NCT01564537 is a Phase 3 clinical trial of Ixazomib in Relapsed Multiple Myeloma, sponsored by Takeda.

Who is sponsoring NCT01564537?

NCT01564537 is sponsored by Takeda.

What drugs are being tested in NCT01564537?

Interventions in NCT01564537: Ixazomib, Lenalidomide, Dexamethasone, Placebo.

What condition does NCT01564537 study?

NCT01564537 studies Relapsed Multiple Myeloma, Refractory Multiple Myeloma.

Is NCT01564537 still recruiting?

NCT01564537 is currently completed. Last updated 10 March 2023.

Are results published for NCT01564537?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2023-03-10 · How we verify

NCT01564537

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Phase 3 Study Comparing Oral Ixazomib Plus Lenalidomide and Dexamethasone Versus Placebo Plus Lenalidomide and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma

Completed Phase 3 Results posted Last updated 10 March 2023

What this trial tests

Phase 3 trial testing Ixazomib in Relapsed Multiple Myeloma in 722 participants. Completed in 8 February 2022.

Timeline

1 August 2012

Primary endpoint
1 October 2014

8 February 2022

Quick facts

Lead sponsor	Takeda
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	722
Start date	1 August 2012
Primary completion	1 October 2014
Estimated completion	8 February 2022
Sites	24 locations across Canada, United States

Drugs / interventions tested

Ixazomib (IXAZOMIB) — full drug profile →
Lenalidomide — full drug profile →
Dexamethasone (dexamethasone) — full drug profile →
Placebo

Conditions studied

Relapsed Multiple Myeloma — all drugs for Relapsed Multiple Myeloma →
Refractory Multiple Myeloma — all drugs for Refractory Multiple Myeloma →

Sponsor

Takeda — full company profile →

Who can join

18 and older, any sex, with Relapsed Multiple Myeloma or Refractory Multiple Myeloma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Progression Free Survival (PFS) as Assessed by the Independent Review Committee (IRC) Primary · From date of randomization until disease progression or death up to approximately 27 months (approximate median follow-up 15 months)

Progression Free Survival (PFS) is defined as the time from the date of randomization to the date of first documentation of disease progression (PD) or death due to any cause, whichever occurs first. Response including PD was assessed by independent review committee (IRC) using the International Myeloma Working Group (IMWG) response criteria. PD requires 1 of the following: Increase of ≥ 25% from nadir in: Serum M-component (absolute increase ≥ 0.5 g/dl); Urine M-component (absolute increase ≥ 200 mg/24 hours); In patients without measurable serum and urine M-protein levels the difference betw

Group	Value	95% CI
Ixazomib+ Lenalidomide + Dexamethasone	20.6	17.02 – NA
Placebo + Lenalidomide + Dexamethasone	14.7	12.91 – 17.58

Overall Survival (OS) Secondary · From date of randomization until death (up to approximately 97 months)

Overall survival is defined as the time from the date of randomization to the date of death. Participants without documentation of death at the time of the analysis were censored at the date when they were last known to be alive.

Group	Value	95% CI
Ixazomib+ Lenalidomide + Dexamethasone	53.6	49.25 – 62.95
Placebo + Lenalidomide + Dexamethasone	51.6	44.78 – 59.14

Overall Survival in High-Risk Participants Carrying Deletion 17 [Del(17)] Secondary · From the time of screening until disease progression and thereafter every 12 weeks until death or study termination (up to approximately 97 months)

Overall survival is defined as the time from the date of randomization to the date of death. The high-risk participants whose myeloma carried del(17) subgroup was defined as the cases reported as positive for del(17) by the central laboratory combined with those cases that lacked a central laboratory result but with known del (17) by local laboratory. Participants without documentation of death at the time of the analysis were censored at the date when they were last known to be alive. Data is only reported high-risk participants with Del(17).

Group	Value	95% CI
Ixazomib+ Lenalidomide + Dexamethasone	42.2	27.56 – 56.74
Placebo + Lenalidomide + Dexamethasone	29.4	16.99 – 44.22

Overall Response Rate (ORR) as Assessed by the IRC Secondary · Day 1 of each cycle (every 4 weeks) until disease progression up to approximately 27 months(approximate median follow-up 15 months)

ORR was defined as the percentage of participants with Complete Response (CR) including stringent complete response (sCR), very good partial response (VGPR) and Partial Response (PR) assessed by the IRC using IMWG criteria. Percentages are rounded off to single decimal.

