Trial Outcomes & Findings for A Post-Marketing Surveillance Study on NesinaAct® Tablet Use Among Type 2 Diabetes Mellitus Participants in Korea (NCT NCT04980014)
NCT ID: NCT04980014
Last Updated: 2022-03-07
Results Overview
An SAE is an adverse event 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. Serious ADRs are defined as SAEs that are, in the investigator's opinion, of causal relationship to the study treatment. 95% Confidence Interval was calculated using exact method.
COMPLETED
730 participants
First dose of surveillance drug treatment to within 30 days after the end of the treatment (up to 153 weeks)
2022-03-07
Participant Flow
Participants took part in this Post-Marketing Surveillance study at 19 investigative sites in Korea from 2 October 2015 to 30 August 2019 from the re-examination period.
Participants with a diagnosis of Type 2 Diabetes who took NesinaAct® Tablet, as prescribed by the physician, were enrolled in this study.
Participant milestones
| Measure |
NesinaAct® Tablet
Participants with a diagnosis of Type 2 Diabetes who took NesinaAct® tablet, a fixed dose combination of alogliptin along with pioglitazone, as prescribed by the physician, were observed in this study.
|
|---|---|
|
Overall Study
STARTED
|
730
|
|
Overall Study
Safety Analysis Set
|
655
|
|
Overall Study
Effectiveness Analysis Set
|
482
|
|
Overall Study
COMPLETED
|
655
|
|
Overall Study
NOT COMPLETED
|
75
|
Reasons for withdrawal
| Measure |
NesinaAct® Tablet
Participants with a diagnosis of Type 2 Diabetes who took NesinaAct® tablet, a fixed dose combination of alogliptin along with pioglitazone, as prescribed by the physician, were observed in this study.
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|---|---|
|
Overall Study
Participants who are Duplicated
|
1
|
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Overall Study
Follow-up Failure
|
13
|
|
Overall Study
Participants who did not Receive NesinaAct® Tablet
|
2
|
|
Overall Study
Participants who Have Been Administered NesinaAct® Tablet prior to the consent
|
2
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|
Overall Study
Participants who Violated Inclusion/Exclusion Criteria
|
57
|
Baseline Characteristics
A Post-Marketing Surveillance Study on NesinaAct® Tablet Use Among Type 2 Diabetes Mellitus Participants in Korea
Baseline characteristics by cohort
| Measure |
NesinaAct® Tablet
n=655 Participants
Participants with a diagnosis of Type 2 Diabetes who took NesinaAct® tablet, a fixed dose combination of alogliptin along with pioglitazone, as prescribed by the physician, were observed in this study.
|
|---|---|
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Age, Continuous
|
58.32 years
STANDARD_DEVIATION 12.54 • n=5 Participants
|
|
Sex: Female, Male
Female
|
400 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
255 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
655 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Korea, Republic Of
|
655 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: First dose of surveillance drug treatment to within 30 days after the end of the treatment (up to 153 weeks)Population: Safety Analysis set included participants who were treated with NesinaAct® tablet at least once and completed the follow-up for safety.
An SAE is an adverse event 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. Serious ADRs are defined as SAEs that are, in the investigator's opinion, of causal relationship to the study treatment. 95% Confidence Interval was calculated using exact method.
Outcome measures
| Measure |
NesinaAct® Tablet
n=655 Participants
Participants with a diagnosis of Type 2 Diabetes who took NesinaAct® tablet, a fixed dose combination of alogliptin along with pioglitazone, as prescribed by the physician, were observed in this study.
|
|---|---|
|
Percentage of Participants With Serious Adverse Events (SAEs) and Serious Adverse Drug Reactions (SADRs)
SAEs
|
0.15 percentage of participants
Interval 0.0 to 0.85
|
|
Percentage of Participants With Serious Adverse Events (SAEs) and Serious Adverse Drug Reactions (SADRs)
SADRs
|
0.00 percentage of participants
Interval 0.0 to 0.56
|
PRIMARY outcome
Timeframe: First dose of surveillance drug treatment to within 30 days after the end of the treatment (up to 153 weeks)Population: Safety Analysis set included participants who were treated with NesinaAct® tablet at least once and completed the follow-up for safety.
An AE is any and all undesirable or unintended signs (including abnormal clinical laboratory values), symptoms, or disease that are incurred when the drug is administered, and is not related to causal relationship with the drug. An ADR is a harmful and unintended reaction resulting from usual administration and use of the drug, whose causal relationship with the drug cannot be excluded, and if causal relationship with the drug is unknown among AEs reported spontaneously, it is regarded as ADR. An unexpected ADR is an ADR with difference in the nature or severity, specificity, or the outcome, compared to the product licensure/notification of the drug. 95% Confidence Interval was calculated using exact method.
