
| Minor bleeding | 3 (13) | 1 (14) | 2 (12) | ||
| Infections | 3 (13) | 1 (14) | 1 (6) | 1 (6) | |
| Cytopenias | 3 (13) | 1 (14) | 2 (12) | ||
| Bacteremia | 2 (8) | 2 (12) | |||
| Allergic rhinitis | 2 (8) | 2 (29) | |||
| Pemphigus rash | 1 (4) | 1 (6) | |||
The number of events and frequency (%) are listed. Pemphigus rash was included as a single grade 2 event, as it was categorized as a serious AE.
GI, gastrointestinal; LFT, liver function test.
P ≤ .01 for differences between IV and SQ administration by Fisher exact test.