Eligibility Criteria Test Plan
Eligibility Criteria is a complex rule to compare the patient values to the corresponding protocol values. Questions on the user interface can be in one of the following forms
Enumerated values (single choice)
Enumerated values (multiple choice)
Free form text input
It is possible that one question on the user interface can be dependent on the answer of another question. In the event of such a situation, complex eligibility criteria is used and a node of the eligibility criteria evaluates the answer for the dependent question.
On a granular level, if we discard the dependency of one question on another than the basis for simple eligibility criteria is formed as follows
Case / Patient Interface Question / Investigator Interface Question1 / Enumerated values (single choice) / Enumerated values (single choice)
2 / Enumerated values (single choice) / Enumerated values (multiple choice)
3 / Enumerated values (multiple choice) / Enumerated values (single choice)
4 / Enumerated values (multiple choice) / Enumerated values (multiple choice)
5 / Free form text input / Free form text input
Testing Strategy for Case 1:
Patient Interface Question: Enumerated values (single choice)
Investigator Interface Question: Enumerated values (single choice)
We can test the validity of this kind of eligibility criteria by taking all the possible combination of values between the patient interface and the investigator interface.
Criteria that fall under this category are
1Gender
2Performance Status
3Pregnancy Status
4Estrogen Receptor Status
5Progesterone Receptor Status
6Hormone Receptor Status
7HER2/neu Receptor Status
8Sites of Spread Include
9Sites of Spread Exclude
10Prior Therapy (Bisphosphonate)#
11Number of Prior Regimens with Metastatic Cancer (Bisphosphonate)#
12Prior Therapy (Immuno)#
13Prior Therapy (Hormone)#
14Number of Prior Regimens with Metastatic Cancer (Hormone)#
15Prior Therapy (Chemo)#
16Number of Prior Regimens with Metastatic Cancer (Chemo)#
Testing Strategy for Case 2:
Patient Interface Question: Enumerated values (single choice)
Investigator Interface Question: Enumerated values (multiple choice)
Criteria that fall under this category are
1Menopausal Status
2Cancer Stage*
Testing Strategy for Case 3:
Patient Interface Question: Enumerated values (multiple choice)
Investigator Interface Question: Enumerated values (single choice)
Criteria that fall under this category are
1Progression with Treatment (Bisphosphonate)
2Progression with Treatment (Immuno)
3Setting Required with Prior Regimens (Hormone)
4Progression with Treatment (Hormone)
5Progression with Treatment (Chemo)
6Setting Required with Prior Regimens (Chemo)
Testing Strategy for Case 4:
Patient Interface Question: Enumerated values (multiple choice)
Investigator Interface Question: Enumerated values (multiple choice)
Criteria that fall under this category are
1Concurrent Medical Conditions*
2Radiation
3Prior Treatment with Individual Agents Excluded (Bisphosphonate)
4Prior Treatment with Individual Agents Excluded (Immuno)
5Prior Treatment with Individual Agents Required (Hormone)
6Prior Treatment with Individual Agents Excluded (Hormone)
7Prior Treatment with Individual Agents Required (Chemo)
8Prior Treatment with Individual Agents Excluded (Chemo)
Testing Strategy for Case 5:
