Sub-Domain: Participant History and Family History
CRF: Toxicity Form
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C19500 | Assessment performed date | AssessmentPerformedDate | The date of assessment of the examination being performed. | The date of assessment of the examination being performed. | Record date of evaluation | Date or Date & Time | Adult;Pediatric | Proposed | 1.00 | 2014-06-18 08:10:12.0 | Toxicity Form | Participant History and Family History | General Health History |
Free-Form Entry |
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| C59074 | Bilirubin toxicity grade | BilirubinToxicityGrade | Grade of bilirubin toxicity exhibited by the patient. | Grade of bilirubin toxicity exhibited by the patient. | Bilirubin | 0;3;4 | Grades 0–2;>3.0–10.0 times upper limit of normal;>10.0 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 | Proposed | 1.00 | 2019-01-11 13:51:29.0 | Toxicity Form | Participant History and Family History | General Health History |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | TXBILIRB | ||||||||||||||||||||||||||
| C59120 | Diarrhea grade | DiarrheaGrade | Grade of diarrhea exhibited by the patient. | Grade of diarrhea exhibited by the patient. | Diarrhea | 0;3;4;5 | Grades 0–2;Increase of >= 7 stools per day, incontinence, severe increase in ostomy, 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 | Proposed | 1.00 | 2019-01-16 13:56:46.0 | Toxicity Form | Participant History and Family History | General Health History |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | DIARRHEA | ||||||||||||||||||||||||||
| C59043 | Chronic kidney disease toxicity grade | ChronKidnyDzToxicityGrade | Grade of chronic kidney disease toxicity exhibited by the patient. | Grade of chronic kidney disease toxicity exhibited by the patient. | Chronic kidney disease | 0;3;4;5 | Grades 0–2;eGFR or CrCI 29-15 mL/min/1.73m^2;eGFR <15 mL/min/1.73 m^2, dialysis or renal transplant 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 | Proposed | 1.00 | 2019-01-10 12:45:24.0 | Toxicity Form | Participant History and Family History | General Health History |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | CHKIDDIS | ||||||||||||||||||||||||||
| C59099 | Liver abnormality infection doppler ultrasound result code | LvrAbnmtyInfDplrUltrsdRstCode | Code denoting whether doppler ultrasound results confirmed an infection etiology for abnormal liver function | Code denoting whether doppler ultrasound results confirmed an infection etiology for abnormal liver function | Infection: doppler ultrasound results | 1;2;3 | Confirmed;Not confirmed;Not done | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2019-01-15 13:39:46.0 | Toxicity Form | Participant History and Family History | General Health History |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | INFDOPP | |||||||||||||||||||||||||||
| C59064 | Thrombotic thrombocytopenic purpura grade | ThrmbotcThrmbocytopencPrpGrade | Grade of thrombotic thrombocytopenic purpura exhibited by the patient. | Grade of thrombotic thrombocytopenic purpura exhibited by the patient. | Thrombotic thrombocytopenic purpura | 0;3;4;5 | Grades 0–2;Laboratory findings with clinical consequences [e.g., renal insufficiency, petechiae];Life-threatening consequences [e.g., CNS hemorrhage or thrombosis/embolism or renal failure];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 | Proposed | 1.00 | 2019-01-11 11:04:12.0 | Toxicity Form | Participant History and Family History | General Health History |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | THRMBPUR | ||||||||||||||||||||||||||
| C59110 | Hematuria grade | HematuriaGrade | Grade of hematuria exhibited by the patient. | Grade of hematuria exhibited by the patient. | Hematuria | 3;0;4;5 | Gross hematuria, transfusion, IV med, hosp., endoscopic, radiologic/operative inervention indicated;Grades 0–2;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 | Proposed | 1.00 | 2019-01-16 11:52:34.0 | Toxicity Form | Participant History and Family History | General Health History |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | HEMATURI | ||||||||||||||||||||||||||
| 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 | Proposed | 1.00 | 2018-01-23 12:29:34.0 | Toxicity Form | Participant History and Family History | General Health History |
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 | Proposed | 1.00 | 2019-01-11 13:51:29.0 | Toxicity Form | Participant History and Family History | General Health History |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | TXALKPH | ||||||||||||||||||||||||||
| 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 | Proposed | 1.00 | 2019-01-17 07:16:45.0 | Toxicity Form | Participant History and Family History | General Health History |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | CONSTIPA | ||||||||||||||||||||||||||
| 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 | Proposed | 1.00 | 2019-01-10 12:51:43.0 | Toxicity Form | Participant History and Family History | General Health History |
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 | Proposed | 1.00 | 2019-01-15 13:39:46.0 | Toxicity Form | Participant History and Family History | General Health History |
