Sub-Domain: Safety Data
CRF:
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C59121 | Constipation grade | ConstipationGrade | Grade of constipation exhibited by the patient | Grade of constipation exhibited by the patient | Constipation | 0;3;4;5 | Grades 0–2;Obstipation with manual evacuation indicated, limiting self care activities of daily living;Life-threatening consequences, urgent intervention indicated;Death | Numeric Values |
Record the highest grade of toxicity diagnosed since the previous evaluation. If this is the first evaluation, record the highest toxicity diagnosed since Day 0. The toxicity grades are based on the NCI CTCAE Version 4.02. |
Adult;Pediatric | Supplemental | 1.00 | 2019-01-17 07:16:45.0 | Toxicity Form | Safety Data | Adverse Events%2FToxicities |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | CONSTIPA | ||||||||||||||||||||||||||
| C58064 | Skin jaundice assessment status | SkinJaundiceAssmtStat | The status of skin jaundice assessment in physical examination. | The status of skin jaundice assessment in physical examination. | Jaundice | 1;2 | Yes;No | Alphanumeric |
Indicate all clinical signs/symptoms of abnormal liver functioning present during this assessment period |
Adult;Pediatric | Supplemental | 1.00 | 2018-01-23 12:29:34.0 | Toxicity Form | Safety Data | Adverse Events%2FToxicities |
Single Pre-Defined Value Selected |
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| C59075 | Alkaline phosphatase toxicity grade | AlkPhosphToxicityGrade | Grade of alkaline phosphatase toxicity exhibited by the patient. | Grade of alkaline phosphatase toxicity exhibited by the patient. | Alkaline phosphatase | 0;3;4 | Grades 0–2;>5.0–20.0 times upper limit of normal;>20.0 times upper limit of normal | Numeric Values |
Record the highest grade of toxicity diagnosed since the previous evaluation. If this is the first evaluation, record the highest toxicity diagnosed since Day 0. The toxicity grades are based on the NCI CTCAE Version 4.02. |
Adult;Pediatric | Supplemental | 1.00 | 2019-01-11 13:51:29.0 | Toxicity Form | Safety Data | Adverse Events%2FToxicities |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | TXALKPH | ||||||||||||||||||||||||||
| C59044 | Dialysis receive indicate code | DialysisReceiveIndCode | Code indicating whether the patient received dialysis | Code indicating whether the patient received dialysis | Did the patient receive dialysis? | 1;2;1;2 | Yes;No;Yes;No | Numeric Values | Adult;Pediatric | Supplemental | 1.00 | 2019-01-10 12:51:43.0 | Toxicity Form | Safety Data | Adverse Events%2FToxicities |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | RCVDIALY | |||||||||||||||||||||||||||
| C59100 | Liver abnormality other doppler ultrasound result code | LvrAbnmtyOthDplrUltrsdRstCode | Code denoting whether doppler ultrasound results confirmed an etiology of Other for abnormal liver function | Code denoting whether doppler ultrasound results confirmed an etiology of Other for abnormal liver function | Other etiology: doppler ultrasound result | 1;2;3 | Confirmed;Not confirmed;Not done | Numeric Values | Adult;Pediatric | Supplemental | 1.00 | 2019-01-15 13:39:46.0 | Toxicity Form | Safety Data | Adverse Events%2FToxicities |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | OTHDOPP | |||||||||||||||||||||||||||
| C59065 | Capillary leak syndrome grade | CapillryLeakSyndromeGrade | Grade of capillary leak syndrome exhibited by the patient. | Grade of capillary leak syndrome exhibited by the patient. | Capillary leak syndrome | 0;3;4;5 | Grades 0–2;Severe symptoms, intervention indicated;Life-threatening consequences, urgent intervention indicated;Death | Numeric Values |
Record the highest grade of toxicity diagnosed since the previous evaluation. If this is the first evaluation, record the highest toxicity diagnosed since Day 0. The toxicity grades are based on the NCI CTCAE Version 4.02. |
Adult;Pediatric | Supplemental | 1.00 | 2019-01-11 11:11:23.0 | Toxicity Form | Safety Data | Adverse Events%2FToxicities |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | CAPLKSYN | ||||||||||||||||||||||||||
| C59111 | Hemolysis grade | HemolysisGrade | Grade of hemolysis exhibited by the patient. | Grade of hemolysis exhibited by the patient. | Hemolysis | 0;3;4;5 | Grades 0–2;Transfusion or medical intervention indicated (e.g. steroids);Life-threatening, urgent radiologic or operative intervention indicated;Death | Numeric Values |
Record the highest grade of toxicity diagnosed since the previous evaluation. If this is the first evaluation, record the highest toxicity diagnosed since Day 0. The toxicity grades are based on the NCI CTCAE Version 4.02. |
Adult;Pediatric | Supplemental | 1.00 | 2019-01-16 11:56:34.0 | Toxicity Form | Safety Data | Adverse Events%2FToxicities |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | HEMOLYSI | ||||||||||||||||||||||||||
