Allergic House Dust Mite Rhinitis/Rhinoconjunctivitis with or without Asthma
Conditions
Brief summary
Proportion of participants with at least one TEAE during the up-dosing phase of the trial
Detailed description
Proportion of participants with at least one TEAE during the trial, Proportion of participants with at least one treatment related TEAE, by maximum intensity, Proportion of participants with at least one local TEAE, by maximum intensity, Number of TEAEs per injection/injection visit, Local injection-site swelling/redness per injection by size category, Proportion of participants with at least one systemic TEAE, by the maximum grade, Proportion of participants with at least one severe TEAE, Proportion of participants with TEAEs leading to dose repetition, dose reduction, or permanent discontinuation, Proportion of participants with at least one early (within 30 minutes after injection) local TEAE, Proportion of participants with at least one early (within 30 minutes after injection) systemic TEAE, Proportion of participants with at least one late (> 30 minutes and up to 24 hours after injection) local TEAE, Proportion of participants with at least one late (> 30 minutes and up to 24 hours after injection) systemic TEAE, Distribution of overall tolerability assessment scores as evaluated by the Investigator, Distribution of overall tolerability assessment scores as evaluated by the participant, Proportion of participants who achieve the planned 0.5 mL maintenance dose within the allowed number of up-dosing injections, Proportion of participants who cannot achieve the planned 0.5 mL maintenance dose within the allowed number of up-dosing injections, Proportion of participants who cannot achieve the planned 0.5 mL maintenance dose within the allowed number of up-dosing injections due to a systemic reaction of grade II or higher within 24 hours after any up dosing injection
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants with at least one TEAE during the up-dosing phase of the trial | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of participants with at least one TEAE during the trial, Proportion of participants with at least one treatment related TEAE, by maximum intensity, Proportion of participants with at least one local TEAE, by maximum intensity, Number of TEAEs per injection/injection visit, Local injection-site swelling/redness per injection by size category, Proportion of participants with at least one systemic TEAE, by the maximum grade, Proportion of participants with at least one severe TEAE, Proportion of participants with TEAEs leading to dose repetition, dose reduction, or permanent discontinuation, Proportion of participants with at least one early (within 30 minutes after injection) local TEAE, Proportion of participants with at least one early (within 30 minutes after injection) systemic TEAE, Proportion of participants with at least one late (> 30 minutes and up to 24 hours after injection) local TEAE, Proportion of participants with at least one late (> 30 | — |