AIM-Harvard/TrialPanorama-filtered huggingface dataset:
Trial: NCT02579096
Drug: allopurinol capsule, 100-800 mg by mouth once daily
DrugBank: Allopurinol (DB00437)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Patients will be up-titrated up to the dose required to reach target uric acid levels.
Trial: NCT02579096
Drug: febuxostat tablet 40-120 mg by mouth once daily
RxNorm normalized name: lisinopril
DrugBank: Febuxostat (DB04854)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Patients will be up-titrated to the dose required to reach target uric acid levels.
Trial: NCT01876186
Drug: Solifenacin for 12 weeks
DrugBank: Solifenacin (DB01591)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Solifenacin 5 mg one a day for 12 weeks
Trial: NCT01876186
Drug: Solifenacin for 24 weeks
DrugBank: Solifenacin (DB01591)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Solifenacin 5 mg once a day for 24 weeks
Trial: NCT03232203
Drug: STRIMVELIS
RxNorm normalized name: Strimvelis
DrugBank: Strimvelis (DB17594)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: It is the Autologous cluster of differentiation (CD) 34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human ADA complementary Deoxyribonucleic acid (cDNA) sequence. HCP who have previously referred a patient for STRIMVELIS treatment or a parent's/carer's child who previously received treatment with STRIMVELIS will be recruited to the study
Trial: NCT04102020
Drug: Venetoclax
RxNorm normalized name: Venetoclax
DrugBank: Venetoclax (DB11581)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Tablet: Oral
Trial: NCT04102020
Drug: Azacitidine
RxNorm normalized name: Azacitidine
DrugBank: Azacitidine (DB00928)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Subcutaneous (SC) or intravenous (IV) injection
Trial: NCT04102020
Drug: Azacitidine
RxNorm normalized name: Azacitidine
DrugBank: Azacitidine (DB00928)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Oral Tablet
Trial: NCT02172248
Drug: BI 10773
RxNorm normalized name: BI 2536
DrugBank: BI 2536 (DB16107)
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT02172248
Drug: Metformin
RxNorm normalized name: Metformin
DrugBank: Metformin (DB00331)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Trial: NCT01968382
Drug: IMM 124-E (Hyperimmune Bovine Colostrum)
RxNorm normalized name: E-EPA
DrugBank: Icosapent ethyl (DB08887)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Hyper-immune bovine colostrum enriched with anti-LPS antibodies and which has been designated by Immuron as IMM-124E.
Trial: NCT01968382
Drug: Placebo (High protein milk powder)
RxNorm normalized name: milk protein concentrate
DrugBank: Protein C (DB11312)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Subjects will receive a total of 4 sachets (2 in the morning and 2 in the evening) daily
Trial: NCT00547547
Drug: irinotecan hydrochloride
RxNorm normalized name: Irinotecan Hydrochloride
DrugBank: Irinotecan (DB00762)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Dose Level 1: 100 mg/m2 on day 1 and day 8 every 21 days. Dose Level -1: 75 mg/m2 on day 1 and day 8 every 21 days.
Trial: NCT01595633
Drug: Switching from adefovir (10mg/day) to tenofovir (300mg/day)
RxNorm normalized name: adefovir dipivoxil 10 MG
DrugBank: Adefovir (DB13868)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: active comparator: Nucleoside analogues (Lamivudine 100mg, Telbivudine 600mg, Entecavir 1mg, or Clevudine 30mg/day) + Adefovir 10mg/day Experimental: Nucleoside analogues (Lamivudine 100mg, Telbivudine 600mg, Entecavir 1mg, or Clevudine 30mg/day) + Tenofovir 300mg/day
Trial: NCT02494713
Drug: Degarelix
RxNorm normalized name: Degarelix
DrugBank: Degarelix (DB06699)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Subcutaneous injection, once/month for 4 months
Trial: NCT02494713
Drug: Ketoconazole
RxNorm normalized name: Ketoconazole
DrugBank: Ketoconazole (DB01026)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 400 mg orally 3 times daily for 7 days, in weeks 1, 3, and 5
Trial: NCT02494713
Drug: Docetaxel
RxNorm normalized name: Docetaxel
DrugBank: Docetaxel (DB01248)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 35 mg/m2 intravenously on day 1 of each week, weeks 2, 4, and 6
Trial: NCT02494713
Drug: Estramustine
RxNorm normalized name: Estramustine
DrugBank: Estramustine (DB01196)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 280 mg orally 3 times daily for 7 days, in weeks 2, 4, and 6
Trial: NCT00023283
Drug: Buprenorphine
RxNorm normalized name: Buprenorphine
DrugBank: Buprenorphine (DB00921)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: 1. Experimental Standard Medical Management with once-weekly medication dispensing~2. Experimental Standard Medical Management with thrice-weekly medication dispensing~3. Experimental Enhanced Medical Management with thrice-weekly medication dispensing
