Sub-Domain: Disease or Treatment Related Events
CRF: Endocrine, Infertility and Bone Health
CDE ID | CDE Name | Variable Name | Definition | Short Description | Additional Notes (Question Text) | Permissible Values | Description | Data Type | Disease Specific Instructions | Disease Specific Reference | Population | Classification (e.g., Core) | Version Number | Version Date | CRF Name (CRF Module / Guideline) | Sub Domain Name | Domain Name | Size | Input Restrictions | Min Value | Max Value | Measurement Type | Source | Form Set | Form | Field | Domain | CDASH Variable | CDASH Definition | CDASH Label | Controlled Terminology | Prompt | Essentiality | Question Text | CDASH imp guidance | SDTM IG target | csDSR | PhenX | Data Type | CRF Completion Inst | SDTMIG Target Var | SDTMIG Target Map | Codelist Name | PVs | Pre Pop Value | Query Display | List Style |
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C60585 | Fertility preservation no reason | FertilityPreservationNoRsn | Reason given by the subject/participant for why he or she did not take steps to preserve his or her fertility. | Reason given by the subject/participant for why he or she did not take steps to preserve his or her fertility. | If no, why (pt may decline to answer) | Alphanumeric | Adult;Pediatric | Core | 1.00 | 2021-04-28 14:52:44.0 | Endocrine, Infertility and Bone Health | Disease or Treatment Related Events | Fertility and Bone | 100 |
Free-Form Entry |
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C60596 | Fertility preservation embryo indicator | FertPresEmbryoInd | Indicator of whether embryos have been preserved for fertility preservation. | Indicator of whether embryos have been preserved for fertility preservation. | If embryos preserved | No;Yes | No;Yes | Alphanumeric | Adult;Pediatric | Core | 1.00 | 2021-04-28 16:12:45.0 | Endocrine, Infertility and Bone Health | Disease or Treatment Related Events | Fertility and Bone |
Single Pre-Defined Value Selected |
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C60586 | Fertility preservation payment source type | FertilityPreservationPaySrcTyp | Type of payment source for the subject/participant's fertility preservation | Type of payment source for the subject/participant's fertility preservation | If Yes, how paid for (check all that apply) | Paid for by gene therapy study;Insurance;Self-pay;Grant/foundation support;Research study about fertility preservation | Paid for by gene therapy study;Insurance;Self-pay;Grant/foundation support;Research study about fertility preservation | Alphanumeric | Adult;Pediatric | Core | 1.00 | 2021-04-28 14:54:40.0 | Endocrine, Infertility and Bone Health | Disease or Treatment Related Events | Fertility and Bone |
Multiple Pre-Defined Values Selected |
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C60597 | Fertility preservation embryo count | FertPresEmbryoCt | Count of embryos preserved as part of fertility preservation. | Count of embryos preserved as part of fertility preservation. | If yes, how many? | Numeric Values | Adult;Pediatric | Core | 1.00 | 2021-04-28 16:16:48.0 | Endocrine, Infertility and Bone Health | Disease or Treatment Related Events | Fertility and Bone |
Free-Form Entry |
0 | embryos | |||||||||||||||||||||||||||||||
C60587 | Fertility preservation payment insurance copay value | FerttyPrsrvtnPymntInsCopayVal | Value in U.S. dollars of the insurance copay paid by the subject/participant for his or her fertility preservation. | Value in U.S. dollars of the insurance copay paid by the subject/participant for his or her fertility preservation. | If insurance, copay | Numeric Values | Adult;Pediatric | Core | 1.00 | 2021-04-28 15:01:15.0 | Endocrine, Infertility and Bone Health | Disease or Treatment Related Events | Fertility and Bone |
Free-Form Entry |
0 | US dollars | |||||||||||||||||||||||||||||||
C60598 | Fertility preservation semen analysis result text | FertPresSemenAnalysResltTxt | Text field for documenting the results of semen analysis performed as part of fertility preservation. | Text field for documenting the results of semen analysis performed as part of fertility preservation. | If semen analysis performed, results: | Alphanumeric | Adult;Pediatric | Core | 1.00 | 2021-04-28 16:21:45.0 | Endocrine, Infertility and Bone Health | Disease or Treatment Related Events | Fertility and Bone | 255 |
Free-Form Entry |
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C60577 | Avascular necrosis before cure indicator | AvascularNecrosisBeforeCureInd | Indicator of whether participant/subject presented with avascular necrosis prior to being cured. | Indicator of whether participant/subject presented with avascular necrosis prior to being cured. | Avascular necrosis at/before cure | No;Yes | No;Yes | Alphanumeric | Adult;Pediatric | Core | 1.00 | 2021-04-28 14:25:43.0 | Endocrine, Infertility and Bone Health | Disease or Treatment Related Events | Fertility and Bone |