Patient Interface Question: Free form text input
Investigator Interface Question: Free form text input
Criteria that fall under this category are
1Age
Possible Combinations required for evaluating eligibility criteria
Gender
Patient Values
Male
Female
Investigator Values
Male
Female
Either Male or Female
Patient / Protocol / Patient Value / Protocol Value / Expected Result1 / 1 / Male / Either Male or Female / NA
2 / 1 / Female / Either Male or Female / NA
1 / 2 / Male / Male / True
2 / 2 / Female / Male / False
1 / 3 / Male / Female / False
2 / 3 / Female / Female / True
3-20 / 4-18 / Female / NA / NA
Performance Status
Patient Values
I am fully active
Can do easy activities
Can do seated activities
Partially confined to bed/chair
Totally confined to bed/chair
Investigator Values
Does not apply
ECOG 0; KPS 100%
ECOG 1; KPS 70-90%
ECOG 2; KPS 60%
ECOG 3; KPS 50%
ECOG 4; KPS < 50%
Patient / Protocol / Patient Value / Protocol Value / Expected Result1 / 1 / I am fully active / Does not apply / NA
2 / 1 / Can do easy activities / Does not apply / NA
3 / 1 / Can do seated activities / Does not apply / NA
4 / 1 / Partially confined to bed/chair / Does not apply / NA
5 / 1 / Totally confined to bed/chair / Does not apply / NA
1 / 2 / I am fully active / ECOG 0; KPS 100% / True
2 / 2 / Can do easy activities / ECOG 0; KPS 100% / False
3 / 2 / Can do seated activities / ECOG 0; KPS 100% / False
4 / 2 / Partially confined to bed/chair / ECOG 0; KPS 100% / False
5 / 2 / Totally confined to bed/chair / ECOG 0; KPS 100% / False
1 / 3 / I am fully active / ECOG 1; KPS 70 / True
2 / 3 / Can do easy activities / ECOG 1; KPS 70 / True
3 / 3 / Can do seated activities / ECOG 1; KPS 70 / False
4 / 3 / Partially confined to bed/chair / ECOG 1; KPS 70 / False
5 / 3 / Totally confined to bed/chair / ECOG 1; KPS 70 / False
1 / 4 / I am fully active / ECOG 2; KPS 60% / True
2 / 4 / Can do easy activities / ECOG 2; KPS 60% / True
3 / 4 / Can do seated activities / ECOG 2; KPS 60% / True
4 / 4 / Partially confined to bed/chair / ECOG 2; KPS 60% / False
5 / 4 / Totally confined to bed/chair / ECOG 2; KPS 60% / False
1 / 5 / I am fully active / ECOG 3; KPS 50% / True
2 / 5 / Can do easy activities / ECOG 3; KPS 50% / True
3 / 5 / Can do seated activities / ECOG 3; KPS 50% / True
4 / 5 / Partially confined to bed/chair / ECOG 3; KPS 50% / True
5 / 5 / Totally confined to bed/chair / ECOG 3; KPS 50% / False
1 / 6 / I am fully active / ECOG 4; KPS < 50% / True
2 / 6 / Can do easy activities / ECOG 4; KPS < 50% / True
3 / 6 / Can do seated activities / ECOG 4; KPS < 50% / True
4 / 6 / Partially confined to bed/chair / ECOG 4; KPS < 50% / True
5 / 6 / Totally confined to bed/chair / ECOG 4; KPS < 50% / True
6-20 / 7-18 / I am fully active / NA / NA
Pregnancy Status
Patient Values
Yes
No
Investigator Values
Yes
No (N/A)
Patient / Protocol / Patient Value / Protocol Value / Expected Result1 / 1 / Yes / No / NA
2 / 1 / No / No / NA
1 / 2 / Yes / Yes / False
2 / 2 / No / Yes / True
3-20 / 3-18 / No / No/NA / NA
Estrogen Receptor Status
Progesterone Receptor Status
HER2/neu Status
Patient Values
Positive
Negative
Not Tested
I don’t know
Investigator Values
N/A
Positive
Negative
Patient / Protocol / Patient Value / Protocol Value / Expected Result1 / 1 / Positive / N/A / NA
