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This randomized clinical trial studies standard GVHD prophylaxis with tacrolimus and methotrexate compared to tacrolimus, mycophenolate mofetil and a reduced-dose methotrexate in patients with hematologic malignancies undergoing allogeneic hematopoietic cell transplant. Both mycophenolate mofetil and reduced-dose methotrexate, in combination with a calcineurin inhibitor, have been shown to be safe and effective in GVHD prevention with less toxicity than standard dose methotrexate. It is not yet known, however, whether this combination of mycophenolate mofetil and reduced-dose methotrexate with tacrolimus is more effective than tacrolimus and standard dose methotrexate in preventing GVHD.
Study Design This is a prospective randomized trial to determine the effectiveness of different doses of GVHD prophylaxis on mucositis, engraftment and aGVHD. Study consists of two study groups of 50 subjects each.
Group A will receive Tac and MTX (15 mg/m2 day +1, 10 mg/m2 day +3, +6, +11). Group B will receive Tac, Mini-dose MTX (5 mg/m2 on day +1, +3, +6) and MMF.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A (tacrolimus, methotrexate) | Active Comparator | Participants receive tacrolimus IV over 24 hours beginning on day -1 (or tacrolimus orally beginning on day -3) and then PO BID after engraftment with a taper from day 100 to day 180 (in the absence of GVHD). Patients also receive methotrexate IV on days 1, 3, 6, and 11. |
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| Group B (tacrolimus, methotrexate, mycophenolate mofetil) | Experimental | Patients receive tacrolimus as in group A and methotrexate (low dose) IV on days 1, 3, and 6. Patients also receive oral mycophenolate mofetil BID beginning on day 1, with a taper from day 45 to day 100 (in the absence of GVHD). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tacrolimus | Drug | Tacrolimus 0.03 mg/kg/day beginning day -1 or tacrolimus 0.03mg/kg/dose BID orally beginning on day -3. If Tac is administered intravenously, it will be given over 24 hours and will be converted to oral administration 2 times a day when the patient has engrafted and/or can tolerate oral medication. Levels of Tac will be obtained to maintain a recommended target serum level of 5-12 ng/mL |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Severe (Grade 3-4) Mucositis Graded According to the World Health Organization (WHO) Grading Scale | Participants (percentage of) will be graded three times per week through day 28 of the study. Incidence will be compared through Wilcoxon rank sum tests. The WHO grading scale for mucositis is scaled depending on the severity of mucositis symptoms, with a lower stage associated with a better outcome and greater stages associated with worse outcomes. The staging is as follows: Stage 0: None Stage 1 (mild): Oral soreness, erythema Stage 2 (moderate): Oral erythema, ulcers, solid diet tolerated Stage 3 (severe): Oral ulcers, liquid diet only Stage 4 (life-threatening): Oral alimentation impossible | Up to day 28 |
| Time to Neutrophil Engraftment | The number of days to reach a neutrophil count of greater than or equal to 500/ul for three consecutive laboratory values obtained on different days. The day of engraftment will be the first day of the three consecutive laboratory values. | Up to 28 days |
| Time to Platelet Engraftment | The number of days to reach a platelet count of greater than or equal to 20,000/ul for three consecutive laboratory values obtained on different days, independent of platelet transfusions the prior 7 days. The day of engraftment will be the first day of the three consecutive laboratory values. For cases of delayed engraftment beyond 28 days, results will be recorded once the participant engrafts. | The date the participant engrafts, up to 28 days |
| Cumulative Incidence of Participants With Acute GVHD | Acute GVHD by grade will be estimated using cumulative incidence methods and compared using the Gray test. A lower clinical grade and/or stage of GVHD corresponds to a better participant outcome and a higher grade corresponds to a worse participant outcome. Grading is as follows: Grade 0: No stage 1-4 of any organ Grade 1: Stage 1-2 skin without liver, upper GI, or lower GI involvement. Grade 2: Stage 3 rash and/or stage 1 liver and/or stage 1 upper GI and/or stage 1 lower GI. Grade 3: Stage 2-3 liver and/or stage 2-3 lower GI, with stage 0-3 skin and/or stage 0-1 upper GI. Grade 4: Stage 4 skin, liver, or lower GI involvement, with stage 0-1 upper GI. A greater stage of GVHD involves worsening end-organ involvement and worse participant outcomes based on the skin, liver, lower GI, and upper GI. |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Hospitalization | Hospital stay will be compared between patients in groups A and B using the Wilcoxon rank sum test. | Date of transplant to date of discharge, assessed up to 1 year |
| Percentage of Participants Using Total Parenteral Nutrition (TPN) Within 100 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Chimerism Results | Donor chimerism will be assessed by analysis of single-tandem repeats on whole marrow and in lymphocyte enriched or sorted CD3+ T cells and CD33+ granulocytes. Blood will be obtained for donor chimerism "Bone Marrow Engraftment analysis" at approximately 1, 2, 3, 6, 9 and 12 months or as clinically indicated. | Up to one year |
Inclusion Criteria:
Patients must have one of the following documented diseases:
Patients must be undergoing a myeloablative allogeneic hematopoietic cell transplant with one of the following conditioning regimens:
Busulfan (≥ 12.8 mg/kg IV or PO) and cyclophosphamide (≥ 120 mg/kg)
--- Busulfan dose may be adjusted according to pharmacokinetics targeting a daily AUC of 5000 μmol-min/L, per institution standard of practice.
Total body irradiation (TBI) (≥ 1200 cGy) and etoposide (60 mg/kg)
TBI (≥ 1200 cGy) and cyclophosphamide (120 mg/kg)
Patient must have achieved and be in complete morphologic remission prior to starting conditioning regimen
Patient's donor must be a related or unrelated human leukocyte antigen (HLA) 8/8 allele-level match (HLA-A, B, C and DRB1)
Adult patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; pediatric patients must have Lansky score ≥ 60%
Patients must have a life expectancy of 100 days
Patients must sign written informed consent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Betty Hamilton, MD | Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center | Cleveland | Ohio | 44195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37352262 | Derived | Hamilton BK, Rybicki LA, Li H, Lucas T, Corrigan D, Kalaycio M, Sobecks R, Hanna R, Rotz SJ, Dean RM, Gerds AT, Jagadeesh D, Brunstein C, Sauter CS, Copelan EA, Majhail NS. Tacrolimus/methotrexate vs tacrolimus/reduced-dose methotrexate/mycophenolate for graft-versus-host disease prevention. Blood Adv. 2023 Aug 22;7(16):4505-4513. doi: 10.1182/bloodadvances.2023010310. |
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Participants were recruited from local hospital from July 2014 thru July 2020
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A (Tacrolimus, Methotrexate) | Participants receive tacrolimus IV over 24 hours beginning on day -1 (or tacrolimus orally beginning on day -3) and then PO BID after engraftment with a taper from day 100 to day 180 (in the absence of GVHD). Patients also receive methotrexate IV on days 1, 3, 6, and 11. tacrolimus: Tacrolimus 0.03 mg/kg/day beginning day -1 or tacrolimus 0.03mg/kg/dose BID orally beginning on day -3. If Tac is administered intravenously, it will be given over 24 hours and will be converted to oral administration 2 times a day when the patient has engrafted and/or can tolerate oral medication. Levels of Tac will be obtained to maintain a recommended target serum level of 5-12 ng/mL methotrexate: MTX 15mg/m2 IV on day +1, followed by 10mg/m2 on day +3, +6, +11. If patient < 10 kg then MTX will be given at 0.5 mg/kg IV on day +1. Then MTX will be given at 0.33 mg/kg on days +3, +6 and +11. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 28, 2022 |
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| methotrexate | Drug | MTX 15mg/m2 IV on day +1, followed by 10mg/m2 on day +3, +6, +11. If patient < 10 kg then MTX will be given at 0.5 mg/kg IV on day +1. Then MTX will be given at 0.33 mg/kg on days +3, +6 and +11. |
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| Mycophenolate mofetil | Drug | Patients will receive Mycophenolate beginning on day +1. Patients >40 kg will receive Mycophenolate 1000 mg twice a day. Mycophenolate should be given orally twice a day. IV formulation may be used if the patient cannot tolerate oral route. Patients < 40 kg will receive MMF 45 mg/kg/day (15 mg/kg three times a day). MMF may be given orally or intravenously as per institutional protocol |
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| Methotrexate (low dose) | Drug | MTX 5mg/m2 IV on day +1, +3, +6. If patient<10 kg MTX will be given at 0.17 mg/kg on day +1, +3, and +6. |
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| Day 7- Day 100 |
TPN use will be compared using the Chi-square test. |
| Up to day 100 |
| Overall Survival | Estimated using the Kaplan-Meier method and compared between the 2 groups using the log-rank test. | Up to 1 year |
| Progression-free Survival | Estimated using the Kaplan-Meier method and compared between the 2 groups using the log-rank test. | Up to 1 year |
