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Addition of Daratumumab to Combination of Bortezomib and Dexamethasone in Participants With Relapsed or Refractory Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT02136134
Recruitment Status : Active, not recruiting
First Posted : May 12, 2014
Results First Posted : February 10, 2017
Last Update Posted : June 1, 2018
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Multiple Myeloma
Interventions: Drug: Daratumumab
Drug: VELCADE (Bortezomib)
Drug: Dexamethasone

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Bortezomib + Dexamethasone (Vd) Participants received bortezomib subcutaneously (SC) on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally (PO) at 20 milligram (mg) on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
Daratumumab + Bortezomib and Dexamethasone (DVd) Participants received daratumumab 16 milligram per kilogram (mg/kg) intravenous (IV) infusion weekly for the first 3 cycles, on Day 1 of Cycles 4-8, and then every 4 weeks thereafter, bortezomib SC administration on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally at 20 mg on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.

Participant Flow:   Overall Study
    Bortezomib + Dexamethasone (Vd)   Daratumumab + Bortezomib and Dexamethasone (DVd)
STARTED   247   251 
Treated   237   243 
COMPLETED   0   0 
NOT COMPLETED   247   251 
Death                35                29 
Withdrawal by Subject                14                4 
Other                3                3 
Ongoing                185                207 
Subjects randomized but not treated                10                8 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Bortezomib + Dexamethasone (Vd) Participants received bortezomib subcutaneously (SC) on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally (PO) at 20 milligram (mg) on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
Daratumumab + Bortezomib and Dexamethasone (DVd) Participants received daratumumab 16 milligram per kilogram (mg/kg) intravenous (IV) infusion weekly for the first 3 cycles, on Day 1 of Cycles 4-8, and then every 4 weeks thereafter, bortezomib SC administration on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally at 20 mg on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
Total Total of all reporting groups

Baseline Measures
   Bortezomib + Dexamethasone (Vd)   Daratumumab + Bortezomib and Dexamethasone (DVd)   Total 
Overall Participants Analyzed 
[Units: Participants]
 247   251   498 
Age 
[Units: Years]
Mean (Standard Deviation)
 63.9  (9.81)   62.8  (9.66)   63.3  (9.74) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      100  40.5%      114  45.4%      214  43.0% 
Male      147  59.5%      137  54.6%      284  57.0% 
Region of Enrollment 
[Units: Participants]
     
Australia   20   23   43 
Brazil   9   13   22 
Czech Republic   19   16   35 
Germany   21   21   42 
Hungary   14   16   30 
Italy   25   24   49 
Korea, Republic of   8   10   18 
Mexico   1   2   3 
Netherlands   14   11   25 
Poland   18   16   34 
Russian Federation   13   21   34 
Spain   19   10   29 
Sweden   9   10   19 
Turkey   14   14   28 
Ukraine   22   28   50 
United States   21   16   37 
Stage of Disease (ISS) [1] 
[Units: Participants]
     
 96   98   194 
II   100   94   194 
III   51   59   110 
[1] The International Staging System (ISS) consists of following 3 stages - Stage I: serum beta2-microglobulin less than (<)3.5 milligram per liter (mg/l) and albumin greater than or equal to (>=) 3.5 gram per 100 Milliliter (g/100 ml); Stage II: neither stage I nor stage III and Stage III: serum beta2-microglobulin >= 5.5 mg/l.
No. of Prior Lines of Therapy 
[Units: Participants]
     
 113   122   235 
 74   70   144 
 32   37   69 
>3   28   22   50 


  Outcome Measures

1.  Primary:   Progression-free Survival (PFS)   [ Time Frame: From the date of randomization to either progressive disease or death, whichever occurs first (approximately 3 years) ]

2.  Secondary:   Time to Disease Progression (TTP)   [ Time Frame: From the date of randomization to the date of first documented evidence of progression or death due to PD whichever occurs first (approximately 3 years) ]

3.  Secondary:   Percentage of Participants With a Very Good Partial Response (VGPR) or Better   [ Time Frame: Up to disease progression (approximately of 3 years) ]

4.  Secondary:   Overall Response Rate (ORR)   [ Time Frame: Up to disease progression (approximately of 3 years) ]

5.  Secondary:   Percentage of Participants With Negative Minimal Residual Disease (MRD)   [ Time Frame: Up to disease progression (approximately of 3 years) ]

6.  Secondary:   Overall Survival (OS)   [ Time Frame: Up to the end of the study (approximately of 3 years) ]


  Serious Adverse Events

Time Frame No text entered.
Additional Description Safety population included all randomized participants who had at least 1 administration of any of the study treatment (partial or complete).