6 / 1 / Negative / N/A / NA
11 / 1 / Not Tested / N/A / NA
16 / 1 / I don’t know / N/A / NA
1 / 2 / Positive / Positive / True
6 / 2 / Negative / Positive / False
11 / 2 / Not Tested / Positive / True
16 / 2 / I don’t know / Positive / True
1 / 3 / Positive / Negative / False
6 / 3 / Negative / Negative / True
11 / 3 / Not Tested / Negative / True
16 / 3 / I don’t know / Negative / True
* / 4-18 / - / N/A / NA
Hormone Receptor Status
Patient Values
Positive
Negative
Not Tested
I don’t know
Investigator Values
N/A
Positive
Negative
Patient / Protocol / Patient Value (ER) / Patient Value (PR) / Protocol Value / Expected Result1 / 1 / Positive / Positive / N/A / NA
2 / 1 / Negative / Positive / N/A / NA
3 / 1 / Not Tested / Positive / N/A / NA
4 / 1 / I don’t know / Positive / N/A / NA
5 / 1 / Positive / Negative / N/A / NA
6 / 1 / Negative / Negative / N/A / NA
7 / 1 / Not Tested / Negative / N/A / NA
8 / 1 / I don’t know / Negative / N/A / NA
9 / 1 / Positive / Not Tested / N/A / NA
10 / 1 / Negative / Not Tested / N/A / NA
11 / 1 / Not Tested / Not Tested / N/A / NA
12 / 1 / I don’t know / Not Tested / N/A / NA
13 / 1 / Positive / I don’t know / N/A / NA
14 / 1 / Negative / I don’t know / N/A / NA
15 / 1 / Not Tested / I don’t know / N/A / NA
16 / 1 / I don’t know / I don’t know / N/A / NA
1 / 4 / Positive / Positive / Positive / True
2 / 4 / Negative / Positive / Positive / True
3 / 4 / Not Tested / Positive / Positive / True
4 / 4 / I don’t know / Positive / Positive / True
5 / 4 / Positive / Negative / Positive / True
6 / 4 / Negative / Negative / Positive / False
7 / 4 / Not Tested / Negative / Positive / True
8 / 4 / I don’t know / Negative / Positive / True
9 / 4 / Positive / Not Tested / Positive / True
10 / 4 / Negative / Not Tested / Positive / True
11 / 4 / Not Tested / Not Tested / Positive / True
12 / 4 / I don’t know / Not Tested / Positive / True
13 / 4 / Positive / I don’t know / Positive / True
14 / 4 / Negative / I don’t know / Positive / True
15 / 4 / Not Tested / I don’t know / Positive / True
16 / 4 / I don’t know / I don’t know / Positive / True
1 / 5 / Positive / Positive / Negative / False
2 / 5 / Negative / Positive / Negative / True
3 / 5 / Not Tested / Positive / Negative / True
4 / 5 / I don’t know / Positive / Negative / True
5 / 5 / Positive / Negative / Negative / True
6 / 5 / Negative / Negative / Negative / True
7 / 5 / Not Tested / Negative / Negative / True
8 / 5 / I don’t know / Negative / Negative / True
9 / 5 / Positive / Not Tested / Negative / True
10 / 5 / Negative / Not Tested / Negative / True
11 / 5 / Not Tested / Not Tested / Negative / True
12 / 5 / I don’t know / Not Tested / Negative / True
13 / 5 / Positive / I don’t know / Negative / True
14 / 5 / Negative / I don’t know / Negative / True
15 / 5 / Not Tested / I don’t know / Negative / True
16 / 5 / I don’t know / I don’t know / Negative / True
17-20 / 2-3,6-18 / I don’t know / I don’t know / N/A / NA
Sites of Spread – Do this for every site of spread
Patient Values
N/A
Cancer has spread
I don’t know
Investigator Values
N/A
Include
Exclude
Patient / Protocol / Patient Value / Protocol Value / Expected Result (Include) / Expected Result (Exclude)1 / 1 / N/A / N/A / NA / NA
2 / 1 / Cancer has Spread / N/A / NA / NA
3 / 1 / I don’t know / N/A / NA / NA
