AIM-Harvard/TrialPanorama-filtered huggingface dataset:
Trial: NCT00783146
Drug: desloratadine
RxNorm normalized name: Desloratadine
DrugBank: Desloratadine (DB00967)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: desloratadine, 5 mg oral tablets, once daily for 15 days
Trial: NCT00783146
Drug: fexofenadine
RxNorm normalized name: Fexofenadine
DrugBank: Fexofenadine (DB00950)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: fexofenadine, 180 mg tablets, once daily for 15 days; for purposes of blinding, fexofenadine tablets were over encapsulated
Trial: NCT00508144
Drug: Alimta
RxNorm normalized name: Alimta
DrugBank: Pemetrexed (DB00642)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: 500 mg/m\^2 by vein Once Over 10 Minutes Every 3 Weeks
Trial: NCT02735707
Drug: Ceftriaxone
RxNorm normalized name: Ceftriaxone
DrugBank: Ceftriaxone (DB01212)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: The duration and dose of empiric antibiotics will be determined by the treating clinician and local guidelines or practice.
Trial: NCT02735707
Drug: Moxifloxacin or Levofloxacin
DrugBank: Moxifloxacin (DB00218)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: The duration and dose of empiric antibiotics will be determined by the treating clinician and local guidelines or practice.
Trial: NCT06245902
Drug: Naltrexone Alone (regular dose)
DrugBank: Naltrexone (DB00704)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Naltrexone Alone plus Placebo
Trial: NCT02735707
Drug: Piperacillin-tazobactam
RxNorm normalized name: piperacillin-tazobactam
DrugBank: Piperacillin (DB00319)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: The duration and dose of empiric antibiotics will be determined by the treating clinician and local guidelines or practice.
Trial: NCT02735707
Drug: Ceftaroline
RxNorm normalized name: Ceftaroline
DrugBank: Ceftaroline fosamil (DB06590)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: The duration and dose of empiric antibiotics will be determined by the treating clinician and local guidelines or practice.~Note: this intervention is now closed.
Trial: NCT02735707
Drug: Amoxicillin-clavulanate
RxNorm normalized name: amoxicillin-clavulanate
DrugBank: Amoxicillin (DB01060)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: The duration and dose of empiric antibiotics will be determined by the treating clinician and local guidelines or practice.
Trial: NCT00115167
Drug: Darbepoetin alfa
RxNorm normalized name: Darbepoetin Alfa
DrugBank: Darbepoetin alfa (DB00012)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Q4W
Trial: NCT00629564
Drug: Esomeprazole
RxNorm normalized name: Esomeprazole
DrugBank: Esomeprazole (DB00736)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 20mg oral
Trial: NCT00629564
Drug: Esomeprazole
RxNorm normalized name: Esomeprazole
DrugBank: Esomeprazole (DB00736)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 15 minute intravenous infusion
Trial: NCT00079222
Drug: itraconazole
RxNorm normalized name: Itraconazole
DrugBank: Itraconazole (DB01167)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT00079222
Drug: voriconazole
RxNorm normalized name: Voriconazole
DrugBank: Voriconazole (DB00582)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT01389791
Drug: magnesium sulfate
RxNorm normalized name: Magnesium Sulfate
DrugBank: Magnesium sulfate (DB00653)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Patients in this group receive intravenous MgSO4 50mg/kg before administration of rocuronium (induction dose).
Trial: NCT01389791
Drug: priming
RxNorm normalized name: LS Plum Priming Set, OL plus Conv
DrugBank: Plum (DB10560)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Patients in this group receive 0.06mg/kg of rocuronium before administration of 0.54mg/kg of rocuronium.
Trial: NCT01389791
Drug: magnesium sulfate and priming
RxNorm normalized name: Magnesium Sulfate
DrugBank: Magnesium sulfate (DB00653)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Patients in this group receive MgSO4 50mg/kg and 0.06mg/kg of rocuronium before administration of 0.54mg/kg of rocuronium.
