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

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ClinicalTrials.gov Identifier: NCT01964950
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 1101

Recruitment Details Participants took part in the study at 221 investigative sites in Japan from 1-Jul-11 to 31-Dec-14.
Pre-assignment Details Participants with type 2 diabetes mellitus started treatment with alogliptin as per routine clinical practice were observed. As per protocol, participants we enrolled in 1 observational group at the start and were divided into 2 groups based on Sulfonylurea (SU) use for analysis of safety endpoints. Participant data was collected for overall arm.
Arm/Group Title All Population (Alogliptin)
Hide Arm/Group Description All participants who received alogliptin (Nesina) 25 milligram (mg), tablets, orally, once daily for up to 12 months along with an SU or without an SU 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 1101 [1]
Completed 1076
Not Completed 25
Reason Not Completed
Protocol Violation             25
[1]
Data reports overall population,since data not collected separately per arm as specified in protocol
Arm/Group Title Alogliptin + SU Alogliptin + Other Total
Hide Arm/Group Description Alogliptin (Nesina) 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received an SU 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 an SU 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 916 160 1076
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 916 participants 160 participants 1076 participants
Less Than (<) 65 Years 380 69 449
Greater Than or Equal to (>=) 65 Years 536 91 627
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 916 participants 160 participants 1076 participants
Female
378
  41.3%
52
  32.5%
430
  40.0%
Male
538
  58.7%
108
  67.5%
646
  60.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Japan Number Analyzed 916 participants 160 participants 1076 participants
916 160 1076
Time From Diagnosis of Type 2 Diabetes  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 916 participants 160 participants 1076 participants
Less than (<)2 years 102 21 123
Greater than or equal to (>=)2 to <5 years 138 22 160
>=5 to <10 years 216 25 241
>=10 years 232 55 287
Unknown 228 37 265
Body Mass Index (BMI)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 916 participants 160 participants 1076 participants
<25 kilogram per square meter (kg/m^2) 326 63 389
>=25 kg/m^2 318 60 378
Unknown 272 37 309
Waist circumference  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 916 participants 160 participants 1076 participants
<85 centimeter (cm) (Male) 52 7 59
>=85 cm (Male) 102 22 124
Unknown (Male) 384 79 463
<90 cm (Female) 52 7 59
>=90 cm (Female) 39 4 43
Unknown (Female) 287 41 328
Pregnancy Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 916 participants 160 participants 1076 participants
Not pregnant 378 52 430
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 916 participants 160 participants 1076 participants
Outpatient 891 156 1047
Inpatient 3 1 4
Outpatient and Inpatient 22 3 25
[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 916 participants 160 participants 1076 participants
Normal 151 25 176
Mild 351 61 412
Moderate 146 25 171
Severe 12 0 12
Unknown 256 49 305
[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 916 participants 160 participants 1076 participants
Did not have allergy 742 131 873
Had allergy 78 8 86
Unknown 96 21 117
Health-related Complications  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 916 participants 160 participants 1076 participants
Had complications 837 145 982
Had no complications 79 15 94
Diabetic Complications  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 916 participants 160 participants 1076 participants
Had complications 187 43 230
Had no complications 729 117 846
Breakdown of Diabetic Complications   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 916 participants 160 participants 1076 participants
Diabetic nephropathy 114 23 137
Diabetic retinopathy 76 21 97
Diabetic neuropathy 61 20 81
[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 916 participants 160 participants 1076 participants
Had complications 593 97 690
Had no complications 323 63 386
Complications of Dyslipidemia  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 916 participants 160 participants 1076 participants
Had complications 582 99 681
Had no complications 334 61 395
Complications of Hyperuricemia  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 916 participants 160 participants 1076 participants
Had complications 74 8 82
Had no complications 842 152 994
Complications of Liver Damage  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 916 participants 160 participants 1076 participants
Had complications 181 35 216
Had no complications 735 125 860
Breakdown of Complications of Liver Damage   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 916 participants 160 participants 1076 participants
Hepatic steatosis 122 24 146
Hepatitis alcoholic 30 9 39
Chronic hepatitis 31 5 36
Hepatic cirrhosis 2 1 3
Other 4 0 4
[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 916 participants 160 participants 1076 participants
Normal 599 111 710
Grade 1 75 11 86
Grade 2 10 2 12
Unknown 232 36 268
