- Measurability of Tumors at Baseline
- Non-measurable Lesions
- Assessment of Lymph Nodes
- Bone Lesion Measurability
- Cystic Lesions
- Prior Local Treatment of Lesions
- Presence of Measurable Disease at Baseline
- Baseline Documentation of Target Lesions
- Documentation of Non-target Lesions
- Definition of Complete Response (CR)
- Definition of Progressive Disease (LR)
- Definition of Unequivocal Progression
- Too Small to Measure
- Lesions that Split or Coalesce
- New Lesions
- PET
- Missing Assessments and Inevaluable Designation
- Overall Response Table, Subjects With Measurable Disease
- Overall Response Table, Subjects Without Measurable Disease
- Best Overall Response
- Confirmation Measurement / Duration of Response
- Lesion Reappearance
- Protocol Design Considerations: Study Endpoints
- Protocol Design Considerations: Imaging Modalities
Change 20: Best Overall Response
RECIST 1.1:
| Overall Response First Timepoint | Overall Response Subsequent Timepoint | BEST overall response |
|---|---|---|
| CR | CR | CR |
| CR | PR | SD, PD, OR PR |
| CR | SD |
SD provided minimum criteria for SD duration are met. Otherwise PD |
| CR | PD |
SD provided minimum criteria for SD duration are met. Otherwise PD |
| CR | NE | SD provided minimum criteria for SD duration are met. Otherwise NE |
| PR | CR | PR |
| PR | PR | PR |
| PR | SD | SD |
| PR | PD | SD provided minimum criteria for SD duration are met. Otherwise PD |
| PR | NE | SD provided minimum criteria for SD duration are met. Otherwise NE |
| NE | NE | NE |