Trial Outcomes & Findings for Specified Drug-Use Survey of Trelagliptin Tablets "Survey on Long-term Use in Patients With Type 2 Diabetes Mellitus" (NCT NCT03555591)
NCT ID: NCT03555591
Last Updated: 2023-12-12
Results Overview
An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Recruitment status
COMPLETED
Target enrollment
3198 participants
Primary outcome timeframe
36 months
Results posted on
2023-12-12
Participant Flow
Participants took part in the survey at 242 investigative sites in Japan, from 1 May 2016 to 31 October 2021.
Participants with a historical diagnosis of type 2 diabetes mellitus were enrolled. Participants received trelagliptin as part of a routine medical care.
Participant milestones
| Measure |
Trelagliptin 100 mg
Trelagliptin 100 mg tablet, orally, once weekly for up to 36 months. Participants received interventions as part of routine medical care.
|
|---|---|
|
Overall Study
STARTED
|
3198
|
|
Overall Study
COMPLETED
|
3121
|
|
Overall Study
NOT COMPLETED
|
77
|
Reasons for withdrawal
| Measure |
Trelagliptin 100 mg
Trelagliptin 100 mg tablet, orally, once weekly for up to 36 months. Participants received interventions as part of routine medical care.
|
|---|---|
|
Overall Study
Protocol Violation
|
77
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Trelagliptin 100 mg
n=3121 Participants
Trelagliptin 100 mg tablet, orally, once weekly for up to 36 months. Participants received interventions as part of routine medical care.
|
|---|---|
|
Age, Continuous
|
66.8 Years
STANDARD_DEVIATION 12.75 • n=3121 Participants
|
|
Sex: Female, Male
Female
|
1870 Participants
n=3121 Participants
|
|
Sex: Female, Male
Male
|
1251 Participants
n=3121 Participants
|
|
Region of Enrollment
Japan
|
3121 Participants
n=3121 Participants
|
|
Duration of Type 2 Diabetes Mellitus
|
7.6 Years
STANDARD_DEVIATION 7.28 • n=2068 Participants • The number analyzed is the number of participants with data available for analysis.
|
|
Weight
|
65.12 Kilogram (kg)
STANDARD_DEVIATION 14.293 • n=2183 Participants • The number analyzed is the number of participants with data available for analysis.
|
|
BMI
|
24.94 Kilogram (kg)/meter (m)^2
STANDARD_DEVIATION 4.217 • n=2006 Participants • The number analyzed is the number of participants with data available for analysis.
|
|
Height
|
161.1 Centimeters (cm)
STANDARD_DEVIATION 9.95 • n=2396 Participants • The number analyzed is the number of participants with data available for analysis.
|
|
Healthcare Category
Outpatient
|
3081 Participants
n=3121 Participants
|
|
Healthcare Category
Inpatient
|
40 Participants
n=3121 Participants
|
|
Predisposition to Hypersensitivity
Had No Predisposition to Hypersensitivity
|
2744 Participants
n=3121 Participants
|
|
Predisposition to Hypersensitivity
Had Predisposition to Hypersensitivity
|
144 Participants
n=3121 Participants
|
|
Predisposition to Hypersensitivity
Unknown
|
233 Participants
n=3121 Participants
|
|
Medical Complications
Had No Medical Complications
|
609 Participants
n=3121 Participants
|
|
Medical Complications
Had Medical Complications
|
2512 Participants
n=3121 Participants
|
|
Medical History
Had No Medical History
|
2383 Participants
n=3121 Participants
|
|
Medical History
Had Medical History
|
500 Participants
n=3121 Participants
|
|
Medical History
Unknown
|
238 Participants
n=3121 Participants
|
|
Smoking Classification
Never Smoked
|
1407 Participants
n=3121 Participants
|
|
Smoking Classification
Current Smoker
|
391 Participants
n=3121 Participants
|
|
Smoking Classification
Ex-Smoker
|
637 Participants
n=3121 Participants
|
|
Smoking Classification
Unknown
|
686 Participants
n=3121 Participants
|
|
Alcohol Classification
Yes
|
645 Participants
n=3121 Participants
|
|
Alcohol Classification
No
|
1863 Participants
n=3121 Participants
|
|
Alcohol Classification
Unknown
|
613 Participants
n=3121 Participants
|
|
Renal Impairment
Had No Renal Impairment
|
2739 Participants
n=3121 Participants
|
|
Renal Impairment
Had Renal Impairment
|
382 Participants
n=3121 Participants
|
|
Hepatic Impairment
Had No Hepatic Impairment
|
2578 Participants
n=3121 Participants
|
|
Hepatic Impairment
Had Hepatic Impairment
|
543 Participants
n=3121 Participants
|
|
Glycosylated Hemoglobin A1c (HbA1c) [National Glycohemoglobin Standardization Program (NGSP)]
|
7.38880 Percent
STANDARD_DEVIATION 1.348643 • n=2635 Participants • The number analyzed is the number of participants with data available for analysis.