Reporting Groups
  Description
Bortezomib + Dexamethasone (Vd) Participants received bortezomib subcutaneously (SC) on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally (PO) at 20 milligram (mg) on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
Daratumumab + Bortezomib and Dexamethasone (DVd) Participants received daratumumab 16 milligram per kilogram (mg/kg) intravenous (IV) infusion weekly for the first 3 cycles, on Day 1 of Cycles 4-8, and then every 4 weeks thereafter, bortezomib SC administration on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally at 20 mg on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.

Serious Adverse Events
    Bortezomib + Dexamethasone (Vd)   Daratumumab + Bortezomib and Dexamethasone (DVd)
Total, Serious Adverse Events     
# participants affected / at risk   80/237 (33.76%)   102/243 (41.98%) 
Blood and lymphatic system disorders     
Anaemia * 1     
# participants affected / at risk   1/237 (0.42%)   8/243 (3.29%) 
Febrile Neutropenia * 1     
# participants affected / at risk   0/237 (0.00%)   2/243 (0.82%) 
Neutropenia * 1     
# participants affected / at risk   0/237 (0.00%)   2/243 (0.82%) 
Thrombocytopenia * 1     
# participants affected / at risk   1/237 (0.42%)   6/243 (2.47%) 
Cardiac disorders     
Acute Coronary Syndrome * 1     
# participants affected / at risk   0/237 (0.00%)   1/243 (0.41%) 
Acute Myocardial Infarction * 1     
# participants affected / at risk   0/237 (0.00%)   1/243 (0.41%) 
Arrhythmia Supraventricular * 1     
# participants affected / at risk   0/237 (0.00%)   1/243 (0.41%) 
Atrial Fibrillation * 1     
# participants affected / at risk   0/237 (0.00%)   5/243 (2.06%) 
Cardiac Arrest * 1     
# participants affected / at risk   1/237 (0.42%)   1/243 (0.41%) 
Cardiac Failure * 1     
# participants affected / at risk   0/237 (0.00%)   1/243 (0.41%) 
Cardiac Failure Congestive * 1     
# participants affected / at risk   1/237 (0.42%)   2/243 (0.82%) 
Cardiogenic Shock * 1     
# participants affected / at risk   1/237 (0.42%)   1/243 (0.41%) 
Myocardial Infarction * 1     
# participants affected / at risk   2/237 (0.84%)   0/243 (0.00%) 
Ventricular Extrasystoles * 1     
# participants affected / at risk   1/237 (0.42%)   0/243 (0.00%) 
Endocrine disorders     
Adrenal Insufficiency * 1     
# participants affected / at risk   1/237 (0.42%)   0/243 (0.00%) 
Hyperthyroidism * 1     
# participants affected / at risk   0/237 (0.00%)   1/243 (0.41%) 
Eye disorders     
Diplopia * 1     
# participants affected / at risk   0/237 (0.00%)   1/243 (0.41%) 
Gastrointestinal disorders     
Abdominal Pain * 1     
# participants affected / at risk   3/237 (1.27%)   0/243 (0.00%) 
Abdominal Pain Upper * 1     
# participants affected / at risk   0/237 (0.00%)   1/243 (0.41%) 
Constipation * 1     
# participants affected / at risk   3/237 (1.27%)   0/243 (0.00%) 
Diarrhoea * 1     
# participants affected / at risk   0/237 (0.00%)   4/243 (1.65%) 
Diverticular Perforation * 1     
# participants affected / at risk   0/237 (0.00%)   1/243 (0.41%) 
Duodenal Ulcer * 1     
# participants affected / at risk   0/237 (0.00%)   1/243 (0.41%) 
Faecaloma * 1     
# participants affected / at risk   1/237 (0.42%)   0/243 (0.00%) 
Gastritis * 1     
