NCT01850524 is a Phase 3 clinical trial of Ixazomib in Multiple Myeloma, sponsored by Millennium Pharmaceuticals, Inc..

Who is sponsoring NCT01850524?

NCT01850524 is sponsored by Millennium Pharmaceuticals, Inc..

What drugs are being tested in NCT01850524?

Interventions in NCT01850524: Ixazomib, Placebo, Dexamethasone, Lenalidomide.

What condition does NCT01850524 study?

NCT01850524 studies Multiple Myeloma.

Is NCT01850524 still recruiting?

NCT01850524 is currently completed. Last updated 21 July 2023.

Are results published for NCT01850524?

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

Last reviewed 2023-07-21 · How we verify

NCT01850524

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

IXAZOMIB Plus Lenalidomide and Dexamethasone Versus Placebo Plus Lenalidomide and Dexamethasone in Adult Patients With Newly Diagnosed Multiple Myeloma

Completed Phase 3 Results posted Last updated 21 July 2023

What this trial tests

Phase 3 trial testing Ixazomib in Multiple Myeloma in 705 participants. Completed in 24 June 2022.

Timeline

29 April 2013

Primary endpoint
2 December 2019

24 June 2022

Quick facts

Lead sponsor	Millennium Pharmaceuticals, Inc.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	705
Start date	29 April 2013
Primary completion	2 December 2019
Estimated completion	24 June 2022
Sites	147 locations across France, New Zealand, Russia, Belgium, South Korea, Canada, United States

Drugs / interventions tested

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

Conditions studied

Multiple Myeloma — all drugs for Multiple Myeloma →

Sponsor

Millennium Pharmaceuticals, Inc. — full company profile →

Who can join

18 and older, any sex, with 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) Primary · Up to approximately 79 months

PFS was defined as the time from the date of randomization to the date of first documentation of progressive disease (PD) or death due to any cause according to International Myeloma Working Group (IMWG) criteria whichever occurs first. PD required one of the following: Increase of \>=25% from nadir in: Serum M-component and/or (the absolute increase must be \>=0.5 g/dL); Urine M-component and/or (the absolute increase must be \>=200 mg/24 hours); in participants without measurable serum and urine M-protein levels: the difference between involved and uninvolved free light chain (FLC) levels (a

Group	Value	95% CI
Placebo + LenDex	21.8	19.65 – 30.78
Ixazomib + LenDex	35.3	26.45 – 43.70

Overall Survival (OS) Secondary · From the date of randomization to death due to any cause (Up to approximately 9 years)

OS was defined as the time from the date of randomization to the date of death. Participants without documented death at the time of analysis are censored at the date last known to be alive.

Group	Value	95% CI
Placebo + LenDex	NA	58.71 – NA
Ixazomib + LenDex	NA	63.18 – NA

Complete Response (CR) Rate Secondary · Up to approximately 9 years

CR rate was defined as the percentage of participants who achieve CR assessed by an IRC relative to the intent-to-treat (ITT) population during the treatment period. Percentage of participants with CR, as assessed by IMWG disease assessment criteria were reported. CR was defined as negative immunofixation of serum and urine along with the disappearance of any soft tissue plasmacytomas and \<5 % plasma cells (PC's) in bone marrow.

Group	Value	95% CI
Placebo + LenDex	14
Ixazomib + LenDex	26

Pain Response Rate as Assessed by the Brief Pain Inventory- Short Form (BPI-SF) and Analgesic Use Secondary · Up to approximately 9 years

Pain response rate was defined as percentage of participants with pain response. Pain response was defined as the occurrence of at least a 30% reduction from baseline in BPI-SF worst pain score over the last 24 hours without an increase in analgesic use for 2 consecutive measurements \> 28 days apart, were reported. Brief Pain Inventory - Short Form (m-BPI-SF) is a participant rated 11-point Likert rating scale ranged from 0 (no pain) to 10 (worst pain imaginable). Percentages are rounded off to the nearest single decimal.

Group	Value	95% CI
Placebo + LenDex	51.3
Ixazomib + LenDex	50.5

Overall Response Rate (ORR) Secondary · Up to approximately 9 years

ORR was defined as the percentage of participants who achieved CR + partial response (PR) + very good partial response (VGPR) (including sCR) or better relative to the ITT population during treatment period. CR was defined as negative immunofixation of serum and urine along with the disappearance of any soft tissue plasmacytomas and \<5 % PC's in bone marrow. PR was defined as ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% along with ≥50% reduction in the size of soft tissue plasmacytomas. VGPR was defined as ≥90% in serum M-component plus urine M-componen

Group	Value	95% CI
Placebo + LenDex	80
Ixazomib + LenDex	82

Time to Response Secondary · Up to approximately 9 years

Time to response was defined as the time from the date of randomization to the first documentation of PR or better, as measured by IMWG criteria.