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 | Proposed | 1.00 | 2019-01-11 11:11:23.0 | Toxicity Form | Participant History and Family History | General Health History |
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 | Proposed | 1.00 | 2019-01-16 11:56:34.0 | Toxicity Form | Participant History and Family History | General Health History |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | HEMOLYSI | ||||||||||||||||||||||||||
| 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 | Proposed | 1.00 | 2019-01-04 13:57:59.0 | Toxicity Form | Participant History and Family History | General Health History |
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 | Proposed | 1.00 | 2019-01-11 14:22:12.0 | Toxicity Form | Participant History and Family History | General Health History |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | HEPTMGLY | ||||||||||||||||||||||||||
| 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 | Proposed | 1.00 | 2019-01-17 07:19:38.0 | Toxicity Form | Participant History and Family History | General Health History |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | HYPEPIGM | |||||||||||||||||||||||||||
| 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 | Proposed | 1.00 | 2019-01-11 10:16:18.0 | Toxicity Form | Participant History and Family History | General Health History |
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 | Proposed | 1.00 | 2019-01-15 14:23:40.0 | Toxicity Form | Participant History and Family History | General Health History |
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 | Proposed | 1.00 | 2019-01-11 11:14:30.0 | Toxicity Form | Participant History and Family History | General Health History |
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 | Proposed | 1.00 | 2019-01-16 11:59:41.0 | Toxicity Form | Participant History and Family History | General Health History |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | INFECTIN | ||||||||||||||||||||||||||
| 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 | Proposed | 1.00 | 2019-01-04 13:57:59.0 | Toxicity Form | Participant History and Family History | General Health History |
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 | Proposed | 1.00 | 2019-01-11 14:24:51.0 | Toxicity Form | Participant History and Family History | General Health History |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | RTQUADPN | ||||||||||||||||||||||||||
| 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 | Proposed | 1.00 | 2019-01-17 07:21:13.0 | Toxicity Form | Participant History and Family History | General Health History |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | THINHAIR | |||||||||||||||||||||||||||
| 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 | Proposed | 1.00 | 2019-01-11 10:20:17.0 | Toxicity Form | Participant History and Family History | General Health History |
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 | Proposed | 1.00 | 2019-01-15 14:30:15.0 | Toxicity Form | Participant History and Family History | General Health History |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | TXFEVER | ||||||||||||||||||||||||||
| 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 | Proposed | 1.00 | 2019-01-11 11:28:38.0 | Toxicity Form | Participant History and Family History | General Health History |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | TXDYSPNA | ||||||||||||||||||||||||||
| 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 | Proposed | 1.00 | 2019-01-16 12:03:06.0 | Toxicity Form | Participant History and Family History | General Health History |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | IRONOVER | ||||||||||||||||||||||||||
| C58973 | Etiology liver abnormality veno-occlusive disease indicate code | EtiolLivrAbnrmVODIndCode | Code indicating whether the etiology of the liver abnormality was determined to be VOD (veno-occlusive disease). | Code indicating whether the etiology of the liver abnormality was determined to be VOD (veno-occlusive disease). | Etiology: VOD | 1;2;1;2 | Yes;No;Yes;No | Numeric Values |
Indicate the etiology of the abnormal liver function |
Adult;Pediatric | Proposed | 1.00 | 2019-01-04 13:57:59.0 | Toxicity Form | Participant History and Family History | General Health History |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Acute GVHD Form (GVH) | LIVETVOD | ||||||||||||||||||||||||||
| C59079 | Weight gain greater 5 percent over baseline indicate code | WtGnGrtr5PctOvrBaslinIndCode | Code indicating whether weight gain greater than 5 percent above baseline is exhibited by the patient. | Code indicating whether weight gain greater than 5 percent above baseline is exhibited by the patient. | Weight gain (>5%) from baseline | 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 | Proposed | 1.00 | 2019-01-11 14:28:31.0 | Toxicity Form | Participant History and Family History | General Health History |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | TXWGHTGN | ||||||||||||||||||||||||||
| C59124 | Oligospermia grade | OligospermiaGrade | Grade of oligospermia (reduced sperm) | Grade of oligospermia (reduced sperm) | Oligospermia (reduced sperm) | 0;3 | Grades 0–2;Sperm concentration <13 million/mL or motility <32% | 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 | Proposed | 1.00 | 2019-01-17 07:23:04.0 | Toxicity Form | Participant History and Family History | General Health History |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | OLGSPERM | ||||||||||||||||||||||||||