Outcome measures
| Measure |
NesinaAct® Tablet
n=655 Participants
Participants with a diagnosis of Type 2 Diabetes who took NesinaAct® tablet, a fixed dose combination of alogliptin along with pioglitazone, as prescribed by the physician, were observed in this study.
|
|---|---|
|
Percentage of Participants With Unexpected Adverse Events (AEs) and Adverse Drug Reactions (ADRs) Not Mentioned in Precautions
Unexpected ADRs
|
1.22 percentage of participants
Interval 0.53 to 2.39
|
|
Percentage of Participants With Unexpected Adverse Events (AEs) and Adverse Drug Reactions (ADRs) Not Mentioned in Precautions
Unexpected AEs
|
4.58 percentage of participants
Interval 3.11 to 6.47
|
PRIMARY outcome
Timeframe: Week 13Population: Safety Analysis Set included participants who were treated with NesinaAct® tablet at least once and completed the follow-up for safety, with data available for analyses.
An ADR is a harmful and unintended reaction resulting from usual administration and use of the drug, whose causal relationship with the drug cannot be excluded, and if causal relationship with the drug is unknown among AEs reported spontaneously, it is regarded as ADR. Expected/already known ADRs are those listed in product licensure/notification of the drug. Data is reported as per duration of study drug treatment for this outcome measure from administration start date to AE onset date. 95% Confidence Interval was calculated using exact method.
Outcome measures
| Measure |
NesinaAct® Tablet
n=653 Participants
Participants with a diagnosis of Type 2 Diabetes who took NesinaAct® tablet, a fixed dose combination of alogliptin along with pioglitazone, as prescribed by the physician, were observed in this study.
|
|---|---|
|
Percentage of Participants With Expected/Already Known ADRs at Week 13
|
1.99 percentage of participants
Interval 1.06 to 3.38
|
PRIMARY outcome
Timeframe: Week 26Population: Safety Analysis set included participants who were treated with NesinaAct® tablet at least once and completed the follow-up for safety, with data available for analyses.
An ADR is a harmful and unintended reaction resulting from usual administration and use of the drug, whose causal relationship with the drug cannot be excluded, and if causal relationship with the drug is unknown among AEs reported spontaneously, it is regarded as ADR. Expected/already known ADRs are those listed in product licensure/notification of the drug. Data is reported as per duration of study drug treatment for this outcome measure from administration start date to AE onset date. 95% Confidence Interval was calculated using exact method.
Outcome measures
| Measure |
NesinaAct® Tablet
n=515 Participants
Participants with a diagnosis of Type 2 Diabetes who took NesinaAct® tablet, a fixed dose combination of alogliptin along with pioglitazone, as prescribed by the physician, were observed in this study.
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|---|---|
|
Percentage of Participants With Expected/Already Known ADRs at Week 26
|
0.19 percentage of participants
Interval 0.0 to 1.08
|
PRIMARY outcome
Timeframe: Week 39Population: Safety Analysis Set included participants who were treated with NesinaAct® tablet at least once and completed the follow-up for safety, with data available for analyses.
An ADR is a harmful and unintended reaction resulting from usual administration and use of the drug, whose causal relationship with the drug cannot be excluded, and if causal relationship with the drug is unknown among AEs reported spontaneously, it is regarded as ADR. Expected/already known ADRs are those listed in product licensure/notification of the drug. Data is reported as per duration of study drug treatment for this outcome measure from administration start date to AE onset date. 95% Confidence Interval was calculated using exact method.
Outcome measures
| Measure |
NesinaAct® Tablet
n=341 Participants
Participants with a diagnosis of Type 2 Diabetes who took NesinaAct® tablet, a fixed dose combination of alogliptin along with pioglitazone, as prescribed by the physician, were observed in this study.
|
|---|---|
|
Percentage of Participants With Expected/Already Known ADRs at Week 39
|
0.00 percentage of participants
Interval 0.0 to 1.08
|
PRIMARY outcome
Timeframe: Week 52Population: Safety Analysis set included participants who were treated with NesinaAct® tablet at least once and completed the follow-up for safety, with data available for analyses.
An ADR is a harmful and unintended reaction resulting from usual administration and use of the drug, whose causal relationship with the drug cannot be excluded, and if causal relationship with the drug is unknown among AEs reported spontaneously, it is regarded as ADR. Expected/already known ADRs are those listed in product licensure/notification of the drug. Data is reported as per duration of study drug treatment for this outcome measure from administration start date to AE onset date. 95% Confidence Interval was calculated using exact method.