| Incidence of Chronic GVHD | Chronic GVHD will be graded as mild, moderate, or severe based on the National Institutes of Health Consensus Development Project. The type and duration of immunosuppressive treatment given for cGVHD will be recorded. Mild grades are associated with a better participant outcome and severe corresponds to a worse participant outcome. Grading is as follows: Mild: 1 or 2 organs involved with no more than score 1 plus Lung score 0 Moderate: 3 or more organs involved with no more than score 1 OR At least 1 organ (not lung) with a score of 2 OR Lung score 1 Severe: At least 1 organ with a score of 3 OR Lung score of 2 or 3 Organ scores can range from 0 to 3, with 0 being no symptoms on the target organ and a better participant outcome while a score of 3 correlates to severe symptoms on the target organ and worse participant outcomes. Potential target organs include: skin, mouth, eyes, GI tract, liver, lungs, joint /fascia, and genital tract | at 6 months |
| Incidence of Chronic GVHD | Chronic GVHD will be graded as mild, moderate, or severe based on the National Institutes of Health Consensus Development Project. The type and duration of immunosuppressive treatment given for cGVHD will be recorded. Mild grades are associated with a better participant outcome and severe corresponds to a worse participant outcome. Grading is as follows: Mild: 1 or 2 organs involved with no more than score 1 plus Lung score 0 Moderate: 3 or more organs involved with no more than score 1 OR At least 1 organ (not lung) with a score of 2 OR Lung score 1 Severe: At least 1 organ with a score of 3 OR Lung score of 2 or 3 Organ scores can range from 0 to 3, with 0 being no symptoms on the target organ and a better participant outcome while a score of 3 correlates to severe symptoms on the target organ and worse participant outcomes. Potential target organs include: skin, mouth, eyes, GI tract, liver, lungs, joint /fascia, and genital tract | at 12 months |
| Length of Time on Continuous Infusion Narcotics | Start and stop dates for the need of continuous IV infusion of narcotics for severe mucositis pain will be recorded. Time on IV infusion will be compared between patients in groups A and B using the Wilcoxon rank sum test. | up to +28 day |
| Incidence of Infection | 100-day incidence of infection will be compared using a the Gray test. | Up to day +100 |
| Incidence of Hepatotoxicity as Measured by Bilirubin | 100-day incidence of hepatotoxicity will be compared using a Gray test. Median and range of largest total bilirubin (mg/dL), | Up to day +100 |
| Incidence of Hepatotoxicity as Measured by Elevated Liver Enzymes | 100-day incidence of hepatotoxicity will be compared using a Gray test. Percentage of patients with elevated Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), and alkaline phosphatase and a 95% confidence interval | Up to day +100 |
| Incidence of Hepatotoxicity as Measured by Veno-occlusive Disease (VOD) | 100-day incidence of hepatotoxicity will be compared using the Gray test. Percentage of patients with VOD and 95% confidence interval | Up to day +100 |
| Incidence of Nephrotoxicity | 100-day incidence of nephrotoxicity will be compared using a Chi-squared test. Percentage of patients requiring dialysis and those with elevated creatinine using a 95% confidence interval | Up to day +100 |
| Incidence of Pulmonary Toxicity Measured by Pulmonary Hemorrhage | 180-day incidence of pulmonary toxicity will be compared using the Gray test. Percentage of patients with pulmonary hemorrhage and 95% confidence interval | Up to day +180 |
| Incidence of Pulmonary Toxicity Measured by Pulmonary Edema | 180-day incidence of pulmonary toxicity will be compared using the Gray test. Percentage of patients with pulmonary edema and 95% confidence interval | Up to day +180 |
| Incidence of Pulmonary Toxicity Measured by Respiratory Failure | 180-day incidence of pulmonary toxicity will be compared using the Gray test. Percentage of patients with respiratory failure and 95% confidence interval | Up to day +180 |
| FG001 | Group B (Tacrolimus, Methotrexate, Mycophenolate Mofetil) | Patients receive tacrolimus as in group A and methotrexate (low dose) IV on days 1, 3, and 6. Patients also receive oral mycophenolate mofetil BID beginning on day 1, with a taper from day 45 to day 100 (in the absence of GVHD). tacrolimus: Tacrolimus 0.03 mg/kg/day beginning day -1 or tacrolimus 0.03mg/kg/dose BID orally beginning on day -3. If Tac is administered intravenously, it will be given over 24 hours and will be converted to oral administration 2 times a day when the patient has engrafted and/or can tolerate oral medication. Levels of Tac will be obtained to maintain a recommended target serum level of 5-12 ng/mL Mycophenolate mofetil: Patients will receive Mycophenolate beginning on day +1. Patients >40 kg will receive Mycophenolate 1000 mg twice a day. Mycophenolate should be given orally twice a day. IV formulation may be used if the patient cannot tolerate oral route. Patients < 40 kg will receive MMF 45 mg/kg/day (15 mg/kg three times a day). MMF may be given orally or intravenously as per institutional protocol Methotrexate (low dose): MTX 5mg/m2 IV on day +1, +3, +6. If patient<10 kg MTX will be given at 0.17 mg/kg on day +1, +3, and +6. |
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| NOT COMPLETED |
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All participants that went on study
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| ID | Title | Description |
|---|---|---|
| BG000 | Group A (Tacrolimus, Methotrexate) | Participants receive tacrolimus IV over 24 hours beginning on day -1 (or tacrolimus orally beginning on day -3) and then PO BID after engraftment with a taper from day 100 to day 180 (in the absence of GVHD). Patients also receive methotrexate IV on days 1, 3, 6, and 11. tacrolimus: Tacrolimus 0.03 mg/kg/day beginning day -1 or tacrolimus 0.03mg/kg/dose BID orally beginning on day -3. If Tac is administered intravenously, it will be given over 24 hours and will be converted to oral administration 2 times a day when the patient has engrafted and/or can tolerate oral medication. Levels of Tac will be obtained to maintain a recommended target serum level of 5-12 ng/mL methotrexate: MTX 15mg/m2 IV on day +1, followed by 10mg/m2 on day +3, +6, +11. If patient < 10 kg then MTX will be given at 0.5 mg/kg IV on day +1. Then MTX will be given at 0.33 mg/kg on days +3, +6 and +11. |
| BG001 | Group B (Tacrolimus, Methotrexate, Mycophenolate Mofetil) | Patients receive tacrolimus as in group A and methotrexate (low dose) IV on days 1, 3, and 6. Patients also receive oral mycophenolate mofetil BID beginning on day 1, with a taper from day 45 to day 100 (in the absence of GVHD). tacrolimus: Tacrolimus 0.03 mg/kg/day beginning day -1 or tacrolimus 0.03mg/kg/dose BID orally beginning on day -3. If Tac is administered intravenously, it will be given over 24 hours and will be converted to oral administration 2 times a day when the patient has engrafted and/or can tolerate oral medication. Levels of Tac will be obtained to maintain a recommended target serum level of 5-12 ng/mL Mycophenolate mofetil: Patients will receive Mycophenolate beginning on day +1. Patients >40 kg will receive Mycophenolate 1000 mg twice a day. Mycophenolate should be given orally twice a day. IV formulation may be used if the patient cannot tolerate oral route. Patients < 40 kg will receive MMF 45 mg/kg/day (15 mg/kg three times a day). MMF may be given orally or intravenously as per institutional protocol Methotrexate (low dose): MTX 5mg/m2 IV on day +1, +3, +6. If patient<10 kg MTX will be given at 0.17 mg/kg on day +1, +3, and +6. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Percentage of Severe (Grade 3-4) Mucositis Graded According to the World Health Organization (WHO) Grading Scale | Participants (percentage of) will be graded three times per week through day 28 of the study. Incidence will be compared through Wilcoxon rank sum tests. The WHO grading scale for mucositis is scaled depending on the severity of mucositis symptoms, with a lower stage associated with a better outcome and greater stages associated with worse outcomes. The staging is as follows: Stage 0: None Stage 1 (mild): Oral soreness, erythema Stage 2 (moderate): Oral erythema, ulcers, solid diet tolerated Stage 3 (severe): Oral ulcers, liquid diet only Stage 4 (life-threatening): Oral alimentation impossible | participants that completed study | Posted | Number | percentage of participants | Up to day 28 |
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| Primary | Time to Neutrophil Engraftment | The number of days to reach a neutrophil count of greater than or equal to 500/ul for three consecutive laboratory values obtained on different days. The day of engraftment will be the first day of the three consecutive laboratory values. | participants that were able to engraft neutrophils | Posted | Median | Full Range | days | Up to 28 days |
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| Primary | Time to Platelet Engraftment | The number of days to reach a platelet count of greater than or equal to 20,000/ul for three consecutive laboratory values obtained on different days, independent of platelet transfusions the prior 7 days. The day of engraftment will be the first day of the three consecutive laboratory values. For cases of delayed engraftment beyond 28 days, results will be recorded once the participant engrafts. | participants that were able to engraft platelets | Posted | Median | Full Range | days | The date the participant engrafts, up to 28 days |
