TABLE 3.
Treatment-Emergent Adverse Events
| 0.025 mmol Gd/kg BW | 0.05 mmol Gd/kg BW | 0.1 mmol Gd/kg BW | 0.03 mmol Gd/kg BW | 0.2 mmol Gd/kg BW | Placebo | |
|---|---|---|---|---|---|---|
| IV Infusion | IV Infusion | IV Infusion or Injection | IV Injection | IV Injection | IV Infusion or Injection | |
| n = 6 | n = 6 | n = 12 | n = 6 | n = 6 | n = 13 | |
| Participants with | ||||||
| At least 1 TEAE | 1 (16.7) | 2 (33.3) | 2 (16.7) | 1 (16.7) | 1 (16.7) | 4 (30.8) |
| Bound to left | ||||||
| Mild | 0 | 2 (33.3) | 1 (8.3) | 1 (16.7) | 1 (16.7) | 4 (30.8) |
| Moderate | 1 (16.7) | 0 | 1 (8.3) | 0 | 0 | 0 |
| Severe | 0 | 0 | 0 | 0 | 0 | 0 |
| Any study drug–related TEAE | 0 | 1 (16.7) | 1 (8.3) | 0 | 0 | 2 (15.4) |
| Any TEAE related to study procedures | 1 (16.7) | 2 (33.3) | 0 | 1 (16.7) | 1 (16.7) | 2 (15.4) |
| Any TEAE leading to discontinuation of study drug | 0 | 0 | 0 | 0 | 0 | 0 |
| Any serious TEAE | 0 | 0 | 0 | 0 | 0 | 0 |
| TEAEs, MedDRA preferred terms | ||||||
| Headache | 1 (16.7) | 2 (33.3) | 1 (8.3) | 0 | 0 | 3 (23.1) |
| Nasopharyngitis | 0 | 0 | 1 (8.3) | 1 (16.7) | 0 | 0 |
| Agitation | 0 | 0 | 0 | 0 | 0 | 1 (7.7) |
| Back pain | 0 | 0 | 0 | 1 (16.7) | 0 | 0 |
| Blood creatinine phosphokinase increased | 1 (16.7) | 0 | 0 | 0 | 0 | 0 |
| C-reactive protein increased | 0 | 0 | 1 (8.3) | 0 | 0 | 0 |
| Dysmenorrhea | 0 | 0 | 0 | 0 | 0 | 1 (7.7) |
| Injection site pain | 0 | 0 | 0 | 0 | 0 | 1 (7.7) |
| Lymphocyte count decreased | 0 | 0 | 1 (8.3) | 0 | 0 | 0 |
| Myalgia | 1 (16.7) | 0 | 0 | 0 | 0 | 0 |
| Presyncope | 0 | 0 | 0 | 0 | 1 (16.7) | 0 |
Data are numbers of participants followed by percentages in parentheses. Preferred terms are sorted by overall incidence and alphabetically. Adverse events were coded using MedDRA v22.0.
BW, body weight; Gd, gadolinium; IV, intravenous; MedDRA, Medical Dictionary for Regulatory Activities; n, number of participants; TEAE, treatment emergent adverse event.