CDISC 终点映射
SDTM / ADaM 标准变量名映射 · 临床终点标准化
关键词检索
Disease疾病专项映射
阿尔茨海默症
MMSECOGSCORE
Cognitive Assessment Score阿尔茨海默症
ADAS-CogCOGSCORE
Alzheimer Disease Assessment Scale阿尔茨海默症
CDR-SBCDRSCORE
Clinical Dementia Rating Sum of Boxes帕金森症
MDS-UPDRSPDSCORE
Movement Disorder Society UPDRS帕金森症
Hoehn-YahrPDSTAGE
Disease Staging Scale乳腺癌
OSOSTIME
Overall Survival TimeADaM有效性终点共 6 项
| 临床终点 | CDISC 变量 | 定义 | 单位 |
|---|---|---|---|
| OS（总生存期）Overall Survival | TTDE | Death Date - Randomization Date | days |
| PFS（无进展生存）Progression-Free Survival | PFS | Progression or Death | days |
| ORR（客观缓解率）Objective Response Rate | BOR | Best Overall Response | % |
| DCR（疾病控制率）Disease Control Rate | DCR | CR+PR+SD | % |
| DFS（无病生存期）Disease-Free Survival | DFS | Recurrence or Death | days |
| TTE（至事件时间）Time to Event | TTE | Time to Event | days |
SDTM安全性终点共 4 项
| 临床终点 | CDISC 变量 | 定义 | 单位 |
|---|---|---|---|
| 不良事件发生率Adverse Event Incidence | AE | Adverse Events | n (%) |
| 严重不良事件Serious Adverse Events | SAE | Serious Adverse Events | n (%) |
| 实验室异常Laboratory Abnormalities | LB | Laboratory Tests | CTC grade |
| 生命体征异常Vital Signs Abnormalities | VS | Vital Signs | n (%) |