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| Primary | Cumulative Incidence of Participants With Acute GVHD | Acute GVHD by grade will be estimated using cumulative incidence methods and compared using the Gray test. A lower clinical grade and/or stage of GVHD corresponds to a better participant outcome and a higher grade corresponds to a worse participant outcome. Grading is as follows: Grade 0: No stage 1-4 of any organ Grade 1: Stage 1-2 skin without liver, upper GI, or lower GI involvement. Grade 2: Stage 3 rash and/or stage 1 liver and/or stage 1 upper GI and/or stage 1 lower GI. Grade 3: Stage 2-3 liver and/or stage 2-3 lower GI, with stage 0-3 skin and/or stage 0-1 upper GI. Grade 4: Stage 4 skin, liver, or lower GI involvement, with stage 0-1 upper GI. A greater stage of GVHD involves worsening end-organ involvement and worse participant outcomes based on the skin, liver, lower GI, and upper GI. | participants who completed the study | Posted | Number | 95% Confidence Interval | percentage of participants | Day 7- Day 100 |
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| Secondary | Length of Hospitalization | Hospital stay will be compared between patients in groups A and B using the Wilcoxon rank sum test. | participants who completed the study | Posted | Median | Full Range | days | Date of transplant to date of discharge, assessed up to 1 year |
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| Secondary | Percentage of Participants Using Total Parenteral Nutrition (TPN) Within 100 Days | TPN use will be compared using the Chi-square test. | participants who completed the study | Posted | Number | percentage of participants | Up to day 100 |
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| Secondary | Overall Survival | Estimated using the Kaplan-Meier method and compared between the 2 groups using the log-rank test. | participants who completed the study | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 1 year |
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| Secondary | Progression-free Survival | Estimated using the Kaplan-Meier method and compared between the 2 groups using the log-rank test. | participants who completed the study | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 1 year |
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| Secondary | Incidence of Chronic GVHD | Chronic GVHD will be graded as mild, moderate, or severe based on the National Institutes of Health Consensus Development Project. The type and duration of immunosuppressive treatment given for cGVHD will be recorded. Mild grades are associated with a better participant outcome and severe corresponds to a worse participant outcome. Grading is as follows: Mild: 1 or 2 organs involved with no more than score 1 plus Lung score 0 Moderate: 3 or more organs involved with no more than score 1 OR At least 1 organ (not lung) with a score of 2 OR Lung score 1 Severe: At least 1 organ with a score of 3 OR Lung score of 2 or 3 Organ scores can range from 0 to 3, with 0 being no symptoms on the target organ and a better participant outcome while a score of 3 correlates to severe symptoms on the target organ and worse participant outcomes. Potential target organs include: skin, mouth, eyes, GI tract, liver, lungs, joint /fascia, and genital tract | participants who completed the study | Posted | Number | 95% Confidence Interval | percentage of participants | at 6 months |
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| Secondary | Incidence of Chronic GVHD | Chronic GVHD will be graded as mild, moderate, or severe based on the National Institutes of Health Consensus Development Project. The type and duration of immunosuppressive treatment given for cGVHD will be recorded. Mild grades are associated with a better participant outcome and severe corresponds to a worse participant outcome. Grading is as follows: Mild: 1 or 2 organs involved with no more than score 1 plus Lung score 0 Moderate: 3 or more organs involved with no more than score 1 OR At least 1 organ (not lung) with a score of 2 OR Lung score 1 Severe: At least 1 organ with a score of 3 OR Lung score of 2 or 3 Organ scores can range from 0 to 3, with 0 being no symptoms on the target organ and a better participant outcome while a score of 3 correlates to severe symptoms on the target organ and worse participant outcomes. Potential target organs include: skin, mouth, eyes, GI tract, liver, lungs, joint /fascia, and genital tract | participants who completed the study | Posted | Number | 95% Confidence Interval | percentage of participants | at 12 months |
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| Secondary | Length of Time on Continuous Infusion Narcotics | Start and stop dates for the need of continuous IV infusion of narcotics for severe mucositis pain will be recorded. Time on IV infusion will be compared between patients in groups A and B using the Wilcoxon rank sum test. | Participants that were on continuous infusion narcotics | Posted | Median | Full Range | days | up to +28 day |
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| Secondary | Incidence of Infection | 100-day incidence of infection will be compared using a the Gray test. | participants that completed the study | Posted | Number | 95% Confidence Interval | percentage of participants | Up to day +100 |
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| Secondary | Incidence of Hepatotoxicity as Measured by Bilirubin | 100-day incidence of hepatotoxicity will be compared using a Gray test. Median and range of largest total bilirubin (mg/dL), | participants that completed the study | Posted | Median | Full Range | mg/dL | Up to day +100 |
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| Secondary | Incidence of Hepatotoxicity as Measured by Elevated Liver Enzymes | 100-day incidence of hepatotoxicity will be compared using a Gray test. Percentage of patients with elevated Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), and alkaline phosphatase and a 95% confidence interval | participants that completed the study | Posted | Number | 95% Confidence Interval | percentage of participants | Up to day +100 |
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| Secondary | Incidence of Hepatotoxicity as Measured by Veno-occlusive Disease (VOD) | 100-day incidence of hepatotoxicity will be compared using the Gray test. Percentage of patients with VOD and 95% confidence interval | participants that completed the study | Posted | Number | 95% Confidence Interval | percentage of participants | Up to day +100 |
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| Secondary | Incidence of Nephrotoxicity | 100-day incidence of nephrotoxicity will be compared using a Chi-squared test. Percentage of patients requiring dialysis and those with elevated creatinine using a 95% confidence interval | participants that completed the study | Posted | Number | 95% Confidence Interval | percentage of participants | Up to day +100 |
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| Secondary | Incidence of Pulmonary Toxicity Measured by Pulmonary Hemorrhage | 180-day incidence of pulmonary toxicity will be compared using the Gray test. Percentage of patients with pulmonary hemorrhage and 95% confidence interval | participants that completed the study | Posted | Number | 95% Confidence Interval | percentage of participants | Up to day +180 |
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| Secondary | Incidence of Pulmonary Toxicity Measured by Pulmonary Edema | 180-day incidence of pulmonary toxicity will be compared using the Gray test. Percentage of patients with pulmonary edema and 95% confidence interval | participants that completed the study | Posted | Number | 95% Confidence Interval | percentage of participants | Up to day +180 |
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| Secondary | Incidence of Pulmonary Toxicity Measured by Respiratory Failure | 180-day incidence of pulmonary toxicity will be compared using the Gray test. Percentage of patients with respiratory failure and 95% confidence interval | participants that completed the study | Posted | Number | 95% Confidence Interval | percentage of participants | Up to day +180 |
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| Other Pre-specified | Chimerism Results | Donor chimerism will be assessed by analysis of single-tandem repeats on whole marrow and in lymphocyte enriched or sorted CD3+ T cells and CD33+ granulocytes. Blood will be obtained for donor chimerism "Bone Marrow Engraftment analysis" at approximately 1, 2, 3, 6, 9 and 12 months or as clinically indicated. | Not Posted | Up to one year | Participants |
Adverse event data were collected through one year post transplant