[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 916 participants 160 participants 1076 participants
Had complications 126 27 153
Had no complications 790 133 923
Breakdown of Complications of Renal Damage   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 916 participants 160 participants 1076 participants
Nephrotic syndrome 3 1 4
Glomerulonephritis 2 1 3
Renal failure chronic 9 0 9
Other 113 25 138
[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 916 participants 160 participants 1076 participants
Had complications 129 18 147
Had no complications 787 142 929
Breakdown of Complications of Heart Disease   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 916 participants 160 participants 1076 participants
Cardiac failure 25 3 28
Myocardial infarction 26 4 30
Angina pectoris 70 7 77
Other 26 4 30
[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 916 participants 160 participants 1076 participants
Had complications 25 3 28
Had no complications 891 157 1048
New York Heart Association (NYHA) Heart Failure Classification   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 916 participants 160 participants 1076 participants
NYHA Class I 16 2 18
NYHA Class II 5 0 5
NYHA Class III 1 0 1
NYHA Class IV 1 0 1
Unknown 2 1 3
[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 916 participants 160 participants 1076 participants
Had complications 65 7 72
Had no complications 851 153 1004
Breakdown of Complications of Stroke-related Disease   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 916 participants 160 participants 1076 participants
Cerebral infarction 64 7 71
Cerebral haemorrhage 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 916 participants 160 participants 1076 participants
Had complications 51 7 58
Had no complications 865 153 1018
Complications of Malignant Tumor  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 916 participants 160 participants 1076 participants
Had complications 19 3 22
Had no complications 897 157 1054
Presence of Medical History  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 916 participants 160 participants 1076 participants
Had medical history 165 31 196
Did not have medical history 652 113 765
Unknown 99 16 115
History of Alcohol Consumption   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 916 participants 160 participants 1076 participants
Yes 228 44 272
No 527 84 611
Unknown 161 32 193
[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 916 participants 160 participants 1076 participants
Never smoked 372 51 423
Current smoker 145 30 175
Ex-smoker 189 39 228
Unknown 210 40 250
Glycosylated Hemoglobin (HbA1c) Level  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 916 participants 160 participants 1076 participants
HbA1c <6.0 percent (%) 14 4 18
HbA1c >=6.0% to <7.0% 149 25 174
HbA1c >=7.0% to <8.0% 312 61 373
HbA1c >=8.0% 374 61 435
Unknown 67 9 76
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 + SU and alogliptin + other arm separately.
Time Frame Baseline up to 12 months
Show Outcome Measure DataHide 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 + SU Alogliptin + Other
Hide Arm/Group Description:
Alogliptin (Nesina) 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received an SU 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 an SU 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 916 160
Measure Type: Number
Unit of Measure: participants
19 1
2.Primary Outcome
Title Number of Participants Reporting One or More Serious Adverse Drug Reaction
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. 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 + SU and alogliptin + other arm separately.
Time Frame Baseline up to 12 months
Show Outcome Measure DataHide 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 + SU Alogliptin + Other
Hide Arm/Group Description:
Alogliptin (Nesina) 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received an SU 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 an SU 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 916 160
Measure Type: Number
Unit of Measure: participants
5 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 SU treatment.
Time Frame Baseline, Months 1, 3, 6, 12, and final assessment (up to Month 12)
Show Outcome Measure DataHide 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 830
Mean (Standard Deviation)
Unit of Measure: percentage of glycosylated hemoglobin
Baseline (n=830) 8.03  (1.348)
Change at Month 1 (n = 655) -0.40  (0.708)
Change at Month 3 (n = 710) -0.66  (1.117)
Change at Month 6 (n = 725) -0.72  (1.117)
Change at Month 12 (n = 670) -0.64  (1.106)
Change at Final Assessment (n = 830) -0.65  (1.145)
4.Secondary Outcome
Title Percentage of Participants Achieving Objective Glycemic Control
Hide Description The rate of achieving objective glycemic control in HbA1c level was calculated at baseline and 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 SU treatment.
Time Frame Baseline and final assessment (up to Month 12)
Show Outcome Measure DataHide 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 830
Measure Type: Number
Unit of Measure: percentage of participants
<8.0 percent: Baseline 56.3
<8.0%: Final Assessment 75.4
<7.0%: Baseline 19.3
<7.0%: Final Assessment 43.0
<6.0%: Baseline 1.7
<6.0%: Final Assessment 4.6
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 SU treatment.
