Sample Data

The following studies are provided as sample data to enable you to run reports. All studies include the SDTM and/or ADaM data sets needed for you to work through the reports.

The data files are located in the Sample Data folder in your Installation directory (typically C:\ProgramData\JMP\JMPClinical\19\Clinical\Sample Data\Nicardipine for Windows machines and /Library/Application Support/JMP/19/Clinical/Sample Data for MACs).

Note: The C:\ProgramData\ directory may be hidden by default. Follow the instructions for your operating system to view hidden folders.

You may need to add these studies prior to running JMP Clinical reports. See Add Study... for more details.

Nicardipine

These data came from a study of the effects of nicardipine on patients suffering from recent aneurismal subarachnoid hemorrhages (Haley, et al. 1993a, 1993b). 906 patients were included in this randomized double-blind placebo-controlled study; 449 patients received nicardipine while 457 received the placebo. Patients in each group were balanced with regard to prognostic factors for overall outcome. Nicardipine and the placebo were delivered continuously at 0.15 mg/Kg/hr for up to 14 days and patients were followed for up to 120 days following administration of the drugs. Results are formatted according to the CDISC Study Tabulation Model (SDTM) and Analysis Data Model (ADaM).

NicardipineAbbr

This sample is an abbreviated version of the Nicardipine sample data. It contains selected SDTM domains only.

Nicardipine CO

This sample is a modified version of the Nicardipine sample data that is suitable for simulating analysis of crossover data. The data for this study are located in the Nicardipine sample folder in the SDTMCO and ADAMCO subdirectories.

Theophylline

This simulated clinical trial is based on the Theophylline data that were described in Pinheiro & Bates (1995). Theophylline is a bronchodilator used to treat the symptoms of asthma and other lung diseases. Theophylline was orally administered to 12 individuals using weight-based doses in mg/kg. Serum concentrations were measured 11 times over 25 hours, at pre-dose and 0.25, 0.5, 1, 2, 3, 5, 7, 9, 12, and 24 hours post-dose.

For the purposes of the simulated clinical trial, doses of 300 mg and 400 mg of theophylline were assumed for the treatment arms, which is in line with current treatment recommendations. The simulated trial assumes patients were enrolled across 3 clinical sites, evenly balanced for males and females with a race distribution which approximates the population of the United States. Weight was randomly generated to occur between 50 and 100 kg. Two visits were assumed with all pharmacokinetic (pk) sampling within 12 hours occurring at Visit 1, with the 24 hour sample collected the following day at Visit 2. Serum concentrations were collected as mg/L.

Note: The CDISC standard for non-compartmental pharmacokinetics (NCA) is captured in the ADaM Implementation Guide for Non-Compartmental Analysis Input Data (ADNCA IG v1.0). This standard defines a structured Basic Data Structure (BDS) subclass tailored specifically for NCA workflows, streamlining the preparation of analysis-ready datasets from SDTM domains (PC and PP) for pharmacokinetic concentration and parameter data. The ADNCA IG ensures compliance by standardizing identifiers, relative timing variables, analysis flags, and traceable algorithm logic.

References

Haley, E.C., N.F Kassell, et al. (1993a). A randomized controlled trial of high-dose intravenous nicardipine in aneurysmal subarachnoid hemorrhage. J. Neurosurg. 78: 537-547.

Haley, E.C., N.F Kassell, et al. (1993b). A randomized trial of nicardipine in subarachnoid hemorrhage: angiographic and transcranial Doppler ultrasound results. J. Neurosurg. 78: 548-553.

Pinheiro JC & Bates DM. (1995). Approximations to the Log-Likelihood Function in the Nonlinear Mixed-Effects Model. Journal of Computational and Graphical Statistics 4: 12–35.

Reinbolt, L. (2025). A discussion of the new ADaM guidance (ADNCA and ADPPK) for pharmacokinetics. PharmaSUG: Paper: DS-169.