Therapeutic Area·DG Japan

Respiratory

Pulmonary function studies, inhaled therapeutics, asthma and COPD trial cohorts. Source data harmonized to SDTM 3.4 with FEV1 / FVC / PEF endpoints maintained as ADaM analysis flows.

Steward · Technical steward · Anatomy · chest-left, chest-right

Avg. quality

Assets

Total rows

3,156,985

Certified

/ 6

Source systems

Source systemsMedidata Rave ClinicalVeeva Vault ClinicalSAS Drug DevelopmentCDP Imaging Repository

Common tagsclinical · 1pulmonary · 1core · 1edc · 1device · 1real-world-evidence · 1adherence · 1glossary · 1

Assets

Asset

Type · Status

Rows

Quality

Updated

Spirometry Measurements
Confidential
rave_eg_spirometry
FEV1, FVC, FEV1/FVC ratio and PEF values collected via ATS/ERS-compliant spirometers across all active respiratory studies. Source-of-truth table joined to SDTM EG via USUBJID and EGSEQ.
TableApproved
184.3K
94
17d ago
Inhaler Adherence Telemetry
Confidential
vault_inhaler_adherence
Daily inhaler usage events streamed from connected device studies (Propeller Health and Adherium Hailie) under ASTHMA-301 and COPD-204 protocols. Used for adherence-stratified efficacy analyses.
TableApproved
2.9M
81
16d ago
COPD Severity (GOLD)
Internal
term_copd_severity
Standardized GOLD 2024 staging classification for COPD severity (GOLD 1-4 by post-bronchodilator FEV1% predicted). Used as stratification variable across all COPD studies.
Business TermApproved
—
100
3mo ago
Asthma Phase III Efficacy Summary
Restricted
rpt_asthma_p3_efficacy
Pre-computed efficacy summary for the ASTHMA-301 Phase III cohort: ACQ-7 score, exacerbation rate, rescue medication use. Refreshed weekly via SAS pipeline.
ReportUnder Review
—
88
22d ago
Patient-Reported Outcomes (Asthma)
Confidential
rave_qs_asthma_pro
ACQ-7, AQLQ(S), and PROMIS questionnaire responses for respiratory program participants. Captured via tablet at site visits and ePRO at home.
TableApproved
56.0K
76
18d ago
HRCT Pulmonary Quantitative Features
Restricted
img_pulm_hrct_features
Quantitative HRCT-derived features (LAA-950%, Pi10, airway wall thickness) processed by VIDA Insights at the imaging core lab.
TableApproved
12.5K
90
23d ago