Trial: NCT01376128
Drug: Paroxetine
RxNorm normalized name: Paroxetine
DrugBank: Paroxetine (DB00715)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT04018261
Drug: Activated T-Lymphocytes
RxNorm normalized name: rabbit anti-human T-lymphocyte globulin Injection [Thymoglobulin]
DrugBank: Rabbit (DB10415)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Activated T-Lymphocytes will be infused intravenously in a single-dose
Trial: NCT02324998
Drug: Olaparib
RxNorm normalized name: Olaparib
DrugBank: Olaparib (DB09074)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: PARP Inhibitor
Trial: NCT02324998
Drug: Degarelix
RxNorm normalized name: Degarelix
DrugBank: Degarelix (DB06699)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Gonadotrophin releasing hormone blocker
Trial: NCT01004172
Drug: bevacizumab
RxNorm normalized name: Bevacizumab
DrugBank: Bevacizumab (DB00112)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Trial: NCT01004172
Drug: herceptin
RxNorm normalized name: Herceptin
DrugBank: Trastuzumab (DB00072)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Trial: NCT03979248
Drug: BMS-986165
RxNorm normalized name: BMS dasatinib
DrugBank: Dasatinib (DB01254)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Specified dose on specified days.
Trial: NCT03979248
Drug: Rabeprazole
RxNorm normalized name: Rabeprazole
DrugBank: Rabeprazole (DB01129)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Specified dose on specified days.
Trial: NCT04232150
Drug: single-dose midazolam for sedation under spinal anesthesia.
DrugBank: Midazolam (DB00683)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Induction of neuraxial anesthesia was done using 2.8cc of 0.5 % Heavy Bupivacaine and 20mcg fentanyl injected intrathecally for all patients. Supplemental oxygen was given via facemask with capnography monitoring. Group O received 0.025mg/kg midazolam at skin incision.
Trial: NCT04232150
Drug: Double-dose midazolam for sedation under spinal anesthesia.
DrugBank: Midazolam (DB00683)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Induction of neuraxial anesthesia was done using 2.8cc of 0.5 % Heavy Bupivacaine and 20mcg fentanyl injected intrathecally for all patients. Supplemental oxygen was given via facemask with capnography monitoring. Group M received 0.025mg/kg midazolam at skin incision and repeated 5 minutes before maximum stimulation.
Trial: NCT01606306
Drug: daily fluticasone propionate
RxNorm normalized name: Fluticasone Propionate
DrugBank: Fluticasone propionate (DB00588)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Flovent® HFA, 44 mcg per inhalation, 2 inhalations twice daily
Trial: NCT01606306
Drug: Montelukast
RxNorm normalized name: Montelukast
DrugBank: Montelukast (DB00471)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Singulair®, 4 mg granules or chewable tablets by mouth once daily in the evening
Trial: NCT01606306
Drug: as-needed fluticasone propionate
RxNorm normalized name: Fluticasone Propionate
DrugBank: Fluticasone propionate (DB00588)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Flovent® HFA, 44 mcg per inhalation, 2 inhalations, as needed for asthma symptoms
Trial: NCT00159965
Drug: sertraline
RxNorm normalized name: Sertraline
DrugBank: Sertraline (DB01104)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: flexible dose sertraline
Trial: NCT00522457
Drug: ertumaxomab
RxNorm normalized name: Ertumaxomab
DrugBank: Ertumaxomab (DB18923)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Ertumaxomab will be intravenously administered to see if it can increase the patient's objective response rate.
Trial: NCT02202525
Drug: Other hypertensives
RxNorm normalized name: Ether
DrugBank: Diethyl ether (DB13598)
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT01918878
Drug: Aflibercept (EYLEA)
RxNorm normalized name: Aflibercept
DrugBank: Aflibercept (DB08885)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: INTARAVITREAL INJECTION OF AFLIBERCEPT
Trial: NCT02793544
Drug: Fludarabine
RxNorm normalized name: Fludarabine
DrugBank: Fludarabine (DB01073)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: * Fludarabine 30 mg/m2/day (adjusted for renal function) is administered over a 30-60 minute IV infusion on Days -6 through -2 (maximum cumulative dose, 150 mg/m2).~* The body surface area (BSA) for fludarabine dosing is based on adjusted ideal body weight (IBW) (Appendix K).~* creatinine clearance may change during the days fludarabine is given. Adjustment in fludarabine dose due to creatinine changes during conditioning is permitted.