1 / 2 / N/A / Include / False / NA
2 / 2 / Cancer has Spread / Include / True / NA
3 / 2 / I don’t know / Include / True / NA
1 / 3 / N/A / Exclude / NA / True
2 / 3 / Cancer has Spread / Exclude / NA / False
3 / 3 / I don’t know / Exclude / NA / True
4-20 / 4-18 / N/A / N/A / NA / NA
Prior Therapy (Hormone, Immuno, Bisphosphonate)
Patient Values
Investigator Values
Yes
No (N/A)
Patient / Protocol / Patient Value / Protocol Value / Expected Result1 / 1 / No Regimens / No / NA
2 / 1 / One Regimen / No / NA
3 / 1 / Two Regimens / No / NA
1 / 2 / No Regimens / Yes / False
2 / 2 / One Regimen / Yes / True
3 / 2 / Two Regimens / Yes / True
4-20 / 3-18 / - / No/NA / NA
Number of Prior Regimens with Metastatic Cancer (Hormone, Chemo, Bisphosphonate)
Patient Values
Patient 1 – No regimen
Patient 2 – One regimen with metastatic setting
Patient 3 – Two regimens with metastatic setting
Patient 4 – Three regimens with metastatic setting
Patient 5 – Four regimens with metastatic setting
Investigator Values
N/A
Any prior therapy for metastatic cancer
More than 1
More than 2
More than 3
Patient / Protocol / Patient Value / Protocol Value / Expected Result1 / 1 / No regimen / N/A / NA
2 / 1 / One regimen with metastatic / N/A / NA
3 / 1 / Two regimen with metastatic / N/A / NA
4 / 1 / Three regimen with metastatic / N/A / NA
5 / 1 / Four regimen with metastatic / N/A / NA
1 / 2 / No regimen / Any / True
2 / 2 / One regimen with metastatic / Any / False
3 / 2 / Two regimen with metastatic / Any / False
4 / 2 / Three regimen with metastatic / Any / False
5 / 2 / Four regimen with metastatic / Any / False
1 / 3 / No regimen / More than 1 / True
2 / 3 / One regimen with metastatic / More than 1 / True
3 / 3 / Two regimen with metastatic / More than 1 / False
4 / 3 / Three regimen with metastatic / More than 1 / False
5 / 3 / Four regimen with metastatic / More than 1 / False
1 / 4 / No regimen / More than 2 / True
2 / 4 / One regimen with metastatic / More than 2 / True
3 / 4 / Two regimen with metastatic / More than 2 / True
4 / 4 / Three regimen with metastatic / More than 2 / False
5 / 4 / Four regimen with metastatic / More than 2 / False
1 / 5 / No regimen / More than 3 / True
2 / 5 / One regimen with metastatic / More than 3 / True
3 / 5 / Two regimen with metastatic / More than 3 / True
4 / 5 / Three regimen with metastatic / More than 3 / True
5 / 5 / Four regimen with metastatic / More than 3 / False
6-20 / 6-18 / - / N/A / NA
Prior Therapy (Chemo)
Patient Values
No regimen for Chemo
One regimen
Two regimen
Three regimen
Four regimen
Investigator Values
No (N/A)
At least 1
At least 2
At least 3
Patient / Protocol / Patient Value / Protocol Value / Expected Result1 / 1 / No regimen for Chemo / N/A / NA
2 / 1 / One regimen / N/A / NA
3 / 1 / Two regimen / N/A / NA
4 / 1 / Three regimen / N/A / NA
5 / 1 / Four regimen / N/A / NA
1 / 2 / No regimen for Chemo / At least 1 / False
2 / 2 / One regimen / At least 1 / True
3 / 2 / Two regimen / At least 1 / True
4 / 2 / Three regimen / At least 1 / True
5 / 2 / Four regimen / At least 1 / True
1 / 3 / No regimen for Chemo / At least 2 / False
2 / 3 / One regimen / At least 2 / False
3 / 3 / Two regimen / At least 2 / True
4 / 3 / Three regimen / At least 2 / True
5 / 3 / Four regimen / At least 2 / True
1 / 4 / No regimen for Chemo / At least 3 / False
