Creates an initial AE analysis dataset based on a general dataset

All AEs in the GDF will be extracted. Dosing and other observation records are removed. Columns needed for the AE analysis will be kept. Among them the covariates and other general information. For each individual in which a particular AE did not appear, a 0 AEGRADE, AESER, AEDRUGREL, and AE will be set in addition to AECENS=1. For all AEs that were recorded in the GDF (and which need to have AEGRADE>1) AECENS=0 will be set. TIME for censored AEs (AECENS=1) will be determined as the TIME of the last record present for an individual in the GDF. No exposure metrics will be added by this function. A "PLACEBO" column is added to the dataset. If already present then it is overwritten. PLACEBO is defined by 1) no doses in subject or 2) all doses of 0 amount.

createAEdata_IQRdataGENERAL(data, FLAGkeepHighestGradeEarliestTime = FALSE)

Arguments

data

Data in the general dataset format, containing adverse event information as defined in the general dataset specification (https://iqrtools.intiquan.com/doc/book/GenDatFormat.html)

FLAGkeepHighestGradeEarliestTime

logical. It TRUE then an AENAME that appears more than once within the same subject will only be kept once. Either highest AEGRADE or (if same grade) earliest occurrence.

Value

IQRaedataER, IQRdataER object.

See also