Trial: NCT02793544
Drug: Busulfan
RxNorm normalized name: Busulfan
DrugBank: Busulfan (DB01008)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: * Busulfan ≥ 9mg/kg total dose (IV or PO) on Days -6, -5, -4, -3 (PK monitoring required to achieve a daily area under the curve (AUC) target of 4800-5300 μM\*min (Perkins et al., 2012))~* Busulfan dosing is based on adjusted IBW (Appendix K)
Trial: NCT02270788
Drug: Crenolanib
RxNorm normalized name: Crenolanib
DrugBank: Crenolanib (DB11832)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Day 1 of Course 1: once followed by pharmacokinetic analysis. Days 2-28 of cycle 1: 3 times per day Crenolanib dose will not be adjusted unless the participant experiences side effects.~All subsequent courses: 3 times per day on Days 1-28. At least 50% of participants in each dose level must be ≤ 18 years old.
Trial: NCT02270788
Drug: Sorafenib
RxNorm normalized name: Sorafenib
DrugBank: Sorafenib (DB00398)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Days 8-28 of course 1: given orally once each day.~All subsequent courses: given orally on days 1-28 once per day~This is a dose-finding study for the use of sorafenib in combination with crenolanib. Different doses will be given to several participants, with the first participants receiving a lower dose than typically used in children as a single agent. If the drug does not cause serious side effects, it will be given to other study participants at a higher dose. If side effects occur, the dose will be lowered.
Trial: NCT01699607
Drug: Amphetamine
RxNorm normalized name: Amphetamine
DrugBank: Amphetamine (DB00182)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: All subjects will receive amphetamine to induce elevated dopamine levels in the brain at 0.5mg/kg
Trial: NCT04572100
Drug: Paclitaxel
RxNorm normalized name: Paclitaxel
DrugBank: Paclitaxel (DB01229)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: This drug will be combined with carboplatin during induction therapy for 9 weeks.
Trial: NCT04572100
Drug: Carboplatin
RxNorm normalized name: Carboplatin
DrugBank: Carboplatin (DB00958)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: This drug will be combined with paclitaxel during induction therapy for 9 weeks.
Trial: NCT01904500
Drug: Pre-operative cefazolin
RxNorm normalized name: lidocaine
DrugBank: Cefazolin (DB01327)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT00449878
Drug: Liprotamase
RxNorm normalized name: Liprotamase
DrugBank: Liprotamase protease (DB16584)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Administered orally
Trial: NCT01035528
Drug: insulin glargine
RxNorm normalized name: Insulin Glargine
DrugBank: Insulin glargine (DB00047)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: antidiabetic treatment with insulin glargine sc o.d. titrated to the target fasting glucose type 2 diabetes ≤110 mg/dl
Trial: NCT01035528
Drug: metformin
RxNorm normalized name: Metformin
DrugBank: Metformin (DB00331)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: use of oral metformin o.d or b.d titrated up to 2000 mg daily for to the target fasting glucose ≤110 mg/dl
Trial: NCT01390883
Drug: Fondaparinux Sodium
RxNorm normalized name: Fondaparinux Sodium
DrugBank: Fondaparinux (DB00569)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT01751347
Drug: Bupivacaine
RxNorm normalized name: Bupivacaine
DrugBank: Bupivacaine (DB00297)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Local anesthetics
Trial: NCT01751347
Drug: Lidocaine
RxNorm normalized name: Lidocaine
DrugBank: Lidocaine (DB00281)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Local anesthetics
Trial: NCT04204577
Drug: Apatinib Mesylate
RxNorm normalized name: mesylate
DrugBank: Rivoceranib (DB14765)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Evaluation of the efficacy and safety of simple local ablation, local ablation combined with apatinib, local ablation combined with apatinib and PD-1 antibody SHR-1210 for advanced liver cancer.
