ShortName = Trial-Related Safety Event Type Response Terminology LongName = Trial-Related Safety Event Type Response Terminology Version = 1.0 CanonicalUri = 2.16.840.1.113883.3.989.2.3.1.22 CanonicalVersionUri = 2.16.840.1.113883.3.989.2.3.1.22.1 Agency
ShortName = M11 LongName = Clinical Trial protocols Identifier = C217287
| code Id="code" (required) Type="string" |
english-label Id="en" (optional) Type="string" Lang="en" |
M11 Definition Id="en_def" (optional) Type="string" Lang="en" |
current flag Id="cf" (optional) Type="string" Lang="en" |
|---|---|---|---|
| C41331 | Adverse Event | Any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. | y |
| C222331 | Drug/Device Combination Product Complaint | Any concern about the safety, quality, and/or performance of a trial-related drug-device combination. | y |
| C218510 | Lactation Event | Any event that occurs when the participant is lactating. | y |
| C218513 | Not Reportable Adverse Event of Special Interest | An adverse event of special interest (serious or non-serious) is one of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor could be appropriate, and which is deemed to be not reportable to the appropriate regulatory authority. | y |
| C17649 | Other | Different than the one(s) previously specified or mentioned. | y |
| C218511 | Post-Partum Event | Any event that occurs when the participant is in the stages of recovery post pregnancy and birth event. | y |
| C218509 | Pregnancy Event | Any event that occurs when the participant or participant's partner becomes pregnant or is pregnant. | y |
| C218512 | Reportable Adverse Event of Special Interest | An adverse event of special interest (serious or non-serious) is one of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor could be appropriate, and which is deemed to be reportable to the appropriate regulatory authority. | y |
| C41335 | Serious Adverse Event | Any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or any other medically significant event that may not be immediately life-threatening or result in death or hospitalisation but may jeopardise the patient or may require intervention to prevent one of the other outcomes listed in the definition. | y |
| C218508 | Trial Intervention Complaint | Any concern about the safety and/or quality of any trial-related interventions. | y |
This file contains a code list co-maintained by ICH M2 ESTRI and CDISC in collaboration with the NCI Enterprise Vocabulary Services (EVS). It is encoded using OASIS genericode. More information on ICH technical standards is available via the M2 ESTRI webpages at www.ich.org.
Change History: v1.0 (November 11 2025)
Report created by ICH_M2_CDISC_Codelist.xsl : [Revision: 1.1 ] : ICH : Harmonisation for Better Health