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Trial record 71 of 914 for:    tablet | Japan

Alogliptin Tablets Special Drug Use Surveillance Type 2 Diabetes Mellitus: Combination Therapy With Biguanides

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ClinicalTrials.gov Identifier: NCT01964976
Recruitment Status : Completed
First Posted : October 17, 2013
Results First Posted : April 13, 2017
Last Update Posted : April 13, 2017
Sponsor:
Information provided by (Responsible Party):
Takeda

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Surveillance
Enrollment 1096
Recruitment Details Participants took part in the study at 207 investigative sites in Japan from 01 July 2011 to 31 December 2014.
Pre-assignment Details Participants with type 2 diabetes mellitus started treatment with alogliptin as per routine clinical practice were observed. As per protocol, participants were enrolled in 1 observational group at the start and were divided into 2 groups based on biguanide use for analysis of safety endpoints. Participant flow data was collected for overall arm.
Arm/Group Title All Population
Hide Arm/Group Description All participants who received alogliptin 25 milligram (mg), tablets, orally, once daily for up to 12 months along with biguanide or without biguanide within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin as per routine clinical practice were observed in this study.
Period Title: Overall Study
Started 1096 [1]
Completed 1065
Not Completed 31
Reason Not Completed
Protocol Violation             31
[1]
Data reports overall population,since data not collected separately per arm as specified in protocol
Arm/Group Title Alogliptin + Biguanides Alogliptin + Other Total
Hide Arm/Group Description Alogliptin 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received a biguanide within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin as per routine clinical practice were observed in this study. Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive a biguanide within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin as per routine clinical practice were observed in this study. Total of all reporting groups
Overall Number of Baseline Participants 954 109 1063
Hide Baseline Analysis Population Description
The safety analysis set was defined as all participants who completed the study and had safety data available.
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 954 participants 109 participants 1063 participants
Less than (<) 65 years 539 68 607
Greater than or equal to (>=) 65 years 415 41 456
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 954 participants 109 participants 1063 participants
Female
388
  40.7%
37
  33.9%
425
  40.0%
Male
566
  59.3%
72
  66.1%
638
  60.0%
Time from Diagnosis of Type 2 Diabetes  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 954 participants 109 participants 1063 participants
<2 years 114 16 130
>=2 to <5 years 169 20 189
>=5 to <10 years 218 19 237
>=10 years 254 27 281
Unknown 199 27 226
Body Mass Index  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 954 participants 109 participants 1063 participants
<25 kilogram per square meter (kg/m^2) 345 35 380
>=25 kg/m^2 410 45 455
Unknown 199 29 228
Waist Circumference  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 954 participants 109 participants 1063 participants
<85 centimeter (cm) (Male) 25 5 30
>=85 cm (Male) 90 4 94
Unknown (Male) 451 63 514
<90 cm (Female) 37 4 41
>=90 cm (Female) 33 3 36
Unknown (Female) 318 30 348
Pregnancy Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 954 participants 109 participants 1063 participants
Not pregnant 388 37 425
Pregnant 0 0 0
[1]
Measure Description: This baseline characteristic was analyzed only in female participants.
Healthcare Category   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 954 participants 109 participants 1063 participants
Outpatient 920 102 1022
Inpatient 2 1 3
Outpatient and inpatient 32 6 38
[1]
Measure Description: Participants were categorized as outpatient, inpatient, and outpatient and inpatient (participants who were both outpatient and inpatient during some point at the time and 3 months prior to enrollment).
Degree of Renal Dysfunction   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 954 participants 109 participants 1063 participants
Normal 213 12 225
Mild 359 50 409
Moderate 135 13 148
Severe 3 0 3
Unknown 244 34 278
[1]
Measure Description: Estimated glomerular filtration rate (eGFR) was calculated using variables of gender, age at the start of treatment, and serum creatinine values, and severity was determined based on the following categories. If the serum creatinine value at the start of treatment was not listed, the severity was listed as “unknown.” Normal: >=90 milliliter per minute (mL/min)/1.73^2, Mild: >=60 mL/min/1.73^2 to <90 mL/min/1.73^2 Moderate: >=30 mL/min/1.73^2 to <60 mL/min/1.73^2, Severe: <30 mL/min/1.73^2. eGFR = 194 * Cr^-1.094 * (age)^-0.287 (* 0.739 if female), where Cr is serum creatinine.
