Trial Outcomes & Findings for Drug Use Surveillance of Vonoprazan for "Gastric Ulcer, Duodenal Ulcer, and Reflux Esophagitis" (NCT NCT03214952)

Last Updated: 2019-12-12

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. Adverse drug reaction refers to AE related to the administered drug.

Recruitment status

COMPLETED

Target enrollment

3183 participants

Primary outcome timeframe

Up to 8 weeks

Results posted on

2019-12-12

Participant Flow

Participants took part in the survey at 291 investigative sites in Japan, from 01 March 2016 to 31 October 2018.

Participants with a historical diagnosis of gastric ulcer, duodenal ulcer, and reflux esophagitis were enrolled. Participants received vonoprazan as part of a routine medical care.

Participant milestones

Participant milestones
Measure	Vonoprazan 20 mg The usual adult dosage for oral use is 20 mg of vonoprazan administered orally once daily. An 8-week treatment for gastric ulcer and a 6-week treatment for duodenal ulcer. For reflux esophagitis, the usual adult dosage for oral use was administered for a total of 4 weeks of treatment, and if that dosing proved insufficient, the administration may have been extended, but for no longer than 8 weeks of treatment. Participants received vonoprazan as part of a routine medical care.
Overall Study STARTED	3183
Overall Study COMPLETED	3125
Overall Study NOT COMPLETED	58

Reasons for withdrawal

Reasons for withdrawal
Measure	Vonoprazan 20 mg The usual adult dosage for oral use is 20 mg of vonoprazan administered orally once daily. An 8-week treatment for gastric ulcer and a 6-week treatment for duodenal ulcer. For reflux esophagitis, the usual adult dosage for oral use was administered for a total of 4 weeks of treatment, and if that dosing proved insufficient, the administration may have been extended, but for no longer than 8 weeks of treatment. Participants received vonoprazan as part of a routine medical care.
Overall Study Protocol Deviation	45
Overall Study Case Report Forms Uncollected	13