2 / 4 / One regimen / At least 3 / False
3 / 4 / Two regimen / At least 3 / False
4 / 4 / Three regimen / At least 3 / True
5 / 4 / Four regimen / At least 3 / True
6-20 / 5-18 / - / N/A / NA
Menopausal Status
Patient Values
I have monthly periods
I do not have regular monthly periods and I sometimes experience hot flashes
I have not had periods for at least 6 months
I don’t know/ I’m not sure
Investigator Values
All women may enroll regardless of menopausal status (NA)
Enrollment is restricted as follows (Yes)
Postmenopausal
Premenopausal
Perimenopausal
Patient / Protocol / Patient Value / Protocol Value 1 / Protocol Values 2 / Expected Result1 / 1 / Premenopausal / NA / - / NA
2 / 1 / Perimenopausal / NA / - / NA
3 / 1 / Postmenopausal / NA / - / NA
4 / 1 / I don’t know / NA / - / NA
1 / 2 / Premenopausal / Yes / Premenopausal / True
2 / 2 / Perimenopausal / Yes / Premenopausal / False
3 / 2 / Postmenopausal / Yes / Premenopausal / False
4 / 2 / I don’t know / Yes / Premenopausal / True
1 / 3 / Premenopausal / Yes / Perimenopausal / False
2 / 3 / Perimenopausal / Yes / Perimenopausal / True
3 / 3 / Postmenopausal / Yes / Perimenopausal / False
4 / 3 / I don’t know / Yes / Perimenopausal / True
1 / 4 / Premenopausal / Yes / Postmenopausal / False
2 / 4 / Perimenopausal / Yes / Postmenopausal / False
3 / 4 / Postmenopausal / Yes / Postmenopausal / True
4 / 4 / I don’t know / Yes / Postmenopausal / True
1 / 5 / Premenopausal / Yes / Premenopausal
Perimenopausal / True
2 / 5 / Perimenopausal / Yes / Premenopausal
Perimenopausal / True
3 / 5 / Postmenopausal / Yes / Premenopausal
Perimenopausal / False
4 / 5 / I don’t know / Yes / Premenopausal
Perimenopausal / True
1 / 6 / Premenopausal / Yes / Premenopausal
Postmenopausal / True
2 / 6 / Perimenopausal / Yes / Premenopausal
Postmenopausal / False
3 / 6 / Postmenopausal / Yes / Premenopausal
Postmenopausal / True
4 / 6 / I don’t know / Yes / Premenopausal
Postmenopausal / True
1 / 7 / Premenopausal / Yes / Perimenopausal
Postmenopausal / False
2 / 7 / Perimenopausal / Yes / Perimenopausal
Postmenopausal / True
3 / 7 / Postmenopausal / Yes / Perimenopausal
Postmenopausal / True
4 / 7 / I don’t know / Yes / Perimenopausal
Postmenopausal / True
1 / 8 / Premenopausal / Yes / Premenopausal
Perimenopausal
Postmenopausal / True
2 / 8 / Perimenopausal / Yes / Premenopausal
Perimenopausal
Postmenopausal / True
3 / 8 / Postmenopausal / Yes / Premenopausal
Perimenopausal
Postmenopausal / True
4 / 8 / I don’t know / Yes / Premenopausal
Perimenopausal
Postmenopausal / True
5-20 / 9-18 / I don’t know / No/NA / NA
Cancer Stage
Patient Values
Q(Cancer Stage)
In Situ (DCIS)
Stage I
Stage II
Stage III
Stage IV (metastatic disease)
I don't know/I'm not sure
Q(Cancer Recur)
Yes
No
I don’t know
Q(Inflammatory)
Yes
No
I don’t know
Investigator Values
N/A
In Situ (DCIS)
Stage I
Stage II
Stage III
Stage IV (metastatic disease)
Inflammatory
Recurrent
Patient / Protocol / Q1 / Q2 / Q3 / Protocol Value / Expected Result- / 1 / - / - / - / N/A / N/A
1 / - / I don’t know / - / - / Anything but N/A / True
2 / - / - / I don’t know / - / Anything but N/A / True
3 / - / - / - / I don’t know / Anything but N/A / True
4 / 2 / In Situ (DCIS) / - / - / In Situ (DCIS) / True
5 / 2 / Stage I / - / - / In Situ (DCIS) / False