Outcome measures
| Measure |
NesinaAct® Tablet
n=108 Participants
Participants with a diagnosis of Type 2 Diabetes who took NesinaAct® tablet, a fixed dose combination of alogliptin along with pioglitazone, as prescribed by the physician, were observed in this study.
|
|---|---|
|
Percentage of Participants With Expected/Already Known ADRs at Week 52
|
0.93 percentage of participants
Interval 0.02 to 5.05
|
PRIMARY outcome
Timeframe: Week 153Population: Safety Analysis set included participants who were treated with NesinaAct® tablet at least once and completed the follow-up for safety, with data available for analyses.
An ADR is a harmful and unintended reaction resulting from usual administration and use of the drug, whose causal relationship with the drug cannot be excluded, and if causal relationship with the drug is unknown among AEs reported spontaneously, it is regarded as ADR. Expected/already known ADRs are those listed in product licensure/notification of the drug. Data is reported as per duration of study drug treatment for this outcome measure from administration start date to AE onset date. 95% Confidence Interval was calculated using exact method.
Outcome measures
| Measure |
NesinaAct® Tablet
n=10 Participants
Participants with a diagnosis of Type 2 Diabetes who took NesinaAct® tablet, a fixed dose combination of alogliptin along with pioglitazone, as prescribed by the physician, were observed in this study.
|
|---|---|
|
Percentage of Participants With Expected/Already Known ADRs at Week 153
|
0.00 percentage of participants
Interval 0.0 to 30.85
|
PRIMARY outcome
Timeframe: First dose of surveillance drug treatment to within 30 days after the end of the treatment (up to 153 weeks)Population: Safety Analysis set included participants who were treated with NesinaAct® tablet at least once and completed the follow-up for safety.
An ADR is a harmful and unintended reaction resulting from usual administration and use of the drug, whose causal relationship with the drug cannot be excluded, and if causal relationship with the drug is unknown among AEs reported spontaneously, it is regarded as ADR. 95% Confidence Interval was calculated using exact method.
Outcome measures
| Measure |
NesinaAct® Tablet
n=655 Participants
Participants with a diagnosis of Type 2 Diabetes who took NesinaAct® tablet, a fixed dose combination of alogliptin along with pioglitazone, as prescribed by the physician, were observed in this study.
|
|---|---|
|
Percentage of Participants With Non-serious ADRs
|
3.36 percentage of participants
Interval 2.12 to 5.04
|
PRIMARY outcome
Timeframe: First dose of surveillance drug treatment to within 30 days after the end of the treatment (up to 153 weeks)Population: Safety Analysis set included participants who were treated with NesinaAct® tablet at least once and completed the follow-up for safety.
Presence and absence of significant data in laboratory results were recorded. 95% Confidence Interval was calculated using exact method.
Outcome measures
| Measure |
NesinaAct® Tablet
n=655 Participants
Participants with a diagnosis of Type 2 Diabetes who took NesinaAct® tablet, a fixed dose combination of alogliptin along with pioglitazone, as prescribed by the physician, were observed in this study.
|
|---|---|
|
Percentage of Participants With Abnormal Laboratory Findings Reported as AEs
Hyperglycaemia
|
0.46 percentage of participants
Interval 0.09 to 1.33
|
|
Percentage of Participants With Abnormal Laboratory Findings Reported as AEs
Weight Increase
|
0.31 percentage of participants
Interval 0.04 to 1.1
|
|
Percentage of Participants With Abnormal Laboratory Findings Reported as AEs
Diabetes Mellitus Aggravated
|
0.15 percentage of participants
Interval 0.0 to 0.85
|
|
Percentage of Participants With Abnormal Laboratory Findings Reported as AEs
Hyperlipaemia
|
0.15 percentage of participants
Interval 0.0 to 0.85
|
|
Percentage of Participants With Abnormal Laboratory Findings Reported as AEs
Sugar Blood Level Increase
|
0.15 percentage of participants
Interval 0.0 to 0.85
|
|
Percentage of Participants With Abnormal Laboratory Findings Reported as AEs
Vitamin D Deficiency
|
0.15 percentage of participants
Interval 0.0 to 0.85
|
SECONDARY outcome
Timeframe: Baseline, Weeks 13 and 26Population: Participants from the Effectiveness Analysis Set, included participants who completed NesinaAct® tablet treatment for more than 13 weeks and performed Final effectiveness assessment according to the investigator's clinical discretion, with data available for analyses. Number analyzed are participants with data available for analyses at the given timepoint.