|
|
Fasting Blood Glucose
|
151.379 milligram (mg)/deciliter (dL)
STANDARD_DEVIATION 59.8728 • n=1494 Participants • The number analyzed is the number of participants with data available for analysis.
|
|
Fasting Glucagon
|
177.52 picogram (pg)/milliliter (mL)
STANDARD_DEVIATION 55.766 • n=83 Participants • The number analyzed is the number of participants with data available for analysis.
|
|
Serum Creatinine Value Within 1 Month Before Start of Treatment with the Study Drug
|
0.7717 mg/dL
STANDARD_DEVIATION 0.21925 • n=2778 Participants • The number analyzed is the number of participants with data available for analysis.
|
|
Creatinine Clearance Within 1 Month Before Start of Treatment with the Study Drug
|
89.54 mL/minute (min)
STANDARD_DEVIATION 41.618 • n=1922 Participants • The number analyzed is the number of participants with data available for analysis.
|
PRIMARY outcome
Timeframe: 36 monthsPopulation: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.
An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Outcome measures
| Measure |
Trelagliptin 100 mg
n=3121 Participants
Trelagliptin 100 mg tablet, orally, once weekly for up to 36 months. Participants received interventions as part of routine medical care.
|
|---|---|
|
Number of Participants Who Had One or More Adverse Events
|
390 Participants
|
PRIMARY outcome
Timeframe: 36 monthsPopulation: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.
An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction refers to AE related to administered drug.
Outcome measures
| Measure |
Trelagliptin 100 mg
n=3121 Participants
Trelagliptin 100 mg tablet, orally, once weekly for up to 36 months. Participants received interventions as part of routine medical care.
|
|---|---|
|
Number of Participants Who Had One or More Adverse Drug Reactions
|
96 Participants
|
SECONDARY outcome
Timeframe: Baseline, up to final assessment point (up to Month 36)Population: Efficacy assessment population, The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available.
The reported data was the change in the mean value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected between baseline and timepoints (up to final assessment point: Month 36). A negative change from baseline indicates improvement.
Outcome measures
| Measure |
Trelagliptin 100 mg
n=3121 Participants
Trelagliptin 100 mg tablet, orally, once weekly for up to 36 months. Participants received interventions as part of routine medical care.
|
|---|---|
|
Change From Baseline in Mean Glycosylated Hemoglobin (HbA1c)
Month 1
|
-0.24813 Percent
Standard Deviation 0.682526
|
|
Change From Baseline in Mean Glycosylated Hemoglobin (HbA1c)
Month 3
|
-0.40573 Percent
Standard Deviation 1.136176
|
|
Change From Baseline in Mean Glycosylated Hemoglobin (HbA1c)
Month 6
|
-0.43716 Percent
Standard Deviation 1.173372
|
|
Change From Baseline in Mean Glycosylated Hemoglobin (HbA1c)
Month 12
|
-0.44281 Percent
Standard Deviation 1.131737
|
|
Change From Baseline in Mean Glycosylated Hemoglobin (HbA1c)
Month 18
|
-0.33933 Percent
Standard Deviation 1.181299
|
|
Change From Baseline in Mean Glycosylated Hemoglobin (HbA1c)
Month 24
|
-0.34909 Percent
Standard Deviation 1.194628
|
|
Change From Baseline in Mean Glycosylated Hemoglobin (HbA1c)
Month 30
|
-0.33164 Percent
Standard Deviation 1.194041
|
|
Change From Baseline in Mean Glycosylated Hemoglobin (HbA1c)
Month 36
|
-0.35018 Percent
Standard Deviation 1.197507
|
|
Change From Baseline in Mean Glycosylated Hemoglobin (HbA1c)
Final Assessment Point (Up to Month 36)
|
-0.33498 Percent
Standard Deviation 1.328413
|
SECONDARY outcome
Timeframe: Baseline, up to final assessment point (up to Month 36)Population: Efficacy assessment population, The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available.
