Table 4.
Summary of Treatment-Emergent Suicidal Ideation and Behavior Reported on the Columbia-Suicide Severity Rating Scale at Any Postbaseline Assessment, Safety Population
| Placebo (n = 119) | Desvenlafaxine low exposure (n = 120) | Desvenlafaxine high exposure (n = 121) | Total (N = 360) | |
|---|---|---|---|---|
| Treatment-emergent SIBa, n/N (%) | 16/119 (13.4) | 9/120 (7.5) | 14/121 (11.6) | 39/360 (10.8) |
| New-onset SIBb | 14/107 (13.1) | 9/113 (8.0) | 13/108 (12.0) | 36/328 (11.0) |
| Worsening SIBc | 2/12 (16.7) | 0/113 (0) | 1/13 (7.7) | 3/32 (9.4) |
| Treatment-emergent SId, n/N (%) | 16/119 (13.4) | 9/120 (7.5) | 14/121 (11.6) | 39/360 (10.8) |
| New-onset SIe | 14/107 (13.1) | 9/113 (8.0) | 13/108 (12.0) | 36/328 (11.0) |
| Wish to be dead | 5 | 5 | 5 | 15 |
| Nonspecific active suicidal thoughts | 4 | 3 | 4 | 11 |
| Active suicidal ideation with any methods (no plan) without intent to act | 4 | 0 | 4 | 8 |
| Active suicidal ideation with specific plan and intent | 1 | 1 | 0 | 2 |
| Worsening SIf | 2/12 (16.7) | 0 | 1/13 (7.7) | 3/32 (9.4) |
| Shift to nonspecific active suicidal thoughts | 1 | 0 | 0 | 1 |
| Shift to active suicidal ideation with any methods (no plan) without intent to act | 0 | 0 | 1 | 1 |
| Shift to active suicidal ideation with specific plan and intent | 1 | 0 | 0 | 1 |
| Treatment-emergent SBg, n/N (%) | 1/119 (0.8) | 1/120 (0.8) | 0/121 (0) | 2/360 (0.6) |
| New-onset suicidal behaviorh | 1/119 (0.8) | 1/120 (0.8) | 0/121 (0) | 2/360 (0.6) |
| Suicide attempt | 1 | 1 | 0 | 2 |
| Worsening SBi | 0 | 0 | 0 | 0 |
There was one poststudy suicide attempt reported as a serious adverse event that was not captured on the C-SSRS; C-SSRS was not performed following that event. N represents the number of subjects in this analysis, that is, subjects who had a baseline and a postbaseline C-SSRS assessment.
Treatment-emergent SIB is defined as (1) new-onset SI or SB, (2) worsening SI or SB, or (3) postbaseline SB on subjects reporting SI at baseline.
New-onset SIB is defined as any SI or SB reported postbaseline on subjects who reported no SI and no SB at baseline.
Worsening SIB is defined as (1) shift from SI at baseline to a more severe SI postbaseline, (2) shift from SI at baseline (and no SB at baseline) to any SB postbaseline, or (3) shift from SB at baseline to a more severe SB postbaseline
Treatment-emergent SI is defined as new-onset SI or worsening SI.
New-onset SI is defined as any SI reported postbaseline on subjects who reported no SI at baseline.
Worsening SI is defined as shift to a more severe SI postbaseline on subjects reporting SI at baseline.
Treatment-emergent SB is defined as new-onset SB or worsening SB.
New-onset SB is defined as any SB reported postbaseline on subjects who reported no SB at baseline.
Worsening SB is defined as shift to a more severe SB postbaseline on subjects reporting SB at baseline.
C-SSRS, Columbia-Suicide Severity Rating Scale; SI, suicidal ideation; SB, suicidal behavior; SIB, suicidal ideation or behavior.