HbA1c are glycated haemoglobin or amount of glucose attached to haemoglobin.
Outcome measures
| Measure |
NesinaAct® Tablet
n=465 Participants
Participants with a diagnosis of Type 2 Diabetes who took NesinaAct® tablet, a fixed dose combination of alogliptin along with pioglitazone, as prescribed by the physician, were observed in this study.
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|---|---|
|
Change From Baseline in Haemoglobin A1c (HbA1c) Levels
Baseline
|
7.90 percentage of HbA1c
Standard Deviation 1.49
|
|
Change From Baseline in Haemoglobin A1c (HbA1c) Levels
Change from Baseline at Week 13
|
-0.93 percentage of HbA1c
Standard Deviation 1.36
|
|
Change From Baseline in Haemoglobin A1c (HbA1c) Levels
Change from Baseline at Week 26
|
-1.40 percentage of HbA1c
Standard Deviation 1.62
|
SECONDARY outcome
Timeframe: Baseline, Weeks 13 and 26Population: Participants from the Effectiveness Analysis Set, included participants who completed NesinaAct® tablet treatment for more than 13 weeks and performed Final effectiveness assessment according to the investigator's clinical discretion, with data available for analyses. Number analyzed are participants with data available for analyses at the given timepoint.
Outcome measures
| Measure |
NesinaAct® Tablet
n=440 Participants
Participants with a diagnosis of Type 2 Diabetes who took NesinaAct® tablet, a fixed dose combination of alogliptin along with pioglitazone, as prescribed by the physician, were observed in this study.
|
|---|---|
|
Change From Baseline in Fasting Serum Glucose
Baseline
|
170.75 g/dL
Standard Deviation 46.65
|
|
Change From Baseline in Fasting Serum Glucose
Change from Baseline at Week 13
|
-25.26 g/dL
Standard Deviation 40.44
|
|
Change From Baseline in Fasting Serum Glucose
Change from Baseline at Week 26
|
-33.49 g/dL
Standard Deviation 43.18
|
SECONDARY outcome
Timeframe: Baseline, Weeks 13 and 26Population: Participants from the Effectiveness Analysis Set, included participants who completed NesinaAct® tablet treatment for more than 13 weeks and performed Final effectiveness assessment according to the investigator's clinical discretion, with data available for analyses. Number analyzed are participants with data available for analyses at the given timepoint.
Total cholesterol is a measure of the total amount of cholesterol in the blood. It includes both low-density lipoprotein (LDL) cholesterol and high-density lipoprotein (HDL) cholesterol.
Outcome measures
| Measure |
NesinaAct® Tablet
n=401 Participants
Participants with a diagnosis of Type 2 Diabetes who took NesinaAct® tablet, a fixed dose combination of alogliptin along with pioglitazone, as prescribed by the physician, were observed in this study.
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|---|---|
|
Change From Baseline in Total Cholesterol
Baseline
|
182.51 mg/dL
Standard Deviation 39.37
|
|
Change From Baseline in Total Cholesterol
Change from Baseline at Week 13
|
-13.14 mg/dL
Standard Deviation 30.86
|
|
Change From Baseline in Total Cholesterol
Change from Baseline at Week 26
|
-8.64 mg/dL
Standard Deviation 35.84
|
SECONDARY outcome
Timeframe: Baseline, Weeks 13 and 26Population: Participants from the Effectiveness Analysis Set, included participants who completed NesinaAct® tablet treatment for more than 13 weeks and performed Final effectiveness assessment according to the investigator's clinical discretion, with data available for analyses. Number analyzed are participants with data available for analyses at the given timepoint.
Outcome measures
| Measure |
NesinaAct® Tablet
n=375 Participants
Participants with a diagnosis of Type 2 Diabetes who took NesinaAct® tablet, a fixed dose combination of alogliptin along with pioglitazone, as prescribed by the physician, were observed in this study.
|
|---|---|
|
Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C)
Baseline
|
104.65 mg/dL
Standard Deviation 33.17
|
|
Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C)
Change from Baseline at Week 13
|
-7.85 mg/dL
Standard Deviation 23.40
|
|
Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C)
Change from Baseline at Week 26
|
-8.28 mg/dL
Standard Deviation 27.99
|
SECONDARY outcome
Timeframe: Baseline, Weeks 13 and 26Population: Participants from the Effectiveness Analysis Set, included participants who completed NesinaAct® tablet treatment for more than 13 weeks and performed Final effectiveness assessment according to the investigator's clinical discretion, with data available for analyses. Number analyzed are participants with data available for analyses at the given timepoint.
