Clinical trial: sites, patients, visits and adverse events
Two trials across nine sites: enrolment, scheduled visits, dosing, lab biomarkers and graded adverse events, all in the right order.
Two clinical trials across nine sites: 314 patients randomised to treatment or placebo, their scheduled visits, dose administrations, lab biomarkers with reference ranges, and adverse events graded by CTCAE. Dates run in the order a monitor would expect.
24,893 rows across 7 tables, 229 KB zipped. Public domain (CC0), no signup, no attribution required.
What is in it
trial_id, trial_code, compound_code, phase, indication, therapeutic_area, target_enrollment, dose_mg, start_date, status
site_id, trial_id, site_name, principal_investigator, country, city, activated_at, accreditation_status
patient_id, site_id, trial_id, enrolled_at, sex, age_at_enrollment, arm, baseline_kps, status, completed_at, withdrawn_at, lost_at
visit_id, patient_id, trial_id, site_id, visit_number, scheduled_date, actual_date, vitals_systolic, vitals_diastolic, visit_completed
admin_id, visit_id, patient_id, dose_given_mg, administered_at, dose_modified
lab_id, visit_id, patient_id, analyte, unit, measured_value, reference_range_low, reference_range_high, is_out_of_range
ae_id, patient_id, visit_id, trial_id, onset_date, ctcae_term, body_system, ctc_grade, serious, related_to_drug, resolution_status
What holds, and how it was checked
Each line was measured against these exact files rather than asserted. The same checks ship inside the zip as INTEGRITY.txt, so you can re-run them yourself.
- 13 foreign-key relationships checked, 0 orphaned rows
- No row is dated before the row it belongs to
- 314 patients in 2 arms (treatment 158, control_placebo 156)
- 716 adverse events graded by CTCAE, 5.9% serious, and 100% have an onset on or after the patient's enrolment
- 15.2% of 17,802 lab values fall outside their reference range, and the flag agrees with the range in 100% of rows
- 96.3% of 3,083 scheduled visits were completed, and 100% of completed visits fall on or after enrolment
Questions it can answer
- Is the adverse event rate different between the treatment and placebo arms?
- Which biomarkers drift out of range after dosing?
- What share of patients withdraw or are lost, and when?
- How does visit completion vary by site?
Generate a custom version
Make your own version in StudioThis dataset was built by Misata Studio's engine and is fixed. RECIPE.json in the zip records the archetype, the sizes and the seed. In Studio you can start from the same kind of data, change the sizes, the rates or the period, and get a new dataset with its own certificate.
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