Table 3.

Data being collected in PEDISTAD

Type	Collected data
Patient and disease characteristics	Patient demographics and medical history. Personal and family history of AD and selected atopic comorbidities. Prior and concomitant medications for AD and comorbidities—all prior systemic therapy ever used, all topical and ultraviolet therapy in the previous 3 months as well as treatment(s) for other diseases, including name, dose, route, frequency and start/stop date. Selected comorbidity presence throughout the study (as diagnosed by an HCP).
Patient-reported/caregiver-reported outcomes	POEM CDLQI/IDQOL DFI Peak Pruritus NRS/worst scratching NRS CGAD Days missed from school for the patient and days missed from work for the primary caregiver due to AD since last visit. TNSS
Physician assessments of AD disease activity	EASI BSA (%) affected by AD.
Safety data	All adverse events regardless of seriousness.
Other data	Visits to HCPs—type of HCP and reason for the visit. Investigator specialty and setting. Photography of a representative area affected by AD—optional (at select centres). Reason for end of study.
Biomarker data	Serial blood samples for protein and RNA expression. Cheek swabs for DNA genomic biomarkers.

AD, atopic dermatitis; BSA, body surface area; CGAD, Caregiver Global Assessment of Disease; CDLQI, Children's Dermatology Life Quality Index; DFI, Dermatitis Family Impact; EASI, Eczema Area and Severity Index; HCP, healthcare professional; IDQOL, Infant's Dermatitis Quality of Life; NRS, Numerical Rating Scale; POEM, Patient-Oriented Eczema Measure; TNSS, Total Nasal Symptom Score.