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QSSCAT alignment with QSTESTCD As stated in Section 3.1 assumptions, the PRO-CTCAE V1.0 VERSION DATE 4/26/2020 is grouped into subcategories. The table below includes the subcategory names along with the applicable question numbers for each category. The values of the subcategories are used to populate QSSCAT and are annotated on the CRF.
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All PRO-CTCAE Severity Questions
QSORRES | QSSTRESC | QSSTRESN |
|---|---|---|
| None | None | |
| Mild | Mild | |
| Moderate | Moderate | |
| Severe | Severe | |
| Very severe | Very severe |
All PRO-CTCAE Interference Questions
QSORRES | QSSTRESC | QSSTRESN |
|---|---|---|
| Not at all | Not at all | |
| A little bit | A little bit | |
| Somewhat | Somewhat | |
| Quite a bit | Quite a bit | |
| Very much | Very much |
All PRO-CTCAE Frequency Questions
QSORRES | QSSTRESC | QSSTRESN |
|---|---|---|
| Never | Never | |
| Rarely | Rarely | |
| Occasionally | Occasionally | |
| Frequently | Frequently | |
| Almost constantly | Almost constantly |
All PRO-CTCAE Presence Questions
QSORRES | QSSTRESC | QSSTRESN |
|---|---|---|
| Yes | Yes | |
| No | No |
All PRO-CTCAE Amount Questions
QSORRES | QSSTRESC | QSSTRESN |
|---|---|---|
| Not at all | Not at all | |
| A little bit | A little bit | |
| Somewhat | Somewhat | |
| Quite a bit | Quite a bit | |
| Very much | Very much |
--TESTCD = "PT01066A" --TEST = "PT01-Achieve/Maintain Erection Severity"
--TESTCD = "PT01068A" --TEST = "PT01-Decreased Libido Severity"
--TESTCD = "PT01071A" --TEST = "PT01-Pain w/Sexual Intercourse Severity"
QSORRES | QSSTRESC | QSSTRESN |
|---|---|---|
| None | None | |
| Mild | Mild | |
| Moderate | Moderate | |
| Severe | Severe | |
| Very severe | Very severe | |
| Not sexually active | Not sexually active | |
| Prefer not to answer | Prefer not to answer |
--TESTCD = "PT01067A" --TEST = "PT01-Ejaculation Frequency"
QSORRES | QSSTRESC | QSSTRESN |
|---|---|---|
| Never | Never | |
| Rarely | Rarely | |
| Occasionally | Occasionally | |
| Frequently | Frequently | |
| Almost constantly | Almost constantly | |
| Not sexually active | Not sexually active | |
| Prefer not to Answer | Prefer not to Answer |
--TESTCD = "PT01069A" --TEST = "PT01-Delayed Orgasm Presence"
--TESTCD = "PT01070A" --TEST = "PT01-Unable to Have Orgasm Presence"
QSORRES | QSSTRESC | QSSTRESN |
|---|---|---|
| Yes | Y | |
| No | N | |
| Not sexually active | Not sexually active | |
| Prefer not to answer | Prefer not to answer |
--TESTCD = "PT01036A" --TEST = "PT01-Radiation Skin Reaction Severity"
QSORRES | QSSTRESC | QSSTRESN |
|---|---|---|
| None | None | |
| Mild | Mild | |
| Moderate | Moderate | |
| Severe | Severe | |
| Very severe | Very severe | |
| Not applicable | Not applicable |
--TESTCD = "PT01057A" --TEST = "PT01-Irregular Menstrual Period Presence"
--TESTCD = "PT01058A" --TEST = "PT01-Missed Menstrual Period Presence"
--TESTCD = "PT01079A" --TEST = "PT01-Pain&Swelling at Inj Site Presence"
QSORRES | QSSTRESC | QSSTRESN |
| Yes | Y | |
| No | N | |
| Not Applicable | Not Applicable |
5 Supplemental Qualifier Name Codes
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