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vonoprazan 20 mg n=3125 Participants The usual adult dosage for oral use is 20 mg of vonoprazan administered orally once daily. An 8-week treatment for gastric ulcer and a 6-week treatment for duodenal ulcer. For reflux esophagitis, the usual adult dosage for oral use was administered for a total of 4 weeks of treatment, and if that dosing proved insufficient, the administration may have been extended, but for no longer than 8 weeks of treatment. Participants received vonoprazan as part of a routine medical care.
Age, Continuous	60.8 Years STANDARD_DEVIATION 16.42 • n=3125 Participants
Sex: Female, Male Female	1375 Participants n=3125 Participants
Sex: Female, Male Male	1750 Participants n=3125 Participants
Region of Enrollment Japan	3125 Participants n=3125 Participants
Target Conditions of Study Treatment Gastric Ulcer	1097 Participants n=3125 Participants
Target Conditions of Study Treatment Duodenal Ulcer	578 Participants n=3125 Participants
Target Conditions of Study Treatment Reflux Esophagitis	1540 Participants n=3125 Participants
Duration of Diagnosis of Gastric Ulcer, Duodenal Ulcer, and Reflux Esophagitis	38.3 Days STANDARD_DEVIATION 281.47 • n=3045 Participants • The number analyzed is the number of participants with data available for analysis.
Healthcare Category Outpatient	2744 Participants n=3125 Participants
Healthcare Category Inpatient	381 Participants n=3125 Participants
Predisposition to Hypersensitivity Had No Predisposition to Hypersensitivity	2893 Participants n=3125 Participants
Predisposition to Hypersensitivity Had Predisposition to Hypersensitivity	117 Participants n=3125 Participants
Predisposition to Hypersensitivity Unknown	115 Participants n=3125 Participants
Medical Complications Had No Medical Complications	1652 Participants n=3125 Participants
Medical Complications Had Medical Complications	1473 Participants n=3125 Participants
Medical History of Gastric Ulcer, Duodenal Ulcer, and Reflux Esophagitis Had No Medical History	2256 Participants n=3125 Participants
Medical History of Gastric Ulcer, Duodenal Ulcer, and Reflux Esophagitis Had Medical History	590 Participants n=3125 Participants
Medical History of Gastric Ulcer, Duodenal Ulcer, and Reflux Esophagitis Unknown	279 Participants n=3125 Participants
Height	161.01 Centimeters (cm) STANDARD_DEVIATION 10.142 • n=1770 Participants • The number analyzed is the number of participants with data available for analysis.
Weight	60.46 Kilograms (kg) STANDARD_DEVIATION 13.377 • n=1830 Participants • The number analyzed is the number of participants with data available for analysis.
BMI	23.15 Kilogram (kg)/meter (m)^2 STANDARD_DEVIATION 3.798 • n=1757 Participants • The number analyzed is the number of participants with data available for analysis.
Helicobacter Pylori Infection Negative	1492 Participants n=3125 Participants
Helicobacter Pylori Infection Positive	862 Participants n=3125 Participants
Helicobacter Pylori Infection Unknown	771 Participants n=3125 Participants
Medical History of Esophageal Hiatal Hernia Had No Esophageal Hiatal Hernia	1920 Participants n=3125 Participants
Medical History of Esophageal Hiatal Hernia Had Esophageal Hiatal Hernia	1034 Participants n=3125 Participants
Medical History of Esophageal Hiatal Hernia Unknown	171 Participants n=3125 Participants
Smoking Classification Never Smoked	1258 Participants n=3125 Participants
Smoking Classification Current Smoker	626 Participants n=3125 Participants
Smoking Classification Ex-Smoker	429 Participants n=3125 Participants
Smoking Classification Unknown	812 Participants n=3125 Participants
Drinking Habits Yes	784 Participants n=3125 Participants
Drinking Habits No	1704 Participants n=3125 Participants
Drinking Habits Unknown	637 Participants n=3125 Participants
Endoscopic Findings; Gastric Ulcer Active stage, A1 and A2	784 Participants n=1031 Participants • The number analyzed is the number of participants with data available for analysis.
Endoscopic Findings; Gastric Ulcer Healing stage, H1 and H2	247 Participants n=1031 Participants • The number analyzed is the number of participants with data available for analysis.
Endoscopic Findings; Duodenal Ulcer Active stage, A1 and A2	370 Participants n=535 Participants • The number analyzed is the number of participants with data available for analysis.
Endoscopic Findings; Duodenal Ulcer Healing stage, H1 and H2	165 Participants n=535 Participants • The number analyzed is the number of participants with data available for analysis.
Endoscopic Findings; Reflux Esophagitis Grade A	626 Participants n=1276 Participants • The number analyzed is the number of participants with data available for analysis.
Endoscopic Findings; Reflux Esophagitis Grade B	389 Participants n=1276 Participants • The number analyzed is the number of participants with data available for analysis.
Endoscopic Findings; Reflux Esophagitis Grade C	171 Participants n=1276 Participants • The number analyzed is the number of participants with data available for analysis.
Endoscopic Findings; Reflux Esophagitis Grade D	90 Participants n=1276 Participants • The number analyzed is the number of participants with data available for analysis.
Prior Treatment for Gastric Ulcer, Duodenal Ulcer, and Reflux Esophagitis Had No Prior Treatment	2280 Participants n=3125 Participants
Prior Treatment for Gastric Ulcer, Duodenal Ulcer, and Reflux Esophagitis Had Prior Treatment	791 Participants n=3125 Participants
Prior Treatment for Gastric Ulcer, Duodenal Ulcer, and Reflux Esophagitis Unknown	54 Participants n=3125 Participants
Duration of Prior Treatment < 1 month	436 Participants n=791 Participants • The number analyzed is the number of participants with data available for analysis.
Duration of Prior Treatment >= 1 month and < 2 months	56 Participants n=791 Participants • The number analyzed is the number of participants with data available for analysis.
Duration of Prior Treatment >= 2 months	299 Participants n=791 Participants • The number analyzed is the number of participants with data available for analysis.

PRIMARY outcome

Timeframe: Up to 8 weeks

Population: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey. Participants who treated for gastric ulcer within the Safety Analysis Set were analyzed for this outcome measure.

