Table 3. Adverse Events and Serious Adverse Events*.
| Event | Mepolizumab (N = 68) |
Placebo (N = 68) |
|---|---|---|
| no. of participants (%) | ||
| Adverse event | ||
| Any event | 66 (97) | 64 (94) |
| Event considered by the investigator to be related to the trial agent | 35 (51) | 24 (35) |
| Event leading to trial-agent discontinuation or trial withdrawal | 2 (3) | 1 (1) |
| Death | 1 (1)† | 0 |
| Serious adverse event‡ | ||
| Any event | 12 (18) | 18 (26) |
| Event considered by the investigator to be related to the trial agent | 3 (4) | 3 (4) |
| Systemic or local-site reaction§ | ||
| Systemic reaction | 4 (6) | 1 (1) |
| Local-site reaction | 10 (15) | 9 (13) |
| Anaphylaxis considered by the investigator to be related to the trial agent | 0 | 0 |
| Cardiovascular adverse event¶ | ||
| Arrhythmia | 2 (3) | 3 (4) |
| Stroke or TIA | 1 (1) | 0 |
| Congestive heart failure | 0 | 1 (1) |
| Myocardial infarction or unstable angina | 1 (1) | 1 (1) |
There were no significant between-group differences. TIA denotes transient ischemic attack.
The event (cardiac arrest) was not considered by the physician to be related to the trial regimen.
Serious adverse events were defined as any untoward medical occurrence that resulted in death, was life-threatening, resulted in hospitalization or prolongation of existing hospitalization, resulted in disability or incapacity, was a congenital anomaly or birth defect, or was indicative of possible drug-induced liver injury with hyperbilirubinemia.
Systemic or local-site reactions were identified by means of an electronic case-report form that was designed for the collection of data on systemic reactions.
Cardiovascular adverse events were identified by means of an electronic case-report form that was designed for the collection of data on cardiovascular events.