| C59122 | Hyperpigmentation skin under nail indicate code | HyprpgmntatnSknUndNailIndCode | Code indicating whether the patient has hyperpigmentation of the skin under the nails | Code indicating whether the patient has hyperpigmentation of the skin under the nails | Does the patient have hyperpigmentation of the skin under the nails? | 1;2;1;2 | Yes;No;Yes;No | Numeric Values | Adult;Pediatric | Supplemental | 1.00 | 2019-01-17 07:19:38.0 | Toxicity Form | Safety Data | Adverse Events%2FToxicities |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | HYPEPIGM | |||||||||||||||||||||||||||
| C58968 | Etiology liver abnormality GVHD indicate code | EtiolLivrAbnormGVHDIndCode | Code indicating whether the etiology of the liver abnormality was determined to be GVHD (graft-versus-host disease). | Code indicating whether the etiology of the liver abnormality was determined to be GVHD (graft-versus-host disease). | Etiology: GVHD | 1;2;1;2 | Yes;No;Yes;No | Numeric Values |
Indicate the etiology of the abnormal liver function |
Adult;Pediatric | Supplemental | 1.00 | 2019-01-04 13:57:59.0 | Toxicity Form | Safety Data | Adverse Events%2FToxicities |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Acute GVHD Form (GVH) | LIVETGVH | ||||||||||||||||||||||||||
| C59077 | Hepatomegaly indicate code | HepatomegalyIndCode | Code indicating whether hepatomegaly is exhibited by the patient. | Code indicating whether hepatomegaly is exhibited by the patient. | Hepatomegaly | 1;2;1;2 | Yes;No;Yes;No | Numeric Values |
Indicate all clinical signs/symptoms of abnormal liver functioning present during this assessment period |
Adult;Pediatric | Supplemental | 1.00 | 2019-01-11 14:22:12.0 | Toxicity Form | Safety Data | Adverse Events%2FToxicities |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | HEPTMGLY | ||||||||||||||||||||||||||
| C59055 | Dialysis result laboratory values correct indicate code | DialysRsltLabValCrctIndCode | Code indicating that dialysis resulted in correct laboratory values. | Code indicating that dialysis resulted in correct laboratory values. | If the patient received dialysis, were the laboratory values corrected? | 1;2;1;2 | Yes;No;Yes;No | Numeric Values | Adult;Pediatric | Supplemental | 1.00 | 2019-01-11 10:16:18.0 | Toxicity Form | Safety Data | Adverse Events%2FToxicities |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | LBVALCOR | |||||||||||||||||||||||||||
| C59101 | Transfusion related reaction grade | TxfusnRelateReactnGrade | Grade of the patient's reaction related to blood transfusion | Grade of the patient's reaction related to blood transfusion | Infusion related reaction | 0;3;4;5 | Grades 0–2;Prolonged, recurrence of symptoms following initial improvement, hospitalization indicated;Life-threatening consequences, urgent intervention indicated;Death | Numeric Values |
Record the highest grade of toxicity diagnosed since the previous evaluation. If this is the first evaluation, record the highest toxicity diagnosed since Day 0. The toxicity grades are based on the NCI CTCAE Version 4.02. |
Adult;Pediatric | Supplemental | 1.00 | 2019-01-15 14:23:40.0 | Toxicity Form | Safety Data | Adverse Events%2FToxicities |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | INFRLRXN | ||||||||||||||||||||||||||
| C59066 | Hypertension grade | HypertensionGrade | Grade of hypertension exhibited by the patient. | Grade of hypertension exhibited by the patient. | Hypertension | 0;3;4;5 | Grades 0–2;Stage 2 [systolic BP 160+ mmHg or diastolic BP 100+ mmHg], medical intervention indicated;Life-threatening consequences, urgent intervention indicated;Death | Numeric Values |
Record the highest grade of toxicity diagnosed since the previous evaluation. If this is the first evaluation, record the highest toxicity diagnosed since Day 0. The toxicity grades are based on the NCI CTCAE Version 4.02. |
Adult;Pediatric | Supplemental | 1.00 | 2019-01-11 11:14:30.0 | Toxicity Form | Safety Data | Adverse Events%2FToxicities |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | HYPERTSN | ||||||||||||||||||||||||||
| C59112 | Infection grade | InfectionGrade | Grade of infection exhibited by the patient. | Grade of infection exhibited by the patient. | Infection | 0;3;4;5 | Grades 0–2;IV antibiotic, antifungal, or antiviral indicated, radiologic, operative intervention indicated;Life-threatening consequences, urgent intervention indicated;Death | Numeric Values |
Record the highest grade of toxicity diagnosed since the previous evaluation. If this is the first evaluation, record the highest toxicity diagnosed since Day 0. The toxicity grades are based on the NCI CTCAE Version 4.02. |
Adult;Pediatric | Supplemental | 1.00 | 2019-01-16 11:59:41.0 | Toxicity Form | Safety Data | Adverse Events%2FToxicities |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | INFECTIN | ||||||||||||||||||||||||||