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group A (Tacrolimus, Methotrexate) | Participants receive tacrolimus IV over 24 hours beginning on day -1 (or tacrolimus orally beginning on day -3) and then PO BID after engraftment with a taper from day 100 to day 180 (in the absence of GVHD). Patients also receive methotrexate IV on days 1, 3, 6, and 11. tacrolimus: Tacrolimus 0.03 mg/kg/day beginning day -1 or tacrolimus 0.03mg/kg/dose BID orally beginning on day -3. If Tac is administered intravenously, it will be given over 24 hours and will be converted to oral administration 2 times a day when the patient has engrafted and/or can tolerate oral medication. Levels of Tac will be obtained to maintain a recommended target serum level of 5-12 ng/mL methotrexate: MTX 15mg/m2 IV on day +1, followed by 10mg/m2 on day +3, +6, +11. If patient < 10 kg then MTX will be given at 0.5 mg/kg IV on day +1. Then MTX will be given at 0.33 mg/kg on days +3, +6 and +11. | 25 | 50 | 13 | 50 | 49 | 50 |
| EG001 | Group B (Tacrolimus, Methotrexate, Mycophenolate Mofetil) | Patients receive tacrolimus as in group A and methotrexate (low dose) IV on days 1, 3, and 6. Patients also receive oral mycophenolate mofetil BID beginning on day 1, with a taper from day 45 to day 100 (in the absence of GVHD). tacrolimus: Tacrolimus 0.03 mg/kg/day beginning day -1 or tacrolimus 0.03mg/kg/dose BID orally beginning on day -3. If Tac is administered intravenously, it will be given over 24 hours and will be converted to oral administration 2 times a day when the patient has engrafted and/or can tolerate oral medication. Levels of Tac will be obtained to maintain a recommended target serum level of 5-12 ng/mL Mycophenolate mofetil: Patients will receive Mycophenolate beginning on day +1. Patients >40 kg will receive Mycophenolate 1000 mg twice a day. Mycophenolate should be given orally twice a day. IV formulation may be used if the patient cannot tolerate oral route. Patients < 40 kg will receive MMF 45 mg/kg/day (15 mg/kg three times a day). MMF may be given orally or intravenously as per institutional protocol Methotrexate (low dose): MTX 5mg/m2 IV on day +1, +3, +6. If patient<10 kg MTX will be given at 0.17 mg/kg on day +1, +3, and +6. | 15 | 51 | 3 | 51 | 47 | 51 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute kidney injury | Renal and urinary disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Adult respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Encephalopathy | Hepatobiliary disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Escherichia Coli (E-Coli) | Infections and infestations | CTCAE v4.0 | Systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Idiopathic pneumonia syndrome | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | CTCAE v4.0 | Systematic Assessment |
| |
| Upper respiratory infection | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Lung infection | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Acidosis | Metabolism and nutrition disorders | CTCAE v4.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| abdominal pain | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| diarrhea | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| encephalopathy | Nervous system disorders | CTCAE v4.0 | Systematic Assessment |
| |
| febrile neutropenia | Blood and lymphatic system disorders | CTCAE v4.0 | Systematic Assessment |
| |
| fever | General disorders | CTCAE v4.0 | Systematic Assessment |
| |
| hyperglycemia | Metabolism and nutrition disorders | CTCAE v4.0 | Systematic Assessment |
| |
| hypertension | Vascular disorders | CTCAE v4.0 | Systematic Assessment |
| |
| hypokalemia | Metabolism and nutrition disorders | CTCAE v4.0 | Systematic Assessment |
| |
| hypomagnesemia | Metabolism and nutrition disorders | CTCAE v4.0 | Systematic Assessment |
| |
| hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| nausea | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| peripheral motor neuropathy | Nervous system disorders | CTCAE v4.0 | Systematic Assessment |
| |
| peripheral sensory neuropathy | Nervous system disorders | CTCAE v4.0 | Systematic Assessment |
| |
| respiratory failure | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| sepsis | Infections and infestations | CTCAE v4.0 | Systematic Assessment |
| |
| tremor | Nervous system disorders | CTCAE v4.0 | Systematic Assessment |
| |
| vomiting | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Infections and infestations - Other, specify: BK virus | Infections and infestations | CTCAE v4.0 | Systematic Assessment |
| |
| Infections and infestations - Other, specify: Candida krusei | Infections and infestations | CTCAE v4.0 | Systematic Assessment |
| |
| Infections and infestations - Other, specify: Clostridioides difficile | Infections and infestations | CTCAE v4.0 | Systematic Assessment |
| |
| Infections and infestations - Other, specify: Cellulitis | Infections and infestations | CTCAE v4.0 | Systematic Assessment |
| |
| Infections and infestations - Other, specify: Citrobacter freundii | Infections and infestations | CTCAE v4.0 | Systematic Assessment |
| |
| Infections and infestations - Other, specify: Cytomegalovirus | Infections and infestations | CTCAE v4.0 | Systematic Assessment |
| |
| Infections and infestations - Other, specify: Coronavirus HKU1 | Infections and infestations | CTCAE v4.0 | Systematic Assessment |
| |
| Infections and infestations - Other, specify: COVID-19 | Infections and infestations | CTCAE v4.0 | Systematic Assessment |
| |
| Infections and infestations - Other, specify: Escherichia coli | Infections and infestations | CTCAE v4.0 | Systematic Assessment |
| |
| Infections and infestations - Other, specify: Enterobacter cloacae complex | Infections and infestations | CTCAE v4.0 | Systematic Assessment |
| |
| Infections and infestations - Other, specify: Enterococcus faecalis | Infections and infestations | CTCAE v4.0 | Systematic Assessment |
| |
| Infections and infestations - Other, specify: Herpes stomatitis | Infections and infestations | CTCAE v4.0 | Systematic Assessment |
| |
| Infections and infestations - Other, specify: Herpes zoster | Infections and infestations | CTCAE v4.0 | Systematic Assessment |
| |
| Infections and infestations - Other, specify: Influenza A | Infections and infestations | CTCAE v4.0 | Systematic Assessment |
| |
| Infections and infestations - Other, specify: Influenza B | Infections and infestations | CTCAE v4.0 | Systematic Assessment |
| |
| Infections and infestations - Other, specify: Klebsiella oxytoca | Infections and infestations | CTCAE v4.0 | Systematic Assessment |
| |
| Infections and infestations - Other, specify: Klebsiella pneumoniae | Infections and infestations | CTCAE v4.0 | Systematic Assessment |
| |
| Infections and infestations - Other, specify: Methicillin-resistant Staphylococcus aureus | Infections and infestations | CTCAE v4.0 | Systematic Assessment |
| |
| Infections and infestations - Other, specify: Methicillin-resistant Staphylococcus epidermidis | Infections and infestations | CTCAE v4.0 | Systematic Assessment |
| |
| Infections and infestations - Other, specify: Pulmonary aspergillosis | Infections and infestations | CTCAE v4.0 | Systematic Assessment |
| |
| Infections and infestations - Other, specify: Pulmonary mucormycosis | Infections and infestations | CTCAE v4.0 | Systematic Assessment |
| |
| Infections and infestations - Other, specify: Raoultella species | Infections and infestations | CTCAE v4.0 | Systematic Assessment |
| |
| Infections and infestations - Other, specify: Rhinovirus | Infections and infestations | CTCAE v4.0 | Systematic Assessment |
| |
| Infections and infestations - Other, specify: Respiratory syncytial virus | Infections and infestations | CTCAE v4.0 | Systematic Assessment |
| |
| Infections and infestations - Other, specify: Sphingomonas (pseudomonas) paucimobilis | Infections and infestations | CTCAE v4.0 | Systematic Assessment |
| |
| Infections and infestations - Other, specify: Staphylococcus aureus pneumonia | Infections and infestations | CTCAE v4.0 | Systematic Assessment |
| |
| Infections and infestations - Other, specify: Staphylococcus epidermidis | Infections and infestations | CTCAE v4.0 | Systematic Assessment |
| |
| Infections and infestations - Other, specify: Streptococcus mitis | Infections and infestations | CTCAE v4.0 | Systematic Assessment |
| |
| Infections and infestations - Other, specify: Streptococcus mitis oralis | Infections and infestations | CTCAE v4.0 | Systematic Assessment |
| |
| Infections and infestations - Other, specify: Thrush | Infections and infestations | CTCAE v4.0 | Systematic Assessment |
| |
| urinary tract infection | Infections and infestations | CTCAE v4.0 | Systematic Assessment |
| |
| Infections and infestations - Other, specify: Varicella zoster | Infections and infestations | CTCAE v4.0 | Systematic Assessment |
| |
| Infections and infestations - Other, specify: Vancomycin-resistant enterococci | Infections and infestations | CTCAE v4.0 | Systematic Assessment |
| |
| catheter related infection | Infections and infestations | CTCAE v4.0 | Systematic Assessment |
| |
| abdominal distension | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| acute kidney injury | Renal and urinary disorders | CTCAE v4.0 | Systematic Assessment |
| |
| adult respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| agitation | Psychiatric disorders | CTCAE v4.0 | Systematic Assessment |
| |
| allergic reaction | Immune system disorders | CTCAE v4.0 | Systematic Assessment |
| |
| allergic rhinitis | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| alopecia | Skin and subcutaneous tissue disorders | CTCAE v4.0 | Systematic Assessment |
| |
| anal fistula | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| anal pain | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| anal ulcer | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| anemia | Blood and lymphatic system disorders | CTCAE v4.0 | Systematic Assessment |