History of Allergy  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 954 participants 109 participants 1063 participants
Had allergy 773 84 857
Did not have allergy 92 10 102
Unknown 89 15 104
Health-related Complications  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 954 participants 109 participants 1063 participants
Had complications 862 91 953
Had no complications 92 18 110
Diabetic complications  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 954 participants 109 participants 1063 participants
Had complications 206 20 226
Had No Complications 748 89 837
Breakdown of diabetic complications   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 954 participants 109 participants 1063 participants
Diabetic nephropathy 110 12 122
Diabetic retinopathy 91 10 101
Diabetic neuropathy 83 8 91
[1]
Measure Description: This baseline characteristic was analyzed only in participants who had diabetic complications. Participants may be represented in more than 1 category.
Complications of Hypertension  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 954 participants 109 participants 1063 participants
Had complications 567 54 621
Had no complications 387 55 442
Complications of Dyslipidemia  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 954 participants 109 participants 1063 participants
Had complications 623 69 692
Had no complications 331 40 371
Complications of Hyperuricemia  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 954 participants 109 participants 1063 participants
Had complications 69 14 83
Had no complications 885 95 980
Complications of Liver Damage  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 954 participants 109 participants 1063 participants
Had complications 203 20 223
Had no complications 751 89 840
Breakdown of Complications of Liver Damage   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 954 participants 109 participants 1063 participants
Hepatic steatosis 158 15 173
Hepatitis alcoholic 23 5 28
Chronic hepatitis 15 5 20
Hepatic cirrhosis 2 1 3
Other 7 0 7
[1]
Measure Description: Liver damage complications were categorized as hepatic steatosis, hepatitis alcoholic, chronic hepatitis, hepatic cirrhosis and any other complications related to liver damage. This baseline characteristic was analyzed only in participants who had complications of liver damage. Participants may be represented in more than 1 category.
Degree of Hepatic Dysfunction   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 954 participants 109 participants 1063 participants
Normal 597 65 662
Grade 1 81 13 94
Grade 2 21 1 22
Unknown 255 30 285
[1]
Measure Description: Severity was determined using aspartate aminotransferase (AST) or alanine transaminase (ALT) values at the start of treatment with alogliptin. For the assessment of severity, the following categories were used and a higher severity grade for either AST or ALT serum levels was adopted. Normal: <50 international units per liter (IU/L), Grade 1: >=50 to <100 IU/L, Grade 2: >=100 to <500 IU/L, and Grade 3: >=500 IU/L.
Complications of Renal Damage  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 954 participants 109 participants 1063 participants
Had complications 114 12 126
Had No Complications 840 97 937
Breakdown of Complications of Renal Damage   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 954 participants 109 participants 1063 participants
Nephrotic syndrome 1 0 1
Glomerulonephritis 1 0 1
Renal failure chronic 2 0 2
Other 110 12 122
[1]
Measure Description: Renal damage complications were categorized as nephrotic syndrome, glomerulonephritis, renal failure chronic and any other complications related to renal damage. This baseline characteristic was analyzed only in participants who had renal damage complications. Participants may be represented in more than 1 category.
Complications of Heart Disease  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 954 participants 109 participants 1063 participants
Had complications 103 7 110
Had no complications 851 102 953
Breakdown of Complications of Heart Disease   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 954 participants 109 participants 1063 participants
Cardiac failure 19 1 20
Myocardial infarction 24 1 25
Angina pectoris 49 3 52
Other 24 2 26
[1]
Measure Description: Heart disease complications were categorized as cardiac failure, myocardial infarction, angina pectoris, and any other complications related to heart disease. This baseline characteristic was analyzed only in participants who had heart disease complications. Participants may be represented in more than 1 category.
