DAPA Datasets for Data Wrangling
The demonstration of Data Wrangling will utilize Dapagliflozin (DAPA) datasets within PumasCP's Data Wrangler. The two datasets are available at the following links: PC and EX.
PC Dataset:
The pc dataset contains pharmacokinetic data, including plasma concentration measurements at various times after administering the study drug. These times are presented in both actual and nominal formats. This dataset is fundamental for pharmacokinetic analysis, offering in-depth information on the drug's absorption, distribution, metabolism, and elimination kinetics.
EX Dataset:
The ex dataset contains information on the exposure of subjects or patients to investigational drugs or interventions in a clinical trial. It usually includes details like the start and end dates of exposure, dosage, route of administration, and other pertinent information concerning the drug or intervention's administration.
Data Structure
The "pc" dataset is structured as a tabular data format, with each row representing a unique observation or timepoint. Dimensions [1536 X 19] Its consists of data for 24 subjects, DAPA01-001, DAPA01-002, ..., DAPA-024. 64 samples per subject.
| column name | column label | column type | Description |
|---|---|---|---|
| STUDYID | Study Identifier | String | Unique identifier for a study. |
| DOMAIN | Domain Abbreviation | String | Two-character abbreviation for the domain. |
| USUBJID | Unique Subject Identifier | String | Unique subject identifier within the submission. |
| PCSEQ | Sequence Number | Number | Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number. |
| PCTESTCD | Pharmacokinetic Test Short Name | String | Short name of the analyte or specimen characteristic. |
| PCTEST | Pharmacokinetic Test Name | String | Name of the analyte or specimen characteristic. |
| PCORRES | Result or Finding in Original Units | String | Result of the measurement or finding as originally received or collected. |
| PCORRESU | Original Units | String | Original units in which the data were collected. The unit for PCORRES. Example: "mg/L". |
| PCSTRESC | Character Result/Finding in Std Format | String | Contains the result value for all findings, copied or derived from PCORRES in a standard format or standard units. PCSTRESC should store all results or findings in character format. |
| PCSTRESN | Numeric Result/Finding in Standard Units | Number | Used for continuous or numeric results or findings in standard format. PCSTRESN should store all numeric test results or findings. |
| PCSTRESU | Standard Units | String | Standardized unit used for PCSTRESC and PCSTRESN. |
| PCSPEC | Specimen Material Type | String | Defines the type of specimen used for a measurement. Examples: "SERUM", "PLASMA", "URINE". |
| PCLLOQ | Lower Limit of Quantitation | Number | Indicates the lower limit of quantitation for an assay. Units should be those used in PCSTRESU. |
| VISIT | Visit Name | String | Protocol-defined description of clinical encounter. Used in addition to VISITNUM. |
| VISITNUM | Visit Number | Number | Timing Clinical encounter number |
| PCDTC | Date/Time of Specimen Collection | String | Date/time of specimen collection represented in character format. If there is no end time, then this will be the collection time. |
| PCDY | Actual Study Day of Specimen Collection | Number | Study day of specimen collection, measured as integer days. |
| PCTPT | Planned Time Point Name | String | Text description of time when specimen should be taken. |
| PCTPTNUM | Planned Time Point Number | Number | Numerical version of PCTPT to aid in sorting. |
The "ex" dataset is structured as a tabular data format, with each row representing a unique observation or timepoint. Dimensions [96 X 15] Its consists of dose data for 24 subjects, 4 doses per subject.
| column name | column label | column type | Description |
|---|---|---|---|
| STUDYID | Study Identifier | String | Unique identifier for a study. |
| DOMAIN | Domain Abbreviation | String | Two-character abbreviation for the domain. |
| USUBJID | Unique Subject Identifier | String | Unique subject identifier within the submission. |
| EXSEQ | Sequence Number | Number | Sequence Number given to ensure uniqueness of subject records within a domain. May be any valid number. |
| EXTRT | Name of Treatment | String | Topic Name of the protocol-specified study treatment given during the dosing period for the observation. |
| EXDOSE | Dose | Number | Amount of EXTRT dose administered. |
| EXDOSU | Dose Units | String | Units for EXDOSE representing protocol-specified values. Examples: "ng", "mg", "mg/kg", "mg/m2". |
| EXDOSFRM | Dose Form | String | Dose form for EXTRT. Examples: "TABLET", "LOTION". |
| EXDOSFRQ | Dosing Frequency per Interval | String | Usually expressed as the number of repeated administrations of EXDOSE within a specific time period. Examples: "ONCE", "QD", "BID". |
| EXROUTE | Route of Administration | String | Route of administration for the intervention. Examples: "ORAL", "INTRAVENOUS". |
| VISIT | Visit Name | String | Protocol-defined description of clinical encounter. Used in addition to VISITNUM. |
| VISITDY | Planned Study Day of Visit | Number | Planned study day of the visit. |
| EXSTDTC | Start Date/Time of Treatment | String | The date/time when administration of the treatment indicated by EXTRT and EXDOSE began. |
| EXSTDY | Study Day of Start of Treatment | Number | Study day of EXSTDTC. |
