| Num | Figure | Reference | Description |
|---|
| 1 | Figure 1 | Study Reference Period | - The study reference period is defined as the timeframe between a subject's first and last exposure to a tobacco product. This study reference period is part of the overall context of the study represented by B and C.
- Observations about concomitant medications used by the subject with the timing of use is are collected in relation to the study reference period; for:
- A, the start and end dates for the concomitant medication are known and are collected.
- Collection fields CMSTDAT and CMENDAT are used to collect the start and end dates for the concomitant medication.
- D, the start date for the concomitant medication is unknown and cannot be collected.
- Collection field CMPRIOR is used to collect that the known start of the concomitant medication relative to exposure is prior to the subject's first exposure.
- Collection field CMENDAT is used to collect the known end date.
- E, the subject has not discontinued the concomitant medication and therefore the end date for the concomitant medication cannot be collected.
- Collection field CMSTDAT is used to collect the known start date
- Collection field CMONGO is used to collect that the use of the concomitant medication is ongoing relative the subject's last exposure.
- The following variables are used to represent collected data in subsequent tabulation datasets:
- RFSTDTC and RFENDDTC represent the dates of the subject's first and last exposure dates respectively in the Demography (DM) dataset.
- CMSTRF and CMENRF represent values from collection variables CMPRIOR and CMONGO.
| | 2 | Figure 2 | Fixed Point in Time | - The fixed point in time is defined as a subject's Screening visit
. - which is part of the overall context of the study (not shown).
- A, the start and end dates for the concomitant medication are known and are collected.
- D, the start date for the concomitant medication is unknown and cannot be collected.
- CMPRIOR is used to collect that the known start of the concomitant medication relative to exposure is prior to the subject's first exposure.
| | 3 | Figure 3 | Fixed Point in Time |
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