Group	Value	95% CI
Ixazomib+ Lenalidomide + Dexamethasone	78.3
Placebo + Lenalidomide + Dexamethasone	71.5

Percentage of Participants With Complete Response (CR) and Very Good Partial Response (VGPR) as Assessed by the IRC Secondary · Day 1 of each cycle (every 4 weeks) until disease progression up to approximately 27 months (approximate median follow-up 15 months)

Response was assessed by the IRC using International Myeloma Working Group (IMWG) Criteria. CR is defined as negative immunofixation on the serum and urine and; disappearance of any soft tissue plasmacytomas and; \< 5% plasma cells in bone marrow. VGPR is defined as Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level \< 100 mg per 24 hours. Percentages are rounded off to single decimal.

Group	Value	95% CI
Ixazomib + Lenalidomide + Dexamethasone	48.1
Placebo + Lenalidomide + Dexamethasone	39.0

Duration of Response (DOR) Secondary · Day 1 of each cycle (every 4 weeks) until disease progression up to approximately 38 months

DOR was measured as the time in months from the date of first documentation of a confirmed response of PR or better (CR \[including sCR\] + PR+ VGPR) to the date of the first documented disease progression (PD) among participants who responded to the treatment. Response was assessed by the investigator using International Myeloma Working Group (IMWG) Criteria.

Group	Value	95% CI
Ixazomib+ Lenalidomide + Dexamethasone	26.0	22.51 – NA
Placebo + Lenalidomide + Dexamethasone	21.7	17.77 – NA

Time to Progression (TTP) as Assessed by the IRC Secondary · Day 1 of each cycle (every 4 weeks) until disease progression up to approximately 27 months (approximate median follow-up 15 months)

TTP was measured as the time in months from the first dose of study treatment to the date of the first documented progressive disease (PD) as assessed by the IRC using IMWG criteria.

Group	Value	95% CI
Ixazomib+ Lenalidomide + Dexamethasone	22.4	18.73 – 27.66
Placebo + Lenalidomide + Dexamethasone	17.6	14.52 – 20.27

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Secondary · From the date of signing of the informed consent form through 30 days after the last dose of study drug up to approximately 115 months

Eastern Cooperative Oncology Group (ECOG) performance score, laboratory values, vital sign measurements and reported adverse events (AEs) were collected and assessed to evaluate the safety of therapy throughout the study. An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a d

TEAEs

Group	Value	95% CI
Ixazomib+ Lenalidomide + Dexamethasone	359
Placebo + Lenalidomide + Dexamethasone	357

SAEs

Group	Value	95% CI
Ixazomib+ Lenalidomide + Dexamethasone	205
Placebo + Lenalidomide + Dexamethasone	201

Number of Participants With Change From Baseline in Pain Response Secondary · Baseline and end of treatment (EOT) (up to approximately 38 months)

Pain response was defined as 30% reduction from Baseline in Brief Pain Inventory-Short Form (BPI-SF) worst pain score over the last 24 hours without an increase in analgesic (oral morphine equivalents) use at 2 consecutive evaluations. The BPI-SF contains 15 items designed to capture the pain severity ("worst," "least," "average," and "now" \[current pain\]), pain location, medication to relieve the pain, and the interference of pain with various daily activities including general activity, mood, walking activity, normal work, relations with other people, sleep, and enjoyment of life. The pain

Baseline

Group	Value	95% CI
Ixazomib+ Lenalidomide + Dexamethasone	345
Placebo + Lenalidomide + Dexamethasone	351

EOT

Group	Value	95% CI
Ixazomib+ Lenalidomide + Dexamethasone	145
Placebo + Lenalidomide + Dexamethasone	153

Change From Baseline in the European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) Questionnaire (EORTC-QLQ-C30) Secondary · Baseline, EOT and follow-up (up to approximately 97 months)

The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer participants. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).The EORTC-QLQ-C30 Global Health Status/QOL Scale is scored between 0 and 100, where higher scores indicate better Global Health Status/QOL. Negative changes from baseline indicate deterioration in QOL or functioni

Global Health Index: Baseline

Group	Value	95% CI
Ixazomib+ Lenalidomide + Dexamethasone	58.4	± 22.60
Placebo + Lenalidomide + Dexamethasone	56.4	± 22.12

Global Health Index: End of Treatment

Group	Value	95% CI
Ixazomib+ Lenalidomide + Dexamethasone	-6.0	± 24.6
Placebo + Lenalidomide + Dexamethasone	-6.0	± 23.85

