Key | Description | Possible Values | Mandatory |
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Registration Number | Reg num/Treatment ID of a patient | Any String | Yes |
SAE case number | SAE case number | Any String |
|
Date of SAE Report | Date of SAE Report | yyyy-mm-dd | Yes |
SAE term | SAE that the patient is suffering | any SAE term concept | Yes |
Other SAE term | Can only be given when SAE term is 'other' | Any String (Case-Sensitive) | Yes if SAE term is "Other" |
Date of SAE onset | Date of SAE onset | yyyy-mm-dd | Yes |
Maximum Severity of SAE | Maximum Severity of SAE | Number, 1 Number, 2 Number, 3 Number, 4 |
|
Date of SAE outcome | Date of SAE outcome | yyyy-mm-dd |
|
SAE outcome | SAE outcome | Fatal/Not Resolved/Resolved/ Resolved with sequel SAE/Resolving/ Unknown |
|
SAE related to TB drugs? | Is the SAE related to TB drugs? | TRUE/FALSE |
|
TB Drug | TB Drug (Can be given only when SAE related is true) | any TB drug concept |
|
TB Drug:Final Action | Final Action taken on the TB drug above (Can be given only when SAE related is true) | Dose maintained/Dose reduced/ Drug permanently withdrawn/Unknown |
|
TB Drug:related? | is SAE related to given TB drug (Can be given only when SAE related is true) | TRUE/FALSE |
|
Non-TB drug | The Non-TB drugs that might be a possible other reason for the SAE | List of all the drugs that apply for the treatment separated by "|" e.g. drug1|drug2|drug3 |
|
Co-morbidity | The co morbidity that might be a possible other reason for the SAE | List of all the co-morbidities that apply for the treatment separated by "|" e.g. cm1|cm2|cm3 |
|
Other causal factor | Any other possible reason for the SAE | List of all the other reasons that apply for the treatment separated by "|" e.g. reason1|reason2|reason3 |
|