Outcome measures

Outcome measures
Measure	Vonoprazan 20 mg n=1097 Participants The usual adult dosage for oral use is 20 mg of vonoprazan administered orally once daily. An 8-week treatment for gastric ulcer and a 6-week treatment for duodenal ulcer. For reflux esophagitis, the usual adult dosage for oral use was administered for a total of 4 weeks of treatment, and if that dosing proved insufficient, the administration may have been extended, but for no longer than 8 weeks of treatment. Participants received vonoprazan as part of a routine medical care.
Percentage of Participants With Gastric Ulcer Who Had One or More Adverse Drug Reactions	1.00 Percentage of Participants

PRIMARY outcome

Timeframe: Up to 6 weeks

Population: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey. Participants who treated for duodenal ulcer within the Safety Analysis Set were analyzed for this outcome measure.

An 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 the administered drug.

Outcome measures

Outcome measures
Measure	Vonoprazan 20 mg n=578 Participants The usual adult dosage for oral use is 20 mg of vonoprazan administered orally once daily. An 8-week treatment for gastric ulcer and a 6-week treatment for duodenal ulcer. For reflux esophagitis, the usual adult dosage for oral use was administered for a total of 4 weeks of treatment, and if that dosing proved insufficient, the administration may have been extended, but for no longer than 8 weeks of treatment. Participants received vonoprazan as part of a routine medical care.
Percentage of Participants With Duodenal Ulcer Who Had One or More Adverse Drug Reactions	1.21 Percentage of Participants

PRIMARY outcome

Timeframe: Up to 8 weeks

Population: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey. Participants who treated for reflux esophagitis within the Safety Analysis Set were analyzed for this outcome measure.

Outcome measures

Outcome measures
Measure	Vonoprazan 20 mg n=1540 Participants The usual adult dosage for oral use is 20 mg of vonoprazan administered orally once daily. An 8-week treatment for gastric ulcer and a 6-week treatment for duodenal ulcer. For reflux esophagitis, the usual adult dosage for oral use was administered for a total of 4 weeks of treatment, and if that dosing proved insufficient, the administration may have been extended, but for no longer than 8 weeks of treatment. Participants received vonoprazan as part of a routine medical care.
Percentage of Participants With Reflux Esophagitis Who Had One or More Adverse Drug Reactions	0.78 Percentage of Participants

SECONDARY outcome

Timeframe: Up to 8 weeks

Population: Efficacy assessment population, participants who completed the survey and evaluable for efficacy; Participants who treated for gastric ulcer within Efficacy assessment population and evaluable for endoscopic cure rate were analyzed for this outcome measure.

Endoscopic cure rate was defined as a percentage of participants treated for gastric ulcer who classified as Scarring stage at the end of survey per Sakita-Miwa Classification. Endoscopic findings of ulcer were classified per Sakita-Miwa Classification as follows; Active stage: A1 and A2, Healing stage: H1 and H2, Scarring stage: S1 and S2.

Outcome measures

Outcome measures
Measure	Vonoprazan 20 mg n=484 Participants The usual adult dosage for oral use is 20 mg of vonoprazan administered orally once daily. An 8-week treatment for gastric ulcer and a 6-week treatment for duodenal ulcer. For reflux esophagitis, the usual adult dosage for oral use was administered for a total of 4 weeks of treatment, and if that dosing proved insufficient, the administration may have been extended, but for no longer than 8 weeks of treatment. Participants received vonoprazan as part of a routine medical care.
Endoscopic Cure Rate in Participants With Gastric Ulcer	78.72 Percentage of Participants Interval 74.8 to 82.28

SECONDARY outcome

Timeframe: Up to 6 weeks

Population: Efficacy assessment population, participants who completed the survey and evaluable for efficacy; Participants who treated for duodenal ulcer within Efficacy assessment population and evaluable for endoscopic cure rate were analyzed for this outcome measure.

Endoscopic cure rate was defined as a percentage of participants treated for duodenal ulcer who classified as Scarring stage at the end of survey per Sakita-Miwa Classification. Endoscopic findings of ulcer were classified per Sakita-Miwa Classification as follows; Active stage: A1 and A2, Healing stage: H1 and H2, Scarring stage: S1 and S2.

Outcome measures

Outcome measures
Measure	Vonoprazan 20 mg n=234 Participants The usual adult dosage for oral use is 20 mg of vonoprazan administered orally once daily. An 8-week treatment for gastric ulcer and a 6-week treatment for duodenal ulcer. For reflux esophagitis, the usual adult dosage for oral use was administered for a total of 4 weeks of treatment, and if that dosing proved insufficient, the administration may have been extended, but for no longer than 8 weeks of treatment. Participants received vonoprazan as part of a routine medical care.
Endoscopic Cure Rate in Participants With Duodenal Ulcer	88.46 Percentage of Participants Interval 83.66 to 92.26

SECONDARY outcome

Timeframe: Up to 8 weeks

Population: Efficacy assessment population, participants who completed the survey and evaluable for efficacy; Participants who treated for reflux esophagitis within Efficacy assessment population and evaluable for endoscopic cure rate were analyzed for this outcome measure.