Complications of Heart Failure  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 954 participants 109 participants 1063 participants
Had complications 19 1 20
Had no complications 935 108 1043
New York Heart Association (NYHA) Heart Failure Classification   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 954 participants 109 participants 1063 participants
NYHA Class I 13 0 13
NYHA Class II 5 0 5
NYHA Class IV 1 1 2
[1]
Measure Description: NYHA functional classification ranges from Class I (participants with cardiac disease but without resulting limitations of physical activity), Class II (participants with cardiac disease resulting in slight limitation of physical activity), Class III (participants with cardiac disease resulting in marked limitation of physical activity), Class IV (participants with cardiac disease resulting in inability to carry on any physical activity without discomfort). This baseline measure was analyzed only for participants who had complications of heart failure.
Complications of Stroke-related Disease  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 954 participants 109 participants 1063 participants
Had complications 58 5 63
Had no complications 896 104 1000
Breakdown of Complications of Stroke-related Disease   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 954 participants 109 participants 1063 participants
Cerebral infarction 57 5 62
Cerebral hemorrhage 1 0 1
[1]
Measure Description: This baseline characteristic was analyzed only in participants who had complications of stroke-related disease.
Complications of Allergic Disease  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 954 participants 109 participants 1063 participants
Had complications 66 7 73
Had no complications 888 102 990
Complications of Malignant Tumor  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 954 participants 109 participants 1063 participants
Had complications 18 6 24
Had no complications 936 103 1039
Other Complications   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 954 participants 109 participants 1063 participants
Had complications 315 38 353
Had no complications 639 71 710
[1]
Measure Description: Participants who had complications other than diabetic, hypertension, dyslipidemia, hyperuricemia, liver damage, renal damage, heart disease, heart failure, stroke-related disease, allergic disease, and malignant tumor were analyzed in this measure.
Presence of Medical History  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 954 participants 109 participants 1063 participants
Had medical history 150 30 180
Did not have medical history 694 68 762
Unknown 110 11 121
History of Alcohol Consumption   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 954 participants 109 participants 1063 participants
Yes 231 26 257
No 573 60 633
Unknown 150 23 173
[1]
Measure Description: In this measure, participants responded whether they consumed alcohol-containing beverages nearly every day or not.
Smoking Classification  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 954 participants 109 participants 1063 participants
Never Smoked 442 45 487
Current Smoker 167 18 185
Ex-smoker 162 15 177
Unknown 183 31 214
Glycosylated Hemoglobin (HbA1c) Level  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 954 participants 109 participants 1063 participants
HbA1c <6.0 percent (%) 12 5 17
HbA1c >=6.0% to <7.0% 177 16 193
HbA1c >=7.0% to <8.0% 381 43 424
HbA1c >=8.0% 341 35 376
Unknown 43 10 53
1.Primary Outcome
Title Number of Participants Reporting One or More Adverse Drug Reactions
Hide Description Adverse drug reactions are defined as adverse events (AEs) which are in the investigator’s opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. The safety analysis was planned to be assessed in alogliptin + biguanides and alogliptin + other arm separately.
Time Frame Baseline up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set was defined as all participants who completed the study and had safety data available.
Arm/Group Title Alogliptin + Biguanides Alogliptin + Other
Hide Arm/Group Description:
Alogliptin 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received a biguanide within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin as per routine clinical practice were observed in this study.
Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive a biguanide within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin as per routine clinical practice were observed in this study.
Overall Number of Participants Analyzed 954 109
Measure Type: Number
Unit of Measure: participants
26 2
2.Primary Outcome
Title Number of Participants Reporting One or More Serious Adverse Drug Reactions
Hide Description Serious adverse drug reactions are defined as serious adverse events (SAEs) which are in the investigator’s opinion of causal relationship to the study treatment. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The safety analysis was planned to be assessed in alogliptin + biguanides and alogliptin + other arm separately.
