Chronic Sialorrhea
Conditions
Interventions
None listed
Sponsors
Contact for Post-marketing surveillance and relate studies
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: This drug is administered to patients who receive it for the indication of chronic sialorrhea.
Exclusion criteria
Exclusion criteria: If the period from the most recent pre registration administration date of type A botulinum toxin (for Botox injections) to the first administration date of this drug does not comply with the dosage and administration specified in the electronic package insert for type A botulinum toxin (for Botox injections), registration will not be permitted from the perspective of promoting appropriate use.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the incidence (risk) of aspiration pneumonia under real-world use of the study drug and to explore associated risk factors. | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse events, including adverse drug reactions, infections, and aspiration pneumonia (including analyses by disease background), as well as efficacy-related information (DSFS, PDS, and QOL). | — |
Contacts
Public Contactsurveillance and relate studies Contact for Post-marketing
Teijin Pharma Limited
Outcome results
None listed