| |
| anorexia | Metabolism and nutrition disorders | CTCAE v4.0 | Systematic Assessment |
| |
| anxiety | Psychiatric disorders | CTCAE v4.0 | Systematic Assessment |
| |
| arthralgia | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | Systematic Assessment |
| |
| atelectasis | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| atrial fibrillation | Cardiac disorders | CTCAE v4.0 | Systematic Assessment |
| |
| avascular necrosis | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | Systematic Assessment |
| |
| back pain | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | Systematic Assessment |
| |
| bladder infection | Infections and infestations | CTCAE v4.0 | Systematic Assessment |
| |
| bloating | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| blurred vision | Eye disorders | CTCAE v4.0 | Systematic Assessment |
| |
| bone pain | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | Systematic Assessment |
| |
| cardiac arrest | Cardiac disorders | CTCAE v4.0 | Systematic Assessment |
| |
| chills | General disorders | CTCAE v4.0 | Systematic Assessment |
| |
| cholecystitis | Hepatobiliary disorders | CTCAE v4.0 | Systematic Assessment |
| |
| cholesterol high | Investigations | CTCAE v4.0 | Systematic Assessment |
| |
| colitis | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| confusion | Psychiatric disorders | CTCAE v4.0 | Systematic Assessment |
| |
| conjunctivitis | Eye disorders | CTCAE v4.0 | Systematic Assessment |
| |
| constipation | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| cough | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| CPK increased | Investigations | CTCAE v4.0 | Systematic Assessment |
| |
| dehydration | Metabolism and nutrition disorders | CTCAE v4.0 | Systematic Assessment |
| |
| delirium | Psychiatric disorders | CTCAE v4.0 | Systematic Assessment |
| |
| depressed level of consciousness | Nervous system disorders | CTCAE v4.0 | Systematic Assessment |
| |
| depression | Psychiatric disorders | CTCAE v4.0 | Systematic Assessment |
| |
| dizziness | Nervous system disorders | CTCAE v4.0 | Systematic Assessment |
| |
| dry eye | Eye disorders | CTCAE v4.0 | Systematic Assessment |
| |
| dry mouth | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| dry skin | Skin and subcutaneous tissue disorders | CTCAE v4.0 | Systematic Assessment |
| |
| dysesthesia | Nervous system disorders | CTCAE v4.0 | Systematic Assessment |
| |
| dysgeusia | Nervous system disorders | CTCAE v4.0 | Systematic Assessment |
| |
| dyspareunia | Reproductive system and breast disorders | CTCAE v4.0 | Systematic Assessment |
| |
| dyspepsia | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| dysphagia | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| ear pain | Ear and labyrinth disorders | CTCAE v4.0 | Systematic Assessment |
| |
| edema cerebral | Nervous system disorders | CTCAE v4.0 | Systematic Assessment |
| |
| edema face | General disorders | CTCAE v4.0 | Systematic Assessment |
| |
| edema limbs | General disorders | CTCAE v4.0 | Systematic Assessment |
| |
| electrocardiogram QT corrected interval prolonged | Investigations | CTCAE v4.0 | Systematic Assessment |
| |
| enterocolitis | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| erectile dysfunction | Reproductive system and breast disorders | CTCAE v4.0 | Systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | CTCAE v4.0 | Systematic Assessment |
| |
| FATIGUE | General disorders | CTCAE v4.0 | Systematic Assessment |
| |
| FECAL INCONTINENCE | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| FLANK PAIN | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | Systematic Assessment |
| |
| FLATULENCE | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| FLOATERS | Eye disorders | CTCAE v4.0 | Systematic Assessment |
| |
| FLUSHING | Vascular disorders | CTCAE v4.0 | Systematic Assessment |
| |
| FORCED EXPIRATORY VOLUME DECREASED | Investigations | CTCAE v4.0 | Systematic Assessment |
| |
| FRACTURE | Injury, poisoning and procedural complications | CTCAE v4.0 | Systematic Assessment |
| |
| GAIT DISTURBANCE | General disorders | CTCAE v4.0 | Systematic Assessment |
| |
| GASTRIC ULCER | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| GASTRITIS | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| GASTROPARESIS | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| GENITAL EDEMA | Reproductive system and breast disorders | CTCAE v4.0 | Systematic Assessment |
| |
| gastroesophageal reflux disease | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| GYNECOMASTIA | Reproductive system and breast disorders | CTCAE v4.0 | Systematic Assessment |
| |
| HALLUCINATIONS | Psychiatric disorders | CTCAE v4.0 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | CTCAE v4.0 | Systematic Assessment |
| |
| HEMATOMA | Vascular disorders | CTCAE v4.0 | Systematic Assessment |
| |
| HEMATURIA | Renal and urinary disorders | CTCAE v4.0 | Systematic Assessment |
| |
| HEMOLYSIS | Blood and lymphatic system disorders | CTCAE v4.0 | Systematic Assessment |
| |
| HEMORRHOIDAL HEMORRHAGE | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| HEMORRHOIDS | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| HEPATIC FAILURE | Hepatobiliary disorders | CTCAE v4.0 | Systematic Assessment |
| |
| HICCUPS | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| HOARSENESS | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| HOT FLASHES | Vascular disorders | CTCAE v4.0 | Systematic Assessment |
| |
| HYDROCEPHALUS | Nervous system disorders | CTCAE v4.0 | Systematic Assessment |
| |
| HYPERCALCEMIA | Metabolism and nutrition disorders | CTCAE v4.0 | Systematic Assessment |
| |
| HYPERKALEMIA | Metabolism and nutrition disorders | CTCAE v4.0 | Systematic Assessment |
| |
| HYPERNATREMIA | Metabolism and nutrition disorders | CTCAE v4.0 | Systematic Assessment |
| |
| HYPOCALCEMIA | Metabolism and nutrition disorders | CTCAE v4.0 | Systematic Assessment |
| |
| HYPOGLYCEMIA | Metabolism and nutrition disorders | CTCAE v4.0 | Systematic Assessment |
| |
| HYPONATREMIA | Metabolism and nutrition disorders | CTCAE v4.0 | Systematic Assessment |
| |
| HYPOPHOSPHATEMIA | Metabolism and nutrition disorders | CTCAE v4.0 | Systematic Assessment |
| |
| HYPOTENSION | Vascular disorders | CTCAE v4.0 | Systematic Assessment |
| |
| HYPOTHERMIA | General disorders | CTCAE v4.0 | Systematic Assessment |
| |
| INFUSION RELATED REACTION | General disorders | CTCAE v4.0 | Systematic Assessment |
| |
| INR INCREASED | Investigations | CTCAE v4.0 | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | CTCAE v4.0 | Systematic Assessment |
| |
| IRRITABILITY | General disorders | CTCAE v4.0 | Systematic Assessment |
| |
| joint effusion | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Reproductive system and breast disorders - Other, specify: LABIAL PAIN | Reproductive system and breast disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Reproductive system and breast disorders - Other, specify: LABIAL ULCER | Reproductive system and breast disorders | CTCAE v4.0 | Systematic Assessment |
| |
| ACIDOSIS | Metabolism and nutrition disorders | CTCAE v4.0 | Systematic Assessment |
| |
| LARYNGEAL EDEMA | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| LARYNGITIS | Infections and infestations | CTCAE v4.0 | Systematic Assessment |
| |
| Nervous system disorders - Other, specify: INTRACEREBRAL HEMORRHAGE | Nervous system disorders | CTCAE v4.0 | Systematic Assessment |
| |
| LETHARGY | Nervous system disorders | CTCAE v4.0 | Systematic Assessment |
| |
| LEUKOCYTOSIS | Blood and lymphatic system disorders | CTCAE v4.0 | Systematic Assessment |
| |
| LIBIDO DECREASED | Psychiatric disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Endocrine disorders - Other, specify: testosterone deficiency | Endocrine disorders | CTCAE v4.0 | Systematic Assessment |
| |
| LYMPHOCYTE COUNT DECREASED | Investigations | CTCAE v4.0 | Systematic Assessment |
| |
| Blood and lymphatic system disorders - Other, specify: MACROCYTIC ANEMIA | Blood and lymphatic system disorders | CTCAE v4.0 | Systematic Assessment |
| |
| RASH MACULO-PAPULAR | Skin and subcutaneous tissue disorders | CTCAE v4.0 | Systematic Assessment |
| |
| MALAISE | General disorders | CTCAE v4.0 | Systematic Assessment |
| |
| MANIA | Psychiatric disorders | CTCAE v4.0 | Systematic Assessment |
| |
| MEMORY IMPAIRMENT | Nervous system disorders | CTCAE v4.0 | Systematic Assessment |
| |
| ALKALOSIS | Metabolism and nutrition disorders | CTCAE v4.0 | Systematic Assessment |
| |
| MITRAL VALVE DISEASE | Cardiac disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Psychiatric disorders - Other, specify: MOOD CHANGES | Psychiatric disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Musculoskeletal and connective tissue disorders - Other, specify: MUSCLE CRAMP | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | Systematic Assessment |
| |
| MUSCLE WEAKNESS LEFT-SIDED | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | Systematic Assessment |
| |
| MUSCLE WEAKNESS LOWER LIMB | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Musculoskeletal and connective tissue disorders - Other, specify: MYOCLONUS | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | Systematic Assessment |
| |