Trial: NCT02735707
Drug: Five-days oseltamivir
DrugBank: Oseltamivir (DB00198)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Oseltamivir administered enterally twice daily for 5 days or until hospital discharge (whichever occurs first)
Trial: NCT02735707
Drug: Ten-days oseltamivir
DrugBank: Oseltamivir (DB00198)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Oseltamivir administered enterally twice daily for 10 days or until hospital discharge (whichever occurs first)
Trial: NCT02735707
Drug: Lopinavir / Ritonavir
RxNorm normalized name: lopinavir / ritonavir
DrugBank: Ritonavir (DB00503)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Lopinavir/ritonavir 400/100mg administered enterally, or 5ml 80/20mg per mL solution suspension via gastric tube, every 12 hours. Administered for a minimum of 5 days, including if discharged from ICU prior to end of study day 5. For patients discharged from ICU between study day 6 and study day 14, lopinavir/ritonavir is ceased at ICU discharge. Lopinavir/ritonavir is ceased at the end of study day 14 if the patient remains in ICU.~Note: this intervention is now closed.
Trial: NCT02735707
Drug: Hydroxychloroquine
RxNorm normalized name: Hydroxychloroquine
DrugBank: Hydroxychloroquine (DB01611)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Loading dose of 800mg hydroxychloroquine administered enterally every 6 hours until 2 doses have been administered. Subsequently, 400mg hydroxychloroquine will be administered enterally every 12 hours for 12 doses or ICU discharge (whichever occurs first).~Note: this intervention is now closed.
Trial: NCT02735707
Drug: Hydroxychloroquine + lopinavir/ritonavir
DrugBank: Ritonavir (DB00503)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Lopinavir/ritonavir 400/100mg administered enterally, or 5ml 80/20mg per mL solution suspension via gastric tube, every 12 hours. Administered for a minimum of 5 days, including if discharged from ICU prior to end of study day 5. For patients discharged from ICU between study day 6 and study day 14, lopinavir/ritonavir is ceased at ICU discharge. Lopinavir/ritonavir is ceased at the end of study day 14 if the patient remains in ICU.~Loading dose of 800mg hydroxychloroquine administered enterally every 6 hours until 2 doses have been administered. Subsequently, 400mg hydroxychloroquine will be administered enterally every 12 hours for 12 doses or ICU discharge (whichever occurs first).~Note: this intervention is now closed.
Trial: NCT02735707
Drug: Ivermectin
RxNorm normalized name: Ivermectin
DrugBank: Ivermectin (DB00602)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Ivermectin administered enterally at a dose of 0.2 mg/kg once daily with a maximum daily dose of 24mg/day.~Note: this intervention is now closed.
Trial: NCT02735707
Drug: Interferon beta-1a
RxNorm normalized name: interferon beta-1a
DrugBank: Interferon beta-1a (DB00060)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: IFN-β1a 10 μg will be administered as an intravenous bolus injection via a central or peripheral line. IFN-β1a will be administered once daily for 6 days or until ICU discharge, whichever occurs first.~Note: this intervention is now closed.
Trial: NCT00882375
Drug: Nicotine
RxNorm normalized name: Nicotine
DrugBank: Nicotine (DB00184)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Nicotine administered using novel NRT user instructions
Trial: NCT01175980
Drug: Vorinostat
RxNorm normalized name: Vorinostat
DrugBank: Vorinostat (DB02546)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Given PO
Trial: NCT02735707
Drug: Anakinra
RxNorm normalized name: ANAKINRA
DrugBank: Anakinra (DB00026)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: A loading dose of 300mg anakinra will be administered as a bolus via central or peripheral line. This is followed by maintenance doses of 100mg of anakinra administered every 6 hours.~In patients with renal impairment, anakinra will be administered on alternate days.~Note: this intervention is now closed.
Trial: NCT02735707
Drug: Tocilizumab
RxNorm normalized name: Tocilizumab
DrugBank: Tocilizumab (DB06273)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Tocilizumab will be administered as a single dose of 8mg/kg estimated or measured body weight, with a maximum total dose of 800mg.~Tocilizumab will be administered as an IV infusion via central or peripheral line over a one-hour period.~Note: this intervention is now closed.
Trial: NCT02735707
Drug: Sarilumab
RxNorm normalized name: Sarilumab
DrugBank: Sarilumab (DB11767)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Sarilumab will be administered as a single dose of 400mg, via IV infusion through peripheral or central line over a one-hour period.~Note: this intervention is now closed.
Trial: NCT02735707
Drug: Conventional low dose thromboprophylaxis
RxNorm normalized name: ethinyl estradiol
DrugBank: Ethinylestradiol (DB00977)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Low dose thromboprophylaxis will be administered for 14 days following randomisation or until hospital discharge, whichever occurs first. Dosing is outlined in the relevant protocol documents for this domain.
