Trial Outcomes & Findings for Special Drug Use Surveillance of Vonoprazan for "Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Low-dose Aspirin: Long-term Use" (NCT NCT03214094)
NCT ID: NCT03214094
Last Updated: 2020-03-11
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. Adverse drug reaction refers to AE related to administered drug.
Recruitment status
COMPLETED
Target enrollment
1119 participants
Primary outcome timeframe
Up to 12 months
Results posted on
2020-03-11
Participant Flow
Participants took part in the survey at 121 investigative sites in Japan, from 01 September 2016 to 28 February 2019.
Participants with a historical diagnosis of gastric or duodenal ulcers were enrolled. Participants received vonoprazan as part of a routine medical care.
Participant milestones
| Measure |
Vonoprazan 10 mg
The usual adult dosage for oral use is 10 mg of Vonoprazan administered once daily. Participants will receive interventions as part of routine medical care.
|
|---|---|
|
Overall Study
STARTED
|
1119
|
|
Overall Study
COMPLETED
|
1059
|
|
Overall Study
NOT COMPLETED
|
60
|
Reasons for withdrawal
| Measure |
Vonoprazan 10 mg
The usual adult dosage for oral use is 10 mg of Vonoprazan administered once daily. Participants will receive interventions as part of routine medical care.
|
|---|---|
|
Overall Study
Case Report Forms Uncollected
|
14
|
|
Overall Study
Protocol Deviation
|
46
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Vonoprazan 10 mg
n=1059 Participants
The usual adult dosage for oral use is 10 mg of Vonoprazan administered once daily. Participants will receive interventions as part of routine medical care.
|
|---|---|
|
Age, Continuous
|
72.2 Years
STANDARD_DEVIATION 10.63 • n=1059 Participants
|
|
Sex: Female, Male
Female
|
309 Participants
n=1059 Participants
|
|
Sex: Female, Male
Male
|
750 Participants
n=1059 Participants
|
|
Region of Enrollment
Japan
|
1059 Participants
n=1059 Participants
|
|
Medical History
Gastric Ulcer
|
946 Participants
n=1059 Participants • Participants could be counted in more than 1 category (including duplicates).
|
|
Medical History
Duodenal Ulcer
|
121 Participants
n=1059 Participants • Participants could be counted in more than 1 category (including duplicates).
|
|
Purpose of Low-Dose Aspirin Use
Angina Pectoris
|
464 Participants
n=1059 Participants • Participants could be counted in more than 1 category (including duplicates).
|
|
Purpose of Low-Dose Aspirin Use
Myocardial Infarction
|
278 Participants
n=1059 Participants • Participants could be counted in more than 1 category (including duplicates).
|
|
Purpose of Low-Dose Aspirin Use
Transient Ischaemic Attack (TIA) Population
|
27 Participants
n=1059 Participants • Participants could be counted in more than 1 category (including duplicates).
|
|
Purpose of Low-Dose Aspirin Use
Cerebral Infarction
|
294 Participants
n=1059 Participants • Participants could be counted in more than 1 category (including duplicates).
|
|
Purpose of Low-Dose Aspirin Use
Others
|
140 Participants
n=1059 Participants • Participants could be counted in more than 1 category (including duplicates).
|
|
Implantation of Coronary Stent
Implanted
|
484 Participants
n=1059 Participants
|
|
Implantation of Coronary Stent
Not Implanted
|
575 Participants
n=1059 Participants
|
|
Healthcare Category
Outpatient
|
695 Participants
n=1059 Participants
|
|
Healthcare Category
Inpatient
|
364 Participants
n=1059 Participants
|
|
Predisposition to Hypersensitivity
Had Predisposition to Hypersensitivity
|
67 Participants
n=1059 Participants
|
|
Predisposition to Hypersensitivity
Had No Predisposition to Hypersensitivity
|
918 Participants
n=1059 Participants
|
|
Predisposition to Hypersensitivity
Unknown
|
74 Participants
n=1059 Participants
|
|
Medical Complications
Had Medical Complications
|
971 Participants
n=1059 Participants
|
|
Medical Complications
Had No Medical Complications
|
88 Participants
n=1059 Participants
|
|
Height
|
160.52 Centimeters (cm)
STANDARD_DEVIATION 9.361 • n=927 Participants • The number analyzed is the number of participants with data available for analysis.