| NASAL CONGESTION | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Respiratory, thoracic and mediastinal disorders - Other, specify: NASAL DRYNESS | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| NECK EDEMA | General disorders | CTCAE v4.0 | Systematic Assessment |
| |
| NECK PAIN | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | Systematic Assessment |
| |
| NEUTROPHIL COUNT DECREASED | Investigations | CTCAE v4.0 | Systematic Assessment |
| |
| Skin and subcutaneous tissue disorders - Other, specify: NIGHT SWEATS | Skin and subcutaneous tissue disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Renal and urinary disorders - Other, specify: NOCTURIA | Renal and urinary disorders | CTCAE v4.0 | Systematic Assessment |
| |
| NON-CARDIAC CHEST PAIN | General disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Renal and urinary disorders - Other, specify: NONOLIGURIC RENAL FAILURE | Renal and urinary disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Gastrointestinal disorders - Other, specify: ODYNOPHAGIA | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| ORAL DYSESTHESIA | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Musculoskeletal and connective tissue disorders - Other, specify: OSTEONECROSIS | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | Systematic Assessment |
| |
| OSTEOPOROSIS | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | Systematic Assessment |
| |
| OTITIS MEDIA | Infections and infestations | CTCAE v4.0 | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | Systematic Assessment |
| |
| PALPITATIONS | Cardiac disorders | CTCAE v4.0 | Systematic Assessment |
| |
| PANCREATITIS | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Skin and subcutaneous tissue disorders - Other, specify: PAPULAR RASH | Skin and subcutaneous tissue disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Skin and subcutaneous tissue disorders - Other, specify: PAPULE | Skin and subcutaneous tissue disorders | CTCAE v4.0 | Systematic Assessment |
| |
| PARESTHESIA | Nervous system disorders | CTCAE v4.0 | Systematic Assessment |
| |
| PELVIC PAIN | Reproductive system and breast disorders | CTCAE v4.0 | Systematic Assessment |
| |
| PERICARDIAL EFFUSION | Cardiac disorders | CTCAE v4.0 | Systematic Assessment |
| |
| PERICARDITIS | Cardiac disorders | CTCAE v4.0 | Systematic Assessment |
| |
| PERIORBITAL EDEMA | Skin and subcutaneous tissue disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Gastrointestinal disorders - Other, specify: PERIRECTAL FISSURE | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| PHLEBITIS | Vascular disorders | CTCAE v4.0 | Systematic Assessment |
| |
| PHOTOPHOBIA | Eye disorders | CTCAE v4.0 | Systematic Assessment |
| |
| PLATELET COUNT DECREASED | Investigations | CTCAE v4.0 | Systematic Assessment |
| |
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| PLEURITIC PAIN | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Respiratory, thoracic and mediastinal disorders - Other, specify: PNEUMOMEDIASTINUM | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Infections and infestations - Other, specify: PNEUMONIA | Infections and infestations | CTCAE v4.0 | Systematic Assessment |
| |
| PNEUMONITIS | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| POSTNASAL DRIP | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| PROCTITIS | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| PRODUCTIVE COUGH | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| PROTEINURIA | Renal and urinary disorders | CTCAE v4.0 | Systematic Assessment |
| |
| PRURITUS | Skin and subcutaneous tissue disorders | CTCAE v4.0 | Systematic Assessment |
| |
| PSYCHOSIS | Psychiatric disorders | CTCAE v4.0 | Systematic Assessment |
| |
| PULMONARY EDEMA | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| PULMONARY HYPERTENSION | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Systematic Assessment |
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| RASH | Skin and subcutaneous tissue disorders | CTCAE v4.0 | Systematic Assessment |
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| RECTAL HEMORRHAGE | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
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| RECTAL PAIN | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
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| Eye disorders - Other, specify: RETINAL HEMORRHAGE | Eye disorders | CTCAE v4.0 | Systematic Assessment |
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| Respiratory, thoracic and mediastinal disorders - Other, specify: RHINORRHEA | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Systematic Assessment |
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| General disorders - Other, specify: RIGORS | General disorders | CTCAE v4.0 | Systematic Assessment |
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| SCALP PAIN | Skin and subcutaneous tissue disorders | CTCAE v4.0 | Systematic Assessment |
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| SINUS PAIN | Nervous system disorders | CTCAE v4.0 | Systematic Assessment |
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| SINUS TACHYCARDIA | Cardiac disorders | CTCAE v4.0 | Systematic Assessment |
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| SKIN HYPERPIGMENTATION | Skin and subcutaneous tissue disorders | CTCAE v4.0 | Systematic Assessment |
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| SKIN ULCERATION | Skin and subcutaneous tissue disorders | CTCAE v4.0 | Systematic Assessment |
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| SLEEP APNEA | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Systematic Assessment |
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| Gastrointestinal disorders - Other, specify: SMALL BOWEL ISCHEMIA | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
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| SMALL INTESTINAL OBSTRUCTION | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
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| SOMNOLENCE | Nervous system disorders | CTCAE v4.0 | Systematic Assessment |
| |
| SORE THROAT | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Systematic Assessment |
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| Musculoskeletal and connective tissue disorders - Other, specify: STEROID MYOPATHY | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | Systematic Assessment |
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| STOMACH PAIN | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
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| STROKE | Nervous system disorders | CTCAE v4.0 | Systematic Assessment |
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| Eye disorders - Other, specify: SUBCONJUNCTIVAL HEMORRHAGE | Eye disorders | CTCAE v4.0 | Systematic Assessment |
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| SUICIDAL IDEATIONS | Psychiatric disorders | CTCAE v4.0 | Systematic Assessment |
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| SYNCOPE | Nervous system disorders | CTCAE v4.0 | Systematic Assessment |
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| Blood antidiuretic hormone abnormal | Investigations | CTCAE v4.0 | Systematic Assessment |
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| TACHYCARDIA | Cardiac disorders | CTCAE v4.0 | Systematic Assessment |
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| Respiratory, thoracic and mediastinal disorders - Other, specify: TACHYPNEA | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Systematic Assessment |
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| TINNITUS | Eye disorders | CTCAE v4.0 | Systematic Assessment |
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| TUMOR LYSIS SYNDROME | Metabolism and nutrition disorders | CTCAE v4.0 | Systematic Assessment |
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| TYPHLITIS | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| UPPER GASTROINTESTINAL HEMORRHAGE | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| UPPER RESPIRATORY INFECTION | Infections and infestations | CTCAE v4.0 | Systematic Assessment |
| |
| URINARY FREQUENCY | Renal and urinary disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Renal and urinary disorders - Other, specify: URINARY HESITANCY | Renal and urinary disorders | CTCAE v4.0 | Systematic Assessment |
| |
| URINARY INCONTINENCE | Renal and urinary disorders | CTCAE v4.0 | Systematic Assessment |
| |
| URINARY RETENTION | Renal and urinary disorders | CTCAE v4.0 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | CTCAE v4.0 | Systematic Assessment |
| |
| URINARY URGENCY | Renal and urinary disorders | CTCAE v4.0 | Systematic Assessment |
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| URTICARIA | Skin and subcutaneous tissue disorders | CTCAE v4.0 | Systematic Assessment |
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| VAGINAL HEMORRHAGE | Reproductive system and breast disorders | CTCAE v4.0 | Systematic Assessment |
| |
| VAGINAL DRYNESS | Reproductive system and breast disorders | CTCAE v4.0 | Systematic Assessment |
| |
| VAGINAL INFECTION | Infections and infestations | CTCAE v4.0 | Systematic Assessment |
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| VAGINAL INFLAMMATION | Reproductive system and breast disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Reproductive system and breast disorders - Other, specify: VAGINAL ITCHING | Reproductive system and breast disorders | CTCAE v4.0 | Systematic Assessment |