Global Health Index: Last Follow-up

Group	Value	95% CI
Placebo + Lenalidomide + Dexamethasone	16.7	± NA

Physical Functioning: Baseline

Group	Value	95% CI
Ixazomib+ Lenalidomide + Dexamethasone	70.0	± 21.74
Placebo + Lenalidomide + Dexamethasone	67.3	± 23.54

Physical Functioning: EOT

Group	Value	95% CI
Ixazomib+ Lenalidomide + Dexamethasone	-4.7	± 22.61
Placebo + Lenalidomide + Dexamethasone	-6.2	± 23.36

Physical Functioning: Last Follow-up

Group	Value	95% CI
Placebo + Lenalidomide + Dexamethasone	0.0	± NA

Role Functioning: Baseline

Group	Value	95% CI
Ixazomib+ Lenalidomide + Dexamethasone	68.4	± 28.75
Placebo + Lenalidomide + Dexamethasone	64.4	± 30.24

Role Functioning: EOT

Group	Value	95% CI
Ixazomib+ Lenalidomide + Dexamethasone	-8.6	± 31.27
Placebo + Lenalidomide + Dexamethasone	-8.6	± 32.90

Change From Baseline in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY-20) Secondary · Baseline, EOT and follow-up (up to approximately 97 months)

The EORTC-QLQ-MY-20 is a patient-completed, 20-question quality of life questionnaire that has 4 independent subscales, 2 functional subscales (body image, future perspective), and 2 symptoms scales (disease symptoms and side-effects of treatment). The participant answers questions about their health during the past week using a 4-point scale where 1=Not at All to 4=Very Much. A negative change from Baseline indicates improvement. Scores are linearly transformed to a 0-100 scale. Higher scores on the symptom scales (e.g. Disease Symptoms, Side Effects of Treatment) represent higher levels of s

Disease Symptoms: Baseline

Group	Value	95% CI
Ixazomib+ Lenalidomide + Dexamethasone	29.71	± 20.850
Placebo + Lenalidomide + Dexamethasone	30.41	± 23.072

Disease Symptoms: EOT

Group	Value	95% CI
Ixazomib+ Lenalidomide + Dexamethasone	-2.35	± 20.752
Placebo + Lenalidomide + Dexamethasone	-2.58	± 21.372

Disease Symptoms: Last Follow-up

Group	Value	95% CI
Ixazomib+ Lenalidomide + Dexamethasone	1.11	± NA

Side Effects of Treatment: Baseline

Group	Value	95% CI
Ixazomib+ Lenalidomide + Dexamethasone	17.23	± 14.289
Placebo + Lenalidomide + Dexamethasone	17.97	± 14.682

Side Effects of Treatment: EOT

Group	Value	95% CI
Ixazomib+ Lenalidomide + Dexamethasone	4.52	± 14.435
Placebo + Lenalidomide + Dexamethasone	4.43	± 13.955

Side Effects of Treatment: Last Follow-up

Group	Value	95% CI
Placebo + Lenalidomide + Dexamethasone	37.04	± NA

Body Image: Baseline

Group	Value	95% CI
Ixazomib+ Lenalidomide + Dexamethasone	78.00	± 29.259
Placebo + Lenalidomide + Dexamethasone	79.48	± 27.233

Body Image: EOT

Group	Value	95% CI
Ixazomib+ Lenalidomide + Dexamethasone	-0.27	± 29.102
Placebo + Lenalidomide + Dexamethasone	-5.38	± 29.368

OS in High-Risk Participants Secondary · From the time of screening until disease progression and thereafter every 12 weeks until death or study termination (up to approximately 97 months)

Overall survival (OS) is defined as the time from the date of randomization to the date of death. High-risk participants are defined as participants carrying cytogenic abnormalities: del(17), translocation t(4;14), or t(14;16) as reported by the central laboratory combined with those cases that lacked a central laboratory result but with known del (17), t(4;14), or t(14;16) by local laboratory. Cytogenetic abnormalities of del(13) and +1q are not included in the analysis. Participants without documentation of death at the time of the analysis were censored at the date when they were last known

Group	Value	95% CI
Ixazomib+ Lenalidomide + Dexamethasone	46.9	34.04 – 64.53
Placebo + Lenalidomide + Dexamethasone	30.9	24.77 – 42.25

Adverse events — posted to ClinicalTrials.gov

Time frame: From the date of signing of the informed consent form through 30 days after the last dose of study drug up to approximately 115 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Ixazomib+ Lenalidomide + Dexamethasone