Trial: NCT02735707
Drug: Vitamin C
RxNorm normalized name: Vitamin C
DrugBank: Ascorbic acid (DB00126)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Intravenous Vitamin C 50mg/kg administered every 6 hours for 16 doses~Note: this intervention is now closed.
Trial: NCT02735707
Drug: Aspirin
RxNorm normalized name: Aspirin
DrugBank: Acetylsalicylic acid (DB00945)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Aspirin administered at either 75mg or 100mg once per day for 14 days or until hospital discharge, whichever occurs first.~Note: this intervention is now closed.
Trial: NCT02735707
Drug: P2Y12 inhibitor
RxNorm normalized name: Fibrinolysis inhibitor
DrugBank: Aprotinin (DB06692)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Site-selected P2Y12 inhibitor:~* Clopidogrel: administered 75 mg once per day for 14 days or until hospital discharge, whichever occurs first.~* Prasugrel: If patient is aged less than 75 years and measured or estimated weight if 60kg or more, and initial loading dose of prasugrel 60 mg will be administered, followed by maintenance dose of 10 mg per day.~* Ticagrelor: administered enterally at 60mg twice daily for 14 days or until hospital discharge, whichever occurs first.~Note: this intervention is now closed.
Trial: NCT01451840
Drug: Alkalinized lidocaine
RxNorm normalized name: Lidocaine
DrugBank: Lidocaine (DB00281)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Administration of alkalinized lidocaine in the endotracheal tube cuff
Trial: NCT00267865
Drug: Rituximab
RxNorm normalized name: Rituximab
DrugBank: Rituximab (DB00073)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: 375 mg/m\^2 intravenous (IV) day 1 of each cycle prior to administration of high-dose methotrexate
Trial: NCT01695044
Drug: PSMA ADC
RxNorm normalized name: Gallium-68 PSMA
DrugBank: Gallium-68 PSMA (DB16303)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: PSMA ADC administered IV at 2.5 mg/kg Q3W for 8 cycles or 2.3 mg/kg Q3W for 8 cycles.
Trial: NCT01929616
Drug: regorafenib
RxNorm normalized name: Regorafenib
DrugBank: Regorafenib (DB08896)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Patients will receive 160 mg regorafenib 1/day 3 weeks out of 4.
Trial: NCT00389285
Drug: rIL-21 + sorafenib
DrugBank: Sorafenib (DB00398)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Part 2: rIL-21 IV, Day 1-5 and 15-19 of each 6-week treatment course + sorafenib (up to 400 mg taken orally twice daily)
Trial: NCT02735707
Drug: Eritoran
RxNorm normalized name: Eritoran
DrugBank: Eritoran (DB04933)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Eritoran initiated with a 26.24 mg loading dose (6.56 mg/h IV for 4 hours), followed by a second 13.12 mg loading dose (6.56 mg/h IV for 2 hours) at 12 hours after initiation. Patients will then receive twenty-six 6.56 mg maintenance doses (3.28 mg/h IV for 2 hours) every 12 hours thereafter (total of 14 days). Dosing will be stopped if the patient is discharged from hospital~Note: this intervention is now closed.
Trial: NCT02735707
Drug: Apremilast
RxNorm normalized name: Apremilast
DrugBank: Apremilast (DB05676)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Apremilast administered 30mg twice daily for 14 days or until hospital discharge, whichever occurs first.~Note: this intervention is now closed.
Trial: NCT02735707
Drug: Angiotensin Receptor Blockers
RxNorm normalized name: ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), COMBINATIONS
DrugBank: Angiotensin II (DB11842)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Site-preferred ARB agent administered as directed by the treating clinician for 10 days or until hospital discharge, whichever occurs first.~Note: this intervention is now closed.
Trial: NCT04445246
Drug: Inhaled ILOPROST
RxNorm normalized name: iloprost Inhalation Solution
DrugBank: Iloprost (DB01088)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Inhaled Iloprost 20 mcg every 8 hours for 5 days only delivered by nebulization.
Trial: NCT02735707
Drug: Fixed-duration dexamethasone
RxNorm normalized name: Dexamethasone
DrugBank: Dexamethasone (DB01234)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: 6 mg of IV or enteral dexamethasone will be administered daily for up to 10 days while in hospital.