# participants affected / at risk   0/237 (0.00%)   1/243 (0.41%) 
Incarcerated Umbilical Hernia * 1     
# participants affected / at risk   1/237 (0.42%)   0/243 (0.00%) 
Intestinal Obstruction * 1     
# participants affected / at risk   0/237 (0.00%)   1/243 (0.41%) 
Melaena * 1     
# participants affected / at risk   0/237 (0.00%)   1/243 (0.41%) 
Pancreatitis Acute * 1     
# participants affected / at risk   0/237 (0.00%)   1/243 (0.41%) 
Pancreatitis Chronic * 1     
# participants affected / at risk   0/237 (0.00%)   1/243 (0.41%) 
Small Intestinal Obstruction * 1     
# participants affected / at risk   0/237 (0.00%)   1/243 (0.41%) 
General disorders     
Asthenia * 1     
# participants affected / at risk   3/237 (1.27%)   0/243 (0.00%) 
Condition Aggravated * 1     
# participants affected / at risk   3/237 (1.27%)   0/243 (0.00%) 
Fatigue * 1     
# participants affected / at risk   0/237 (0.00%)   2/243 (0.82%) 
General Physical Health Deterioration * 1     
# participants affected / at risk   3/237 (1.27%)   1/243 (0.41%) 
Influenza Like Illness * 1     
# participants affected / at risk   1/237 (0.42%)   0/243 (0.00%) 
Oedema Peripheral * 1     
# participants affected / at risk   0/237 (0.00%)   1/243 (0.41%) 
Pain * 1     
# participants affected / at risk   0/237 (0.00%)   1/243 (0.41%) 
Pyrexia * 1     
# participants affected / at risk   4/237 (1.69%)   4/243 (1.65%) 
Infections and infestations     
Bacterial Infection * 1     
# participants affected / at risk   1/237 (0.42%)   0/243 (0.00%) 
Brain Abscess * 1     
# participants affected / at risk   1/237 (0.42%)   0/243 (0.00%) 
Bronchitis * 1     
# participants affected / at risk   1/237 (0.42%)   5/243 (2.06%) 
Bronchopneumonia * 1     
# participants affected / at risk   1/237 (0.42%)   3/243 (1.23%) 
Cellulitis * 1     
# participants affected / at risk   0/237 (0.00%)   1/243 (0.41%) 
Epididymitis * 1     
# participants affected / at risk   1/237 (0.42%)   0/243 (0.00%) 
Fungal Oesophagitis * 1     
# participants affected / at risk   0/237 (0.00%)   1/243 (0.41%) 
Gangrene * 1     
# participants affected / at risk   1/237 (0.42%)   0/243 (0.00%) 
Gastroenteritis * 1     
# participants affected / at risk   3/237 (1.27%)   2/243 (0.82%) 
Herpes Zoster * 1     
# participants affected / at risk   2/237 (0.84%)   1/243 (0.41%) 
Influenza * 1     
# participants affected / at risk   2/237 (0.84%)   0/243 (0.00%) 
Lobar Pneumonia * 1     
# participants affected / at risk   1/237 (0.42%)   0/243 (0.00%) 
Lower Respiratory Tract Infection * 1     
# participants affected / at risk   2/237 (0.84%)   2/243 (0.82%) 
Lung Infection * 1     
# participants affected / at risk   1/237 (0.42%)   1/243 (0.41%) 
Metapneumovirus Infection * 1     
# participants affected / at risk   0/237 (0.00%)   1/243 (0.41%) 
Nocardiosis * 1     
# participants affected / at risk   1/237 (0.42%)   0/243 (0.00%) 
Ophthalmic Herpes Simplex * 1     
# participants affected / at risk   1/237 (0.42%)   0/243 (0.00%) 
Peritonitis * 1     
# participants affected / at risk   0/237 (0.00%)   1/243 (0.41%) 
Pneumocystis Jirovecii Pneumonia * 1     
# participants affected / at risk   0/237 (0.00%)   1/243 (0.41%) 
Pneumonia * 1     