| C59057 | Hemorrhage organ system code | HemorrhagOrgnSystmCode | Code denoting the organ system with which hemorrhage was associated | Code denoting the organ system with which hemorrhage was associated | Which organ system was the hemorrhage associated with? | 1;2;3;4;5 | Central nervous system;Gastrointestinal;Genitourinary;Pulmonary, upper respiratory;Other | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2019-01-11 10:27:10.0 | Toxicity Form | Participant History and Family History | General Health History |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | ORGSYHEM | |||||||||||||||||||||||||||
| C59103 | Maculo-papular rash grade | MaculoPapularRashGrade | Grade of the patient's maculo-papular rash | Grade of the patient's maculo-papular rash | Maculo-papular rash | 0;3 | Grades 0–2;Macules/papules covering >30% body surface area with our without associated symptoms, limiting self-care ADL | 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 | Proposed | 1.00 | 2019-01-15 14:38:17.0 | Toxicity Form | Participant History and Family History | General Health History |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | MAPARASH | ||||||||||||||||||||||||||
| C59068 | Idiopathic pneumonia syndrome indicate code | IPSIndCode | Code indicating whether the patient experienced idiopathic pneumonia syndrome (IPS). | Code indicating whether the patient experienced idiopathic pneumonia syndrome (IPS). | Did the patient experience idiopathic pneumonia syndrome (IPS)? | 1;2;1;2 | Yes;No;Yes;No | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2019-01-11 11:32:52.0 | Toxicity Form | Participant History and Family History | General Health History |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | TXXIPS | |||||||||||||||||||||||||||
| C59114 | Allo-antibody indicate code | AlloAntibodyIndCode | Code indicating whether the patient exhibited allo-antibodies. | Code indicating whether the patient exhibited allo-antibodies. | Did the patient develop allo-antibodies? | 1;2;1;2 | Yes;No;Yes;No | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2019-01-16 12:35:26.0 | Toxicity Form | Participant History and Family History | General Health History |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | ALLOANTB | |||||||||||||||||||||||||||
| C58974 | Etiology liver abnormality other indicate code | EtiolLivrAbnrmOthrIndCode | Code indicating whether the etiology of the liver abnormality was determined to be Other. | Code indicating whether the etiology of the liver abnormality was determined to be Other. | Etiology: other | 1;2;1;2 | Yes;No;Yes;No | Numeric Values |
Indicate the etiology of the abnormal liver function |
Adult;Pediatric | Proposed | 1.00 | 2019-01-04 13:57:59.0 | Toxicity Form | Participant History and Family History | General Health History |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Acute GVHD Form (GVH) | LIVETOTH | ||||||||||||||||||||||||||
| C59093 | Liver biopsy VOD result code | LivrBiopsyVODResultCode | Code for the result of the liver biopsy performed for hepatic veno-occlusive disease (VOD). | Code for the result of the liver biopsy performed for hepatic veno-occlusive disease (VOD). | VOD: biopsy results | 1;2;3;4 | Positive;Negative;Equivocal;Not done | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2019-01-04 14:12:38.0 | Toxicity Form | Participant History and Family History | General Health History |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | VODBIOP | |||||||||||||||||||||||||||
| C59058 | Hemorrhage organ system code other text | HemorrhagOrgnSystmCodeOTH | The free-text field related to 'Hemorrhage organ system code' specifying other text. | The free-text field related to 'Hemorrhage organ system code' specifying other text. | Specify other organ system | Alphanumeric | Adult;Pediatric | Proposed | 1.00 | 2019-01-11 10:38:04.0 | Toxicity Form | Participant History and Family History | General Health History | 100 |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | ORGSYHSP | ||||||||||||||||||||||||||||
| C59104 | Urticaria grade | UrticariaGrade | Grade of the patient's urticaria | Grade of the patient's urticaria | Urticaria | 0;3 | Grades 0–2;Urticarial lesions covering >30% body surface area, IV intervention indicated | 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 | Proposed | 1.00 | 2019-01-15 14:41:05.0 | Toxicity Form | Participant History and Family History | General Health History |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | URTICARI | ||||||||||||||||||||||||||
| C59069 | Pneumonia radiographic evidence infection no evidence indicate code | PneumRadEvInfctnNoEvIndCode | Code indicating whether there is radiographic evidence of pnemonia without evidence of infection. | Code indicating whether there is radiographic evidence of pnemonia without evidence of infection. | Did the patient have radiographic evidence of bilateral, multi-lobar infiltrates by chest x-ray or CT scan without evidence of an infection? | 1;2;1;2 | Yes;No;Yes;No | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2019-01-11 13:17:56.0 | Toxicity Form | Participant History and Family History | General Health History |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | TXXRADEV | |||||||||||||||||||||||||||