Group	Value	95% CI
Placebo + LenDex	1.87	1.15 – 1.87
Ixazomib + LenDex	1.02	0.99 – 1.08

Duration of Response Secondary · Up to approximately 9 years

Duration of response was measured as the time from the date of first documentation of PR or better to the date of first documented progression (PD) for responders, as measured by IMWG criteria.

Group	Value	95% CI
Placebo + LenDex	37.5	25.69 – 50.27
Ixazomib + LenDex	50.6	39.98 – NA

Time to Progression (TTP) Secondary · Up to approximately 9 years

Time to progression was defined as the time from randomization to the date of first documented disease progression.

Group	Value	95% CI
Placebo + LenDex	26.8	21.22 – 37.91
Ixazomib + LenDex	45.8	31.84 – 56.25

Progression Free Survival (PFS)-2 Secondary · Up to approximately 9 years

PFS2 was defined as the time from the date of randomization to the date of documentation of disease progression on the subsequent line of anticancer therapy, as assessed by the investigator in accordance with IMWG criteria, or death due to any cause, whichever occurs first.

Group	Value	95% CI
Placebo + LenDex	52.2	45.21 – 61.90
Ixazomib + LenDex	63.2	54.70 – NA

Number of Participants With Shifts From Baseline to Worst Value in Eastern Cooperative Oncology Group (ECOG) Performance Score Secondary · Up to approximately 9 years

Eastern Cooperative Oncology Group (ECOG) scale score ranged from 0 to 5, where 0 indicated normal activity and 5 indicated death. The data is reported for those categories where at least 1 participant had worst post-baseline value for each ECOG score.

Baseline Score 0, Post-Baseline Score 0

Group	Value	95% CI
Placebo + LenDex	23
Ixazomib + LenDex	23

Baseline Score 0, Post-Baseline Score 1

Group	Value	95% CI
Placebo + LenDex	57
Ixazomib + LenDex	52

Baseline Score 0, Post-Baseline Score 2

Group	Value	95% CI
Placebo + LenDex	20
Ixazomib + LenDex	23

Baseline Score 0, Post-Baseline Score 3

Group	Value	95% CI
Placebo + LenDex	2
Ixazomib + LenDex	10

Baseline Score 1, Post-Baseline Score 0

Group	Value	95% CI
Placebo + LenDex	1
Ixazomib + LenDex	1

Baseline Score 1, Post-Baseline Score 1

Group	Value	95% CI
Placebo + LenDex	96
Ixazomib + LenDex	104

Baseline Score 1, Post-Baseline Score 2

Group	Value	95% CI
Placebo + LenDex	72
Ixazomib + LenDex	57

Baseline Score 1, Post-Baseline Score 3

Group	Value	95% CI
Placebo + LenDex	18
Ixazomib + LenDex	9

Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Secondary · From the date of randomization through 30 days after the last dose of study drug up to end of study (up to approximately 9 years)

An AE was any untoward medical occurrence in a participant administered a medicinal investigational drug. The untoward medical occurrence does not necessarily have to have a causal relationship with treatment. An SAE is any untoward medical occurrence that results in death; is life-threatening; requires inpatient hospitalization or prolongation of present hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect or is a medically important event that may not be immediately life-threatening or result in death or hospitalization, but may je

TEAEs

Group	Value	95% CI
Placebo + LenDex (Exposure Up to 18 Cycles)	160
Ixazomib+ LenDex (Exposure Up to 18 Cycles)	163
Placebo + LenDex (Exposure ≥19 Cycles)	189
Ixazomib + LenDex (Exposure ≥19 Cycles)	191

SAEs

Group	Value	95% CI
Placebo + LenDex (Exposure Up to 18 Cycles)	105
Ixazomib+ LenDex (Exposure Up to 18 Cycles)	119
Placebo + LenDex (Exposure ≥19 Cycles)	119
Ixazomib + LenDex (Exposure ≥19 Cycles)	125

Number of Participants With Abnormal Serum Chemistry and Hematology Laboratory Values Based on Treatment-emergent Adverse Events (TEAEs) Secondary · From the date of randomization through 30 days after the last dose of study drug up to end of study (up to approximately 9 years)