# participants affected / at risk   22/237 (9.28%)   19/243 (7.82%) 
Pneumonia Cytomegaloviral * 1     
# participants affected / at risk   0/237 (0.00%)   2/243 (0.82%) 
Pneumonia Pneumococcal * 1     
# participants affected / at risk   0/237 (0.00%)   1/243 (0.41%) 
Pulmonary Sepsis * 1     
# participants affected / at risk   0/237 (0.00%)   2/243 (0.82%) 
Pyelonephritis * 1     
# participants affected / at risk   0/237 (0.00%)   1/243 (0.41%) 
Pyelonephritis Chronic * 1     
# participants affected / at risk   1/237 (0.42%)   0/243 (0.00%) 
Respiratory Syncytial Virus Infection * 1     
# participants affected / at risk   0/237 (0.00%)   1/243 (0.41%) 
Respiratory Tract Infection * 1     
# participants affected / at risk   1/237 (0.42%)   0/243 (0.00%) 
Rhinovirus Infection * 1     
# participants affected / at risk   0/237 (0.00%)   1/243 (0.41%) 
Sepsis * 1     
# participants affected / at risk   2/237 (0.84%)   2/243 (0.82%) 
Septic Shock * 1     
# participants affected / at risk   1/237 (0.42%)   0/243 (0.00%) 
Sinusitis * 1     
# participants affected / at risk   0/237 (0.00%)   1/243 (0.41%) 
Tracheobronchitis * 1     
# participants affected / at risk   1/237 (0.42%)   0/243 (0.00%) 
Upper Respiratory Tract Infection * 1     
# participants affected / at risk   2/237 (0.84%)   4/243 (1.65%) 
Urinary Tract Infection * 1     
# participants affected / at risk   1/237 (0.42%)   0/243 (0.00%) 
Injury, poisoning and procedural complications     
Contusion * 1     
# participants affected / at risk   1/237 (0.42%)   0/243 (0.00%) 
Femur Fracture * 1     
# participants affected / at risk   0/237 (0.00%)   2/243 (0.82%) 
Hip Fracture * 1     
# participants affected / at risk   1/237 (0.42%)   1/243 (0.41%) 
Humerus Fracture * 1     
# participants affected / at risk   0/237 (0.00%)   2/243 (0.82%) 
Rib Fracture * 1     
# participants affected / at risk   1/237 (0.42%)   1/243 (0.41%) 
Spinal Fracture * 1     
# participants affected / at risk   0/237 (0.00%)   1/243 (0.41%) 
Subdural Haematoma * 1     
# participants affected / at risk   1/237 (0.42%)   0/243 (0.00%) 
Thoracic Vertebral Fracture * 1     
# participants affected / at risk   1/237 (0.42%)   0/243 (0.00%) 
Upper Limb Fracture * 1     
# participants affected / at risk   0/237 (0.00%)   1/243 (0.41%) 
Investigations     
Alanine Aminotransferase Increased * 1     
# participants affected / at risk   0/237 (0.00%)   1/243 (0.41%) 
Electrocardiogram QT Interval Abnormal * 1     
# participants affected / at risk   0/237 (0.00%)   1/243 (0.41%) 
Gamma-Glutamyltransferase Increased * 1     
# participants affected / at risk   0/237 (0.00%)   1/243 (0.41%) 
Metabolism and nutrition disorders     
Dehydration * 1     
# participants affected / at risk   2/237 (0.84%)   1/243 (0.41%) 
Hypercalcaemia * 1     
# participants affected / at risk   0/237 (0.00%)   2/243 (0.82%) 
Hyperglycaemia * 1     
# participants affected / at risk   2/237 (0.84%)   2/243 (0.82%) 
Hypoglycaemia * 1     
# participants affected / at risk   1/237 (0.42%)   0/243 (0.00%) 
Hyponatraemia * 1     
# participants affected / at risk   2/237 (0.84%)   0/243 (0.00%) 
Metabolic Acidosis * 1     
# participants affected / at risk   1/237 (0.42%)   1/243 (0.41%) 
Tumour Lysis Syndrome * 1     