Endoscopic cure rate was defined as a percentage of participants who treated for reflux esophagitis and met the criteria of Grade N or M in the modified Los Angeles (LA) classification at the end of survey. Grade N: normal mucosa; Grade M: minimal changes to the mucosa, such as erythema and/or whitish turbidity.

Outcome measures

Outcome measures
Measure	Vonoprazan 20 mg n=226 Participants The usual adult dosage for oral use is 20 mg of vonoprazan administered orally once daily. An 8-week treatment for gastric ulcer and a 6-week treatment for duodenal ulcer. For reflux esophagitis, the usual adult dosage for oral use was administered for a total of 4 weeks of treatment, and if that dosing proved insufficient, the administration may have been extended, but for no longer than 8 weeks of treatment. Participants received vonoprazan as part of a routine medical care.
Endoscopic Cure Rate in Participants With Reflux Esophagitis	65.04 Percentage of Participants Interval 58.44 to 71.25

SECONDARY outcome

Timeframe: Baseline and at the end of the survey (up to 8 weeks)

Population: Efficacy assessment population, participants who completed the survey and evaluable for efficacy; Participants who treated for gastric ulcer within Efficacy assessment population and evaluable for subjective symptoms were analyzed for this outcome measure.

Percentage of participants who treated for gastric ulcer and whose subjective symptoms, including heartburn, acid reflux, postprandial fullness, early satiation, epigastric pain, epigastric burning, abdominal bloating, nausea/vomiting, belching and anorexia, were improved was reported. Presence or absence and severity of subjective symptoms were graded as asymptomatic, mild (occasionally or slightly symptomatic), moderate (considerably symptomatic), and severe (unendurably symptomatic). Participants with whose subjective symptom was improved by one grade or better were defined as "Improved".

Outcome measures

Outcome measures
Measure	Vonoprazan 20 mg n=1060 Participants The usual adult dosage for oral use is 20 mg of vonoprazan administered orally once daily. An 8-week treatment for gastric ulcer and a 6-week treatment for duodenal ulcer. For reflux esophagitis, the usual adult dosage for oral use was administered for a total of 4 weeks of treatment, and if that dosing proved insufficient, the administration may have been extended, but for no longer than 8 weeks of treatment. Participants received vonoprazan as part of a routine medical care.
Percentage of Participants With Gastric Ulcer Whose Subjective Symptoms Improved Heartburn	96.68 Percentage of Participants Interval 93.28 to 98.66
Percentage of Participants With Gastric Ulcer Whose Subjective Symptoms Improved Acid Reflux	96.86 Percentage of Participants Interval 92.81 to 98.97
Percentage of Participants With Gastric Ulcer Whose Subjective Symptoms Improved Postprandial Fullness	96.09 Percentage of Participants Interval 93.27 to 97.96
Percentage of Participants With Gastric Ulcer Whose Subjective Symptoms Improved Early Satiation	97.08 Percentage of Participants Interval 93.31 to 99.04
Percentage of Participants With Gastric Ulcer Whose Subjective Symptoms Improved Epigastric Pain	98.78 Percentage of Participants Interval 97.6 to 99.47
Percentage of Participants With Gastric Ulcer Whose Subjective Symptoms Improved Epigastric Burning	97.62 Percentage of Participants Interval 94.02 to 99.35
Percentage of Participants With Gastric Ulcer Whose Subjective Symptoms Improved Abdominal Bloating	95.65 Percentage of Participants Interval 91.91 to 97.99
Percentage of Participants With Gastric Ulcer Whose Subjective Symptoms Improved Nausea/Vomiting	97.52 Percentage of Participants Interval 94.68 to 99.08
Percentage of Participants With Gastric Ulcer Whose Subjective Symptoms Improved Belching	91.67 Percentage of Participants Interval 85.21 to 95.93
Percentage of Participants With Gastric Ulcer Whose Subjective Symptoms Improved Anorexia	98.22 Percentage of Participants Interval 96.17 to 99.34

SECONDARY outcome

Timeframe: Baseline and at the end of the survey (up to 6 weeks)

Population: Efficacy assessment population, participants who completed the survey and evaluable for efficacy; Participants who treated for duodenal ulcer within Efficacy assessment population and evaluable for subjective symptoms were analyzed for this outcome measure.

