Table 2.
Candidate 1 |
Candidate 2 |
Total |
|||||
---|---|---|---|---|---|---|---|
Number of participants (% of n=15) | Number of events | Number of participants (% of n=15) | Number of events | Number of participants (% of n=30) | Number of events | ||
≥1 serious adverse event | 0 | 0 | 0 | 0 | 0 | 0 | |
≥1 severe adverse event | 6 (40%) | 8 | 9 (60%) | 12 | 15 (50%) | 20 | |
Probable | 0 | 0 | 0 | 0 | 0 | 0 | |
Possible | 6 (40%) | 7 | 9 (60%) | 10 | 15 (50%) | 17 | |
Unlikely | 0 | 1 | 0 | 2 | 0 (3%) | 3 | |
Unrelated | 0 | 0 | 0 | 0 | 0 | 0 | |
Adverse events that led to study withdrawal | 0 | 0 | 0 | 0 | 0 | 0 | |
≥1 adverse event | 15 (100%) | 103 | 15 (100%) | 84 | 30 (100%) | 187 | |
Any solicited | 13 (87%) | 31 | 9 (60%) | 18 | 22 (73%) | 49 | |
Mild solicited | 8 (53%) | 25 | 8 (53%) | 17 | 16 (53%) | 42 | |
Moderate solicited | 5 (33%) | 6 | 1 (7%) | 1 | 6 (20%) | 7 | |
Severe solicited | 0 | 0 | 0 | 0 | 0 | 0 | |
Any unsolicited | 15 (100%) | 72 | 15 (100%) | 66 | 30 (100%) | 138 | |
Mild unsolicited | 3 (20%) | 51 | 3 (20%) | 37 | 6 (20%) | 88 | |
Moderate unsolicited | 6 (40%) | 13 | 3 (20%) | 17 | 9 (30%) | 30 | |
Severe unsolicited | 6 (40%) | 8 | 9 (60%) | 12 | 15 (50%) | 20 |
Each participant was counted only once in each category, under the maximum causality or severity. Both solicited and unsolicited events are included, unless otherwise noted. Serious adverse events are medical events that are life-threatening, require admission to hospital, or result in notable incapacity of the individual. Severe adverse events are medical events that prevent normal everyday activities, and this category did not include serious adverse events. Solicited events comprised signs and symptoms that were reported by use of a predefined checklist in a diary card; or a fever, as determined by the participant's measurement of their body temperature. Unsolicited events comprised other signs and symptoms that participants recorded in their diary card. Participants graded their adverse events from mild to severe.