| Variable | Comments |
| *DOSDCTFL | To support the derivation of the parameters DOSDCTS and NDOSDCTS (dose discontinuations) should an equivalent flag be added to ADEX in line with DOSONTFL, DOSDELFL, DOSREDFL. |
| AETM | Change AETM to AENTM. |
ASTDT AENDT | Is it possible to give instructions about how to derive them?. |
ASTDTF AENDTF | Should we consider these imputation flag variables in case of partial EXSTDTC or EXENDTC?. |
ASTDTM AENDTM | Since we are including date and time variables, these might be useful to have alongside. |
| ASTM | Change ASTM to ASTTM. |
| DOSINTFL DOSDELFL | Can we explicitly define dose interruptions and delays in this context - is this just relating to infusions or would a pause in continuous dosing (e.g. daily tablets) also be classified as an interruption as opposed to a delay?. |
| DOSREDFL | Would protocol permitted down titrations also be classifIed as dose reductions. |
| DOSREDFL DOSINTFL DOSDELFL | These are conditional: what is the condition for these variables to be included? Is it based on whether information is collected, or based on whether applicable for the study?. |
| Are these obtained from CRF or computed for analysis?. Need to clarify. Dose reduction and Dose Interrupted are usually collected under CRF. What is the expectation of Dose delay or FDA definItion of Dose delay?. | |
| DTHFL | Replace with ADTHFL to be consistent with ADSL?. |
| EPOCH | What is the added value as all epoch value is equals to "TREATMENT"?. |
| EXADJ | Can this be made conditional based on whether this information is mapped to EX or not? We have this information only in ECADJ. |
| Please clarify the definition of this variable, whether it is only for oral-dosing? Or for IV drug as well? If for IV drug, reason are captured for each of discontinuation, delay, dose reduction and omit depends on the study drug. There might be multiple choices, even though it's rare. Will EXADJ allow to store all the reasons, eg 'delay: Adverse Events; reduction: other'?. | |
| EXDOSE | Populate Core as Req from SDTM. |
| EXDOSEU | Change EXDOSEU to EXDOSU. |
| EXDURD | Is this derived at record level (AENDT - ASTDT +1)?. |
| What is the purpose of this Variable ? When we already have EXDUR collected in SDTM. | |
| EXTRT EXDOSE EXDOSFRM … | Is it the intent to add rows for missed doses from EC? If so, the all EX dosing related variables will be blank for records coming from EC. At Janssen we are adding analysis variables (ATRT, ADOSE, ADOSFRM, …) which contain EX for records coming from EX, and which contain information from EC for missed dose records. |
| General | Analysis dose may be computed from original EXDOSE from CRF. |
| What is the content of ADEX? Is it based only on EX (so only containing actual dosing), or would it also take EC into account. E.g. DOSINTFL (dose interruption flag) cannot be set for an EX record because interruptions will not be in EX. Please clarify whether missed doses should be included. | |
| The delay/interruption/escalation.. These data is already captured already SUPPEX.. Keeping this in mind why do we need these additional flag variables. | |
| Should a flag variable be added to capture Dose escalations if collected in the CRF?. | |
| TRTSDT TRTEDT | Similar to ADAE, may be better to keep these Req, since TRTEDY is Req. |
| Why are these conditional? What is the condition that needs to be fulfilled for these variables to be included? Additionally, if these are only conditional, why is TRTEDY required?. | |
| TRTxxA TRxxSDT TRxxEDT | Similar to ADAE/ADLB, add note that these are required for multi-period studies. |