Outcome measures
| Measure |
NesinaAct® Tablet
n=385 Participants
Participants with a diagnosis of Type 2 Diabetes who took NesinaAct® tablet, a fixed dose combination of alogliptin along with pioglitazone, as prescribed by the physician, were observed in this study.
|
|---|---|
|
Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C)
Baseline
|
47.18 mg/dL
Standard Deviation 10.46
|
|
Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C)
Change from Baseline at Week 13
|
2.36 mg/dL
Standard Deviation 6.61
|
|
Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C)
Change from Baseline at Week 126
|
1.90 mg/dL
Standard Deviation 7.02
|
SECONDARY outcome
Timeframe: Baseline, Weeks 13 and 26Population: Participants from the Effectiveness Analysis Set, included participants who completed NesinaAct® tablet treatment for more than 13 weeks and performed Final effectiveness assessment according to the investigator's clinical discretion, with data available for analyses. Number analyzed are participants with data available for analyses at the given timepoint.
Outcome measures
| Measure |
NesinaAct® Tablet
n=530 Participants
Participants with a diagnosis of Type 2 Diabetes who took NesinaAct® tablet, a fixed dose combination of alogliptin along with pioglitazone, as prescribed by the physician, were observed in this study.
|
|---|---|
|
Change From Baseline in Body Weight
Baseline
|
69.98 kg
Standard Deviation 11.73
|
|
Change From Baseline in Body Weight
Change from Baseline at Week 13
|
-0.67 kg
Standard Deviation 2.01
|
|
Change From Baseline in Body Weight
Change from Baseline at Week 26
|
-0.48 kg
Standard Deviation 2.60
|
SECONDARY outcome
Timeframe: Baseline, Weeks 13 and 26Population: Participants from the Effectiveness Analysis Set, included participants who completed NesinaAct® tablet treatment for more than 13 weeks and performed Final effectiveness assessment according to the investigator's clinical discretion, with data available for analyses. Number analyzed are participants with data available for analyses at the given timepoint.
Outcome measures
| Measure |
NesinaAct® Tablet
n=547 Participants
Participants with a diagnosis of Type 2 Diabetes who took NesinaAct® tablet, a fixed dose combination of alogliptin along with pioglitazone, as prescribed by the physician, were observed in this study.
|
|---|---|
|
Change From Baseline in Systolic Blood Pressure
Baseline
|
128.20 mm Hg
Standard Deviation 12.52
|
|
Change From Baseline in Systolic Blood Pressure
Change from Baseline at Week 13
|
-0.88 mm Hg
Standard Deviation 11.48
|
|
Change From Baseline in Systolic Blood Pressure
Change from Baseline at Week 26
|
-1.66 mm Hg
Standard Deviation 12.44
|
SECONDARY outcome
Timeframe: Baseline, Weeks 13 and 26Population: Participants from the Effectiveness Analysis Set, included participants who completed NesinaAct® tablet treatment for more than 13 weeks and performed Final effectiveness assessment according to the investigator's clinical discretion, with data available for analyses. Number analyzed are participants with data available for analyses at the given timepoint.
Outcome measures
| Measure |
NesinaAct® Tablet
n=547 Participants
Participants with a diagnosis of Type 2 Diabetes who took NesinaAct® tablet, a fixed dose combination of alogliptin along with pioglitazone, as prescribed by the physician, were observed in this study.
|
|---|---|
|
Change From Baseline in Diastolic Blood Pressure
Baseline
|
79.84 mm Hg
Standard Deviation 10.98
|
|
Change From Baseline in Diastolic Blood Pressure
Change from Baseline at Week 13
|
-1.40 mm Hg
Standard Deviation 9.75
|
|
Change From Baseline in Diastolic Blood Pressure
Change from Baseline at Week 26
|
-0.34 mm Hg
Standard Deviation 9.32
|
Adverse Events
NesinaAct® Tablet
Serious adverse events
| Measure |
NesinaAct® Tablet
n=655 participants at risk
Participants with a diagnosis of Type 2 Diabetes who took NesinaAct® tablet, a fixed dose combination of alogliptin along with pioglitazone, as prescribed by the physician, were observed in this study.
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Tendon Rupture
|
0.15%
1/655 • First dose of surveillance drug treatment to within 30 days after the end of the treatment (up to 153 weeks)
Safety Analysis set included participants who were treated with NesinaAct® tablet at least once and completed the follow-up for safety.
|
Other adverse events
Adverse event data not reported
Additional Information
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