6.0 GBq (n = 23) | 7.4 GBq (n = 41) | Overall (n = 64) | ||||
---|---|---|---|---|---|---|
Adverse event | All severity (n) | Severe (n) | All severity (n) | Severe (n) | All severity (n) | Severe (n) |
Any event | 22 (95.7) | 2 (8.7) | 39 (95.1) | 7 (17.1) | 61 (95.3) | 9 (14.1) |
Dry mouth | 11 (47.8) | 0 | 26 (63.4) | 0 | 37 (57.8) | 0 |
Fatigue | 13 (56.5) | 0 | 21 (51.2) | 0 | 34 (53.1) | 0 |
Nausea | 12 (52.2) | 0 | 18 (43.9) | 1 (2.4) | 30 (46.9) | 1 (1.6) |
Diarrhea | 3 (13.0) | 0 | 13 (31.7) | 0 | 16 (25.0) | 0 |
Constipation | 6 (26.1) | 0 | 9 (22.0) | 0 | 15 (23.4) | 0 |
Vomiting | 4 (17.4) | 0 | 8 (19.5) | 1 (2.4) | 12 (18.8) | 1 (1.6) |
Taste disorder | 4 (17.4) | 0 | 7 (17.1) | 0 | 11 (17.2) | 0 |
Pain | 3 (13.0) | 0 | 6 (14.6) | 1 (2.4) | 9 (14.0) | 1 (1.6) |
Decreased appetite | 1 (4.3) | 0 | 5 (12.2) | 0 | 6 (9.4) | 0 |
Arthralgia | 3 (13.0) | 0 | 2 (4.9) | 0 | 5 (7.8) | 0 |
Hemorrhage/hematoma | 1 (4.3) | 1 (4.3) | 3 (7.3) | 1 (2.4) | 4 (6.3) | 2 (3.1) |
Infection | 1 (4.3) | 0 | 3 (7.3) | 1 (2.4) | 4 (6.3) | 1 (1.6) |
Headache | 2 (8.7) | 0 | 2 (4.9) | 0 | 4 (6.3) | 0 |
Dry eye | 1 (4.3) | 0 | 3 (7.3) | 0 | 4 (6.3) | 0 |
Back pain | 2 (8.7) | 0 | 1 (2.4) | 0 | 3 (4.7) | 0 |
Dyspnea | 0 | 0 | 3 (7.3) | 1 (2.4) | 3 (4.7) | 1 (1.6) |
Key laboratory tests events | ||||||
Anemia | 4 (17.4) | 0 | 4 (9.8) | 1 (2.4) | 8 (12.5) | 1 (1.6) |
Thrombocytopenia | 0 | 0 | 1 (2.4) | 1 (2.4) | 1 (1.6) | 1 (1.6) |
Leukopenia | 0 | 0 | 1 (2.4) | 0 | 1 (1.6) | 0 |
Lymphopenia | 0 | 0 | 1 (2.4) | 0 | 1 (1.6) | 0 |
Acute kidney injury | 0 | 0 | 1 (2.4) | 1 (2.4) | 1 (1.6) | 1 (1.6) |
GFR decreased | 1 (4.3) | 0 | 0 | 0 | 1 (1.6) | 0 |
Results given as xx (xx.x) where xx = number of patients with AEs, (xx.x) = percentage of patients. Every patient was counted a single time for each applicable specific AE. All AE tables are coded using MedDRA, version 22.1. Preferred terms are sorted in descending frequency of 'All severity' column, as reported in the 'Overall' column. Data in parentheses are percentages, unless otherwise indicated.