Table 3.
Summary of Insomnia-Related and Decreased Appetite-Related Treatment-Emergent Adverse Events, Safety Analysis Set
| Insomnia* | Decreased appetite | |||
|---|---|---|---|---|
| Placebo (n = 131) | SHP465 MAS (n = 132) | Placebo (n = 131) | SHP465 MAS (n = 132) | |
| Participants with event, n (%) | 3 (2.3) | 22 (16.7) | 9 (6.9) | 40 (30.5) |
| Number of events | 3 | 27 | 9 | 44 |
| Mean ± SD number of events per individual† | 1.0 ± 0 | 1.2 ± 0.53 | 1.0 ± 0 | 1.1 ± 0.38 |
| Mean ± SD onset day of event‡ | 6.3 ± 9.24 | 6.8 ± 6.36 | 6.4 ± 4.28 | 4.4 ± 4.52 |
| Mean ± SD duration of event while on the study drug in days† | 13.3 ± 2.89 | 12.1 ± 8.53 | 19.4 ± 7.58 | 19.8 ± 9.50 |
| Severity of event, n (%) | ||||
| Mild | 2 (66.7) | 14 (51.9) | 6 (66.7) | 26 (59.1) |
| Moderate | 1 (33.3) | 12 (44.4) | 3 (33.3) | 18 (40.9) |
| Severe | 0 | 1 (3.7) | 0 | 0 |
| Outcome of event, n (%) | ||||
| Resolved§ | 3 (100) | 26 (96.3) | 8 (88.9) | 38 (86.4) |
| Ongoing¶ | 0 | 1 (3.7) | 1 (11.1) | 5 (11.6) |
| Dose adjustment, n (%)£ | ||||
| Dose increased | 0 | 0 | 0 | 0 |
| Dose reduced | 0 | 1 (3.7) | 0 | 1 (2.3) |
| Dose not changed | 3 (100) | 23 (85.2) | 8 (88.9) | 42 (95.5) |
| Dose interrupted | 0 | 0 | 0 | 0 |
| Dose withdrawn | 0 | 1 (3.7) | 0 | 1 (2.3) |
| Not applicable | 0 | 2 (7.4) | 1 (11.1) | 0 |
| Led to discontinuation | 0 | 1 (3.7) | 0 | 1 (2.3) |
Includes adverse events with preferred terms insomnia, initial insomnia, and middle insomnia.
Overlapping events with different preferred terms were counted as multiple events. If a participant had multiple events of the same type that were not overlapping or adjacent in time, the durations were averaged and summary statistics were based on average durations. Event duration was the number of days from the onset of the event while on the study drug until the earlier of the end date of the event or the date of the last dose +3 days. If the date of the last dose was missing, the date of the last day of study was used. Events that either overlapped or were adjacent in time were merged into one event only when calculating event duration.
Calculated as follows: (onset day of first event–date of first dose) +1.
Events having a resolution date on or before the participant's last dose date +3 days; if the last event of overlapping or adjacent adverse events of the same type was ongoing, the other event was not counted as resolved even if it had a resolution date.
Includes adverse events without a resolution date; percentages are based on the number of treatment-emergent events, excluding from the denominator overlapping or adjacent events where a later event was still ongoing.
Percentages based on the number of treatment-emergent adverse events.
MAS, mixed amphetamine salts; SD, standard deviation.