Time Frame Baseline, Months 1, 3, 6, 12, and final assessment (up to Month 12)
Show Outcome Measure DataHide 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 250
Mean (Standard Deviation)
Unit of Measure: milligram per deciliter (mg/dL)
Baseline (n = 250) 151.1  (43.07)
Change at Month 1 (n = 159) -14.6  (42.91)
Change at Month 3 (n = 175) -13.8  (40.08)
Change at Month 6 (n = 185) -13.1  (47.37)
Change at Month 12 (n = 168) -16.4  (43.97)
Change at Final Assessment (n = 250) -13.7  (49.10)
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 SU treatment.
Time Frame Months 1, 3, 6, 12, and final assessment (up to Month 12)
Show Outcome Measure DataHide 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 33
Mean (Standard Deviation)
Unit of Measure: micro units per milliliter (mcU/mL)
Baseline (n = 33) 7.88  (5.674)
Change at Month 1 (n = 15) 1.27  (12.138)
Change at Month 3 (n = 17) 0.21  (3.474)
Change at Month 6 (n = 20) 0.69  (5.629)
Change at Month 12 (n = 22) 1.17  (3.521)
Change at Final Assessment (n = 33) 1.86  (5.455)
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 + SU Alogliptin + Other
Hide Arm/Group Description Alogliptin (Nesina) 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received an SU 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 an SU 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 + SU Alogliptin + Other
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Alogliptin + SU Alogliptin + Other
Affected / at Risk (%) Affected / at Risk (%)
Total   5/916 (0.55%)   0/160 (0.00%) 
Infections and infestations     
Pneumonia pneumococcal  1  1/916 (0.11%)  0/160 (0.00%) 
Injury, poisoning and procedural complications     
Road traffic accident  1  1/916 (0.11%)  0/160 (0.00%) 
Metabolism and nutrition disorders     
Hypoglycaemia  1  1/916 (0.11%)  0/160 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Oesophageal carcinoma  1  1/916 (0.11%)  0/160 (0.00%) 
Nervous system disorders     
Cerebral infarction  1  1/916 (0.11%)  0/160 (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 + SU Alogliptin + Other
Affected / at Risk (%) Affected / at Risk (%)
Total   19/916 (2.07%)   1/160 (0.63%) 
Cardiac disorders     
Ventricular extrasystoles  1  1/916 (0.11%)  0/160 (0.00%) 
Gastrointestinal disorders     
Abdominal distension  1  1/916 (0.11%)  0/160 (0.00%) 
Aphthous stomatitis  1  1/916 (0.11%)  0/160 (0.00%) 
Nausea  1  1/916 (0.11%)  0/160 (0.00%) 
General disorders     
Feeling abnormal  1  2/916 (0.22%)  0/160 (0.00%) 
Malaise  1  1/916 (0.11%)  1/160 (0.63%) 
Pyrexia  1  1/916 (0.11%)  0/160 (0.00%) 
Infections and infestations     
Influenza  1  1/916 (0.11%)  0/160 (0.00%) 
Investigations     
Gamma-glutamyltransferase increased  1  1/916 (0.11%)  0/160 (0.00%) 
Glycosylated haemoglobin increased  1  1/916 (0.11%)  0/160 (0.00%) 
Metabolism and nutrition disorders     
Hypercholesterolaemia  1  1/916 (0.11%)  0/160 (0.00%) 
Hypoglycaemia  1  2/916 (0.22%)  0/160 (0.00%) 
Decreased appetite  1  1/916 (0.11%)  0/160 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Dry throat  1  1/916 (0.11%)  0/160 (0.00%) 
Skin and subcutaneous tissue disorders     
Erythema multiforme  1  1/916 (0.11%)  0/160 (0.00%) 
Rash  1  1/916 (0.11%)  0/160 (0.00%) 
Vascular disorders     
Hypertension  1  1/916 (0.11%)  0/160 (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 Pharmaceutical Company Limited
Phone: +1-877-825-3327
Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01964950     History of Changes
Other Study ID Numbers: 121-013
JapicCTI-132266 ( Registry Identifier: JapicCTI )
JapicCTI-R160882 ( Registry Identifier: JapicCTI )
First Submitted: October 15, 2013
First Posted: October 17, 2013
Results First Submitted: August 23, 2016
Results First Posted: April 13, 2017
Last Update Posted: April 13, 2017