Safety Oversight
Cross-source consensus on Safety Oversight from 1 sources and 4 claims.
1 sources · 4 claims
Risks & contraindications
Other
Highlighted claims
- The main trial remains double-blind from randomisation until database lock. — Daridorexant in children and adolescents with insomnia disorder: study protocol for a multicentre randomised controlled trial
- An Independent Safety Board reviews predefined adverse events of special interest in a blinded manner. — Daridorexant in children and adolescents with insomnia disorder: study protocol for a multicentre randomised controlled trial
- An Independent Data Monitoring Committee monitors unblinded efficacy and safety data and can recommend continuing, modifying, or terminating the trial. — Daridorexant in children and adolescents with insomnia disorder: study protocol for a multicentre randomised controlled trial
- Potential adverse events of special interest include narcolepsy-like symptoms, complex sleep behaviours, hallucinations or sleep paralysis, suicidality, and drug-abuse-potential events. — Daridorexant in children and adolescents with insomnia disorder: study protocol for a multicentre randomised controlled trial