Acute Migraine (with or without aura)
Conditions
Brief summary
The frequency and severity of on-treatment and treatment-emergent adverse events (TEAEs) that occur in at least 5% of treated participants, the frequency of serious adverse events (SAEs) , adverse events (AEs) leading to discontinuation and clinically significant laboratory abnormalities during the treatment period will be assessed. Clinically significant laboratory abnormalities will be identified as on-treatment Grade 3 to 4 laboratory test results.
Detailed description
The frequency and severity of hepatic-related adverse events (AEs) and frequency of hepatic-related AEs leading to treatment discontinuation will be tabulated from case report forms and will be based on unique participants reporting such events. Severity will be assessed as the worst severity observed while the participant is on treatment.
Interventions
Sponsors
Pfizer Inc.
Eligibility
Sex/Gender
All
Age
0 Years to 17 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The frequency and severity of on-treatment and treatment-emergent adverse events (TEAEs) that occur in at least 5% of treated participants, the frequency of serious adverse events (SAEs) , adverse events (AEs) leading to discontinuation and clinically significant laboratory abnormalities during the treatment period will be assessed. Clinically significant laboratory abnormalities will be identified as on-treatment Grade 3 to 4 laboratory test results. | — |
Secondary
| Measure | Time frame |
|---|---|
| The frequency and severity of hepatic-related adverse events (AEs) and frequency of hepatic-related AEs leading to treatment discontinuation will be tabulated from case report forms and will be based on unique participants reporting such events. Severity will be assessed as the worst severity observed while the participant is on treatment. | — |
Countries
Poland, Spain
Outcome results
None listed