|
|
Weight
|
61.92 Kilograms (kg)
STANDARD_DEVIATION 12.591 • n=949 Participants • The number analyzed is the number of participants with data available for analysis.
|
|
BMI
|
23.96 Kilogram (kg)/meter (m)^2
STANDARD_DEVIATION 3.710 • n=920 Participants • The number analyzed is the number of participants with data available for analysis.
|
|
Helicobacter Pylori Infection
Helicobacter Pylori Positive
|
16 Participants
n=1059 Participants
|
|
Helicobacter Pylori Infection
Helicobacter Pylori Negative
|
107 Participants
n=1059 Participants
|
|
Helicobacter Pylori Infection
Unknown
|
936 Participants
n=1059 Participants
|
|
Smoking Classification
Never Smoked
|
324 Participants
n=1059 Participants
|
|
Smoking Classification
Current Smoker
|
136 Participants
n=1059 Participants
|
|
Smoking Classification
Ex-Smoker
|
394 Participants
n=1059 Participants
|
|
Smoking Classification
Unknown
|
205 Participants
n=1059 Participants
|
|
Drinking Habits
Current Drinker
|
226 Participants
n=1059 Participants
|
|
Drinking Habits
Never Drank or Ex Drinker
|
537 Participants
n=1059 Participants
|
|
Drinking Habits
Unknown
|
296 Participants
n=1059 Participants
|
|
Presence of Stress as a Risk Factor of Gastric or Duodenal Ulcer
Present
|
117 Participants
n=1059 Participants
|
|
Presence of Stress as a Risk Factor of Gastric or Duodenal Ulcer
Absent
|
381 Participants
n=1059 Participants
|
|
Presence of Stress as a Risk Factor of Gastric or Duodenal Ulcer
Unknown
|
561 Participants
n=1059 Participants
|
|
Prior Treatment with Acid Suppressants to Prevent Recurrent Gastric or Duodenal Ulcer
Had Prior Treatment with Acid Suppressants
|
507 Participants
n=1059 Participants
|
|
Prior Treatment with Acid Suppressants to Prevent Recurrent Gastric or Duodenal Ulcer
Had No Prior Treatment with Acid Suppressants
|
529 Participants
n=1059 Participants
|
|
Prior Treatment with Acid Suppressants to Prevent Recurrent Gastric or Duodenal Ulcer
Unknown
|
23 Participants
n=1059 Participants
|
PRIMARY outcome
Timeframe: Up to 12 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 |
Vonoprazan 10 mg
n=1059 Participants
The usual adult dosage for oral use is 10 mg of Vonoprazan administered once daily. Participants will receive interventions as part of routine medical care.
|
|---|---|
|
Percentage of Participants Who Had One or More Adverse Drug Reactions
|
1.79 Percentage of Participants
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: 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.
Reported data were percentage of participants who experienced an onset of gastric ulcers after the start of administration of vonoprazan tablets.
Outcome measures
| Measure |
Vonoprazan 10 mg
n=1038 Participants
The usual adult dosage for oral use is 10 mg of Vonoprazan administered once daily. Participants will receive interventions as part of routine medical care.
|
|---|---|
|
Percentage of Participants With Gastric Ulcers After the Start of Administration of Vonoprazan Tablets
|
0.67 Percentage of Participants
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: 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.
Reported data were percentage of participants who experienced an onset of duodenal ulcers after the start of administration of vonoprazan tablets.
Outcome measures
| Measure |
Vonoprazan 10 mg
n=1038 Participants
The usual adult dosage for oral use is 10 mg of Vonoprazan administered once daily. Participants will receive interventions as part of routine medical care.
|
|---|---|
|
Percentage of Participants With Duodenal Ulcers After the Start of Administration of Vonoprazan Tablets
|
0.19 Percentage of Participants
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: 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.
Reported data were percentage of participants who had hemorrhagic lesions on stomach after the start of administration of vonoprazan tablets.
