Table 2.
Characterizations of adverse events
| Type | No | Subjects | R | Comments | |
|---|---|---|---|---|---|
| 1 |
Elevated BP |
7 |
7 |
I |
Transient, responding to adjusting the infusion rate |
| 2 |
Accidental injury |
1 |
1 |
N |
After It4, nose fracture |
| 3 |
UTI |
1 |
1 |
N |
After It5, treated with antibiotics |
| 4 |
Pruritic skin rash |
4 |
3 |
I |
2 subjects withdrew from the study. In these subjects, one subject experienced rash after It1 and second after It2. 1 subject experienced rash after I4 and I5 and was treated with Diphenhydramine, Acetaminophen and oral Prednisone |
| 5 |
Increased temperature and/or skin flushing |
5 |
1 |
I |
Treated with Diphenhydramine, Acetaminophen, and slowing the infusion rate |
| 6 |
RLS |
1 |
1 |
N |
Diagnosed after It4, treated with iron supplements |
| 8 |
Decreased GFR |
1 |
2 |
N |
After It5 and It6, resolved |
| 9 |
Ankle edema |
1 |
|
N |
After It5, treated with diazide diuretics |
| 10 |
Elevated BUN |
1 |
1 |
N |
After It5, started trial with elevated BUN at screening visit, resolved |
| 11 |
Worsening of allergies |
2 |
1 |
N |
Worsening of running nose and cough after It5 and It6, also associated with cold and fever after It6, treated with Acetaminophen, Pseudoephedrine, and Diphenhydramine. |
| 13 |
Nodular lung abnormality |
1 |
1 |
N |
Later determined to be abnormal tangle of veins, probably since birth |
| 14 |
Low potassium |
1 |
1 |
P |
After It1, treated with increased dose of potassium |
| 15 |
GI viral infection |
1 |
1 |
N |
After It5, treated with fluids, antiemetics and anti-diarrheal agents |
| 16 |
Elevated PSA |
1 |
1 |
N |
Before It1, resolved |
| 17 |
Wrist strain |
1 |
1 |
N |
After It1, resolved |
| 18 | Worsening of sleep apnea | 1 | 1 | N | After It2, prrescribed CPAP |
Legends: UTI=urinary tract infection, BUN=blood urea nitrogen, GFR=glomerular filtration rate, PSA=prostate specific antigen, CPAP=continuous positive airway pressure. R= relationship of the AE to the study drug, N= not related, PR=possibly related, I=infusional AE. It1-6 designates the infusion treatment 1–6.