| C59123 | Hair thinning indicate code | HairThinningIndCode | Code indicating whether the patient has thinning hair | Code indicating whether the patient has thinning hair | Does the patient have thinning hair? | 1;2;1;2 | Yes;No;Yes;No | Numeric Values | Adult;Pediatric | Supplemental | 1.00 | 2019-01-17 07:21:13.0 | Toxicity Form | Safety Data | Adverse Events%2FToxicities |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | THINHAIR | |||||||||||||||||||||||||||
| C58972 | Etiology liver abnormality infection indicate code | EtiolLivrAbnrmInfctnIndCode | Code indicating whether the etiology of the liver abnormality was determined to be an infection. | Code indicating whether the etiology of the liver abnormality was determined to be an infection. | Etiology: infection | 1;2;1;2 | Yes;No;Yes;No | Numeric Values |
Indicate the etiology of the abnormal liver function |
Adult;Pediatric | Supplemental | 1.00 | 2019-01-04 13:57:59.0 | Toxicity Form | Safety Data | Adverse Events%2FToxicities |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Acute GVHD Form (GVH) | LIVETINF | ||||||||||||||||||||||||||
| C59078 | Pain right upper quadrant indicate code | PnRtUpQuadIndCode | Code indicating whether pain in the right upper quadrant indicative of abnormal liver function is exhibited by the patient. | Code indicating whether pain in the right upper quadrant indicative of abnormal liver function is exhibited by the patient. | Right upper quadrant pain | 1;2;1;2 | Yes;No;Yes;No | Numeric Values |
Indicate all clinical signs/symptoms of abnormal liver functioning present during this assessment period |
Adult;Pediatric | Supplemental | 1.00 | 2019-01-11 14:24:51.0 | Toxicity Form | Safety Data | Adverse Events%2FToxicities |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | RTQUADPN | ||||||||||||||||||||||||||
| C59056 | Hemorrhage grade | HemorrhageGrade | Grade of hemorrhage | Grade of hemorrhage | Hemorrhage | 0;3;4;5 | Grades 0–2;Transfusion, radiologic, endoscopic, or elective operative intervention indicated;Life-threatening consequences, urgent intervention indicated;Death | Numeric Values |
Record the highest grade of toxicity diagnosed since the previous evaluation. If this is the first evaluation, record the highest toxicity diagnosed since Day 0. The toxicity grades are based on the NCI CTCAE Version 4.02. |
Adult;Pediatric | Supplemental | 1.00 | 2019-01-11 10:20:17.0 | Toxicity Form | Safety Data | Adverse Events%2FToxicities |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | HEMORRHG | ||||||||||||||||||||||||||
| C59102 | Fever grade | FeverGrade | Grade of fever exhibited by the patient | Grade of fever exhibited by the patient | Fever | 0;3;4;5 | Grades 0–2;>40.0 degrees C (>104.0 degrees F) for <= 24 hours;>40.0 degrees C (>104.0 degrees F) for > 24 hours;Death | Numeric Values |
Record the highest grade of toxicity diagnosed since the previous evaluation. If this is the first evaluation, record the highest toxicity diagnosed since Day 0. The toxicity grades are based on the NCI CTCAE Version 4.02. |
Adult;Pediatric | Supplemental | 1.00 | 2019-01-15 14:30:15.0 | Toxicity Form | Safety Data | Adverse Events%2FToxicities |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | TXFEVER | ||||||||||||||||||||||||||
| C59113 | Iron overload grade | IronOverloadGrade | Grade of iron overload exhibited by the patient. | Grade of iron overload exhibited by the patient. | Iron overload | 0;3;4;5 | Grades 0–2;Severe symptoms, intervention indicated;Life-threatening, urgent radiologic or operative intervention indicated;Death | Numeric Values |
Record the highest grade of toxicity diagnosed since the previous evaluation. If this is the first evaluation, record the highest toxicity diagnosed since Day 0. The toxicity grades are based on the NCI CTCAE Version 4.02. |
Adult;Pediatric | Supplemental | 1.00 | 2019-01-16 12:03:06.0 | Toxicity Form | Safety Data | Adverse Events%2FToxicities |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | IRONOVER | ||||||||||||||||||||||||||
| C59067 | Dyspnea grade | DyspneaGrade | Grade of dyspnea exhibited by the patient. | Grade of dyspnea exhibited by the patient. | Dyspnea | 0;3;4;5 | Grades 0–2;Shortness of breath at rest, limiting self care ADL;Life-threatening consequences, urgent intervention indicated;Death | Numeric Values |
Record the highest grade of toxicity diagnosed since the previous evaluation. If this is the first evaluation, record the highest toxicity diagnosed since Day 0. The toxicity grades are based on the NCI CTCAE Version 4.02. |
Adult;Pediatric | Supplemental | 1.00 | 2019-01-11 11:28:38.0 | Toxicity Form | Safety Data | Adverse Events%2FToxicities |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | TXDYSPNA |