Single Pre-Defined Value Selected |
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C60588 | Hydroxyurea take time fertility preservation indicator | HydrxyurTkTmFertPresInd | Indicator of whether the subject/participant was taking hydroxyurea at the time of his or her fertility preservation. | Indicator of whether the subject/participant was taking hydroxyurea at the time of his or her fertility preservation. | If Yes, taking hydroxyurea at fertility preservation? | No;Yes | No;Yes | Alphanumeric | Adult;Pediatric | Core | 1.00 | 2021-04-28 15:04:03.0 | Endocrine, Infertility and Bone Health | Disease or Treatment Related Events | Fertility and Bone |
Single Pre-Defined Value Selected |
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C60599 | Fertility preservation semen analysis sperm concentration text | FrtPrsSmnAnlysSprmConcnTxt | Text field for recording the value and units of sperm concentration from semen analysis performed as part of fertility preservation. | Text field for recording the value and units of sperm concentration from semen analysis performed as part of fertility preservation. | Sperm concentration | Alphanumeric | Adult;Pediatric | Core | 1.00 | 2021-04-28 16:23:29.0 | Endocrine, Infertility and Bone Health | Disease or Treatment Related Events | Fertility and Bone | 25 |
Free-Form Entry |
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C60578 | Avascular necrosis anatomic site | AvascularNecrosisAnatSite | Anatomic site(s) of subject/participant's avascular necrosis. | Anatomic site(s) of subject/participant's avascular necrosis. | If yes, where | Alphanumeric | Adult;Pediatric | Core | 1.00 | 2021-04-28 14:29:34.0 | Endocrine, Infertility and Bone Health | Disease or Treatment Related Events | Fertility and Bone | 100 |
Free-Form Entry |
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C60589 | Hydroxyurea stop duration | HydroxyureaStopDur | Duration of time in months for which the subject/participant's hydroxyurea treatment has been stopped. | Duration of time in months for which the subject/participant's hydroxyurea treatment has been stopped. | If HU has been stopped, please indicate for how long? | Numeric Values | Adult;Pediatric | Core | 1.00 | 2021-04-28 15:06:07.0 | Endocrine, Infertility and Bone Health | Disease or Treatment Related Events | Fertility and Bone |
Free-Form Entry |
0 | months | |||||||||||||||||||||||||||||||
C60600 | Fertility preservation semen analysis sperm motility text | FrtPrsSmnAnlysSprmMotiltyTxt | Text field for recording the value and units of sperm motility from semen analysis performed as part of fertility preservation. | Text field for recording the value and units of sperm motility from semen analysis performed as part of fertility preservation. | Sperm motility: | Alphanumeric | Adult;Pediatric | Core | 1.00 | 2021-04-28 16:23:29.0 | Endocrine, Infertility and Bone Health | Disease or Treatment Related Events | Fertility and Bone | 25 |
Free-Form Entry |
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C60579 | Avascular necrosis Lesion 1 stage number | AvascularNecrosisLesn1StgNum | Number denoting the stage of avascular necrosis at the site of Lesion 1. | Number denoting the stage of avascular necrosis at the site of Lesion 1. | If yes, stage (1-4) of Lesion 1 | 1;2;3;4 | 1;2;3;4 | Numeric Values | Adult;Pediatric | Core | 1.00 | 2021-04-28 14:31:15.0 | Endocrine, Infertility and Bone Health | Disease or Treatment Related Events | Fertility and Bone |
Single Pre-Defined Value Selected |
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C60590 | Fertility preservation bank material category | FertPresBankMatCat | Category of material that has been banked as part of the subject/participant's fertility preservation. | Category of material that has been banked as part of the subject/participant's fertility preservation. | If yes, what is banked | Embryos;Ovarian tissue;Oocytes | Embryos;Ovarian tissue;Oocytes | Alphanumeric | Adult;Pediatric | Core | 1.00 | 2021-04-28 15:09:14.0 | Endocrine, Infertility and Bone Health | Disease or Treatment Related Events | Fertility and Bone |
Multiple Pre-Defined Values Selected |
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C60601 | Fertility preservation semen analysis sperm morphology text | FrtPrsSmnAnlysSprmMorphTxt | Text field for recording the value and units of sperm morphology from semen analysis performed as part of fertility preservation. | Text field for recording the value and units of sperm morphology from semen analysis performed as part of fertility preservation. | Sperm morphology | Alphanumeric | Adult;Pediatric | Core | 1.00 | 2021-04-28 16:23:29.0 | Endocrine, Infertility and Bone Health | Disease or Treatment Related Events | Fertility and Bone | 25 |