Time Frame Baseline up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set was defined as all participants who completed the study and had safety data available.
Arm/Group Title Alogliptin + Biguanides Alogliptin + Other
Hide Arm/Group Description:
Alogliptin 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received a biguanide within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin as per routine clinical practice were observed in this study.
Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive a biguanide within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin as per routine clinical practice were observed in this study.
Overall Number of Participants Analyzed 954 109
Measure Type: Number
Unit of Measure: participants
4 0
3.Secondary Outcome
Title Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Hide Description The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at 1 month, 3 months, 6 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of biguanide treatment.
Time Frame Baseline, Months 1, 3, 6, 12, and final assessment (up to Month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.
Arm/Group Title Alogliptin
Hide Arm/Group Description:
Participants who took alogliptin 25 mg, tablets, orally, once daily for up to 12 months as per routine clinical practice were observed.
Overall Number of Participants Analyzed 880
Mean (Standard Deviation)
Unit of Measure: percentage of glycosylated hemoglobin
Baseline (n = 880) 7.84  (1.215)
Change at Month 1 (n = 671) -0.35  (0.630)
Change at Month 3 (n = 768) -0.59  (0.943)
Change at Month 6 (n = 776) -0.62  (1.011)
Change at Month 12 (n = 723) -0.65  (1.027)
Change at Final Assessment (n = 880) -0.58  (1.066)
4.Secondary Outcome
Title Percentage of Participants of Achieving Objective Glycemic Control
Hide Description The rate of achieving objective glycemic control in HbA1c level, was calculated at 12 month or final visit (last visit for a participant in the study, up to Month 12). Glycemic control was measured as <8.0%, <7.0%, and <6.0% of glycosylated hemoglobin. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of biguanide treatment.
Time Frame Baseline and final assessment (up to Month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.
Arm/Group Title Alogliptin
Hide Arm/Group Description:
Participants who took alogliptin 25 mg, tablets, orally, once daily for up to 12 months as per routine clinical practice were observed.
Overall Number of Participants Analyzed 880
Measure Type: Number
Unit of Measure: percentage of participants
<8.0% (Baseline) 62.8
<8.0% (Final assessment [upto month 12]) 80.5
<7.0% (Baseline) 21.4
<7.0% (Final assessment [upto month 12]) 47.2
<6.0% (Baseline) 1.4
<6.0% (Final assessment [upto month 12]) 5.2
5.Secondary Outcome
Title Change From Baseline in Fasting Blood Glucose
Hide Description The change between the fasting blood glucose value collected at 1 month, 3 months, 6 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of the biguanide treatment.
Time Frame Baseline, Months 1, 3, 6, 12, and final assessment (up to Month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy assessment population was defined as participants who completed the study and had fasting blood glucose data at baseline and post-baseline time points available.
Arm/Group Title Alogliptin
Hide Arm/Group Description:
Participants who took alogliptin 25 mg, tablets, orally, once daily for up to 12 months as per routine clinical practice were observed.
Overall Number of Participants Analyzed 253
Mean (Standard Deviation)
Unit of Measure: milligram per deciliter (mg/dL)
Baseline (n = 253) 151.8  (48.68)
Change at Month 1 (n = 160) -16.7  (40.47)
Change at Month 3 (n = 198) -17.1  (47.05)
Change at Month 6 (n = 189) -16.0  (44.03)
Change at Month 12 (n = 186) -19.1  (40.04)
Change at final assessment (n = 253) -17.2  (44.25)
6.Secondary Outcome
Title Change From Baseline in Fasting Insulin Level
Hide Description The change between the fasting insulin value collected at 1 month, 3 months, 6 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of biguanide treatment.
Time Frame Baseline, Months 1, 3, 6, 12, and final assessment (up to Month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy assessment population was defined as participants who completed the study and had fasting insulin data at baseline and post-baseline time points available.
