In order to have a simpler and more effective data management through all MonolixSuite application, data management evolved from the previous MonolixSuite versions. We describe in the following all the differences w.r.t. the different column types.
Column-types used to identify subject-occasions (ID – OCCASION)
- [ID] Several ID columns in a data set is not supported anymore
- [OCCASION] Sequences of covariates are no more generated
Column-types used to time-stamp data (TIME – DATE – DAT1 – DAT2 – DAT3)
- [TIME] Time is converted into relative hours based on the smallest value per individual. If both DATE and TIME are present, time will be defined in hour starting at the first day of the individual.
- [DATE/DAT1/DAT2/DAT3] The separator “-” is now allowed.
Column-types used to define responses (OBSERVATION – OBSERVATION ID – CENSORING – LIMIT)
- Y column has been renamed OBSERVATION and YTYPE column has been renamed OBSERVATION ID.
- [OBSERVATION] If there is a non null dose and a value in the response-column, we consider it as both dose and response. It was formerly considered as a response.
- Regressor is taken into account even if the measurement is not (due to a MDV or EVID column).
- [OBSERVATION ID] Several OBSERVATION ID columns in a data set is not supported anymore.
Column-types used to define a dose regimen (AMOUNT – ADMINISTRATION ID – INFUSION DURATION – INFUSION RATE – STEADY STATE – INTERDOSE INTERVAL – ADDITIONAL DOSES)
- ADM column has been renamed ADMINISTRATION ID,
- TINF and RATE columns have been renamed INFUSION DURATION and INFUSION RATE respectively
- SS, II, and ADDL columns have been renamed STEADY STATE, INTERDOSE INTERVAL and ADDITIONAL DOSES respectively
- [AMOUNT] If there is a non null dose and a value in the response-column, we consider it as both dose and response. Is was formerly considered as a response.
- [ADMINISTRATION ID] Several ADMINISTRATION ID columns in a data set is not supported anymore.
- [ADMINISTRATION ID] ADMINISTRATION IDis used only for dose lines. It is not possible anymore to use ADMINISTRATION ID as both dose identifiers and observation identifiers.
- [STEADY STATE] Steady state column does not create a new occasion anymore.
- [STEADY STATE] When the number of implied doses overlap another dose or measurement, we stop adding doses.
- [STEADY STATE] The number of applied doses using steady state in not managed anymore using the configuration file but in the project and through the user interface.
- [STEADY STATE] STEADY STATE = 2 and STEADY STATE = 3 are now possible. It generate doses without any washout (contrary to STEADY STATE=1).
- [STEADY STATE/INTERDOSE INTERVAL/ADDITIONAL DOSES] When a data set contained a column with column-type INTERDOSE INTERVAL and no column with column-type STEADY STATE but a column with column-type ADDITIONAL DOSES, a STEADY STATE column was artificially created with. It is not the case anymore.
- [INTERDOSE INTERVAL] INTERDOSE INTERVAL column alone is no longer possible.
- [ADDITIONAL DOSES/INTERDOSE INTERVAL] If ADDITIONAL DOSES equals 0 and INTERDOSE INTERVAL> 0, we no longer create occasions.
Column-types used to define covariates (CONTINUOUS COVARIATE – CATEGORICAL COVARIATE )
- CAT and COV columns have been renamed respectively CATEGORICAL COVARIATE and CONTINUOUS COVARIATE
- [CONTINUOUS COVARIATE] If a covariate varies within the same subject-occasion, only the first evaluation (by time ordering) of the covariate is taken into account. However, the covariate is still considered as constant within the same subject-occasion
- [CATEGORICAL COVARIATE] ‘.’ is not a valid category anymore, it is considered as the repetition of the previous valid defined category.
Column-types used to define regressions (REGRESSOR)
- X columns has been renamed as REGRESSOR
Column-types used to define controls and events (MDV /EVENT ID)
- EVID columns have been renamed EVENT ID
- Management of EVID=2 and EVID=3
Evolution of the data set in the Mlxtran
There were some evolution in the Mlxtran associated to the data set which corresponds to the section <DATAFILE> of the Mlxtran project both used in Datxplore (with .datxplore extension) and Monolix (using a .mlxtran extension).
– the number of doses is indicated in the definition of the SS column,
– in the definition of the observation, ytype is removed when there is only one measurement, and changed to yname when there are several ones.
Character definition for data set elements naming
In the previous version, only alphanumeric characters and the underscore “_” character were allowed in the strings of your data set (headers, categorical covariate names, etc), i.e. special characters such as spaces ” “, stars “*”, parentheses “(“, brackets “[“, dashes “-“, dots “.”, quotes ” and slashes “/” were not supported.
Starting on the 2018R1 version, these characters are supported.
These characters restrictions were impacting
- The headers.
- The strings that can be used in ID, YTYPE, and CAT columns.