Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
Navigate: Correlations HPO
There is one clinical trial.
Primary Objective: To evaluate the long-term safety and tolerability of dupilumab in pediatric patients with asthma who participated in a previous dupilumab asthma clinical study. Secondary Objectives: - To evaluate the long-term efficacy of dupilumab in pediatric patients with asthma who participated in a previous dupilumab asthma clinical study. - To evaluate dupilumab in pediatric patients with asthma who participated in a previous dupilumab asthma clinical study with regard to: - Systemic exposure. - Anti-drug antibodies (ADAs). - Biomarkers.
Description: The number (n) and percentage (%) of patients experiencing any TEAE
Measure: Treatment-emergent adverse events (TEAEs) Time: From Day 1 up to Week 64Description: Annualized rate of severe asthma exacerbation events, during the treatment period
Measure: Severe asthma exacerbation events Time: From Day 1 up to Week 52Description: Change in percentage (%) predicted forced expiratory volume in 1 second (FEV1) - Clinically significant changes from baseline
Measure: Change in % predicted FEV1 Time: From Day 1 up to Week 64Description: Change in absolute FEV1 - Clinically significant changes from baseline
Measure: Change in absolute FEV1 Time: From Day 1 up to Week 64Description: Change in forced vital capacity (FVC)
Measure: Change in FVC Time: From Day 1 up to Week 64Description: Change in forced expiratory flow (FEF) 25-75%
Measure: Change in FEF Time: From Day 1 up to Week 64Description: Serum dupilumab concentrations - Changes from first dupilumab injection
Measure: Assessment of dupilumab concentration Time: From Day 1 up to Week 64Description: Titers of Anti-dupilumab antibodies
Measure: Assessment of immunogenicity Time: From Day 1 up to Week 64Description: Blood: Eosinophil count
Measure: Assessment of blood Eosinophil count Time: From Day 1 up to Week 64Description: Serum: total IgE
Measure: Assessment of total immunoglobulin E (IgE) Time: From Day 1 up to Week 64Alphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on September 26, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
Drug Reports MeSH Reports HPO Reports