Outcome measures
| Measure |
Vonoprazan 10 mg
n=1038 Participants
The usual adult dosage for oral use is 10 mg of Vonoprazan administered once daily. Participants will receive interventions as part of routine medical care.
|
|---|---|
|
Percentage of Participants With Hemorrhagic Lesions on Stomach After the Start of Administration of Vonoprazan Tablets
|
0.19 Percentage of Participants
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: 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.
Reported data were percentage of participants who had hemorrhagic lesions on duodenum after the start of administration of vonoprazan tablets.
Outcome measures
| Measure |
Vonoprazan 10 mg
n=1038 Participants
The usual adult dosage for oral use is 10 mg of Vonoprazan administered once daily. Participants will receive interventions as part of routine medical care.
|
|---|---|
|
Percentage of Participants With Hemorrhagic Lesions on Duodenum After the Start of Administration of Vonoprazan Tablets
|
0.00 Percentage of Participants
|
Adverse Events
Vonoprazan 10 mg
Serious events: 50 serious events
Other events: 4 other events
Deaths: 9 deaths
Serious adverse events
| Measure |
Vonoprazan 10 mg
n=1059 participants at risk
The usual adult dosage for oral use is 10 mg of Vonoprazan administered once daily. Participants will receive interventions as part of routine medical care.
|
|---|---|
|
Infections and infestations
Endocarditis
|
0.09%
1/1059 • Up to 12 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
Gangrene
|
0.09%
1/1059 • Up to 12 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
|
0.28%
3/1059 • Up to 12 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
|
0.19%
2/1059 • Up to 12 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
|
0.09%
1/1059 • Up to 12 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
|
0.19%
2/1059 • Up to 12 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
|
0.09%
1/1059 • Up to 12 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)
Rectal cancer
|
0.09%
1/1059 • Up to 12 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)
Renal cancer
|
0.09%
1/1059 • Up to 12 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
|
0.09%
1/1059 • Up to 12 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 artery stenosis
|
0.09%
1/1059 • Up to 12 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%
2/1059 • Up to 12 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
Dizziness
|
0.09%
1/1059 • Up to 12 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
Motor neurone disease
|
0.09%
1/1059 • Up to 12 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
Myelopathy
|
0.09%
1/1059 • Up to 12 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
|
0.09%
1/1059 • Up to 12 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
|
0.66%
7/1059 • Up to 12 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
|
0.19%
2/1059 • Up to 12 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
|
0.09%
1/1059 • Up to 12 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
Heart failures
|
0.28%
3/1059 • Up to 12 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 congestive
|
0.19%
2/1059 • Up to 12 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
|
0.09%
1/1059 • Up to 12 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
Sinus node dysfunction
|
0.09%
1/1059 • Up to 12 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
Aortic aneurysm
|
0.09%
1/1059 • Up to 12 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 arterial occlusive disease
|
0.09%
1/1059 • Up to 12 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
Acute respiratory failure
|
0.09%
1/1059 • Up to 12 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
|
0.09%
1/1059 • Up to 12 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
Pneumonia aspiration
|
0.19%
2/1059 • Up to 12 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 alveolar haemorrhage
|
0.09%
1/1059 • Up to 12 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
|
0.09%
1/1059 • Up to 12 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
|
0.09%
1/1059 • Up to 12 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
Pancreatitis
|
0.09%
1/1059 • Up to 12 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
Lower gastrointestinal haemorrhage
|
0.09%
1/1059 • Up to 12 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
|
0.09%
1/1059 • Up to 12 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
|
0.19%
2/1059 • Up to 12 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
|
0.19%
2/1059 • Up to 12 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.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.09%
1/1059 • Up to 12 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
Haemarthrosis
|
0.09%
1/1059 • Up to 12 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
|
0.09%
1/1059 • Up to 12 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
Vascular complication associated with device
|
0.09%
1/1059 • Up to 12 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
Vascular stent stenosis
|
0.09%
1/1059 • Up to 12 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
Angiocardiogram
|
0.09%
1/1059 • Up to 12 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
Shunt occlusion
|
0.09%
1/1059 • Up to 12 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
Shunt stenosis
|
0.09%
1/1059 • Up to 12 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 |
Vonoprazan 10 mg
n=1059 participants at risk
The usual adult dosage for oral use is 10 mg of Vonoprazan administered once daily. Participants will receive interventions as part of routine medical care.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.38%
4/1059 • Up to 12 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
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