# participants affected / at risk   0/237 (0.00%)   1/243 (0.41%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1     
# participants affected / at risk   0/237 (0.00%)   1/243 (0.41%) 
Back Pain * 1     
# participants affected / at risk   2/237 (0.84%)   1/243 (0.41%) 
Bone Pain * 1     
# participants affected / at risk   1/237 (0.42%)   2/243 (0.82%) 
Flank Pain * 1     
# participants affected / at risk   0/237 (0.00%)   1/243 (0.41%) 
Musculoskeletal Chest Pain * 1     
# participants affected / at risk   0/237 (0.00%)   1/243 (0.41%) 
Neck Pain * 1     
# participants affected / at risk   1/237 (0.42%)   0/243 (0.00%) 
Osteonecrosis of Jaw * 1     
# participants affected / at risk   1/237 (0.42%)   0/243 (0.00%) 
Pain in Extremity * 1     
# participants affected / at risk   2/237 (0.84%)   0/243 (0.00%) 
Pathological Fracture * 1     
# participants affected / at risk   0/237 (0.00%)   2/243 (0.82%) 
Spinal Pain * 1     
# participants affected / at risk   1/237 (0.42%)   1/243 (0.41%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Adenocarcinoma of Colon * 1     
# participants affected / at risk   0/237 (0.00%)   1/243 (0.41%) 
Breast Cancer * 1     
# participants affected / at risk   0/237 (0.00%)   1/243 (0.41%) 
Breast Cancer Recurrent * 1     
# participants affected / at risk   1/237 (0.42%)   0/243 (0.00%) 
Gastrointestinal Tract Adenoma * 1     
# participants affected / at risk   0/237 (0.00%)   1/243 (0.41%) 
Liposarcoma * 1     
# participants affected / at risk   0/237 (0.00%)   1/243 (0.41%) 
Plasmacytoma * 1     
# participants affected / at risk   0/237 (0.00%)   1/243 (0.41%) 
Squamous Cell Carcinoma of Skin * 1     
# participants affected / at risk   0/237 (0.00%)   1/243 (0.41%) 
Transitional Cell Carcinoma * 1     
# participants affected / at risk   0/237 (0.00%)   1/243 (0.41%) 
Nervous system disorders     
Cerebral Infarction * 1     
# participants affected / at risk   0/237 (0.00%)   1/243 (0.41%) 
Cerebrovascular Accident * 1     
# participants affected / at risk   1/237 (0.42%)   0/243 (0.00%) 
Embolic Stroke * 1     
# participants affected / at risk   0/237 (0.00%)   1/243 (0.41%) 
Headache * 1     
# participants affected / at risk   0/237 (0.00%)   1/243 (0.41%) 
Ischaemic Stroke * 1     
# participants affected / at risk   0/237 (0.00%)   2/243 (0.82%) 
Monoparesis * 1     
# participants affected / at risk   1/237 (0.42%)   0/243 (0.00%) 
Radicular Syndrome * 1     
# participants affected / at risk   0/237 (0.00%)   1/243 (0.41%) 
Restless Legs Syndrome * 1     
# participants affected / at risk   1/237 (0.42%)   0/243 (0.00%) 
Syncope * 1     
# participants affected / at risk   2/237 (0.84%)   1/243 (0.41%) 
Transient Ischaemic Attack * 1     
# participants affected / at risk   0/237 (0.00%)   1/243 (0.41%) 
Vith Nerve Paralysis * 1     
# participants affected / at risk   0/237 (0.00%)   1/243 (0.41%) 
Psychiatric disorders     
Confusional State * 1     
# participants affected / at risk   0/237 (0.00%)   1/243 (0.41%) 
Depressed Mood * 1     
# participants affected / at risk   0/237 (0.00%)   1/243 (0.41%) 
Depression * 1     
# participants affected / at risk   1/237 (0.42%)   0/243 (0.00%) 
Renal and urinary disorders     
Acute Kidney Injury * 1     
# participants affected / at risk   1/237 (0.42%)   3/243 (1.23%) 
Chronic Kidney Disease * 1     
# participants affected / at risk   1/237 (0.42%)   1/243 (0.41%) 
Haematuria * 1     
# participants affected / at risk   0/237 (0.00%)   1/243 (0.41%) 
Myeloma Cast Nephropathy * 1     
# participants affected / at risk   1/237 (0.42%)   0/243 (0.00%) 
Renal Impairment * 1     
# participants affected / at risk   0/237 (0.00%)   1/243 (0.41%) 
Urinary Retention * 1     
# participants affected / at risk   1/237 (0.42%)   0/243 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Asthma * 1     
# participants affected / at risk   0/237 (0.00%)   1/243 (0.41%) 
Chronic Obstructive Pulmonary Disease * 1     
# participants affected / at risk   1/237 (0.42%)   1/243 (0.41%) 
Epistaxis * 1     
# participants affected / at risk   0/237 (0.00%)   2/243 (0.82%) 
Hydrothorax * 1     
# participants affected / at risk   0/237 (0.00%)   1/243 (0.41%) 
Hyperventilation * 1     
# participants affected / at risk   0/237 (0.00%)   1/243 (0.41%) 
Laryngeal Oedema * 1     
# participants affected / at risk   0/237 (0.00%)   1/243 (0.41%) 
Organising Pneumonia * 1     
# participants affected / at risk   0/237 (0.00%)   1/243 (0.41%) 
Oropharyngeal Swelling * 1     
# participants affected / at risk   0/237 (0.00%)   1/243 (0.41%) 
Pleural Effusion * 1     
# participants affected / at risk   0/237 (0.00%)   2/243 (0.82%) 
Pneumonia Aspiration * 1     
# participants affected / at risk   0/237 (0.00%)   1/243 (0.41%) 
Pulmonary Alveolar Haemorrhage * 1     
# participants affected / at risk   1/237 (0.42%)   0/243 (0.00%) 
Pulmonary Artery Thrombosis * 1     
# participants affected / at risk   0/237 (0.00%)   1/243 (0.41%) 
Pulmonary Embolism * 1     
# participants affected / at risk   2/237 (0.84%)   1/243 (0.41%) 
Pulmonary Haemorrhage * 1     
# participants affected / at risk   0/237 (0.00%)   1/243 (0.41%) 
Pulmonary Oedema * 1     
# participants affected / at risk   1/237 (0.42%)   0/243 (0.00%) 
Respiratory Failure * 1     
# participants affected / at risk   2/237 (0.84%)   2/243 (0.82%) 
Vascular disorders     
Hypertension * 1     
# participants affected / at risk   0/237 (0.00%)   1/243 (0.41%) 
Hypertensive Crisis * 1     
# participants affected / at risk   0/237 (0.00%)   1/243 (0.41%) 
Orthostatic Hypotension * 1     
# participants affected / at risk   2/237 (0.84%)   0/243 (0.00%) 
Peripheral Artery Aneurysm * 1     
# participants affected / at risk   0/237 (0.00%)   1/243 (0.41%) 
* Events were collected by non-systematic assessment
1 Term from vocabulary, MedDRA Version 18.0




  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Director, Clinical Research
Organization: Janssen R&D US
e-mail: ClinicalTrialDisclosure@its.jnj.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT02136134     History of Changes
Obsolete Identifiers: NCT01620879
Other Study ID Numbers: CR103995
2014-000255-85 ( EudraCT Number )
54767414MMY3004 ( Other Identifier: Janssen Research & Development, LLC )
First Submitted: May 1, 2014
First Posted: May 12, 2014
Results First Submitted: December 20, 2016
Results First Posted: February 10, 2017
Last Update Posted: June 1, 2018