The reported data was the change in the mean value of fasting blood glucose collected between baseline and timepoints (up to final assessment point: Month 36). A negative change from baseline indicates improvement.
Outcome measures
| Measure |
Trelagliptin 100 mg
n=3121 Participants
Trelagliptin 100 mg tablet, orally, once weekly for up to 36 months. Participants received interventions as part of routine medical care.
|
|---|---|
|
Change From Baseline in Fasting Blood Glucose
Month 1
|
-11.733 mg/dL
Standard Deviation 50.2247
|
|
Change From Baseline in Fasting Blood Glucose
Month 3
|
-11.896 mg/dL
Standard Deviation 50.4982
|
|
Change From Baseline in Fasting Blood Glucose
Month 6
|
-13.816 mg/dL
Standard Deviation 57.8209
|
|
Change From Baseline in Fasting Blood Glucose
Month 12
|
-14.698 mg/dL
Standard Deviation 53.3678
|
|
Change From Baseline in Fasting Blood Glucose
Month 18
|
-10.999 mg/dL
Standard Deviation 55.6319
|
|
Change From Baseline in Fasting Blood Glucose
Month 24
|
-7.056 mg/dL
Standard Deviation 58.7981
|
|
Change From Baseline in Fasting Blood Glucose
Month 30
|
-9.183 mg/dL
Standard Deviation 58.2264
|
|
Change From Baseline in Fasting Blood Glucose
Month 36
|
-9.928 mg/dL
Standard Deviation 55.3334
|
|
Change From Baseline in Fasting Blood Glucose
Final Assessment Point (Up to Month 36)
|
-9.765 mg/dL
Standard Deviation 59.2496
|
SECONDARY outcome
Timeframe: Baseline, up to final assessment point (up to Month 36)Population: Efficacy assessment population, The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available.
The reported data was the change in the mean value of fasting insulin level collected between baseline and timepoints (up to final assessment point: Month 36).
Outcome measures
| Measure |
Trelagliptin 100 mg
n=3121 Participants
Trelagliptin 100 mg tablet, orally, once weekly for up to 36 months. Participants received interventions as part of routine medical care.
|
|---|---|
|
Change From Baseline in Fasting Insulin Level
Month 1
|
-7.079 microunit/milliliter (mcrU/mL)
Standard Deviation 19.5631
|
|
Change From Baseline in Fasting Insulin Level
Month 3
|
-5.520 microunit/milliliter (mcrU/mL)
Standard Deviation 19.7015
|
|
Change From Baseline in Fasting Insulin Level
Month 6
|
-6.999 microunit/milliliter (mcrU/mL)
Standard Deviation 18.9998
|
|
Change From Baseline in Fasting Insulin Level
Month 12
|
-4.354 microunit/milliliter (mcrU/mL)
Standard Deviation 18.4697
|
|
Change From Baseline in Fasting Insulin Level
Month 18
|
-4.905 microunit/milliliter (mcrU/mL)
Standard Deviation 15.3859
|
|
Change From Baseline in Fasting Insulin Level
Month 24
|
-6.601 microunit/milliliter (mcrU/mL)
Standard Deviation 16.6195
|
|
Change From Baseline in Fasting Insulin Level
Month 30
|
-7.114 microunit/milliliter (mcrU/mL)
Standard Deviation 17.3951
|
|
Change From Baseline in Fasting Insulin Level
Month 36
|
-5.740 microunit/milliliter (mcrU/mL)
Standard Deviation 18.2392
|
|
Change From Baseline in Fasting Insulin Level
Final Assessment Point (Up to Month 36)
|
-4.675 microunit/milliliter (mcrU/mL)
Standard Deviation 15.9822
|
SECONDARY outcome
Timeframe: Baseline, up to final assessment point (up to Month 36)Population: Efficacy assessment population, The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available.
The reported data was the change in the mean value of HOMA-beta. HOMA-beta measures as following; HOMA-beta = fasting insulin (microU/mL) ×360/ \[fasting glucose (mg/dL) - 63\].