Free-Form Entry |
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C60580 | Avascular necrosis Lesion 2 stage number | AvascularNecrosisLesn2StgNum | Number denoting the stage of avascular necrosis at the site of Lesion 2. | Number denoting the stage of avascular necrosis at the site of Lesion 2. | If yes, stage (1-4) of Lesion 2 | 1;2;3;4 | 1;2;3;4 | Numeric Values | Adult;Pediatric | Core | 1.00 | 2021-04-28 14:31:15.0 | Endocrine, Infertility and Bone Health | Disease or Treatment Related Events | Fertility and Bone |
Single Pre-Defined Value Selected |
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C60591 | Fertility preservation tissue gamete cryopreserve cost year value | FrtPrsTsGamCryprsvCstYrVal | Value in U.S. dollars of the cost per year of cryopreservation of tissue and/or gametes as part of the subject/participant's fertility preservation. | Value in U.S. dollars of the cost per year of cryopreservation of tissue and/or gametes as part of the subject/participant's fertility preservation. | If yes, storage cost for cryopreserved tissue/gametes (per year): | Numeric Values | Adult;Pediatric | Core | 1.00 | 2021-04-28 15:13:27.0 | Endocrine, Infertility and Bone Health | Disease or Treatment Related Events | Fertility and Bone |
Free-Form Entry |
0 | U.S. dollars | |||||||||||||||||||||||||||||||
C60602 | Fertility preservation sperm indicator | FertPresSpermInd | Indicator of whether sperm has been preserved for fertility preservation. | Indicator of whether sperm has been preserved for fertility preservation. | Sperm preserved | No;Yes | No;Yes | Alphanumeric | Adult;Pediatric | Core | 1.00 | 2021-04-28 16:12:45.0 | Endocrine, Infertility and Bone Health | Disease or Treatment Related Events | Fertility and Bone |
Single Pre-Defined Value Selected |
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C60581 | Avascular necrosis lesion stage number not record reason | AvascNecrsLesnStgNumNoRecRsn | Reason why the stage number for the avascular necrosis legion has not been recorded. | Reason why the stage number for the avascular necrosis legion has not been recorded. | If yes, stage Unknown/Unavailable | Unknown;Unavailable | Unknown;Unavailable | Alphanumeric | Adult;Pediatric | Core | 1.00 | 2021-04-28 14:37:09.0 | Endocrine, Infertility and Bone Health | Disease or Treatment Related Events | Fertility and Bone |
Single Pre-Defined Value Selected |
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C60592 | Fertility preservation tissue gamete cryopreserve cost payment source type | FrtPrsTsGamCryprsCstPaySrcTyp | Type(s) of source(s) for the payment of the cost of cryopreservation of tissue and/or gametes as part of the subject/participant's fertility preservation. | Type(s) of source(s) for the payment of the cost of cryopreservation of tissue and/or gametes as part of the subject/participant's fertility preservation. | Storage cost paid by | Insurance;Research study;Foundation/grant;Patient/family | Insurance;Research study;Foundation/grant;Patient/family | Alphanumeric | Adult;Pediatric | Core | 1.00 | 2021-04-28 15:16:08.0 | Endocrine, Infertility and Bone Health | Disease or Treatment Related Events | Fertility and Bone |
Multiple Pre-Defined Values Selected |
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C60603 | Fertility preservation oocyte ovarian tissue embryo continue preserve indicator | FrtPrsOocytOvrTissEmbCntPrsInd | Indicator of whether the subject/participant is continuing to preserve oocytes, ovarian tissue, and/or embryos for fertility preservation. | Indicator of whether the subject/participant is continuing to preserve oocytes, ovarian tissue, and/or embryos for fertility preservation. | Are you continuing to preserve your oocytes/ ovarian tissue /embryos? | No;Yes | No;Yes | Alphanumeric | Adult;Pediatric | Core | 1.00 | 2021-04-29 13:12:49.0 | Endocrine, Infertility and Bone Health | Disease or Treatment Related Events | Fertility and Bone |
Single Pre-Defined Value Selected |
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C60582 | Growth hormone receive response deficiency ever indicator | GrowHormRecvRespDeficEvrInd | Indicator of whether the subject/participant ever received growth hormone in response to a deficiency thereof. | Indicator of whether the subject/participant ever received growth hormone in response to a deficiency thereof. | If Yes, did you receive growth hormone? | No;Yes;Unknown | No;Yes;Unknown | Alphanumeric | Adult;Pediatric | Core | 1.00 | 2021-04-28 14:41:44.0 | Endocrine, Infertility and Bone Health | Disease or Treatment Related Events | Fertility and Bone |
Single Pre-Defined Value Selected |