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| VAGINAL PAIN | Reproductive system and breast disorders | CTCAE v4.0 | Systematic Assessment |
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| Thromboembolic event | Vascular disorders | CTCAE v4.0 | Systematic Assessment |
| |
| VERTIGO | Ear and labyrinth disorders | CTCAE v4.0 | Systematic Assessment |
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| Investigations - Other, specify: VITAMIN D DEFICIENCY | Investigations | CTCAE v4.0 | Systematic Assessment |
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| WATERING EYES | Eye disorders | CTCAE v4.0 | Systematic Assessment |
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| WEIGHT GAIN | Investigations | CTCAE v4.0 | Systematic Assessment |
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| WEIGHT LOSS | Investigations | CTCAE v4.0 | Systematic Assessment |
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| WHEEZING | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Systematic Assessment |
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| WHITE BLOOD CELL DECREASED | Investigations | CTCAE v4.0 | Systematic Assessment |
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| irregular menstruation | Reproductive system and breast disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Eye disorders - Other, specify: decreased visual acuity | Eye disorders | CTCAE v4.0 | Systematic Assessment |
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| Renal and urinary disorders - Other, specify: dysuria | Renal and urinary disorders | CTCAE v4.0 | Systematic Assessment |
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| Infections and infestations - Other, specify: folliculitis | Infections and infestations | CTCAE v4.0 | Systematic Assessment |
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| General disorders, Other, specify: generalized edema | General disorders | CTCAE v4.0 | Systematic Assessment |
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| Renal and urinary disorders - Other, specify: glucosuria | Renal and urinary disorders | CTCAE v4.0 | Systematic Assessment |
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| Metabolism and nutrition disorders - Other, specify: hyperlipidemia | Metabolism and nutrition disorders | CTCAE v4.0 | Systematic Assessment |
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| Metabolism and nutrition disorders - Other, specify: hyperphosphatemia | Metabolism and nutrition disorders | CTCAE v4.0 | Systematic Assessment |
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| SKIN INFECTION | Infections and infestations | CTCAE v4.0 | Systematic Assessment |
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| Infections and infestations - Other, specify: ABSCESS | Infections and infestations | CTCAE v4.0 | Systematic Assessment |
| |
| Renal and urinary disorders - Other, specify: ACUTE TUBULAR NECROSIS | Renal and urinary disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Psychiatric disorders - Other, specify: ALTERED MENTAL STATUS | Psychiatric disorders | CTCAE v4.0 | Systematic Assessment |
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| Eye disorders - Other, specify: ANISOCORIA | Eye disorders | CTCAE v4.0 | Systematic Assessment |
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| BRADYCARDIA | Cardiac disorders | CTCAE v4.0 | Systematic Assessment |
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| Cardiac disorders - Other, specify: CARDIAC MURMUR | Cardiac disorders | CTCAE v4.0 | Systematic Assessment |
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| Musculoskeletal and connective tissue disorders - Other, specify: CERVICAL DISC HERNIATION | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | Systematic Assessment |
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| Hepatobiliary disorders - Other, specify: CHOLELITHIASIS | Hepatobiliary disorders | CTCAE v4.0 | Systematic Assessment |
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| Hepatobiliary disorders - Other, specify: CHOLESTASIS | Hepatobiliary disorders | CTCAE v4.0 | Systematic Assessment |
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| Gastrointestinal disorders - Other, specify: COLONIC ILEUS | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
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| Eye disorders - Other, specify: CONJUNCTIVAL HEMORRHAGE | Eye disorders | CTCAE v4.0 | Systematic Assessment |
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| Musculoskeletal and connective tissue disorders - Other, specify: COSTOCHONDRITIS | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | Systematic Assessment |
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| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify: CYSTS | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE v4.0 | Systematic Assessment |
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| Skin and subcutaneous tissue disorders - Other, specify: DERMATITIS | Skin and subcutaneous tissue disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Skin and subcutaneous tissue disorders - Other, specify: ATOPIC DERMATITIS | Skin and subcutaneous tissue disorders | CTCAE v4.0 | Systematic Assessment |
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| Skin and subcutaneous tissue disorders - Other, specify: DIAPER DERMATITIS | Skin and subcutaneous tissue disorders | CTCAE v4.0 | Systematic Assessment |
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| Skin and subcutaneous tissue disorders - Other, specify: SEBORRHEIC DERMATITIS | Skin and subcutaneous tissue disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Skin and subcutaneous tissue disorders - Other, specify: SPONGIOTIC DERMATITIS | Skin and subcutaneous tissue disorders | CTCAE v4.0 | Systematic Assessment |
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| Respiratory, thoracic and mediastinal disorders - Other, specify: DIFFUSE ALVEOLAR HEMORRHAGE | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Systematic Assessment |
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| Gastrointestinal disorders - Other, specify: DIVERTICULITIS | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
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| Musculoskeletal and connective tissue disorders - Other, specify: DYSTONIA | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | Systematic Assessment |
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| Ear and labyrinth disorders - Other, specify: EAR BLEEDING | Ear and labyrinth disorders | CTCAE v4.0 | Systematic Assessment |
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| Metabolism and nutrition disorders - Other, specify: EARLY SATIETY | Metabolism and nutrition disorders | CTCAE v4.0 | Systematic Assessment |
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| Respiratory, thoracic and mediastinal disorders - Other, specify: EMPHYSEMA | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Systematic Assessment |
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| Infections and infestations - Other, specify: GASTROENTERITIS | Infections and infestations | CTCAE v4.0 | Systematic Assessment |
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| Gastrointestinal disorders - Other, specify: GASTROINTESTINAL HEMORRHAGE | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
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| Gastrointestinal disorders - Other, specify: HEMATOCHEZIA | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
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| Vascular disorders - Other, specify: SUBDURAL HEMATOMA | Vascular disorders | CTCAE v4.0 | Systematic Assessment |
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| Respiratory, thoracic and mediastinal disorders - Other, specify: HEMOPTYSIS | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Systematic Assessment |
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| Renal and urinary disorders - Other, specify: HYDRONEPHROSIS | Renal and urinary disorders | CTCAE v4.0 | Systematic Assessment |
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| Nervous system disorders - Other, specify: HYPERESTHESIA | Nervous system disorders | CTCAE v4.0 | Systematic Assessment |
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| Metabolism and nutrition disorders - Other, specify: INCREASE IN APPETITE | Metabolism and nutrition disorders | CTCAE v4.0 | Systematic Assessment |
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| Metabolism and nutrition disorders - Other, specify: INDIGESTION | Metabolism and nutrition disorders | CTCAE v4.0 | Systematic Assessment |
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| Respiratory, thoracic and mediastinal disorders - Other, specify: RESPIRATORY DISTRESS | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Systematic Assessment |
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| Respiratory, thoracic and mediastinal disorders - Other, specify: SINUS DRAINAGE | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Systematic Assessment |
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| Musculoskeletal and connective tissue disorders - Other, specify: HIP PAIN | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | Systematic Assessment |
