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Record all sites of disease, even if they will not be followed for response.
Field Name | Description / Instructions | Format | |
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Visit Date | The Visit Date is optional on this case report form. Hit the "Tab" key to leave it empty and move to the Lesion # field. | DD-MMM-YYYY | |
Lesion #(m) | Select a unique number for each lesion. Once a lesion number is designated for a specific lesion, that number may not change or be used to denote a different lesion.
| Use pick list. | |
Anatomic Site(m) | Select the anatomic position where the lesion is located, i.e. Lung, Skull, etc. | Use pick list. | |
Description of Location(m) | Select a brief description of the lesion location. | Use pick list. | |
Description of Lesion | If applicable, enter a brief description of each lesion, e.g. cystic, well-defined, encapsulated, necrotic appearing center. | 32 characters | |
Previously Irradiated(m) | If the site or lesion has previously been irradiated, enter "Y" for Yes, otherwise enter "N" for No. | Use pick list. | |
Measurable / Non-Measurable(m) | Enter "M", for measurable, and "N" for non-measurable, as defined in the protocol. | Use pick list. | |
Target / Non-Target(m) | Enter "Target" for target lesions that will be assessed for response (e.g. using the RECIST response criteria). Enter "NonTarget" for non target lesions.
| Use pick list. |
Legend: (d) derived field, (m) RDC mandatory, (c) for CTEP reporting only. |
Code | Description | Resolutions |
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EXT01 | Lesion Number appears more than once on the description section. | Extent of Disease Lesion Number should be unique in the description section (top repeating group). |
Field Name | Description / Instructions | Format | |
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Lesion #(m) | Select a lesion number from the pick list.
| Use pick list. | |
Course #(d) | Indicates the course number that this lesion evaluation was done in as derived from the course initiation start date. | 5 digits | |
Day in Course(d) | Indicates the day since the beginning of course that this lesion evaluation was done as derived from the course initiation start date. | 5 digits | |
Evaluation Date(m) | Enter the date of the evaluation (i.e.: date of CT scan). Do not enter the date of the report or when the results were received. | DD-MMM-YYYY | |
How Measured(m) | Select how the lesion measurement was determined. The same method should be used to measure a specific lesion throughout the study. For example, if the measurements were determined by a chest x-ray, enter CXR. | Use pick list. | |
First Longest Measurement | Enter the longest lesion measurement in centimeters.
| 6 digits and 2 decimals | |
Second Longest Measurement | Enter the second longest lesion measurement in centimeters.
| 6 digits and 2 decimals | |
Third Longest Measurement | Enter the third longest lesion measurement in centimeters.
| 6 digits and 2 decimals | |
Product | Enter the tumor product which is the multiplication of the First and Second Longest Measurements. | 8 digits and 2 decimals | |
Total Tumor Volume | Enter the total tumor volume which is the multiplication of all three measurements. | 8 digits and 2 decimals | |
Evaluation #(m) | Number each evaluation sequentially for each lesion. Use 0 for the baseline evaluation, 1 for the first evaluation, 2 for the second evaluation, etc.
| 2 digits | |
Evaluation Code | Select the status of non-measurable lesions at the time of each evaluation. | Use pick list. |
Legend: (d) derived field, (m) RDC mandatory, (c) for CTEP reporting only. |
EXT02 | Lesion Number in the measurement section does not have a corresponding number in the description section (Lesion Identification Page). | Verify that lesion number in the measurement section is recorded in the description section(Lesion Identification Page). |
EXT03 | Evaluation Number of a "Non-Measurable"lesion is "0" and Evaluation Code is not "B, and vice-versa. | If Evaluation Number of a "Non-Measurable"lesion is "0", Evaluation Code should be "B - Baseline". |
EXT12 | Lesion is marked as "Measurable" and longest measurement do not exist. | Enter the lesion's longest measurement. |
EXT05 | Date of Evaluation is in the future. | Enter a date that is equal to or prior to the current date. |
EXT09 | Lesion is marked as "Non-Measurable" and Evaluation Code was not provided. | Lesion is marked as "Non-Measurable" should have an Evaluation Code. |
EXT13 | The lesion has an Evaluation Code of "B - Baseline" and the Evaluation Date is not prior to Start Date of the first course. | Correct the lesion's Evaluation Date or the Evaluation Code. |
EXT14 | Evaluation Date for New lesion is prior to the Start Date of first course. | Enter a date that is equal or after the first course Start Date. |
EXT15 | Evaluation number for New lesion (with Evaluation Code 'N-New') is 0. | Enter a correct sequential number. |
EXT16 | New lesion (with Evaluation Code 'N-New') does not have the lowest evaluation number for the corresponding lesion. | Enter a correct sequential number. |
Code | Field Name | Description |
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EXT1001 | Course # | Course number is derived based on the course initiation start dates and the extent of disease evaluation date. |
EXT1002 | Day in Course | Number of days since the beginning of the course is derived from the course initiation start date and the extent of disease evaluation date. |