Serious: 205/361 (57%)

Deaths: 250/361

Placebo + Lenalidomide + Dexamethasone

Serious: 202/359 (56%)

Deaths: 251/359

Serious adverse events (326 terms)

Reaction	System	Ixazomib+ Lenalidomide + D…	Placebo + Lenalidomide + D…
Pneumonia	Infections and infestations	—	—
Pyrexia	General disorders	—	—
Diarrhoea	Gastrointestinal disorders	—	—
Anaemia	Blood and lymphatic system disorders	—	—
Bronchitis	Infections and infestations	—	—
Febrile neutropenia	Blood and lymphatic system disorders	—	—
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—
Influenza	Infections and infestations	—	—
Atrial fibrillation	Cardiac disorders	—	—
Cataract	Eye disorders	—	—
Deep vein thrombosis	Vascular disorders	—	—
Respiratory tract infection	Infections and infestations	—	—
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Acute kidney injury	Renal and urinary disorders	—	—
Cardiac failure	Cardiac disorders	—	—
Lower respiratory tract infection	Infections and infestations	—	—
Syncope	Nervous system disorders	—	—
Thrombocytopenia	Blood and lymphatic system disorders	—	—
Urinary tract infection	Infections and infestations	—	—
Cholecystitis acute	Hepatobiliary disorders	—	—
Gastroenteritis	Infections and infestations	—	—
Myocardial infarction	Cardiac disorders	—	—
Pathological fracture	Musculoskeletal and connective tissue disorders	—	—
Sepsis	Infections and infestations	—	—

Other adverse events (80 terms — click to expand)

Reaction	System	Ixazomib+ Lenalidomide + D…	Placebo + Lenalidomide + D…
Diarrhoea	Gastrointestinal disorders	—	—
Constipation	Gastrointestinal disorders	—	—
Anaemia	Blood and lymphatic system disorders	—	—
Nausea	Gastrointestinal disorders	—	—
Fatigue	General disorders	—	—
Neutropenia	Blood and lymphatic system disorders	—	—
Insomnia	Psychiatric disorders	—	—
Muscle spasms	Musculoskeletal and connective tissue disorders	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—
Oedema peripheral	General disorders	—	—
Upper respiratory tract infection	Infections and infestations	—	—
Thrombocytopenia	Blood and lymphatic system disorders	—	—
Vomiting	Gastrointestinal disorders	—	—
Nasopharyngitis	Infections and infestations	—	—
Peripheral sensory neuropathy	Nervous system disorders	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—
Bronchitis	Infections and infestations	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—
Pyrexia	General disorders	—	—
Asthenia	General disorders	—	—
Cataract	Eye disorders	—	—
Hypokalaemia	Metabolism and nutrition disorders	—	—
Dizziness	Nervous system disorders	—	—
Headache	Nervous system disorders	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—
Pneumonia	Infections and infestations	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—
Urinary tract infection	Infections and infestations	—	—
Fall	Injury, poisoning and procedural complications	—	—
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	—	—
Tremor	Nervous system disorders	—	—
Abdominal pain	Gastrointestinal disorders	—	—
Platelet count decreased	Investigations	—	—
Weight decreased	Investigations	—	—
Neuropathy peripheral	Nervous system disorders	—	—
Bone pain	Musculoskeletal and connective tissue disorders	—	—
Conjunctivitis	Infections and infestations	—	—
Rash maculo-papular	Skin and subcutaneous tissue disorders	—	—

Most-reported serious reactions: Pneumonia, Pyrexia, Diarrhoea, Anaemia, Bronchitis, Febrile neutropenia, Pulmonary embolism, Back pain.

Data from ClinicalTrials.gov NCT01564537 adverse events section.

