Table 2.
Summary of Reported Adverse Events During Treatment
Single Administration | Multiple Administration | |||||
---|---|---|---|---|---|---|
Placebo (6) | Adrenomedullin | Placebo (6) | Adrenomedullin | |||
Low (6) | Medium (6) | High (6) | High (6) | |||
Any adverse event | 1(16.7%) | 0 | 3(50.0%) | 2(33.3%) | 1(16.7%) | 3(50.0%) |
Treatment-related adverse events | 1(16.7%) | 0 | 3(50.0%) | 2(33.3%) | 1(16.7%) | 3(50.0%) |
Severe adverse events | 0 | 0 | 0 | 0 | 0 | 0 |
Serious adverse events | 0 | 0 | 0 | 0 | 0 | 0 |
Deaths | 0 | 0 | 0 | 0 | 0 | 0 |
Adverse events reported in >1 participant in any group | ||||||
Nervous system disorders | ||||||
Headache | 1(16.7%) | 0 | 1(16.7%) | 1(16.7%) | 0 | 3(50.0%) |
Cardiac disorders | ||||||
Palpitations | 0 | 0 | 0 | 0 | 0 | 2(33.3%) |
Wenckebach type atrioventricular block | 0 | 0 | 2(33.3%) | 1(16.7%) | 0 | 0 |
Gastrointestinal disorders | ||||||
Diarrhea | 0 | 0 | 0 | 0 | 1(16.7%) | 1(16.7%) |