Trial: NCT02495324
Drug: Fimasartan
RxNorm normalized name: Fimasartan
DrugBank: Fimasartan (DB09279)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 60mg 1 tab PO daily for 2 weeks and 120mg 1 tab PO daily for 4 weeks
Trial: NCT02495324
Drug: Valsartan
RxNorm normalized name: Valsartan
DrugBank: Valsartan (DB00177)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: 80mg 1 tab PO daily for 2 weeks and 160mg 1 tab PO daily for 4 weeks
Trial: NCT02495324
Drug: Olmesartan medoxomil
RxNorm normalized name: Olmesartan Medoxomil
DrugBank: Olmesartan (DB00275)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 10mg 1 tab PO daily for 2 weeks and 20mg 1 tab PO daily for 4 weeks
Trial: NCT00513968
Drug: Adefovir
RxNorm normalized name: Adefovir
DrugBank: Adefovir (DB13868)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Adefovir(Adefovir dipivoxil)10mg, od, from week -10 to week 48.
Trial: NCT02793544
Drug: Sirolimus
RxNorm normalized name: Sirolimus
DrugBank: Sirolimus (DB00877)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: * Sirolimus dosing is based on adjusted IBW (Appendix K).~* Sirolimus prophylaxis is discontinued after the last dose on Day+180, or may be continued if there is GVHD.~For subjects ≥ 18 years old:~* A one-time sirolimus loading dose, 6 mg PO, is given on Day+5, at least 24 hours after Cy completion.~* Sirolimus is then continued at a maintenance dose (starting dose 2 mg PO QD), with dose adjustments to maintain a trough of 5 - 15 ng/mL as measured by high performance liquid chromatography (HPLC) or immunoassay.~For subjects \< 18 years old:~* A one-time sirolimus loading dose, 3 mg/m2 PO with the dose not to exceed 6 mg, is given on Day+5, at least 24 hours after Cy completion.~* Sirolimus is then continued at a maintenance dose (starting dose 1 mg/m2 PO QD, maximum 2 mg PO QD), with dose adjustments to maintain a trough of 5 - 15 ng/mL as measured by HPLC or immunoassay.
Trial: NCT02276196
Drug: Lixisenatide
RxNorm normalized name: Lixisenatide
DrugBank: Lixisenatide (DB09265)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: GLP-1 receptor agonist
Trial: NCT02276196
Drug: Insulin glulisine
RxNorm normalized name: Insulin Glulisine
DrugBank: Insulin glulisine (DB01309)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Insulin analogue
Trial: NCT01290263
Drug: Amgen 386
RxNorm normalized name: Amben ethyl ester
DrugBank: Benzocaine (DB01086)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: For Cohort A, AMG 386 will be administered intravenously at 30 mg/kg every week.~For Cohort B Phase I, AMG 386 will be administered intravenously at beginning at starting dose level of 15 mg/kg every week.~For Cohort B Phase II, AMG 386 will be administered intravenously at the maximum tolerated dose determined in the Phase I portion of the study every week.
Trial: NCT01290263
Drug: Bevacizumab
RxNorm normalized name: Bevacizumab
DrugBank: Bevacizumab (DB00112)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: The dose of bevacizumab will be 10 mg/kg and will be administered intravenously every other week.
Trial: NCT04807114
Drug: Immune checkpoint inhibitor
RxNorm normalized name: Anti-tim3 checkpoint inhibitor mbg453
DrugBank: Sabatolimab (DB16322)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Standard-of-care treatment for st.IV NSCLC (no driver mutation, PD-L1 \> 50%)
Trial: NCT04807114
Drug: Chemotherapy + Immune checkpoint inhibitor
RxNorm normalized name: Anti-tim3 checkpoint inhibitor mbg453
DrugBank: Sabatolimab (DB16322)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Standard-of-care treatment for st.IV NSCLC (no driver mutation, PD-L1 \< 50%)
Trial: NCT00043836
Drug: ALT-711
RxNorm normalized name: ALT-801
DrugBank: ALT-801 (DB15386)
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT00035087
Drug: epothilone b
RxNorm normalized name: Epothilone B
DrugBank: Patupilone (DB03010)
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT00718159
Drug: LY573636-sodium
RxNorm normalized name: LY573636
DrugBank: Sodium citrate (DB09154)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Dosing will be done on Day 1 of a 35-day cycle for acute myeloid leukemia (AML) and Day 1 of a 28-day cycle for essential thrombocythemia (ET) for at least one cycle. A participant may have additional cycles of LY573636 if he or she is receiving benefit from the study drug and does not fulfill any of the criteria for study discontinuation.
Trial: NCT01083875
Drug: amlexanox
RxNorm normalized name: Amlexanox
DrugBank: Amlexanox (DB01025)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 0.5% amlexanox oral rinse; use 5 ml every 2-3 hours during the awake hours of each day (a minimum of 6 times each day). The liquid was be swirled around the mouth then to be swallowed. Repeated daily until completion of radiation therapy: approximately 7-8 weeks.