Percentage of participants who treated for duodenal ulcer and whose subjective symptoms, including heartburn, acid reflux, postprandial fullness, early satiation, epigastric pain, epigastric burning, abdominal bloating, nausea/vomiting, belching and anorexia, were improved was reported. Presence or absence and severity of subjective symptoms were graded as asymptomatic, mild (occasionally or slightly symptomatic), moderate (considerably symptomatic), and severe (unendurably symptomatic). Participants with whose subjective symptom was improved by one grade or better were defined as "Improved".

Outcome measures

Outcome measures
Measure	Vonoprazan 20 mg n=577 Participants The usual adult dosage for oral use is 20 mg of vonoprazan administered orally once daily. An 8-week treatment for gastric ulcer and a 6-week treatment for duodenal ulcer. For reflux esophagitis, the usual adult dosage for oral use was administered for a total of 4 weeks of treatment, and if that dosing proved insufficient, the administration may have been extended, but for no longer than 8 weeks of treatment. Participants received vonoprazan as part of a routine medical care.
Percentage of Participants With Duodenal Ulcer Whose Subjective Symptoms Improved Heartburn	96.94 Percentage of Participants Interval 91.31 to 99.36
Percentage of Participants With Duodenal Ulcer Whose Subjective Symptoms Improved Acid Reflux	97.22 Percentage of Participants Interval 90.32 to 99.66
Percentage of Participants With Duodenal Ulcer Whose Subjective Symptoms Improved Postprandial Fullness	95.65 Percentage of Participants Interval 90.78 to 98.39
Percentage of Participants With Duodenal Ulcer Whose Subjective Symptoms Improved Early Satiation	98.78 Percentage of Participants Interval 93.39 to 99.97
Percentage of Participants With Duodenal Ulcer Whose Subjective Symptoms Improved Epigastric Pain	98.58 Percentage of Participants Interval 96.71 to 99.54
Percentage of Participants With Duodenal Ulcer Whose Subjective Symptoms Improved Epigastric Burning	100.00 Percentage of Participants Interval 94.64 to 100.0
Percentage of Participants With Duodenal Ulcer Whose Subjective Symptoms Improved Abdominal Bloating	93.81 Percentage of Participants Interval 87.02 to 97.7
Percentage of Participants With Duodenal Ulcer Whose Subjective Symptoms Improved Nausea/Vomiting	96.92 Percentage of Participants Interval 92.31 to 99.16
Percentage of Participants With Duodenal Ulcer Whose Subjective Symptoms Improved Belching	93.55 Percentage of Participants Interval 84.3 to 98.21
Percentage of Participants With Duodenal Ulcer Whose Subjective Symptoms Improved Anorexia	99.30 Percentage of Participants Interval 96.17 to 99.98

SECONDARY outcome

Timeframe: Baseline and at the end of the survey (up to 8 weeks)

Population: Efficacy assessment population, participants who completed the survey and evaluable for efficacy; Participants who treated for reflux esophagitis within Efficacy assessment population and evaluable for subjective symptoms were analyzed for this outcome measure.

Percentage of participants who treated for reflux esophagitis and whose subjective symptoms, including heartburn, acid reflux, postprandial fullness, early satiation, epigastric pain, epigastric burning, abdominal bloating, nausea/vomiting, belching and anorexia, were improved was reported. Presence or absence and severity of subjective symptoms were graded as asymptomatic, mild (occasionally or slightly symptomatic), moderate (considerably symptomatic), and severe (unendurably symptomatic). Participants with whose subjective symptom was improved by one grade or better were defined as "Improved".