6 / 2 / Stage II / - / - / In Situ (DCIS) / False
7 / 2 / Stage III / - / - / In Situ (DCIS) / False
8 / 2 / Stage IV / - / - / In Situ (DCIS) / False
4 / 3 / In Situ (DCIS) / - / - / Stage I / False
5 / 3 / Stage I / - / - / Stage I / True
6 / 3 / Stage II / - / - / Stage I / False
7 / 3 / Stage III / - / - / Stage I / False
8 / 3 / Stage IV / - / - / Stage I / False
4 / 4 / In Situ (DCIS) / - / - / Stage II / False
5 / 4 / Stage I / - / - / Stage II / False
6 / 4 / Stage II / - / - / Stage II / True
7 / 4 / Stage III / - / - / Stage II / False
8 / 4 / Stage IV / - / - / Stage II / False
4 / 5 / In Situ (DCIS) / - / - / Stage III / False
5 / 5 / Stage I / - / - / Stage III / False
6 / 5 / Stage II / - / - / Stage III / False
7 / 5 / Stage III / - / - / Stage III / True
8 / 5 / Stage IV / - / - / Stage III / False
4 / 6 / In Situ (DCIS) / - / - / Stage IV / False
5 / 6 / Stage I / - / - / Stage IV / False
6 / 6 / Stage II / - / - / Stage IV / False
7 / 6 / Stage III / - / - / Stage IV / False
8 / 6 / Stage IV / - / - / Stage IV / True
1 / 7 / - / Yes / - / Recurrent / True
3 / 7 / - / No / - / Recurrent / False
1 / 8 / Yes / Inflammatory / True
2 / 8 / No / Inflammatory / False
4 / 9 / In Situ (DCIS) / - / - / In Situ (DCIS)
Stage I
Stage II / True
5 / 9 / Stage I / - / - / In Situ (DCIS)
Stage I
Stage II / True
6 / 9 / Stage II / - / - / In Situ (DCIS)
Stage I
Stage II / True
7 / 9 / Stage III / - / - / In Situ (DCIS)
Stage I
Stage II / False
8 / 9 / Stage IV / - / - / In Situ (DCIS)
Stage I
Stage II / False
4 / 10 / In Situ (DCIS) / - / - / Stage III
Stage IV / False
5 / 10 / Stage I / - / - / Stage III
Stage IV / False
6 / 10 / Stage II / - / - / Stage III
Stage IV / False
7 / 10 / Stage III / - / - / Stage III
Stage IV / True
8 / 10 / Stage IV / - / - / Stage III
Stage IV / True
4 / 11 / In Situ (DCIS) / No / - / Stage IV
Recurrent / False
5 / 11 / Stage I / No / - / Stage IV
Recurrent / False
6 / 11 / Stage II / No / - / Stage IV
Recurrent / False
7 / 11 / Stage III / No / - / Stage IV
Recurrent / False
8 / 11 / Stage IV / No / - / Stage IV
Recurrent / True
1 / 11 / - / Yes / - / Stage IV
Recurrent / True
4 / 12 / In Situ (DCIS) / - / No / Stage III
Inflammatory / False
5 / 12 / Stage I / - / No / Stage III
Inflammatory / False
6 / 12 / Stage II / - / No / Stage III
Inflammatory / False
7 / 12 / Stage III / - / No / Stage III
Inflammatory / True
8 / 12 / Stage IV / - / No / Stage III
Inflammatory / False
1 / 12 / - / - / Yes / Stage III
Inflammatory / True
9-20 / 13-18 / I don’t know / I don’t know / I don’t know / N/A / NA
Progression with Treatment (Bisphosphonate, Imuno, Hormone, Chemo)
Patient Values
Patient 1- No regimens
Patient 2- One regimen with no progression
Patient 3-Two regimens, one has progression
Patient 6- One regimen with Progression
Investigator Values
Yes
No (N/A)
Patient / Protocol / Patient Value / Protocol Value / Expected Result1 / 1 / No regimens / N/A / NA
2 / 1 / One regimen, no progression / N/A / NA
3 / 1 / Two regimens, one progression / N/A / NA
6 / 1 / One regimen with progression / N/A / NA
1 / 2 / No regimens / Yes / False
2 / 2 / One regimen, no progression / Yes / False
3 / 2 / Two regimens, one progression / Yes / True
6 / 2 / One regimen with progression / Yes / True
4-5,7-20 / 3-18 / - / N/A / NA