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| Musculoskeletal and connective tissue disorders - Other, specify: JAW PAIN | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | Systematic Assessment |
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| Musculoskeletal and connective tissue disorders - Other, specify: SHOULDER PAIN | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | Systematic Assessment |
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| Musculoskeletal and connective tissue disorders - Other, specify: RIB PAIN | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | Systematic Assessment |
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| Renal and urinary disorders - Other, specify: HEMORRHAGIC CYSTITIS | Renal and urinary disorders | CTCAE v4.0 | Systematic Assessment |
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| Endocrine disorders - Other, specify: HYPERGONADISM | Endocrine disorders | CTCAE v4.0 | Systematic Assessment |
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| Ear and labyrinth disorders - Other, specify: IMPACTED CERUMEN | Ear and labyrinth disorders | CTCAE v4.0 | Systematic Assessment |
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| Respiratory, thoracic and mediastinal disorders - Other, specify: RHONCHI | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Systematic Assessment |
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| Blood and lymphatic system disorders - Other, specify: INFARCTION OF SPLEEN | Blood and lymphatic system disorders | CTCAE v4.0 | Systematic Assessment |
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| General disorders - Other, specify: generalized body aches | General disorders | CTCAE v4.0 | Systematic Assessment |
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| General disorders - Other, specify: generalized pain | General disorders | CTCAE v4.0 | Systematic Assessment |
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| GENERALIZED MUSCLE WEAKNESS | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | Systematic Assessment |
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| Vascular disorders - Other, specify: SUBARACHNOID HEMORRHAGE | Vascular disorders | CTCAE v4.0 | Systematic Assessment |
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| Eye disorders - Other, specify: SUPERFICIAL PUNCTATE KERATITIS | Eye disorders | CTCAE v4.0 | Systematic Assessment |
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| Nervous system disorders - Other, specify: FOOT DROP | Nervous system disorders | CTCAE v4.0 | Systematic Assessment |
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| Cardiac disorders - Other, specify: DEMAND ISCHEMIA | Cardiac disorders | CTCAE v4.0 | Systematic Assessment |
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| General disorders - Other, specify: CHEST PAIN | General disorders | CTCAE v4.0 | Systematic Assessment |
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| MYALGIA | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | Systematic Assessment |
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Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Betty Hamilton MD | Case Comprehensive Cancer Center | 866-223-8100 | TaussigResearch@ccf.org |
| Aug 18, 2022 |
| Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 4, 2022 | Sep 6, 2022 | ICF_003.pdf |
| ID | Term |
|---|---|
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D015470 | Leukemia, Myeloid, Acute |
| D015456 | Leukemia, Biphenotypic, Acute |
| D009190 | Myelodysplastic Syndromes |
| D009196 | Myeloproliferative Disorders |
| D008228 | Lymphoma, Non-Hodgkin |
| D006689 | Hodgkin Disease |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007945 | Leukemia, Lymphoid |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D008223 | Lymphoma |
| D015448 | Leukemia, B-Cell |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D016559 | Tacrolimus |
| D008727 | Methotrexate |
| C015342 | merphos |
| D009173 | Mycophenolic Acid |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
Not provided
Not provided
| Title | Measurements |
|---|---|
|
| 20-29 years old |
|
| 30-39 years old |
|
| 40-49 years old |
|
| 50-59 years old |
|
| 60-69 years old |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
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| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
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Patients receive tacrolimus as in group A and methotrexate (low dose) IV on days 1, 3, and 6. Patients also receive oral mycophenolate mofetil BID beginning on day 1, with a taper from day 45 to day 100 (in the absence of GVHD). tacrolimus: Tacrolimus 0.03 mg/kg/day beginning day -1 or tacrolimus 0.03mg/kg/dose BID orally beginning on day -3. If Tac is administered intravenously, it will be given over 24 hours and will be converted to oral administration 2 times a day when the patient has engrafted and/or can tolerate oral medication. Levels of Tac will be obtained to maintain a recommended target serum level of 5-12 ng/mL Mycophenolate mofetil: Patients will receive Mycophenolate beginning on day +1. Patients >40 kg will receive Mycophenolate 1000 mg twice a day. Mycophenolate should be given orally twice a day. IV formulation may be used if the patient cannot tolerate oral route. Patients < 40 kg will receive MMF 45 mg/kg/day (15 mg/kg three times a day). MMF may be given orally or intravenously as per institutional protocol Methotrexate (low dose): MTX 5mg/m2 IV on day +1, +3, +6. If patient<10 kg MTX will be given at 0.17 mg/kg on day +1, +3, and +6. |
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| OG001 | Group B (Tacrolimus, Methotrexate, Mycophenolate Mofetil) | Patients receive tacrolimus as in group A and methotrexate (low dose) IV on days 1, 3, and 6. Patients also receive oral mycophenolate mofetil BID beginning on day 1, with a taper from day 45 to day 100 (in the absence of GVHD). tacrolimus: Tacrolimus 0.03 mg/kg/day beginning day -1 or tacrolimus 0.03mg/kg/dose BID orally beginning on day -3. If Tac is administered intravenously, it will be given over 24 hours and will be converted to oral administration 2 times a day when the patient has engrafted and/or can tolerate oral medication. Levels of Tac will be obtained to maintain a recommended target serum level of 5-12 ng/mL Mycophenolate mofetil: Patients will receive Mycophenolate beginning on day +1. Patients >40 kg will receive Mycophenolate 1000 mg twice a day. Mycophenolate should be given orally twice a day. IV formulation may be used if the patient cannot tolerate oral route. Patients < 40 kg will receive MMF 45 mg/kg/day (15 mg/kg three times a day). MMF may be given orally or intravenously as per institutional protocol Methotrexate (low dose): MTX 5mg/m2 IV on day +1, +3, +6. If patient<10 kg MTX will be given at 0.17 mg/kg on day +1, +3, and +6. |
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| OG001 | Group B (Tacrolimus, Methotrexate, Mycophenolate Mofetil) | Patients receive tacrolimus as in group A and methotrexate (low dose) IV on days 1, 3, and 6. Patients also receive oral mycophenolate mofetil BID beginning on day 1, with a taper from day 45 to day 100 (in the absence of GVHD). tacrolimus: Tacrolimus 0.03 mg/kg/day beginning day -1 or tacrolimus 0.03mg/kg/dose BID orally beginning on day -3. If Tac is administered intravenously, it will be given over 24 hours and will be converted to oral administration 2 times a day when the patient has engrafted and/or can tolerate oral medication. Levels of Tac will be obtained to maintain a recommended target serum level of 5-12 ng/mL Mycophenolate mofetil: Patients will receive Mycophenolate beginning on day +1. Patients >40 kg will receive Mycophenolate 1000 mg twice a day. Mycophenolate should be given orally twice a day. IV formulation may be used if the patient cannot tolerate oral route. Patients < 40 kg will receive MMF 45 mg/kg/day (15 mg/kg three times a day). MMF may be given orally or intravenously as per institutional protocol Methotrexate (low dose): MTX 5mg/m2 IV on day +1, +3, +6. If patient<10 kg MTX will be given at 0.17 mg/kg on day +1, +3, and +6. |
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| OG001 | Group B (Tacrolimus, Methotrexate, Mycophenolate Mofetil) | Patients receive tacrolimus as in group A and methotrexate (low dose) IV on days 1, 3, and 6. Patients also receive oral mycophenolate mofetil BID beginning on day 1, with a taper from day 45 to day 100 (in the absence of GVHD). tacrolimus: Tacrolimus 0.03 mg/kg/day beginning day -1 or tacrolimus 0.03mg/kg/dose BID orally beginning on day -3. If Tac is administered intravenously, it will be given over 24 hours and will be converted to oral administration 2 times a day when the patient has engrafted and/or can tolerate oral medication. Levels of Tac will be obtained to maintain a recommended target serum level of 5-12 ng/mL Mycophenolate mofetil: Patients will receive Mycophenolate beginning on day +1. Patients >40 kg will receive Mycophenolate 1000 mg twice a day. Mycophenolate should be given orally twice a day. IV formulation may be used if the patient cannot tolerate oral route. Patients < 40 kg will receive MMF 45 mg/kg/day (15 mg/kg three times a day). MMF may be given orally or intravenously as per institutional protocol Methotrexate (low dose): MTX 5mg/m2 IV on day +1, +3, +6. If patient<10 kg MTX will be given at 0.17 mg/kg on day +1, +3, and +6. |
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