Outcome measures

Outcome measures
Measure	Vonoprazan 20 mg n=1527 Participants The usual adult dosage for oral use is 20 mg of vonoprazan administered orally once daily. An 8-week treatment for gastric ulcer and a 6-week treatment for duodenal ulcer. For reflux esophagitis, the usual adult dosage for oral use was administered for a total of 4 weeks of treatment, and if that dosing proved insufficient, the administration may have been extended, but for no longer than 8 weeks of treatment. Participants received vonoprazan as part of a routine medical care.
Percentage of Participants With Reflux Esophagitis Whose Subjective Symptoms Improved Heartburn	96.20 Percentage of Participants Interval 94.85 to 97.29
Percentage of Participants With Reflux Esophagitis Whose Subjective Symptoms Improved Acid Reflux	94.33 Percentage of Participants Interval 92.46 to 95.85
Percentage of Participants With Reflux Esophagitis Whose Subjective Symptoms Improved Postprandial Fullness	93.22 Percentage of Participants Interval 90.78 to 95.18
Percentage of Participants With Reflux Esophagitis Whose Subjective Symptoms Improved Early Satiation	92.37 Percentage of Participants Interval 88.21 to 95.42
Percentage of Participants With Reflux Esophagitis Whose Subjective Symptoms Improved Epigastric Pain	95.79 Percentage of Participants Interval 93.69 to 97.34
Percentage of Participants With Reflux Esophagitis Whose Subjective Symptoms Improved Epigastric Burning	96.72 Percentage of Participants Interval 94.45 to 98.24
Percentage of Participants With Reflux Esophagitis Whose Subjective Symptoms Improved Abdominal Bloating	90.04 Percentage of Participants Interval 85.92 to 93.28
Percentage of Participants With Reflux Esophagitis Whose Subjective Symptoms Improved Nausea/Vomiting	95.47 Percentage of Participants Interval 92.22 to 97.64
Percentage of Participants With Reflux Esophagitis Whose Subjective Symptoms Improved Belching	89.38 Percentage of Participants Interval 85.97 to 92.21
Percentage of Participants With Reflux Esophagitis Whose Subjective Symptoms Improved Anorexia	93.96 Percentage of Participants Interval 90.38 to 96.51

Adverse Events

Vonoprazan 20 mg

Serious events: 20 serious events

Other events: 10 other events

Deaths: 6 deaths

Serious adverse events

Serious adverse events
Measure	Vonoprazan 20 mg n=3125 participants at risk The usual adult dosage for oral use is 20 mg of vonoprazan administered orally once daily. An 8-week treatment for gastric ulcer and a 6-week treatment for duodenal ulcer. For reflux esophagitis, the usual adult dosage for oral use was administered for a total of 4 weeks of treatment, and if that dosing proved insufficient, the administration may have been extended, but for no longer than 8 weeks of treatment. Participants received vonoprazan as part of a routine medical care.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.06% 2/3125 • Up to 8 weeks 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% 4/3125 • Up to 8 weeks 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	0.03% 1/3125 • Up to 8 weeks 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% 1/3125 • Up to 8 weeks 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	0.03% 1/3125 • Up to 8 weeks 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	0.03% 1/3125 • Up to 8 weeks 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	0.06% 2/3125 • Up to 8 weeks 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 Alcoholic psychosis	0.03% 1/3125 • Up to 8 weeks 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	0.03% 1/3125 • Up to 8 weeks 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 rupture	0.03% 1/3125 • Up to 8 weeks 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 Diarrhoea	0.03% 1/3125 • Up to 8 weeks 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 Duodenal ulcer haemorrhage	0.03% 1/3125 • Up to 8 weeks 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% 1/3125 • Up to 8 weeks 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 Arthritis	0.03% 1/3125 • Up to 8 weeks 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 Pyrexia	0.03% 1/3125 • Up to 8 weeks 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

Other adverse events
Measure	Vonoprazan 20 mg n=3125 participants at risk The usual adult dosage for oral use is 20 mg of vonoprazan administered orally once daily. An 8-week treatment for gastric ulcer and a 6-week treatment for duodenal ulcer. For reflux esophagitis, the usual adult dosage for oral use was administered for a total of 4 weeks of treatment, and if that dosing proved insufficient, the administration may have been extended, but for no longer than 8 weeks of treatment. Participants received vonoprazan as part of a routine medical care.
Gastrointestinal disorders Nausea	0.10% 3/3125 • Up to 8 weeks 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 Rash	0.13% 4/3125 • Up to 8 weeks 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 Urticaria	0.10% 3/3125 • Up to 8 weeks 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

Medical Director

Takeda

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