Setting Required with Prior Regimens (Hormone)
Patient Values
Neoadjuvant
Adjuvant
Metastatic
I don’t know
Investigator Values
N/A
Neoadjuvant
Adjuvant
Metastatic
Patient / Protocol / Patient Value / Protocol Value / Expected Result1 / 1 / No Regimen / N/A / NA
7 / 1 / Neoadjuvant / N/A / NA
6 / 1 / Adjuvant / N/A / NA
2 / 1 / Metastatic / N/A / NA
8 / 1 / I don’t know / N/A / NA
7 / 2 / Neoadjuvant / Neoadjuvant / True
1 / 2 / No regimen / Neoadjuvant / False
6 / 2 / Adjuvant / Neoadjuvant / False
2 / 2 / Metastatic / Neoadjuvant / False
8 / 2 / I don’t know / Neoadjuvant / True
7 / 3 / Neoadjuvant / Adjuvant / False
6 / 3 / Adjuvant / Adjuvant / True
2 / 3 / Metastatic / Adjuvant / False
8 / 3 / I don’t know / Adjuvant / True
7 / 4 / Neoadjuvant / Metastatic / False
6 / 4 / Adjuvant / Metastatic / False
2 / 4 / Metastatic / Metastatic / True
8 / 4 / I don’t know / Metastatic / True
7 / 5 / Neoadjuvant / Neoadjuvant
Adjuvant / True
6 / 5 / Adjuvant / Neoadjuvant
Adjuvant / True
2 / 5 / Metastatic / Neoadjuvant
Adjuvant / False
8 / 5 / I don’t know / Neoadjuvant
Adjuvant / True
7 / 6 / Neoadjuvant / Neoadjuvant
Metastatic / True
6 / 6 / Adjuvant / Neoadjuvant
Metastatic / False
2 / 6 / Metastatic / Neoadjuvant
Metastatic / True
8 / 6 / I don’t know / Neoadjuvant
Metastatic / True
7 / 7 / Neoadjuvant / Adjuvant
Metastatic / False
6 / 7 / Adjuvant / Adjuvant
Metastatic / True
2 / 7 / Metastatic / Adjuvant
Metastatic / True
8 / 7 / I don’t know / Adjuvant
Metastatic / True
7 / 8 / Neoadjuvant / Neoadjuvant
Adjuvant
Metastatic / True
6 / 8 / Adjuvant / Neoadjuvant Adjuvant
Metastatic / True
2 / 8 / Metastatic / Neoadjuvant Adjuvant
Metastatic / True
8 / 8 / I don’t know / Neoadjuvant Adjuvant
Metastatic / True
3-5,9-20 / 9-18 / - / N/A / NA
Setting Required with Prior Regimens (Chemo)
Patient Values
Neoadjuvant
Adjuvant
Metastatic
I don’t know
Investigator Values
N/A
Neoadjuvant
Adjuvant
Metastatic
Patient / Protocol / Patient Value / Protocol Value / Expected Result7 / 1 / Neoadjuvant / N/A / NA
6 / 1 / Adjuvant / N/A / NA
2 / 1 / Metastatic / N/A / NA
8 / 1 / I don’t know / N/A / NA
7 / 2 / Neoadjuvant / Neoadjuvant / True
6 / 2 / Adjuvant / Neoadjuvant / False
2 / 2 / Metastatic / Neoadjuvant / False
8 / 2 / I don’t know / Neoadjuvant / True
7 / 3 / Neoadjuvant / Adjuvant / False
6 / 3 / Adjuvant / Adjuvant / True
2 / 3 / Metastatic / Adjuvant / False
8 / 3 / I don’t know / Adjuvant / True
7 / 4 / Neoadjuvant / Metastatic / False
6 / 4 / Adjuvant / Metastatic / False
2 / 4 / Metastatic / Metastatic / True
8 / 4 / I don’t know / Metastatic / True
Age
Patient Values
Date of Birth
Investigator Values
All ages may participate
Patient age is restricted as follows
Lowest permissible age
Highest permissible age
Patient / Protocol / Patient Value / Protocol Value 1 / Protocol Values 2 / Protocol Values 3 / Expected Result1 / 1 / 5 / NA / - / - / NA
2 / 1 / 15 / NA / - / - / NA
3 / 1 / 25 / NA / - / - / NA
4 / 1 / 45 / NA / - / - / NA
1 / 2 / 5 / Yes / 10 / 20
2 / 2 / 15 / Yes / 10 / 20
3 / 2 / 25 / Yes / 10 / 20
4 / 2 / 45 / Yes / 10 / 20
1 / 3 / 5 / Yes / 40 / 50
2 / 3 / 15 / Yes / 40 / 50
3 / 3 / 25 / Yes / 40 / 50
4 / 3 / 45 / Yes / 40 / 50
1 / 3 / 5 / Yes / 10 / 50
2 / 3 / 15 / Yes / 10 / 50
3 / 3 / 25 / Yes / 10 / 50
4 / 3 / 45 / Yes / 10 / 50
Concurrent Medical Conditions