Trial: NCT02735707
Drug: Baloxavir Marboxil
RxNorm normalized name: Baloxavir Marboxil
DrugBank: Baloxavir marboxil (DB13997)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Baloxavir marboxil administered on days 1 and 4 post-randomisation.
Trial: NCT02735707
Drug: Five-days oseltamivir + baloxavir marboxil
DrugBank: Oseltamivir (DB00198)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Oseltamivir administered enterally twice daily for 5 days or until hospital discharge (whichever occurs first), in addition to baloxavir marboxil administered on days 1 and 4 post-randomisation.
Trial: NCT00071188
Drug: Paclitaxel
RxNorm normalized name: Paclitaxel
DrugBank: Paclitaxel (DB01229)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Trial: NCT00071188
Drug: Carboplatin
RxNorm normalized name: Carboplatin
DrugBank: Carboplatin (DB00958)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Trial: NCT02735707
Drug: Imatinib
RxNorm normalized name: Imatinib
DrugBank: Imatinib (DB00619)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Enteral imatinib will be administered as a single 800mg loading dose (study day 1) followed by 400mg daily until study day 14 or discharge.
Trial: NCT02735707
Drug: Tocilizumab
RxNorm normalized name: Tocilizumab
DrugBank: Tocilizumab (DB06273)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Tocilizumab will be administered as a single dose of 8mg/kg estimated or measured body weight, with a maximum total dose of 800mg. In children weighing less than 30kg, tocilizumab dose will be 12mg/kg.~Tocilizumab will be administered as an IV infusion via central or peripheral line over a one-hour period.
Trial: NCT02735707
Drug: Baricitinib
RxNorm normalized name: baricitinib
DrugBank: Baricitinib (DB11817)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Baricitinib will be administered at a dose that is determined by age and renal function, for up to 10 days or hospital discharge (whichever occurs first).
Trial: NCT02735707
Drug: Nirmatrelvir/ritonavir
RxNorm normalized name: NIRMATRELVIR/RITONAVIR
DrugBank: Ritonavir (DB00503)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Nirmatrelvir-ritonavir will be administered at a dose that is dependent on renal function, for five days.
Trial: NCT02735707
Drug: Remdesivir
RxNorm normalized name: remdesivir
DrugBank: Remdesivir (DB14761)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Remdesivir is administered at 200 mg on day one followed by 100 mg daily for a further four doses (i.e., for five doses in total) or until hospital discharge, whichever occurs first.
Trial: NCT02735707
Drug: Nirmatrelvir/ritonavir + remdesivir
DrugBank: Ritonavir (DB00503)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Nirmatrelvir-ritonavir will be administered at a dose that is dependent on renal function, for five days. Remdesivir is administered at 200 mg on day one followed by 100 mg daily for a further four doses (i.e., for five doses in total) or until hospital discharge, whichever occurs first.
Trial: NCT02614131
Drug: Solanezumab
RxNorm normalized name: Solanezumab
DrugBank: Solanezumab (DB11756)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Administered IV
Trial: NCT03352843
Drug: Primaquine
RxNorm normalized name: Primaquine
DrugBank: Primaquine (DB01087)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: All patients will be administered with a single low-dose of primaquine in addition to standard artemether-lumefantrine regimen, and then followed-up for 28 days for clinical and laboratory assessment to assess safety and efficacy.
