Table 6. Adverse Events in Study Participants.
| Adverse eventa,b | Relation to study drugc | Magnesium group (n = 409) | Placebo group (n = 407) |
|---|---|---|---|
| Nausea/vomiting | Total | 9 | 5 |
| Unlikely | 5 | 4 | |
| Possibly | 3 | 1 | |
| Other | 1 | 0 | |
| Sore throat/nose, burning tongue, epistaxis | Total | 8 | 0 |
| Possibly | 7 | 0 | |
| Definitely | 1 | 0 | |
| Rash | Total | 2 | 1 |
| Unlikely | 1 | 1 | |
| Possibly | 1 | 0 | |
| Ear pain | Possibly | 1 | 0 |
| Headache | Unlikely | 0 | 1 |
| Hyperglycemia | Unlikely | 1 | 0 |
| Hypertension | Possibly | 1 | 0 |
| Hypotension | Unlikely | 0 | 1 |
| Metabolic acidosis | Unlikely | 2 | 0 |
| Night terrors | Unlikely | 0 | 1 |
| Possible pneumonia | Unlikely | 0 | 1 |
| Possible sepsis | Unlikely | 0 | 1 |
| Status asthmaticus | Unlikely | 1 | 0 |
| Any adverse event | 25 | 11 | |
| Any serious adverse eventd | 5 | 14 |
No patient had more than 1 adverse event.
These a priori–defined asthma/study-related occurrences were not considered adverse events: cough, respiratory distress (disease-related), asthma-related hospitalization, intravenous insertion, sinus tachycardia, and bitter/salty taste of the experimental solution.
Relation of adverse events to the study drug was evaluated by site investigators according to clinical relationship or theoretical pharmacologic relationship, using the following scale: not related, unlikely related, possibly related, definitely related, other.
Serious adverse events were defined a priori as hypotension requiring medical intervention, apnea, or admission to intensive care unit. All observed serious adverse events consisted of admissions to intensive care unit and none were attributed to the experimental therapy.