| C59115 | Hydroxyurea receive indicate code | HydroxyureaRcvIndCode | Code indicating whether the patient received hydroxyurea. | Code indicating whether the patient received hydroxyurea. | Did the patient receive Hydroxyurea during this reporting period? | 1;2;1;2 | Yes;No;Yes;No | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2019-01-16 12:48:41.0 | Toxicity Form | Participant History and Family History | General Health History |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | HUREC | |||||||||||||||||||||||||||
| C58975 | Etiology liver abnormality other indicate code other text | EtiolLivrAbnrmOthrIndCodeOTH | The free-text field related to 'Etiology liver abnormality other indicate code' specifying other text. | The free-text field related to 'Etiology liver abnormality other indicate code' specifying other text. | Specify other etiology | Alphanumeric | Adult;Pediatric | Proposed | 1.00 | 2019-01-04 14:09:08.0 | Toxicity Form | Participant History and Family History | General Health History | 100 |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | Acute GVHD Form (GVH) | GVHLIVRS | ||||||||||||||||||||||||||||
| C59094 | Liver biopsy infection result code | LivrBiopsyInfctnResultCode | Code for the result of the liver biopsy performed for infection. | Code for the result of the liver biopsy performed for infection. | Infection: biopsy results | 1;2;3;4 | Positive;Negative;Equivocal;Not done | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2019-01-04 14:12:38.0 | Toxicity Form | Participant History and Family History | General Health History |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | INFBIOP | |||||||||||||||||||||||||||
| C59059 | Cardiac arrhythmia grade | CardiacArrhythmiaGrade | Grade of cardiac arrhythmia exhibited by the patient. | Grade of cardiac arrhythmia exhibited by the patient. | Cardiac arrhythmia | 0;3;4;5 | Grades 0–2;Severe, medically significant, medical intervention indicated;Life-threatening consequences, hemodynamic compromise, 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 | Proposed | 1.00 | 2019-01-11 10:41:25.0 | Toxicity Form | Participant History and Family History | General Health History |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | CRDARRHY | ||||||||||||||||||||||||||
| C59105 | Transfusion related allergic reaction grade | TxfusnRelateAllergReactnGrade | Grade of the patient's allergic reaction related to blood transfusion | Grade of the patient's allergic reaction related to blood transfusion | Allergic 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 | Proposed | 1.00 | 2019-01-15 14:23:40.0 | Toxicity Form | Participant History and Family History | General Health History |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | ALRGCRXN | ||||||||||||||||||||||||||
| C59070 | Idiopathic pneumonia syndrome date | IPSDate | Date of idiopathic pneumonia syndrome | Date of idiopathic pneumonia syndrome | Date of IPS | Date or Date & Time | Adult;Pediatric | Proposed | 1.00 | 2019-01-11 13:20:38.0 | Toxicity Form | Participant History and Family History | General Health History |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | TXXIPSDT | |||||||||||||||||||||||||||||
| C59116 | Anemia grade | AnemiaGrade | Grade of anemia exhibited by the patient. | Grade of anemia exhibited by the patient. | Anemia | 0;3;4;5 | Grades 0–2;Hemoglobin <8.0–6.5 g/dL, <4.9–4.0 mmol/L, <80–65 g/L, transfusion 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 | Proposed | 1.00 | 2019-01-16 13:32:44.0 | Toxicity Form | Participant History and Family History | General Health History |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | ANEMIA | ||||||||||||||||||||||||||
| C58976 | Liver biopsy GVHD result code | LivrBiopsyGVHDResultCode | Code for the result of the liver biopsy performed for graft-versus-host disease (GVHD) | Code for the result of the liver biopsy performed for graft-versus-host disease (GVHD) | GVHD: biopsy results | 1;2;3;4 | Positive;Negative;Equivocal;Not done | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2019-01-04 14:12:38.0 | Toxicity Form | Participant History and Family History | General Health History |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Acute GVHD Form (GVH) | GVHLIVRB | |||||||||||||||||||||||||||
| C59095 | Liver biopsy other etiology result code | LivrBiopsyOthEtResultCode | Code for the result of the liver biopsy performed for other etiology. | Code for the result of the liver biopsy performed for other etiology. | Other etiology: biopsy results | 1;2;3;4 | Positive;Negative;Equivocal;Not done | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2019-01-04 14:12:38.0 | Toxicity Form | Participant History and Family History | General Health History |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | OTHBIOP | |||||||||||||||||||||||||||
| C59060 | Cardiac arrhythmia specify text | CardiacArrhythmiaSpcfyTxt | Text specifying the cardiac arrhythmia exhibited by the patient. | Text specifying the cardiac arrhythmia exhibited by the patient. | Specify arryhthmia | Alphanumeric | Adult;Pediatric | Proposed | 1.00 | 2019-01-11 10:46:51.0 | Toxicity Form | Participant History and Family History | General Health History | 100 |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | CRDARRSP |