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C60593 | Fertility preservation ovarian tissue indicator | FertPresOvarianTissueInd | Indicator of whether ovarian tissue has been preserved for fertility preservation. | Indicator of whether ovarian tissue has been preserved for fertility preservation. | Ovarian tissue preserved | No;Yes | No;Yes | Alphanumeric | Adult;Pediatric | Core | 1.00 | 2021-04-28 16:12:45.0 | Endocrine, Infertility and Bone Health | Disease or Treatment Related Events | Fertility and Bone |
Single Pre-Defined Value Selected |
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C60604 | Fertility preservation oocyte ovarian tissue embryo continue preserve current cost text | FrtPrsOcytOvTsEmbCntPsCrCstTxt | Text for reporting the U.S. dollar value and payment frequency of the current cost of the continued preservation of oocytes, ovarian tissue, and/or embryos as part of the subject/participant's fertility preservation. | Text for reporting the U.S. dollar value and payment frequency of the current cost of the continued preservation of oocytes, ovarian tissue, and/or embryos as part of the subject/participant's fertility preservation. | If yes, what is current cost of preservation | Alphanumeric | Adult;Pediatric | Core | 1.00 | 2021-04-29 13:15:58.0 | Endocrine, Infertility and Bone Health | Disease or Treatment Related Events | Fertility and Bone | 25 |
Free-Form Entry |
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C60583 | Hypogonadotropic hypogonadism diagnosis age integer | HypogndtropHypogndsmDxAgeIntg | Integer for the age in years of the subject/participant at the time of his or her diagnosis of hypogonadotropic hypogonadism. | Integer for the age in years of the subject/participant at the time of his or her diagnosis of hypogonadotropic hypogonadism. | Hypogonadotropic hypogonadism: Age at diagnosis | Numeric Values | Adult;Pediatric | Core | 1.00 | 2021-04-28 14:45:24.0 | Endocrine, Infertility and Bone Health | Disease or Treatment Related Events | Fertility and Bone |
Free-Form Entry |
0 | 100 | year | ||||||||||||||||||||||||||||||
C60594 | Fertility preservation oocyte indicator | FertPresOocyteInd | Indicator of whether oocytes have been preserved for fertility preservation. | Indicator of whether oocytes have been preserved for fertility preservation. | If oocytes preserved | No;Yes | No;Yes | Alphanumeric | Adult;Pediatric | Core | 1.00 | 2021-04-28 16:12:45.0 | Endocrine, Infertility and Bone Health | Disease or Treatment Related Events | Fertility and Bone |
Single Pre-Defined Value Selected |
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C60605 | Fertility preservation oocyte ovarian tissue embryo not preserve reason | FrtPrsOocytOvaTisEmbNoPrsRsn | Reason why the subject/participant is no longer continuing to preserve oocytes, ovarian tissue, and/or embryos as part of fertility preservation. | Reason why the subject/participant is no longer continuing to preserve oocytes, ovarian tissue, and/or embryos as part of fertility preservation. | If no, why | Lab accident;Family complete;Cost | Lab accident;Family complete;Cost | Alphanumeric | Adult;Pediatric | Core | 1.00 | 2021-04-29 13:20:26.0 | Endocrine, Infertility and Bone Health | Disease or Treatment Related Events | Fertility and Bone |
Single Pre-Defined Value Selected |
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C60584 | Fertility preservation indicator | FertilityPreservationInd | Indicator of whether the subject/participant took steps to preserve his or her fertility. | Indicator of whether the subject/participant took steps to preserve his or her fertility. | Fertility Preservation | Yes;No;Decline | Yes;No;Decline to answer | Alphanumeric | Adult;Pediatric | Core | 1.00 | 2021-04-28 14:49:47.0 | Endocrine, Infertility and Bone Health | Disease or Treatment Related Events | Fertility and Bone |
Single Pre-Defined Value Selected |
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C60595 | Fertility preservation oocyte count | FertPresOocyteCt | Count of oocytes preserved as part of fertility preservation. | Count of oocytes preserved as part of fertility preservation. | If yes, how many? | Numeric Values | Adult;Pediatric | Core | 1.00 | 2021-04-28 16:16:48.0 | Endocrine, Infertility and Bone Health | Disease or Treatment Related Events | Fertility and Bone |
Free-Form Entry |
0 | oocytes | |||||||||||||||||||||||||||||||
C60606 | Pregnancy since last study visit indicator | PregSincLastStdyVistInd | Indicator of whether the subject/participant has been pregnant since her last study visit. | Indicator of whether the subject/participant has been pregnant since her last study visit. | Have you been pregnant since your last study visit? | No;Yes | No;Yes | Alphanumeric | Adult;Pediatric | Core | 1.00 | 2021-04-29 13:23:57.0 | Endocrine, Infertility and Bone Health | Disease or Treatment Related Events | Fertility and Bone |
Single Pre-Defined Value Selected |