| Variable | Comment |
| ASCNSD01 | This variable is only populated when AEACN='MULTIPLE'? |
| These would be direct copies from SDTM SUPPAE variables, right? Would it be sufficient/better to keep the SUPPAE variables instead of creating an ADaM variable? Could a suggestion be made for the SDTM SUPPAE variable names instead of adding an ADaM variable. e.g. SUPPAE.AEACNSzz | |
| Would prefer that XX notation be used to allow for multiple drugs to be referenced. | |
| AEACNSD01 | if there are multiple actions taken for a study drug, can all the actions be concatenated? For eg 'Dose reduced' 'Dose interrupted' for SD01.. |
| At GSK, we create a single variable AEACTTX to capture actions taken for each study drug - ACN : SD01 SD02, ACN2 : SD01 etc... | |
| AEACN | Can we put this variable optional when we have several drugs? (meaning we kept only the collected action taken for each drug - present in the SUPPAE dataset) |
AEDCOD AEBODSYS AEHLT AEHLGT | We typically include the numeric code variables for MedDRA terms for easier use in searches. Suggest adding them here. |
| AEDUR | Does the Agency have a duration calculation in mind that could be included? I've typically seen some form of end day - start day + 1 used, but whether to span the gaps between events for the same AE is a question. This may need to take into account the proposed GRPID now, e.g., earliest start date and latest end date. |
| in case of an available GRPID and more than one entry, is it expected to calculate the duration for every single entry or just having the overall duration for the corresponding grouped event? | |
| AELLT | The MedDRA lower level term isn't included in the dataset. We typically include in the code/decode variables in our ADAE since we remap to later MedDRA versions using the LLT code. Suggest adding them here for completeness. |
AEONGO PREFL (Pre treat flag) FUPFL (Follow up flag) | Some of the flags which we use for analysis are missing. |
| AEOSI Category Flag | Add Safety Topic of Interest (STI) category flag - this is a broader category than just AEs of Special Interest |
| AEOSIxxFL | AEOSIxxFL is not part of ADaM OCCDS IG v1.0. Could the agency clarify what the expected content of this variable is. Is it related to overdose/misuse, those defined in the protocol or those that might be identified by an SMQ? |
| How does this flag relate to the ADaM CQzzNAM variable? CQzzNAM is the ADaM variable for AE of special interest category. Would FDA expect to see both, i.e. CQxxNAM containing the name of the AE category, and AEOSIxxFL that holds Y for that same category? if so, would xx in both variables need to match? Or is AEOSIxxFL a higher level categorization of CQxxNAM? | |
| The variable name is 9 chars; 'xx' should be 'zz' (per ADaMIG 3.1.1 #2 variable conventions); and the variable label is missing the '01'. Would the name of the category be put in the define comment? | |
| For oncology, this can be used for immune-mediated AE's. May also consider adding AESIxxGR as perm for the grouping of AE's. For example, all the AE PT's considered immune-mediated pneumonitis will have the AESI01FL of Y, and AESI01GR="Pneumonitis". | |
| According to the spec: Create separate variable for each adverse event of special interest category. This will generate a lot of variables. At Merck, we have two variables to cover this, AEOSICT (AEOSI Category) and AEOSIFL (AEOSI Flag) | |
| AEREL | Note mentions additional variables should be created if this is collected by study drug. Suggest adding the placeholder variables like we have for action taken. |
| AERELS | Can there be only 1 AEREL variable and multiple related study treatments like AERDG1, AERDG2? |
| This is conditionally required so assume this is only needed in the case the sponsor makes an assessment of relateness (e.g. adjudication) | |
| AESEV | AESEV Variable is missing |
| AETOXGR | Does the Agency have an expectation regarding the CTCAE version to be used? Including some text may be helpful to sponsors. |