Trial Outcomes & Findings for Special Drug Use Surveillance of Vonoprazan for "Maintenance Therapy of Reflux Esophagitis: Long-term Use" (NCT NCT03214081)
NCT ID: NCT03214081
Last Updated: 2025-06-10
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.
COMPLETED
1237 participants
Up to 12 months
2025-06-10
Participant Flow
Participants took part in the survey at 122 investigative sites in Japan, from 01 March 2016 to 31 August 2018.
Participants with a historical diagnosis of reflux esophagitis were enrolled. Participants received vonoprazan as part of a routine medical care.
Participant milestones
| Measure |
Vonoprazan 10 mg or 20 mg
Usually, for adults, 10 mg of vonoprazan administered orally once daily. If that dosing proved insufficient, the dosage may have been increased up to 20 mg once daily. Participants received vonoprazan as part of a routine medical care.
|
|---|---|
|
Overall Study
STARTED
|
1237
|
|
Overall Study
COMPLETED
|
1174
|
|
Overall Study
NOT COMPLETED
|
63
|
Reasons for withdrawal
| Measure |
Vonoprazan 10 mg or 20 mg
Usually, for adults, 10 mg of vonoprazan administered orally once daily. If that dosing proved insufficient, the dosage may have been increased up to 20 mg once daily. Participants received vonoprazan as part of a routine medical care.
|
|---|---|
|
Overall Study
Case Report Forms Uncollected
|
9
|
|
Overall Study
Protocol Deviation
|
54
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Vonoprazan 10 mg or 20 mg
n=1174 Participants
Usually, for adults, 10 mg of vonoprazan administered orally once daily. If that dosing proved insufficient, the dosage may have been increased up to 20 mg once daily. Participants received vonoprazan as part of a routine medical care.
|
|---|---|
|
Age, Continuous
|
67.8 Years
STANDARD_DEVIATION 13.60 • n=1174 Participants
|
|
Sex: Female, Male
Female
|
683 Participants
n=1174 Participants
|
|
Sex: Female, Male
Male
|
491 Participants
n=1174 Participants
|
|
Region of Enrollment
Japan
|
1174 Participants
n=1174 Participants
|
|
Duration of Diagnosis of Reflux esophagitis
|
1109.5 Days
STANDARD_DEVIATION 1449.98 • n=666 Participants • The number analyzed is the number of participants with data available for analysis.
|
|
Healthcare Category
Outpatient
|
1146 Participants
n=1174 Participants
|
|
Healthcare Category
Inpatient
|
28 Participants
n=1174 Participants
|
|
Predisposition to Hypersensitivity
Had No Predisposition to Hypersensitivity
|
1045 Participants
n=1174 Participants
|
|
Predisposition to Hypersensitivity
Had Predisposition to Hypersensitivity
|
72 Participants
n=1174 Participants
|
|
Predisposition to Hypersensitivity
Unknown
|
57 Participants
n=1174 Participants
|
|
Medical Complications
Had No Medical Complications
|
394 Participants
n=1174 Participants
|
|
Medical Complications
Had Medical Complications
|
780 Participants
n=1174 Participants
|
|
Height
|
157.86 Centimeters (cm)
STANDARD_DEVIATION 9.727 • n=727 Participants • The number analyzed is the number of participants with data available for analysis.
|
|
Weight
|
58.05 Kilograms (kg)
STANDARD_DEVIATION 12.985 • n=781 Participants • The number analyzed is the number of participants with data available for analysis.
|
|
BMI
|
23.17 Kilogram (kg)/meter (m)^2
STANDARD_DEVIATION 3.862 • n=725 Participants • The number analyzed is the number of participants with data available for analysis.
|
|
Helicobacter Pylori Infection
Negative
|
664 Participants
n=1174 Participants
|
|
Helicobacter Pylori Infection
Positive
|
72 Participants
n=1174 Participants
|
|
Helicobacter Pylori Infection
Unknown
|
438 Participants
n=1174 Participants
|
|
Medical History of Esophageal Hiatal Hernia
Had No Esophageal Hiatal Hernia
|
591 Participants
n=1174 Participants
|
|
Medical History of Esophageal Hiatal Hernia
Had Esophageal Hiatal Hernia
|
425 Participants
n=1174 Participants
|
|
Medical History of Esophageal Hiatal Hernia
Unknown
|
158 Participants
n=1174 Participants
|
|
Smoking Classification
Never Smoked
|
563 Participants
n=1174 Participants
|
|
Smoking Classification
Current Smoker
|
100 Participants
n=1174 Participants
|
|
Smoking Classification
Ex-Smoker
|
181 Participants
n=1174 Participants
|
|
Smoking Classification
Unknown
|
330 Participants
n=1174 Participants
|
|
Drinking Habits
Yes
|
156 Participants
n=1174 Participants
|
|
Drinking Habits
No
|
701 Participants
n=1174 Participants
|
|
Drinking Habits
Unknown
|
317 Participants
n=1174 Participants
|
|
Endoscopic Findings
Grade N
|
130 Participants
n=1051 Participants • The number analyzed is the number of participants with data available for analysis.