The laboratory values assessment included serum chemistry and hematology. The Serum chemistry assessment included blood urea nitrogen (BUN), creatinine, bilirubin (total), urate, lactate dehydrogenase, phosphate, albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), alanine aminotransferase (ALT), glucose, sodium, potassium, calcium, chloride, carbon dioxide (CO2), magnesium, thyroid stimulating hormone (TSH). Hematology assessment included hemoglobin, hematocrit, platelet (count), leukocytes with differential neutrophils (ANC). Participants with abnormal serum chemistry labor

Hypokalaemia

Group	Value	95% CI
Placebo + LenDex (Exposure Up to 18 Cycles)	16
Ixazomib+ LenDex (Exposure Up to 18 Cycles)	33
Placebo + LenDex (Exposure ≥19 Cycles)	33
Ixazomib + LenDex (Exposure ≥19 Cycles)	39

Blood creatinine increased

Group	Value	95% CI
Placebo + LenDex (Exposure Up to 18 Cycles)	9
Ixazomib+ LenDex (Exposure Up to 18 Cycles)	6
Placebo + LenDex (Exposure ≥19 Cycles)	12
Ixazomib + LenDex (Exposure ≥19 Cycles)	16

Hypophosphataemia

Group	Value	95% CI
Placebo + LenDex (Exposure Up to 18 Cycles)	2
Ixazomib+ LenDex (Exposure Up to 18 Cycles)	9
Placebo + LenDex (Exposure ≥19 Cycles)	3
Ixazomib + LenDex (Exposure ≥19 Cycles)	9

Hypomagnesaemia

Group	Value	95% CI
Placebo + LenDex (Exposure Up to 18 Cycles)	8
Ixazomib+ LenDex (Exposure Up to 18 Cycles)	6
Placebo + LenDex (Exposure ≥19 Cycles)	11
Ixazomib + LenDex (Exposure ≥19 Cycles)	15

Hyponatraemia

Group	Value	95% CI
Placebo + LenDex (Exposure Up to 18 Cycles)	7
Ixazomib+ LenDex (Exposure Up to 18 Cycles)	10
Placebo + LenDex (Exposure ≥19 Cycles)	8
Ixazomib + LenDex (Exposure ≥19 Cycles)	7

Hyperglycaemia

Group	Value	95% CI
Placebo + LenDex (Exposure Up to 18 Cycles)	4
Ixazomib+ LenDex (Exposure Up to 18 Cycles)	7
Placebo + LenDex (Exposure ≥19 Cycles)	16
Ixazomib + LenDex (Exposure ≥19 Cycles)	6

Hypocalcaemia

Group	Value	95% CI
Placebo + LenDex (Exposure Up to 18 Cycles)	13
Ixazomib+ LenDex (Exposure Up to 18 Cycles)	6
Placebo + LenDex (Exposure ≥19 Cycles)	12
Ixazomib + LenDex (Exposure ≥19 Cycles)	4

Hyperkalaemia

Group	Value	95% CI
Placebo + LenDex (Exposure Up to 18 Cycles)	3
Ixazomib+ LenDex (Exposure Up to 18 Cycles)	7
Placebo + LenDex (Exposure ≥19 Cycles)	3
Ixazomib + LenDex (Exposure ≥19 Cycles)	3

Adverse events — posted to ClinicalTrials.gov

Time frame: From the date of randomization through 30 days after the last dose of study drug up to end of study (up to approximately 9 years). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo + LenDex (Exposure Up to 18 Cycles)

Serious: 105/160 (66%)

Deaths: 107/160

Ixazomib+ LenDex (Exposure Up to 18 Cycles)

Serious: 119/163 (73%)

Deaths: 95/163

Placebo + LenDex (Exposure ≥19 Cycles)

Serious: 119/189 (63%)

Deaths: 63/189

Ixazomib + LenDex (Exposure ≥19 Cycles)

Serious: 125/191 (65%)

Deaths: 63/191

Serious adverse events (360 terms)