Outcome measures
| Measure |
Trelagliptin 100 mg
n=3121 Participants
Trelagliptin 100 mg tablet, orally, once weekly for up to 36 months. Participants received interventions as part of routine medical care.
|
|---|---|
|
Change From Baseline in Homeostasis Model Assessment of Beat-cell Function (HOMA-beta)
Month 1
|
-26.523 Percent
Standard Deviation 106.9238
|
|
Change From Baseline in Homeostasis Model Assessment of Beat-cell Function (HOMA-beta)
Month 3
|
-21.155 Percent
Standard Deviation 116.4317
|
|
Change From Baseline in Homeostasis Model Assessment of Beat-cell Function (HOMA-beta)
Month 6
|
-23.442 Percent
Standard Deviation 107.4707
|
|
Change From Baseline in Homeostasis Model Assessment of Beat-cell Function (HOMA-beta)
Month 12
|
-16.312 Percent
Standard Deviation 104.6056
|
|
Change From Baseline in Homeostasis Model Assessment of Beat-cell Function (HOMA-beta)
Month 18
|
-21.949 Percent
Standard Deviation 104.5351
|
|
Change From Baseline in Homeostasis Model Assessment of Beat-cell Function (HOMA-beta)
Month 24
|
-34.083 Percent
Standard Deviation 102.0591
|
|
Change From Baseline in Homeostasis Model Assessment of Beat-cell Function (HOMA-beta)
Month 30
|
-39.639 Percent
Standard Deviation 120.4540
|
|
Change From Baseline in Homeostasis Model Assessment of Beat-cell Function (HOMA-beta)
Month 36
|
-31.484 Percent
Standard Deviation 129.2697
|
|
Change From Baseline in Homeostasis Model Assessment of Beat-cell Function (HOMA-beta)
Final Assessment Point (Up to Month 36)
|
-19.551 Percent
Standard Deviation 106.4136
|
SECONDARY outcome
Timeframe: Baseline, up to final assessment point (up to Month 36)Population: Efficacy assessment population, The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available.
The reported data was the change in the mean value of fasting glucagon collected between baseline and timepoints (up to final assessment point: Month 36).
Outcome measures
| Measure |
Trelagliptin 100 mg
n=3121 Participants
Trelagliptin 100 mg tablet, orally, once weekly for up to 36 months. Participants received interventions as part of routine medical care.
|
|---|---|
|
Change From Baseline in Fasting Glucagon
Month 24
|
-3.56 pg/mL
Standard Deviation 54.207
|
|
Change From Baseline in Fasting Glucagon
Month 1
|
-7.88 pg/mL
Standard Deviation 46.589
|
|
Change From Baseline in Fasting Glucagon
Month 3
|
-9.22 pg/mL
Standard Deviation 51.995
|
|
Change From Baseline in Fasting Glucagon
Month 6
|
6.65 pg/mL
Standard Deviation 42.295
|
|
Change From Baseline in Fasting Glucagon
Month 12
|
-1.41 pg/mL
Standard Deviation 46.540
|
|
Change From Baseline in Fasting Glucagon
Month 18
|
10.38 pg/mL
Standard Deviation 51.088
|
|
Change From Baseline in Fasting Glucagon
Month 30
|
18.65 pg/mL
Standard Deviation 91.492
|
|
Change From Baseline in Fasting Glucagon
Month 36
|
0.18 pg/mL
Standard Deviation 82.427
|
|
Change From Baseline in Fasting Glucagon
Final Assessment Point (Month 36)
|
4.27 pg/mL
Standard Deviation 70.248
|
SECONDARY outcome
Timeframe: Baseline, up to final assessment point (up to Month 36)Population: Efficacy assessment population, The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available.
The reported data was percentage of participants who achieved good glycemic control (defined as reduction in HbA1c values \< 8.0 Percent) at baseline and timepoints (up to final assessment point: Month 36).
Outcome measures
| Measure |
Trelagliptin 100 mg
n=3121 Participants
Trelagliptin 100 mg tablet, orally, once weekly for up to 36 months. Participants received interventions as part of routine medical care.
|
|---|---|
|
Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 8.0 Percent)
Baseline
|
78.0 Percent
|
|
Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 8.0 Percent)
Month 1
|
81.9 Percent
|
|
Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 8.0 Percent)
Month 3
|
86.1 Percent
|
|
Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 8.0 Percent)
Month 6
|
87.3 Percent
|
|
Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 8.0 Percent)
Month 12
|
88.8 Percent
|
|
Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 8.0 Percent)
Month 18
|
87.5 Percent
|
|
Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 8.0 Percent)
Month 24
|
88.1 Percent
|
|
Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 8.0 Percent)
Month 30
|
88.4 Percent
|
|
Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 8.0 Percent)
Month 36
|
89.3 Percent
|
|
Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 8.0 Percent)
Final Assessment Point (Up to Month 36)
|
84.6 Percent
|
SECONDARY outcome
Timeframe: Baseline, up to final assessment point (up to Month 36)Population: Efficacy assessment population, The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available.