Sponsor's own description

The purpose of this study is to determine whether the addition of oral ixazomib to the background therapy of lenalidomide and dexamethasone improves progression free survival (PFS) in participants with relapsed and/or refractory multiple myeloma (RRMM).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Oral Ixazomib, Lenalidomide, and Dexamethasone for Multiple Myeloma.
Moreau P, Masszi T, Grzasko N, Bahlis NJ, et al · · 2016 · cited 787× · PMID 27119237 · DOI 10.1056/nejmoa1516282
Proteasome inhibitors in cancer therapy.
Manasanch EE, Orlowski RZ. · · 2017 · cited 743× · PMID 28117417 · DOI 10.1038/nrclinonc.2016.206
NF-κB signaling in inflammation and cancer.
Zhang T, Ma C, Zhang Z, Zhang H, et al · · 2021 · cited 386× · PMID 34977871 · DOI 10.1002/mco2.104
VTD is superior to VCD prior to intensive therapy in multiple myeloma: results of the prospective IFM2013-04 trial.
Moreau P, Hulin C, Macro M, Caillot D, et al · · 2016 · cited 191× · PMID 27002117 · DOI 10.1182/blood-2016-01-693580
Phase 1 study of twice-weekly ixazomib, an oral proteasome inhibitor, in relapsed/refractory multiple myeloma patients.
Richardson PG, Baz R, Wang M, Jakubowiak AJ, et al · · 2014 · cited 162× · PMID 24920586 · DOI 10.1182/blood-2014-01-548826
Phase 1 study of weekly dosing with the investigational oral proteasome inhibitor ixazomib in relapsed/refractory multiple myeloma.
Kumar SK, Bensinger WI, Zimmerman TM, Reeder CB, et al · · 2014 · cited 154× · PMID 24904120 · DOI 10.1182/blood-2014-01-548941
Proteasome inhibitors - molecular basis and current perspectives in multiple myeloma.
Kubiczkova L, Pour L, Sedlarikova L, Hajek R, et al · · 2014 · cited 139× · PMID 24712303 · DOI 10.1111/jcmm.12279
Targeting ubiquitination for cancer therapies.
Morrow JK, Lin HK, Sun SC, Zhang S. · · 2015 · cited 91× · PMID 26630263 · DOI 10.4155/fmc.15.148

Verify or expand the search:

Other trials of Ixazomib

Trials testing the same drug.

NCT05722405 — Ixazomib Plus Low-dose Lenalidomide Versus Ixazomib Alone for Maintenance Treatment of High Risk Multiple Myeloma · Phase 4 · recruiting
NCT05183139 — A Multicenter In-class Transition Study of Ixazomib Combined With Pomalidomide and Dexamethasone or With Lenalidomide an · Phase 4 · withdrawn
NCT04998786 — A Multi-center Open-label Phase 2 Study of Ixazomib, Iberdomide and Dexamethasone in Elderly Patients With Multiple Myel · Phase 2 · active not recruiting
NCT04837131 — A Study to Evaluate the Safety and Tolerability of Oral Ixazomib in Scleroderma-related Lung Disease Patients · Phase 2 · terminated
NCT03888534 — Intravenous Ixazomib in Pediatric Participants With Relapsed or Refractory Acute Lymphoblastic Leukemia (ALL) or Lymphob · Phase 1 · withdrawn

Other recruiting trials for Relapsed Multiple Myeloma

Currently open trials in the same condition.

NCT06348108 — Talquetamab in Combination With Iberdomide and Dexamethasone for Relapsed or Refractory Multiple Myeloma · Phase 1 · recruiting
NCT05896228 — Iberdomide, Daratumumab, Carfilzomib, and Dexamethasone (Iber-KDd) in Patients With Relapsed/Refractory Multiple Myeloma · Phase 2 · recruiting
NCT06119685 — IDP-023 as a Single Agent and in Combination With Antibody Therapies in Patients With Advanced Hematologic Cancers · Phase 1, PHASE2 · recruiting
NCT05577000 — Anti-BCMA Chimeric Antigen Receptor T Cells for Relapsed or Refractory Multiple Myeloma · Phase 1 · active not recruiting
NCT04965155 — A Trial for Relapsed Multiple Myeloma Patients (Isatuximab-dexamethasone) · Phase 2 · active not recruiting

Other Takeda trials

Trials by the same sponsor.

NCT05669729 — A Survey to Assess Participants', Caregivers', and Nurses' Use and Understanding of Educational Material on Velagluceras · not yet recruiting
NCT07403968 — A Study of Zasocitinib (TAK-279) in Adults With Active Crohn's Disease · Phase 2 · not yet recruiting
NCT07293364 — A Study to Learn About the C1-Inhibitor Function as Diagnosis for Hereditary Angioedema · NA · not yet recruiting
NCT07218393 — A Study About the Diagnosis and Management of Hereditary Angioedema (HAE) in Egypt · not yet recruiting
NCT07445087 — A Study of Takhzyro in Teenagers and Adults With Hereditary Angioedema (HAE) in South Korea · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01564537 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Takeda
Last refreshed: 10 March 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01564537.

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