Reaction	System	Placebo + LenDex (Exposure…	Ixazomib+ LenDex (Exposure…	Placebo + LenDex (Exposure…	Ixazomib + LenDex (Exposur…
Peripheral sensory neuropathy	Nervous system disorders	—	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—
Pathological fracture	Musculoskeletal and connective tissue disorders	—	—	—	—
Syncope	Nervous system disorders	—	—	—	—
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—
Dehydration	Metabolism and nutrition disorders	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—
Acute kidney injury	Renal and urinary disorders	—	—	—	—
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—
Bronchitis	Infections and infestations	—	—	—	—
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—
General physical health deterioration	General disorders	—	—	—	—
Cardiac failure congestive	Cardiac disorders	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—
Deep vein thrombosis	Vascular disorders	—	—	—	—
Confusional state	Psychiatric disorders	—	—	—	—
Sepsis	Infections and infestations	—	—	—	—
Septic shock	Infections and infestations	—	—	—	—
Gastroenteritis	Infections and infestations	—	—	—	—
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—
Small intestinal obstruction	Gastrointestinal disorders	—	—	—	—
Pyrexia	General disorders	—	—	—	—

Other adverse events (126 terms — click to expand)

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

Most-reported serious reactions: Peripheral sensory neuropathy, Decreased appetite, Pneumonia, Pathological fracture, Syncope, Basal cell carcinoma, Dehydration, Diarrhoea.

Data from ClinicalTrials.gov NCT01850524 adverse events section.

Sponsor's own description

The purpose of this study is to provide continued access to ixazomib and/or lenalidomide to participants who are continuing to have clinical benefit and to continue collecting relevant safety data to monitor safety in participants with Newly Diagnosed Multiple Myeloma (NDMM) who are not eligible for stem cell transplant.

Publications & conference data

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

Proteasome inhibitors in cancer therapy.
Manasanch EE, Orlowski RZ. · · 2017 · cited 743× · PMID 28117417 · DOI 10.1038/nrclinonc.2016.206
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
A phase 2 study of modified lenalidomide, bortezomib and dexamethasone in transplant-ineligible multiple myeloma.
O'Donnell EK, Laubach JP, Yee AJ, Chen T, et al · · 2018 · cited 123× · PMID 29740809 · DOI 10.1111/bjh.15261
A phase 1/2 study of the oral proteasome inhibitor ixazomib in relapsed or refractory AL amyloidosis.
Sanchorawala V, Palladini G, Kukreti V, Zonder JA, et al · · 2017 · cited 97× · PMID 28550039 · DOI 10.1182/blood-2017-03-771220
Developments in continuous therapy and maintenance treatment approaches for patients with newly diagnosed multiple myeloma.
Dimopoulos MA, Jakubowiak AJ, McCarthy PL, Orlowski RZ, et al · · 2020 · cited 87× · PMID 32054831 · DOI 10.1038/s41408-020-0273-x
Spotlight on ixazomib: potential in the treatment of multiple myeloma.
Muz B, Ghazarian RN, Ou M, Luderer MJ, et al · · 2016 · cited 87× · PMID 26811670 · DOI 10.2147/dddt.s93602

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 Multiple Myeloma

Currently open trials in the same condition.

NCT07200102 — Selinexor Maintenance Post CAR-T Cell Therapy for Multiple Myeloma · Phase 1 · recruiting
NCT07340853 — CRISPR Delivered Anti-BCMA Car-T Therapy for Relapsed or Refractory Multiple Myeloma · Phase 1 · recruiting
NCT07454382 — A Study of Elranatamab and Cyclophosphamide in People With Multiple Myeloma · Phase 2 · recruiting
NCT07266441 — A Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma · Phase 2 · recruiting
NCT07258511 — A Study Comparing JNJ-79635322 and an Anti-B-cell Maturation Antigen (BCMA)xCD3 Bispecific Antibody in Participants With · Phase 3 · recruiting

Other Millennium Pharmaceuticals, Inc. trials

Trials by the same sponsor.

NCT03888534 — Intravenous Ixazomib in Pediatric Participants With Relapsed or Refractory Acute Lymphoblastic Leukemia (ALL) or Lymphob · Phase 1 · withdrawn
NCT04056468 — A Study to Evaluate Pharmacokinetics (PK) and Safety of Oral Mobocertinib in Participants With Moderate or Severe Hepati · Phase 1 · completed
NCT04454918 — Study to Assess Absolute Bioavailability (ABA) of TAK-906 and to Characterize Mass Balance, Pharmacokinetics (PK), Metab · Phase 1 · completed
NCT04056455 — A Study of Mobocertinib Capsules in People With Severe Kidney Problems and People With Healthy Kidneys · Phase 1 · completed
NCT04091438 — A Study of a Single Intravenous Infusion Dose of TAK-925 in Participants With Idiopathic Hypersomnia · Phase 1 · completed

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 NCT01850524 (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 Millennium Pharmaceuticals, Inc.
Last refreshed: 21 July 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/NCT01850524.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing