Table 2.
Summary of adverse or unanticipated events
| No. | Events | Suramin (N = 5) | CTCAEa grade | Placebo (N = 5) | CTCAEa grade | P valueb |
|---|---|---|---|---|---|---|
| 1 | Asymptomatic rash | 5 | 1 | 0 | – | 0.0079 |
| 2 | Uncomplicated URIc | 2 | 1 | 2 | 1 | 0.99 |
| 3 | Headache | 1 | 1 | 0 | – | 0.99 |
| 4 | Emesis × 1 | 1d | 1 | 1e | 1 | 0.99 |
| 5 | Hyperactivity | 2f | 1 | 1 | 1 | 0.99 |
| 6 | Hypoglycemiaf | 1 | 2 | 1 | 2 | 0.99 |
| 7 | Leukocytosis | 0 | – | 1g | 1 | 0.99 |
| 8 | Enuresis | 1h | 1 | 0 | – | 0.99 |
| 9 | Peripheral neuropathy | 0 | – | 0 | – | 0.99 |
| Total: | 13 | – | 6 | – | 0.12 | |
| Nonrash AEs: | 8 | – | 6 | – | 0.77 |
CTCAE, common terminology criteria for adverse events v4.03. Mild to moderate = Grades 1–2; Serious = Grades 3–5.
Fisher's exact test.
URI, upper respiratory tract infection, common cold. Infusions occurred October–February.
In 7‐year‐old after pizza and slushee consumption after playing youth league basketball.
In a 6‐year‐old after a car ride.
In a 5‐ and 14‐year‐old intermixed with periods of calm focus in first week (the 14‐year‐old) or first 3 weeks (the 5‐year‐old).
Six weeks after the infusion, after several days of a URI and fasting before lunch. Hypoglycemia was asymptomatic and corrected after a normal lunch.
Leukocytosis (12.2k WBC) occurred on the day of the saline infusion and preceded a URI.
In a 7‐year‐old briefly for a few days while sick with a cold. None of the events required medical intervention. No serious adverse events (SAEs) occurred in this study.