Table 3 Relevance and novelty of conclusion claims based on manual validation
From: Dynamic enhancement of drug product labels to support drug safety, efficacy, and effectiveness
Drug | ClinicalTrials.gov | Published results from ClinicalTrials.gov | |||
|---|---|---|---|---|---|
| Â | studies involving the drug | studies involving the drug | |||
| Â | Â | N | Relevant N (%) | Novel (indication) | Novel (off-label use) |
Antidepressants | Â | Â | Â | Â | Â |
Citalopram | 4 | 25 | 5 (20) | 5 | Â |
Duloxetine | 4 | 4 | 4 (100) | 3 | Â |
Escitalopram | 6 | 9 | 3 (33) | 1 | 2 |
Mirtazapine | 1 | 22 | 1 (5) | 1 | 0 |
Nortriptyline | 3 | 24 | 2 (8) | 1 | 1 |
Venlafaxine | 2 | 2 | 2 (100) | 1 | 1 |
Antipsychotics | Â | Â | Â | Â | Â |
Olanzapine | 5 | 13 | 7 (54) | 6 | 1 |
Risperidone | 23 | 70 | 26 (37) | 21 | 5 |
Sedative Hypnotics | Â | Â | Â | Â | Â |
Eszopiclone | 1 | 1 | 1 (100) | 0 | 1 |