The reported data was percentage of participants who achieved good glycemic control (defined as reduction in HbA1c values \< 7.0 Percent) at baseline and timepoints (up to final assessment point: Month 36).
Outcome measures
| Measure |
Trelagliptin 100 mg
n=3121 Participants
Trelagliptin 100 mg tablet, orally, once weekly for up to 36 months. Participants received interventions as part of routine medical care.
|
|---|---|
|
Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 7.0 Percent)
Baseline
|
44.3 Percent
|
|
Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 7.0 Percent)
Month 1
|
50.3 Percent
|
|
Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 7.0 Percent)
Month 3
|
58.4 Percent
|
|
Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 7.0 Percent)
Month 6
|
60.9 Percent
|
|
Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 7.0 Percent)
Month 12
|
62.5 Percent
|
|
Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 7.0 Percent)
Month 18
|
58.5 Percent
|
|
Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 7.0 Percent)
Month 24
|
60.0 Percent
|
|
Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 7.0 Percent)
Month 30
|
59.7 Percent
|
|
Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 7.0 Percent)
Month 36
|
63.1 Percent
|
|
Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 7.0 Percent)
Final Assessment Point (Up to Month 36)
|
58.0 Percent
|
SECONDARY outcome
Timeframe: Baseline, up to final assessment point (up to Month 36)Population: Efficacy assessment population, The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available.
The reported data was percentage of participants who achieved good glycemic control (defined as reduction in HbA1c values \< 6.0 Percent) at baseline and timepoints (up to final assessment point: Month 36).
Outcome measures
| Measure |
Trelagliptin 100 mg
n=3121 Participants
Trelagliptin 100 mg tablet, orally, once weekly for up to 36 months. Participants received interventions as part of routine medical care.
|
|---|---|
|
Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 6.0 Percent)
Baseline
|
6.0 Percent
|
|
Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 6.0 Percent)
Month 1
|
6.8 Percent
|
|
Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 6.0 Percent)
Month 3
|
8.7 Percent
|
|
Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 6.0 Percent)
Month 6
|
9.8 Percent
|
|
Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 6.0 Percent)
Month 12
|
11.0 Percent
|
|
Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 6.0 Percent)
Month 18
|
8.2 Percent
|
|
Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 6.0 Percent)
Month 24
|
8.1 Percent
|
|
Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 6.0 Percent)
Month 30
|
9.3 Percent
|
|
Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 6.0 Percent)
Month 36
|
11.2 Percent
|
|
Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 6.0 Percent)
Final Assessment Point (Up to Month 36)
|
11.3 Percent
|
Adverse Events
Trelagliptin 100 mg
Serious events: 167 serious events
Other events: 54 other events
Deaths: 24 deaths
Serious adverse events
| Measure |
Trelagliptin 100 mg
n=3121 participants at risk
Trelagliptin 100 mg tablet, orally, once weekly for up to 36 months. Participants received interventions as part of routine medical care.
