| CodeList |
| CodeListItem |
| NCI attributes |
| C177909 | Serious Adverse Event Report Category |
| C181164 | Study Agent Dechallenge Reaction Response |
| C181163 | Study Agent Rechallenge Reaction Response |
| OID | Name
(CDISC Submission Value) | DataType
Extensible | NCI Code | CDISC Synonym | CDISC Definition | Preferred Term |
|---|---|---|---|---|---|---|
| CDISC Submission Value [ODM:CodedValue] | ||||||
| CL.C177909.SAERCAT | Serious Adverse Event Report Category
(SAERCAT) | text
Extensible: No | C177909 | Serious Adverse Event Report Category | Terminology relevant to the classification of a serious adverse event report. | CDISC CDASH Serious Adverse Event Report Category Response Terminology |
| AMENDMENT | C41200 | Amended | Action(s) undertaken to modify by means of correction, addition, subtraction, or replacement. | Amendment | ||
| NULLIFICATION | C178052 | Nullified | Action(s) undertaken to void, negate, or invalidate. | Nullification | ||
| ORIGINAL | C25604 | Preceding all others in time or being as first made or performed. | Original | |||
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| CL.C181164.SADCRR | Study Agent Dechallenge Reaction Response
(SADCRR) | text
Extensible: Yes | C181164 | Study Agent Dechallenge Reaction Response | A terminology codelist relevant to the resultant reaction due to withdrawing, interrupting, or otherwise altering administration of study treatment. | CDISC CDASH Study Agent Dechallenge Reaction Response Terminology |
| NEGATIVE DECHALLENGE | C181222 | Continued presence of an adverse event after decrease or change in dose, or withdrawal of the product/drug. | Negative Dechallenge Response | |||
| NOT APPLICABLE DECHALLENGE | C181224 | The outcome of decreasing the dose or discontinuation of the product/drug is not relevant in the current context. | Not Applicable Dechallenge Response | |||
| POSITIVE DECHALLENGE | C181223 | Partial or complete abatement of an adverse event after decrease or change in dose, or withdrawal of the product/drug. | Positive Dechallenge Response | |||
| UNKNOWN DECHALLENGE | C181225 | No information regarding the outcome of decreasing the dose or discontinuation of the product/drug. | Unknown Dechallenge Response | |||
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| CL.C181163.SARCRR | Study Agent Rechallenge Reaction Response
(SARCRR) | text
Extensible: Yes | C181163 | Study Agent Rechallenge Reaction Response | A terminology codelist relevant to the resultant reaction due to restarting or otherwise returning administration of study treatment to previous level, after a dechallenge event. | CDISC CDASH Study Agent Rechallenge Reaction Response Terminology |
| NEGATIVE RECHALLENGE | C181226 | Failure of the product/drug, when reintroduced, to produce signs or symptoms similar to those observed when the product/drug was previously used. | Negative Rechallenge Response | |||
| NOT APPLICABLE RECHALLENGE | C181228 | The outcome of reintroduction of product/drug is not relevant in the current context. | Not Applicable Rechallenge Response | |||
| POSITIVE RECHALLENGE | C181227 | Recurrence of similar or new signs and symptoms upon reintroduction of the product/drug. | Positive Rechallenge Response | |||
| UKNOWN RECHALLENGE | C181229 | No information regarding the outcome of reintroduction of product/drug. | Unknown Rechallenge Response | |||
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