Trial: NCT02473458
Drug: Licorice whole extract
RxNorm normalized name: LICORICE EXTRACT
DrugBank: Rice (DB10563)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Patients randomly received one of below capsules labeled with codes during the first 24 hours after stroke attack:~1. Starch-filled capsules (as placebo)~2. 450 mg whole licorice extract capsules~3. 900 mg whole licorice extract capsules
Trial: NCT01280682
Drug: rituximab
RxNorm normalized name: Rituximab
DrugBank: Rituximab (DB00073)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: anti-CD20 monoclonal antibody 125mg/m\^2 day1 day8 day15 day22 repeat after six months (only day1 and day8)
Trial: NCT00167401
Drug: docetaxel
RxNorm normalized name: Docetaxel
DrugBank: Docetaxel (DB01248)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT00167401
Drug: cisplatin
RxNorm normalized name: Cisplatin
DrugBank: Cisplatin (DB00515)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT00699712
Drug: CD-NP (Chimeric natriuretic peptide)
RxNorm normalized name: NP Thyroid Pill
DrugBank: Cenderitide (DB11777)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Infusion of CDNP at two of four doses
Trial: NCT00390624
Drug: URODILATIN (ULARITIDE, ATRIAL NATRIURETIC PEPTIDE)
RxNorm normalized name: Brain natriuretic peptide
DrugBank: .gamma.-brain natriuretic peptide (DB19026)
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT00390624
Drug: MANNITOL
RxNorm normalized name: Mannitol
DrugBank: Mannitol (DB00742)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT03209518
Drug: Leuprorelin acetate
RxNorm normalized name: Leuprorelin acetate
DrugBank: Leuprolide (DB00007)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Leuplin PRO for Injection Kit 22.5 mg
Trial: NCT01864213
Drug: Ametop cream
DrugBank: Sulfametopyrazine (DB00664)
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT03516006
Drug: UCMSC
RxNorm normalized name: HUCMSCs
DrugBank: Human Umbilical Cord Mesenchymal Stem Cells (DB15726)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: infusion of aUCMSC at day 0, 7, 14, and 21
Trial: NCT03516006
Drug: UDCA
RxNorm normalized name: UDCA
DrugBank: Ursodeoxycholic acid (DB01586)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: oral administration of ursodeoxycholic acid (UDCA) 15mg/kg/d
Trial: NCT00236899
Drug: Gemcitabine
RxNorm normalized name: Gemcitabine
DrugBank: Gemcitabine (DB00441)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Arm A: 1000 mg/m², 30 minute (min) intravenous (IV) infusion on Days 1 and 8, repeated every 21 days for 10 cycles for complete responders (CRs=disappearance of all target lesions) or partial responders (PRs≥30% decrease in sum of longest diameter of target lesions); 6 cycles for stable disease (SD=small changes that do not meet the above criteria); or until progressive disease (PD≥20% increase in sum of longest diameter of target lesions).~Arm B: 1250 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Arm C: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Arm D: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Trial: NCT00236899
Drug: Docetaxel
RxNorm normalized name: Docetaxel
DrugBank: Docetaxel (DB01248)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Arm A: 75 milligram per square meter (mg/m²), 60 min IV infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Arm C: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15, to be given 30 min prior to Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Trial: NCT00236899
Drug: Paclitaxel
RxNorm normalized name: Paclitaxel
DrugBank: Paclitaxel (DB01229)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Arm B: 175 mg/m², IV infusion over approximately 3 hours, followed by Gemcitabine, on Day 1, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Arm D: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15, followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Trial: NCT02477280
Drug: Methylphenidate
RxNorm normalized name: Methylphenidate
DrugBank: Methylphenidate (DB00422)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Cross-over
Trial: NCT03555942
Drug: Follicular phase corifollitropin alfa
RxNorm normalized name: Darbepoetin Alfa
DrugBank: Follitropin (DB00066)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: GnRH antagonist protocol with corifollitropin alfa initiated in the follicular phase (day 2 or 3 of the menstrual cycle)
Trial: NCT03555942
Drug: Luteal phase corifollitropin alfa
RxNorm normalized name: Darbepoetin Alfa
DrugBank: Follitropin (DB00066)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: GnRH antagonist protocol with corifollitropin alfa initiated in the luteal phase (5 days after an LH peak)
Trial: NCT00934856
Drug: Docetaxel
RxNorm normalized name: Docetaxel
DrugBank: Docetaxel (DB01248)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Docetaxel will be administered on Day 1 of each 3-week cycle at a dose specified in the respective arms (as per summary of product characteristics \[SmPC\]).
Trial: NCT01332396
Drug: Lapatinib
RxNorm normalized name: Lapatinib
DrugBank: Lapatinib (DB01259)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Trial: NCT00284141
Drug: Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)
RxNorm normalized name: Aflibercept
DrugBank: Aflibercept (DB08885)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Aflibercept 4.0 mg/kg administered intravenously (IV) over a period of at least 1 hour once every 2 weeks.~Aflibercept could be reduced by 1 dose level (to 3.0 mg/kg) or 2 dose levels (to 2.0 mg/kg) in case of uncontrolled hypertension or urinary protein \>3.5 g/24 hours. Intrapatient dose escalation was not to be permitted. Participants requiring more than 2 dose level reductions would be withdrawn from study treatment.