|
|---|---|
|
Infections and infestations
Cellulitis
|
0.06%
2/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Infections and infestations
Diabetic gangrene
|
0.03%
1/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Infections and infestations
Gastroenteritis
|
0.03%
1/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Infections and infestations
Liver abscess
|
0.03%
1/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Infections and infestations
Meningitis aseptic
|
0.03%
1/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Infections and infestations
Pneumonia
|
0.16%
5/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Infections and infestations
Pneumonia aspiration
|
0.06%
2/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.03%
1/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Infections and infestations
Pyelonephritis
|
0.03%
1/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Infections and infestations
Pyelonephritis acute
|
0.03%
1/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Infections and infestations
Sepsis
|
0.03%
1/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Infections and infestations
Urinary tract infection
|
0.06%
2/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Infections and infestations
Hepatitis B reactivation
|
0.03%
1/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Infections and infestations
Bacterial pyelonephritis
|
0.03%
1/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile duct cancer
|
0.03%
1/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Biliary neoplasm
|
0.03%
1/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.03%
1/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer recurrent
|
0.06%
2/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.06%
2/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid tumour of the gastrointestinal tract
|
0.03%
1/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.16%
5/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.13%
4/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.13%
4/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.03%
1/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.19%
6/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer
|
0.06%
2/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.03%
1/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to peritoneum
|
0.03%
1/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.16%
5/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.06%
2/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer
|
0.03%
1/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.03%
1/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.03%
1/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.03%
1/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenic purpura
|
0.03%
1/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Endocrine disorders
Hypothyroidism
|
0.03%
1/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.03%
1/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.48%
15/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.26%
8/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.03%
1/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.03%
1/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.06%
2/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.03%
1/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Metabolism and nutrition disorders
Ketoacidosis
|
0.03%
1/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.03%
1/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.03%
1/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.03%
1/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Psychiatric disorders
Completed suicide
|
0.03%
1/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Psychiatric disorders
Schizophrenia
|
0.03%
1/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Nervous system disorders
Altered state of consciousness
|
0.03%
1/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Nervous system disorders
Cerebral infarction
|
0.19%
6/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Nervous system disorders
Embolic stroke
|
0.03%
1/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Nervous system disorders
Facial paralysis
|
0.03%
1/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.03%
1/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.03%
1/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.03%
1/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Nervous system disorders
Carotid arteriosclerosis
|
0.10%
3/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Eye disorders
Cataract nuclear
|
0.03%
1/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Eye disorders
Retinopathy
|
0.03%
1/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.03%
1/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.03%
1/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Cardiac disorders
Angina pectoris
|
0.16%
5/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Cardiac disorders
Angina unstable
|
0.03%
1/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Cardiac disorders
Arrhythmia
|
0.03%
1/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Cardiac disorders
Atrial fibrillation
|
0.13%
4/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.03%
1/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Cardiac disorders
Cardiac failure
|
0.06%
2/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Cardiac disorders
Cardiac tamponade
|
0.03%
1/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.03%
1/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Cardiac disorders
Myocardial infarction
|
0.03%
1/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.06%
2/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.03%
1/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.03%
1/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Vascular disorders
Peripheral artery occlusion
|
0.03%
1/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.03%
1/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic respiratory failure
|
0.03%
1/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
0.03%
1/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.06%
2/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.03%
1/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.03%
1/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic interstitial pneumonia
|
0.03%
1/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.03%
1/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Gastrointestinal disorders
Ileus
|
0.03%
1/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.03%
1/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.03%
1/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.03%
1/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.06%
2/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Gastrointestinal disorders
Mechanical ileus
|
0.03%
1/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.03%
1/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Gastrointestinal disorders
Autoimmune pancreatitis
|
0.06%
2/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.03%
1/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.03%
1/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.03%
1/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.06%
2/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Hepatobiliary disorders
Chronic hepatitis
|
0.03%
1/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.03%
1/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.03%
1/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
0.03%
1/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Musculoskeletal and connective tissue disorders
Sjogren's syndrome
|
0.03%
1/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
0.03%
1/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.03%
1/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Renal and urinary disorders
Postrenal failure
|
0.03%
1/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Renal and urinary disorders
Renal impairment
|
0.16%
5/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.03%
1/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.03%
1/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.03%
1/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.03%
1/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
General disorders
Oedema peripheral
|
0.03%
1/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
General disorders
Sudden death
|
0.03%
1/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.03%
1/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.03%
1/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Investigations
Electrocardiogram Q wave abnormal
|
0.03%
1/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.03%
1/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Investigations
Hepatic enzyme increased
|
0.03%
1/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.03%
1/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.03%
1/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.03%
1/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.03%
1/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Surgical and medical procedures
Transcatheter aortic valve implantation
|
0.03%
1/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
Other adverse events
| Measure |
Trelagliptin 100 mg
n=3121 participants at risk
Trelagliptin 100 mg tablet, orally, once weekly for up to 36 months. Participants received interventions as part of routine medical care.
|
|---|---|
|
Vascular disorders
Hypertension
|
1.7%
54/3121 • 36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
Additional Information
Study Director
Takeda (Note: This product was divested to Teijin Pharma Limited in 2023)
Phone: +1-877-825-3327
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER