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Trial record 76 of 372 for:    LENALIDOMIDE AND Dexamethasone

Phase 1 Pharmacokinetic Study of Oral Ixazomib Plus Lenalidomide and Dexamethasone in Adult Asian Participants With Relapsed and/or Refractory Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT01645930
Recruitment Status : Completed
First Posted : July 20, 2012
Results First Posted : November 8, 2018
Last Update Posted : November 8, 2018
Sponsor:
Information provided by (Responsible Party):
Takeda ( Millennium Pharmaceuticals, Inc. )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Multiple Myeloma
Interventions Drug: Ixazomib
Drug: Lenalidomide
Drug: Dexamethasone
Enrollment 43
Recruitment Details Participants took part in the study at 8 investigative sites in Singapore, Hong Kong and South Korea from 17 December 2012 to 11 April 2017. Data cut-off for the analysis was 14 July 2014.
Pre-assignment Details Asian participants with a diagnosis of relapsed and/or refractory multiple myeloma were enrolled and received a combination of ixazomib, lenalidomide and dexamethasone.
Arm/Group Title Ixazomib+Lenalidomide+Dexamethasone
Hide Arm/Group Description Ixazomib 4 mg, capsules, orally, once on Days 1, 8, and 15; lenalidomide 25 mg, capsules, orally, once on Days 1 through 21; and dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15, and 22 of a 28-day treatment cycle until progressive disease (PD) or unacceptable toxicity (up to 20 cycles)
Period Title: Overall Study
Started 43
Completed 0
Not Completed 43
Reason Not Completed
Participants Ongoing on Study Treatment             22
Progressive Disease             12
Adverse Event             4
Unsatisfactory Therapeutic Response             2
Withdrawal by Participant             2
Reason not Defined             1
Arm/Group Title Ixazomib+Lenalidomide+Dexamethasone
Hide Arm/Group Description Ixazomib 4 mg, capsules, orally, once on Days 1, 8, and 15; lenalidomide 25 mg, capsules, orally, once on Days 1 through 21; and dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15, and 22 of a 28-day treatment cycle until progressive disease (PD) or unacceptable toxicity (up to 20 cycles)
Overall Number of Baseline Participants 43
Hide Baseline Analysis Population Description
Safety Population included all participants who received at least one dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 43 participants
61.5  (9.84)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants
Female
16
  37.2%
Male
27
  62.8%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Not Hispanic or Latino Number Analyzed 43 participants
43
 100.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Asian Number Analyzed 43 participants
43
 100.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants
Singapore
21
  48.8%
Hong Kong
6
  14.0%
Korea, Republic Of
16
  37.2%
Height at Baseline  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 43 participants
160.2  (7.80)
Weight at Baseline  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 43 participants
60.6  (10.47)
1.Primary Outcome
Title Cmax: Maximum Observed Plasma Concentration for Ixazomib
Hide Description [Not Specified]
Time Frame Cycle 1, Day 1 pre-dose and multiple time-points (up to 168 hours) post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Pharmacokinetic (PK)-evaluable population, all participants who received protocol-specified dosing during Cycle 1, did not receive any excluded concomitant medications and had sufficient concentration-time data to permit reliable estimation of PK parameters, with data available for analysis.
Arm/Group Title Ixazomib+Lenalidomide+Dexamethasone
Hide Arm/Group Description:
Ixazomib 4 mg, capsules, orally, once on Days 1, 8, and 15; lenalidomide 25 mg, capsules, orally, once on Days 1 through 21; and dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15, and 22 of a 28-day treatment cycle until progressive disease (PD) or unacceptable toxicity (up to 20 cycles)
Overall Number of Participants Analyzed 22
Mean (Standard Deviation)
Unit of Measure: ng/mL
37.57  (31.701)
2.Primary Outcome
Title Cmax: Maximum Observed Plasma Concentration for Ixazomib
Hide Description [Not Specified]
Time Frame Cycle 1, Day 15 pre-dose and multiple time-points (up to 336 hours) post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK-evaluable population included all participants who received protocol-specified dosing during Cycle 1, did not receive any excluded concomitant medications and had sufficient concentration-time data to permit reliable estimation of PK parameters.
Arm/Group Title Ixazomib+Lenalidomide+Dexamethasone
Hide Arm/Group Description:
Ixazomib 4 mg, capsules, orally, once on Days 1, 8, and 15; lenalidomide 25 mg, capsules, orally, once on Days 1 through 21; and dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15, and 22 of a 28-day treatment cycle until progressive disease (PD) or unacceptable toxicity (up to 20 cycles)
Overall Number of Participants Analyzed 24
Mean (Standard Deviation)
Unit of Measure: ng/mL
57.57  (38.507)
3.Primary Outcome
Title Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Ixazomib
Hide Description [Not Specified]
Time Frame Cycle 1, Day 1 pre-dose and multiple time-points (up to 168 hours) post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the PK-evaluable population, all participants who received protocol-specified dosing during Cycle 1, did not receive any excluded concomitant medications and had sufficient concentration-time data to permit reliable estimation of PK parameters, with data available for analysis.
Arm/Group Title Ixazomib+Lenalidomide+Dexamethasone
Hide Arm/Group Description:
Ixazomib 4 mg, capsules, orally, once on Days 1, 8, and 15; lenalidomide 25 mg, capsules, orally, once on Days 1 through 21; and dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15, and 22 of a 28-day treatment cycle until progressive disease (PD) or unacceptable toxicity (up to 20 cycles)
Overall Number of Participants Analyzed 22
Median (Full Range)
Unit of Measure: hours
1.5
(0.5 to 7.0)
4.Primary Outcome
Title Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Ixazomib
Hide Description [Not Specified]
Time Frame Cycle 1, Day 15 pre-dose and multiple time-points (up to 336 hours) post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK-evaluable population included all participants who received protocol-specified dosing during Cycle 1, did not receive any excluded concomitant medications and had sufficient concentration-time data to permit reliable estimation of PK parameters.
Arm/Group Title Ixazomib+Lenalidomide+Dexamethasone
Hide Arm/Group Description:
Ixazomib 4 mg, capsules, orally, once on Days 1, 8, and 15; lenalidomide 25 mg, capsules, orally, once on Days 1 through 21; and dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15, and 22 of a 28-day treatment cycle until progressive disease (PD) or unacceptable toxicity (up to 20 cycles)
Overall Number of Participants Analyzed 24
Median (Full Range)
Unit of Measure: hours
2.0
(0.5 to 7.97)
5.Primary Outcome
Title AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for Ixazomib
Hide Description [Not Specified]
Time Frame Cycle 1, Day 1 pre-dose and multiple time-points (up to 168 hours) post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the PK-evaluable population, all participants who received protocol-specified dosing during Cycle 1, did not receive any excluded concomitant medications and had sufficient concentration-time data to permit reliable estimation of PK parameters, with data available for analysis.
Arm/Group Title Ixazomib+Lenalidomide+Dexamethasone
Hide Arm/Group Description:
Ixazomib 4 mg, capsules, orally, once on Days 1, 8, and 15; lenalidomide 25 mg, capsules, orally, once on Days 1 through 21; and dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15, and 22 of a 28-day treatment cycle until progressive disease (PD) or unacceptable toxicity (up to 20 cycles)
Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: hr*ng/mL
685.9  (246.35)
6.Primary Outcome
Title AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for Ixazomib
Hide Description [Not Specified]
Time Frame Cycle 1, Day 15 pre-dose and multiple time-points (up to 336 hours) post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK-evaluable population included all participants who received protocol-specified dosing during Cycle 1, did not receive any excluded concomitant medications and had sufficient concentration-time data to permit reliable estimation of PK parameters.
Arm/Group Title Ixazomib+Lenalidomide+Dexamethasone
Hide Arm/Group Description:
Ixazomib 4 mg, capsules, orally, once on Days 1, 8, and 15; lenalidomide 25 mg, capsules, orally, once on Days 1 through 21; and dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15, and 22 of a 28-day treatment cycle until progressive disease (PD) or unacceptable toxicity (up to 20 cycles)
Overall Number of Participants Analyzed 24
Mean (Standard Deviation)
Unit of Measure: hr*ng/mL
1746.0  (798.60)
7.Primary Outcome
Title Number of Participants With Dose Limiting Toxicities (DLTs)
Hide Description DLT was defined as any of the following AEs that were considered by investigator to be possibly related to therapy: 1. Grade 4 neutropenia lasting at least 7 consecutive days; 2. Grade 3 neutropenia with fever and/or infection; 3. Grade 4 thrombocytopenia at least 7 consecutive days; 4. Grade 3 thrombocytopenia with clinically significant bleeding; 5. Platelet count <10,000/mm^3; 6. Grade 2 peripheral neuropathy with pain or ≥Grade 3 peripheral neuropathy; 7. Grade 3 or greater nausea and / or emesis despite the use of optimal anti-emetic prophylaxis; 8. Grade 3 or greater diarrhea that occurred despite maximal supportive therapy; 9. Any other Grade 3 or greater nonhematologic toxicity with the following exceptions: Grade 3 arthralgia/myalgia, <1 week Grade 3 fatigue; 10. A delay of >2 weeks in the subsequent cycle of treatment; 11. Other combination study drug-related nonhematologic toxicities ≥Grade 2 that, in the opinion of the investigator, required discontinuation of study drug.
Time Frame Cycle 1 (up to Day 28)
Hide Outcome Measure Data
Hide Analysis Population Description
DLT-evaluable population consisted of participants who either had a DLT during Cycle 1 or received all scheduled doses and completed all study procedures in Cycle 1 without having a DLT.
Arm/Group Title Ixazomib+Lenalidomide+Dexamethasone
Hide Arm/Group Description:
Ixazomib 4 mg, capsules, orally, once on Days 1, 8, and 15; lenalidomide 25 mg, capsules, orally, once on Days 1 through 21; and dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15, and 22 of a 28-day treatment cycle until progressive disease (PD) or unacceptable toxicity (up to 20 cycles)
Overall Number of Participants Analyzed 24
Measure Type: Number
Unit of Measure: participants
2
8.Primary Outcome
Title Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide Description An Adverse Event (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. A SAE is defined as any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or was a medically important event.
Time Frame From the first dose of study drug through 30 days after the last dose of study drug (up to 577 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population was defined as all participants who received at least 1 dose of study drug.
Arm/Group Title Ixazomib+Lenalidomide+Dexamethasone
Hide Arm/Group Description:
Ixazomib 4 mg, capsules, orally, once on Days 1, 8, and 15; lenalidomide 25 mg, capsules, orally, once on Days 1 through 21; and dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15, and 22 of a 28-day treatment cycle until progressive disease (PD) or unacceptable toxicity (up to 20 cycles)
Overall Number of Participants Analyzed 43
Measure Type: Number
Unit of Measure: participants
AEs 43
SAEs 18
9.Primary Outcome
Title Number of Participants With Clinically Significant Laboratory Abnormalities Reported as Adverse Events of ≥Grade 3 Intensity
Hide Description Clinically significant laboratory abnormalities were defined as any test results which were observed beyond the clinically acceptable limits as per the discretion of investigator. Clinical laboratory tests included chemistry, hematology and urinalysis tests.
Time Frame From the first dose of study drug through 30 days after the last dose of study drug (up to 577 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population was defined as all participants who received at least 1 dose of study drug.
Arm/Group Title Ixazomib+Lenalidomide+Dexamethasone
Hide Arm/Group Description:
Ixazomib 4 mg, capsules, orally, once on Days 1, 8, and 15; lenalidomide 25 mg, capsules, orally, once on Days 1 through 21; and dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15, and 22 of a 28-day treatment cycle until progressive disease (PD) or unacceptable toxicity (up to 20 cycles)
Overall Number of Participants Analyzed 43
Measure Type: Number
Unit of Measure: participants
Alanine Aminotransferase Increased 2
Aspartate Aminotransferase Increased 1
Blood Creatinine Increased 1
Haemoglobin Decreased 1
Neutrophil Count Decreased 2
Platelet Count Decreased 4
Anaemia 6
Febrile Neutropenia 1
Neutropenia 12
Thrombocytopenia 8
Hyperglycaemia 1
Hypocalcaemia 3
Hypokalaemia 5
Hypomagnesaemia 1
Hyponatraemia 1
Hypophosphataemia 2
10.Primary Outcome
Title Number of Participants With Clinically Significant Vital Signs Reported as Adverse Events
Hide Description The number of participants who meet markedly abnormal criteria for vital signs, included diastolic and systolic blood pressure, heart rate, oral temperature, respiratory rate, and body weight.
Time Frame From the first dose of study drug through 30 days after the last dose of study drug (up to 577 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population was defined as all participants who received at least 1 dose of study drug.
Arm/Group Title Ixazomib+Lenalidomide+Dexamethasone
Hide Arm/Group Description:
Ixazomib 4 mg, capsules, orally, once on Days 1, 8, and 15; lenalidomide 25 mg, capsules, orally, once on Days 1 through 21; and dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15, and 22 of a 28-day treatment cycle until progressive disease (PD) or unacceptable toxicity (up to 20 cycles)
Overall Number of Participants Analyzed 43
Measure Type: Number
Unit of Measure: participants
Grade 1 or 2 Hypertension 4
Grade 2 Hypotension 1
11.Secondary Outcome
Title Percentage of Participants With Confirmed Best Response Category
Hide Description Percentage of participants who achieve or maintain any best response category during the treatment period were reported. Best response includes complete response (CR), very good partial response (VGPR), and partial response (PR). Response was assessed according to IMWG criteria. CR: negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in bone marrow; PR: ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to <200 mg per 24 hours. VGPR: serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein plus urine M-protein level <100 mg per 24 hour.
Time Frame From Cycle 1, Day 1 to Cycle 3, Day 1 until disease progression (approximately 20 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population was defined as all participants who received at least 1 dose of study drug.
Arm/Group Title Ixazomib+Lenalidomide+Dexamethasone
Hide Arm/Group Description:
Ixazomib 4 mg, capsules, orally, once on Days 1, 8, and 15; lenalidomide 25 mg, capsules, orally, once on Days 1 through 21; and dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15, and 22 of a 28-day treatment cycle until progressive disease (PD) or unacceptable toxicity (up to 20 cycles)
Overall Number of Participants Analyzed 43
Measure Type: Number
Unit of Measure: percentage of participants
53.5
12.Secondary Outcome
Title Duration of Response (DOR)
Hide Description DOR was defined as the length of time between the date of first documented response (PR, VGPR, or CR) and the date of first documented progressive disease (PD). According to IMWG criteria: CR: negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in bone marrow; PR: ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to <200 mg per 24 hours. VGPR: serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein plus urine M-protein level <100 mg per 24 hour.
Time Frame From date of documentation of a confirmed response to date of progressive disease, (approximately 20 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population was defined as all participants who received at least 1 dose of study drug.
Arm/Group Title Ixazomib+Lenalidomide+Dexamethasone
Hide Arm/Group Description:
Ixazomib 4 mg, capsules, orally, once on Days 1, 8, and 15; lenalidomide 25 mg, capsules, orally, once on Days 1 through 21; and dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15, and 22 of a 28-day treatment cycle until progressive disease (PD) or unacceptable toxicity (up to 20 cycles)
Overall Number of Participants Analyzed 43
Median (Full Range)
Unit of Measure: months
12.9
(1.8 to 15.0)
Time Frame First dose of study drug through 30 days after the last dose of study drug (up to 577 days)
Adverse Event Reporting Description At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
 
Arm/Group Title Ixazomib+Lenalidomide+Dexamethasone
Hide Arm/Group Description Ixazomib 4 mg, capsules, orally, once on Days 1, 8, and 15; lenalidomide 25 mg, capsules, orally, once on Days 1 through 21; and dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15, and 22 of a 28-day treatment cycle until progressive disease (PD) or unacceptable toxicity (up to 20 cycles)
All-Cause Mortality
Ixazomib+Lenalidomide+Dexamethasone
Affected / at Risk (%)
Total   0/43 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Ixazomib+Lenalidomide+Dexamethasone
Affected / at Risk (%)
Total   18/43 (41.86%) 
Blood and lymphatic system disorders   
Thrombocytopenia  1  1/43 (2.33%) 
Gastrointestinal disorders   
Diarrhoea  1  3/43 (6.98%) 
Gastritis atrophic  1  1/43 (2.33%) 
Vomiting  1  1/43 (2.33%) 
General disorders   
Pyrexia  1  1/43 (2.33%) 
General physical health deterioration  1  1/43 (2.33%) 
Immune system disorders   
Drug hypersensitivity  1  1/43 (2.33%) 
Food allergy  1  1/43 (2.33%) 
Infections and infestations   
Pneumonia  1  3/43 (6.98%) 
Lung infection  1  2/43 (4.65%) 
Diarrhoea infectious  1  1/43 (2.33%) 
Gastroenteritis  1  1/43 (2.33%) 
Upper respiratory tract infection  1  2/43 (4.65%) 
Injury, poisoning and procedural complications   
Laceration  1  1/43 (2.33%) 
Spinal fracture  1  1/43 (2.33%) 
Investigations   
Platelet count decreased  1  1/43 (2.33%) 
Blood creatinine increased  1  1/43 (2.33%) 
Metabolism and nutrition disorders   
Hypophagia  1  1/43 (2.33%) 
Hypokalaemia  1  1/43 (2.33%) 
Musculoskeletal and connective tissue disorders   
Back pain  1  2/43 (4.65%) 
Osteoporotic fracture  1  1/43 (2.33%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Plasmacytoma  1  2/43 (4.65%) 
Renal cell carcinoma  1  1/43 (2.33%) 
Nervous system disorders   
Presyncope  1  1/43 (2.33%) 
Spinal cord compression  1  1/43 (2.33%) 
Renal and urinary disorders   
Renal impairment  1  1/43 (2.33%) 
1
Term from vocabulary, MedDRA version: 16.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ixazomib+Lenalidomide+Dexamethasone
Affected / at Risk (%)
Total   43/43 (100.00%) 
Blood and lymphatic system disorders   
Neutropenia  1  13/43 (30.23%) 
Thrombocytopenia  1  13/43 (30.23%) 
Anaemia  1  12/43 (27.91%) 
Eye disorders   
Cataract  1  7/43 (16.28%) 
Gastrointestinal disorders   
Diarrhoea  1  23/43 (53.49%) 
Vomiting  1  15/43 (34.88%) 
Nausea  1  12/43 (27.91%) 
Constipation  1  10/43 (23.26%) 
Abdominal pain  1  5/43 (11.63%) 
Abdominal discomfort  1  4/43 (9.30%) 
Dyspepsia  1  4/43 (9.30%) 
Abdominal pain upper  1  3/43 (6.98%) 
Stomatitis  1  3/43 (6.98%) 
General disorders   
Fatigue  1  14/43 (32.56%) 
Pyrexia  1  8/43 (18.60%) 