Arm/Group Title Alogliptin
Hide Arm/Group Description:
Participants who took alogliptin 25 mg, tablets, orally, once daily for up to 12 months as per routine clinical practice were observed.
Overall Number of Participants Analyzed 32
Mean (Standard Deviation)
Unit of Measure: microunits per milliliter
Baseline (n = 32) 9.00  (6.712)
Change at Month 1 (n = 21) 1.79  (5.485)
Change at Month 3 (n = 18) 2.21  (6.305)
Change at Month 6 (n = 24) 0.04  (4.913)
Change at Month 12 (n = 19) -1.21  (3.711)
Change at final assessment (n = 32) -0.25  (5.286)
Time Frame Baseline up to 12 months.
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. Only adverse drug reactions were collected in the safety population.
 
Arm/Group Title Alogliptin + Biguanides Alogliptin + Other
Hide Arm/Group Description Alogliptin 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received a biguanide within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin as per routine clinical practice were observed in this study. Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive a biguanide within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin as per routine clinical practice were observed in this study.
All-Cause Mortality
Alogliptin + Biguanides Alogliptin + Other
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Alogliptin + Biguanides Alogliptin + Other
Affected / at Risk (%) Affected / at Risk (%)
Total   4/954 (0.42%)   0/109 (0.00%) 
Injury, poisoning and procedural complications     
Fall  1  1/954 (0.10%)  0/109 (0.00%) 
Metabolism and nutrition disorders     
Diabetes mellitus  1  1/954 (0.10%)  0/109 (0.00%) 
Hypoglycaemia  1  1/954 (0.10%)  0/109 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Renal cancer  1  1/954 (0.10%)  0/109 (0.00%) 
Prostate cancer  1  1/954 (0.10%)  0/109 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (17.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Alogliptin + Biguanides Alogliptin + Other
Affected / at Risk (%) Affected / at Risk (%)
Total   24/954 (2.52%)   2/109 (1.83%) 
Gastrointestinal disorders     
Constipation  1  2/954 (0.21%)  0/109 (0.00%) 
Nausea  1  2/954 (0.21%)  0/109 (0.00%) 
General disorders     
Feeling abnormal  1  2/954 (0.21%)  0/109 (0.00%) 
Hepatobiliary disorders     
Hepatic function abnormal  1  2/954 (0.21%)  0/109 (0.00%) 
Investigations     
Weight increased  1  1/954 (0.10%)  0/109 (0.00%) 
Metabolism and nutrition disorders     
Hypercholesterolaemia  1  1/954 (0.10%)  0/109 (0.00%) 
Hypoglycaemia  1  3/954 (0.31%)  0/109 (0.00%) 
Dyslipidaemia  1  1/954 (0.10%)  0/109 (0.00%) 
Nervous system disorders     
Dysgeusia  1  1/954 (0.10%)  1/109 (0.92%) 
Somnolence  1  1/954 (0.10%)  0/109 (0.00%) 
Renal and urinary disorders     
Nephropathy toxic  1  1/954 (0.10%)  0/109 (0.00%) 
Renal disorder  1  1/954 (0.10%)  0/109 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  1/954 (0.10%)  0/109 (0.00%) 
Skin and subcutaneous tissue disorders     
Photosensitivity reaction  1  0/954 (0.00%)  1/109 (0.92%) 
Pruritus  1  0/954 (0.00%)  1/109 (0.92%) 
Rash  1  5/954 (0.52%)  0/109 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (17.1)
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 first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
Results Point of Contact
Name/Title: Medical Director
Organization: Takeda
Phone: +1-877-825-3327
Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01964976     History of Changes
Other Study ID Numbers: 121-014
JapicCTI-132282 ( Registry Identifier: JapicCTI )
JapicCTI-R150790 ( Registry Identifier: JapicCTI )
First Submitted: October 15, 2013
First Posted: October 17, 2013
Results First Submitted: August 31, 2016
Results First Posted: April 13, 2017
Last Update Posted: April 13, 2017