Safety Monitoring
Cross-source consensus on Safety Monitoring from 1 sources and 5 claims.
1 sources · 5 claims
Risks & contraindications
Other
Highlighted claims
- The DSMB performs an interim efficacy and safety analysis after 38 patients are evaluable for the primary endpoint. — Transfer of faeces in ulcerative colitis 2: improving efficacy – study protocol for a multicentre randomised controlled trial (TURN2 study)
- TURN2 has prespecified stopping rules for safety, futility, and placebo-favouring treatment effects. — Transfer of faeces in ulcerative colitis 2: improving efficacy – study protocol for a multicentre randomised controlled trial (TURN2 study)
- TURN2 procedure-specific risks include sigmoidoscopy bleeding or perforation and nasoduodenal tube aspiration, malposition, or perforation. — Transfer of faeces in ulcerative colitis 2: improving efficacy – study protocol for a multicentre randomised controlled trial (TURN2 study)
- FMT is generally safe, with most adverse events described as transient gastrointestinal symptoms. — Transfer of faeces in ulcerative colitis 2: improving efficacy – study protocol for a multicentre randomised controlled trial (TURN2 study)
- Serious adverse events from FMT are rare. — Transfer of faeces in ulcerative colitis 2: improving efficacy – study protocol for a multicentre randomised controlled trial (TURN2 study)