Oedema peripheral  1  6/43 (13.95%) 
Asthenia  1  5/43 (11.63%) 
Influenza like illness  1  5/43 (11.63%) 
Infections and infestations   
Upper respiratory tract infection  1  15/43 (34.88%) 
Influenza  1  3/43 (6.98%) 
Nasopharyngitis  1  3/43 (6.98%) 
Pneumonia  1  3/43 (6.98%) 
Urinary tract infection  1  3/43 (6.98%) 
Injury, poisoning and procedural complications   
Spinal compression fracture  1  3/43 (6.98%) 
Investigations   
Alanine aminotransferase increased  1  7/43 (16.28%) 
Platelet count decreased  1  7/43 (16.28%) 
Blood creatinine increased  1  6/43 (13.95%) 
Aspartate aminotransferase increased  1  5/43 (11.63%) 
Neutrophil count decreased  1  4/43 (9.30%) 
Weight decreased  1  4/43 (9.30%) 
Blood alkaline phosphatase increased  1  3/43 (6.98%) 
Gamma-glutamyltransferase increased  1  3/43 (6.98%) 
Metabolism and nutrition disorders   
Decreased appetite  1  12/43 (27.91%) 
Hypokalaemia  1  12/43 (27.91%) 
Hypocalcaemia  1  6/43 (13.95%) 
Hypomagnesaemia  1  4/43 (9.30%) 
Hypophosphataemia  1  4/43 (9.30%) 
Hypercalcaemia  1  3/43 (6.98%) 
Musculoskeletal and connective tissue disorders   
Back pain  1  6/43 (13.95%) 
Muscle spasms  1  4/43 (9.30%) 
Myalgia  1  4/43 (9.30%) 
Muscular weakness  1  3/43 (6.98%) 
Musculoskeletal chest pain  1  3/43 (6.98%) 
Musculoskeletal pain  1  3/43 (6.98%) 
Nervous system disorders   
Dizziness  1  12/43 (27.91%) 
Neuropathy peripheral  1  9/43 (20.93%) 
Hypoaesthesia  1  5/43 (11.63%) 
Headache  1  4/43 (9.30%) 
Lethargy  1  3/43 (6.98%) 
Peripheral sensory neuropathy  1  4/43 (9.30%) 
Psychiatric disorders   
Insomnia  1  13/43 (30.23%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  13/43 (30.23%) 
Productive cough  1  5/43 (11.63%) 
Rhinorrhoea  1  4/43 (9.30%) 
Dyspnoea  1  3/43 (6.98%) 
Skin and subcutaneous tissue disorders   
Pruritus  1  6/43 (13.95%) 
Rash maculo-papular  1  6/43 (13.95%) 
Rash pruritic  1  6/43 (13.95%) 
Dry skin  1  5/43 (11.63%) 
Rash macular  1  5/43 (11.63%) 
Skin hyperpigmentation  1  4/43 (9.30%) 
Pruritus generalised  1  3/43 (6.98%) 
Vascular disorders   
Hypertension  1  4/43 (9.30%) 
1
Term from vocabulary, MedDRA version: 16.0
Indicates events were collected by systematic assessment
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.
In general, Investigators may publish clinical data after the earlier of (i) publication by the Sponsor or (ii) 12 months following the abandonment, early termination or database lock; provided a copy of the publication provided to Sponsor at least 30 days ahead of publication, the Sponsor’s confidential information is removed as may be requested by Sponsor and Investigator defers publication for up to 60 days in the event Sponsor provides notice that it intends to file a patent application
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Director
Organization: Takeda
Phone: +1-877-825-3327
EMail: trialdisclosures@takeda.com
Layout table for additonal information
Responsible Party: Takeda ( Millennium Pharmaceuticals, Inc. )
ClinicalTrials.gov Identifier: NCT01645930     History of Changes
Other Study ID Numbers: C16013
U1111-1155-5943 ( Registry Identifier: WHO )
HKUCTR-1593 ( Registry Identifier: HKUCTR )
First Submitted: July 18, 2012
First Posted: July 20, 2012
Results First Submitted: March 20, 2018
Results First Posted: November 8, 2018
Last Update Posted: November 8, 2018