Definition:

Best overall response

Notes:

The most favorable visit (overall) response seen during the trial, per RECIST 1.1

Definition:

Complete response

Notes:

A RECIST 1.1 response applied to either a lesion category (e.g. target lesions) or to the subject overall at a particular visit.

Definition:

Computed tomography and magnetic resonance

Notes:

Imaging modalities that show details of anatomy

Definition:

Fluorodeoxyglucose - positron emission tomography

Notes:

An imaging modality that shows metabolic activity in tumors, using radioactively labeled glucose as a tracer.

Definition:

Not Evaluable/Non-Evaluable

Definition:

Nuclear medicine bone scan

Notes:

An imaging modality that shows increased metabolic activity at sites of bone damage, from tumor or other causes.

Definition:

Non-complete response/non-progressive disease

Notes:

A RECIST 1.1 response applied specifically to non-target lesions, or as an overall response if no target lesions were present at baseline.

Definition:

Objective Response Rate

Notes:

The proportion of subjects in a treatment group who achieve an objective response, which is either PR or CR.

Definition:

Progressive disease

Notes:

A RECIST 1.1 response applied to either a lesion category (e.g. target lesions) or to the subject overall at a particular visit.

Definition:

Progression-free survival

Notes:

The time from start of treatment until progression by RECIST 1.1, or death from any cause.

Definition:

Partial response

Notes:

A RECIST 1.1 response applied to either a lesion category (e.g. target lesions) or to the subject overall at a particular visit.

Definition:

Response Evaluation Criteria In Solid Tumors

Notes:

Response criteria used for primary endpoint in trials. Currently in version 1.1.

Definition:

Stable disease

Notes:

A RECIST 1.1 response applied to either a lesion category (e.g. target lesions) or to the subject overall at a particular visit.

Definition:

Standardized uptake value

Notes:

A measurement of tracer uptake made on PET scans.