Trial: NCT01083875
Drug: Vehicle rinse
RxNorm normalized name: meningococcal group B vaccine / Neisseria meningitidis serogroup B recombinant FHBP fusion protein antigen / Neisseria meningitidis serogroup B recombinant NHBA fusion protein antigen / Neisseria meningitidis serogroup B strain NZ98/254 outer membrane vesicle Prefilled Syringe [Bexsero]
DrugBank: Neisseria meningitidis serogroup B strain NZ98/254 outer membrane vesicle (DB10786)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: use 5 ml of the vehicle rinse every 2-3 hours during the awake hours of each day (a minimum of 6 times each day). The liquid is be swirled around the mouth then swallowed.
Trial: NCT00929409
Drug: Ferric carboxymaltose
RxNorm normalized name: Ferric Carboxymaltose
DrugBank: Ferric carboxymaltose (DB08917)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Intravenous infusion of Ferric carboxymaltose in a dose calculated to meet the individual patient's requirements following the Ganzoni formula
Trial: NCT00929409
Drug: Ferrous sulfate tablets
RxNorm normalized name: Ferrous Sulfate Tablets
DrugBank: Ferrous tartrate (DB13639)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Standard tablets containing 100 mg ferrous sulfate, 1 tablet two times daily
Trial: NCT03558477
Drug: Nexium
RxNorm normalized name: Nexium
DrugBank: Esomeprazole (DB00736)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Nexium
Trial: NCT01315145
Drug: Epidural Steroid Injection
RxNorm normalized name: epidermal growth factor
DrugBank: Nepidermin (DB14145)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Injection of epidural steroids into the lumbar spine
Trial: NCT02112526
Drug: Acalabrutinib
RxNorm normalized name: Acalabrutinib
DrugBank: Acalabrutinib (DB11703)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Trial: NCT02793544
Drug: Mycophenolate mofetil
RxNorm normalized name: Mycophenolate Mofetil
DrugBank: Mycophenolate mofetil (DB00688)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: MMF begins on Day+5, at least 24 hours after completion of PTCy. MMF dose is 15 mg/kg PO TID (adjusted IBW (Appendix K)) with total daily dose not to exceed 3 grams (i.e. maximum 1 g PO TID).~An equivalent IV dose (1:1 conversion) may instead be given. MMF prophylaxis is discontinued after the last dose on Day+35, or may be continued if there is GVHD.
Trial: NCT01462565
Drug: current marketed FLOLAN (epoprostenol sodium)
RxNorm normalized name: epoprostenol Injection [Flolan]
DrugBank: Epoprostenol (DB01240)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: continuous intravenous infusion
Trial: NCT01462565
Drug: new thermo stable formulation of epoprostenol sodium
DrugBank: Epoprostenol (DB01240)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: continuous intravenous infusion
Trial: NCT02793544
Drug: G-CSF
RxNorm normalized name: G-CSF
DrugBank: Filgrastim (DB00099)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Granulocyte-colony stimulating factor (G-CSF): filgrastim or a biosimilar begins on Day+5 at a dose of 5 mcg/kg/day (actual body weight) IV or subcutaneously (SC) (rounding to the nearest vial dose is allowed), until the absolute neutrophil count (ANC) is ≥ 1,000/mm3 over the course of 3 consecutive days.~Additional G-CSF may be administered as warranted.
Trial: NCT02793544
Drug: Pre-HCT Mesna on Days -6 and -5
RxNorm normalized name: Mesna
DrugBank: Coenzyme M (DB09110)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Use of Mesna and dosing will be done according to institutional standards. A recommended approach is as follows: Mesna IV dose of ≥ 80% of the total daily dose of Cy and given in divided doses 30 minutes before and at 3, 6, and 8-9 hours after completion of Cy.~Mesna is dosed according to adjusted IBW (Appendix K), unless the subject weighs less than IBW, in which case Mesna will be dosed according to actual weight.
Trial: NCT02793544
Drug: Pre-HCT Mesna on Days -2 and -1
RxNorm normalized name: Mesna
DrugBank: Coenzyme M (DB09110)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Use of Mesna and dosing will be done according to institutional standards. A recommended approach is as follows: Mesna IV dose of ≥ 80% of the total daily dose of Cy and given in divided doses 30 minutes before and at 3, 6, and 8-9 hours after completion of Cy.~Mesna is dosed according to adjusted IBW (Appendix K), unless the subject weighs less than IBW, in which case Mesna will be dosed according to actual weight.