|
|
Endoscopic Findings
Grade M
|
205 Participants
n=1051 Participants • The number analyzed is the number of participants with data available for analysis.
|
|
Endoscopic Findings
Unassessed
|
716 Participants
n=1051 Participants • The number analyzed is the number of participants with data available for analysis.
|
|
Prior Treatment with Acid Suppressants
Had No Prior Treatment with Acid Suppressants
|
214 Participants
n=1174 Participants
|
|
Prior Treatment with Acid Suppressants
Had Prior Treatment with Acid Suppressants
|
931 Participants
n=1174 Participants
|
|
Prior Treatment with Acid Suppressants
Unknown
|
29 Participants
n=1174 Participants
|
|
Purpose of Acid Suppressants Treatment
Curative Therapy for Reflux Esophagitis
|
325 Participants
n=931 Participants • Population Analysis Description: The number analyzed is the number of participants with data available for analysis.
|
|
Purpose of Acid Suppressants Treatment
Maintenance Therapy for Reflux Esophagitis
|
606 Participants
n=931 Participants • Population Analysis Description: The number analyzed is the number of participants with data available for analysis.
|
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 or 20 mg
n=1174 Participants
Usually, for adults, 10 mg of vonoprazan administered orally once daily. If that dosing proved insufficient, the dosage may have been increased up to 20 mg once daily. Participants received vonoprazan as part of a routine medical care.
|
|---|---|
|
Percentage of Participants Who Had One or More Adverse Drug Reactions
|
2.30 Percentage of Participants
|
SECONDARY outcome
Timeframe: From the initiation of the maintenance therapy to Month 12 (or discontinuation of the therapy), 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.
Endoscopic relapse rate was defined as a percentage of participants who met the criteria of Grade A to D in the modified Los Angeles (LA) classification. The modified LA classification graded endoscopic findings as follows- Grade N: normal mucosa; Grade M: minimal changes to the mucosa, such as erythema and/or whitish turbidity; Grade A: non-confluent mucosal breaks \<5 mm in length; Grade B: nonconfluent mucosal breaks ≥ 5 mm in length; Grade C: confluent mucosal breaks \<75% circumferential; Grade D: confluent mucosal breaks \>=75% circumferential.
Outcome measures
| Measure |
Vonoprazan 10 mg or 20 mg
n=425 Participants
Usually, for adults, 10 mg of vonoprazan administered orally once daily. If that dosing proved insufficient, the dosage may have been increased up to 20 mg once daily. Participants received vonoprazan as part of a routine medical care.
|
|---|---|
|
Endoscopic Relapse Rate
|
4.00 Percentage of Participants
Interval 2.35 to 6.33
|
SECONDARY outcome
Timeframe: Baseline, Month 6 and at Month 12Population: 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. Number analyzed is the number of participants who were evaluable at each time point.
Presence or absence and severity of subjective symptoms were collected from participants during medical interviews of each visit as none (asymptomatic), mild (occasionally or slightly symptomatic), moderate (considerably symptomatic), severe (unendurably symptomatic), and unknown. Number of participants who had mild, moderate, or severe heartburn at each time points were reported.
Outcome measures
| Measure |
Vonoprazan 10 mg or 20 mg
n=1141 Participants
Usually, for adults, 10 mg of vonoprazan administered orally once daily. If that dosing proved insufficient, the dosage may have been increased up to 20 mg once daily. Participants received vonoprazan as part of a routine medical care.
|
|---|---|
|
Number of Participants With Recorded Severity of Subjective Symptoms of Heartburn
Baseline · Mild
|
368 Participants
|
|
Number of Participants With Recorded Severity of Subjective Symptoms of Heartburn
Baseline · Moderate
|
270 Participants
|
|
Number of Participants With Recorded Severity of Subjective Symptoms of Heartburn
Baseline · Severe
|
26 Participants
|
|
Number of Participants With Recorded Severity of Subjective Symptoms of Heartburn
Month 6 · Mild
|
136 Participants
|
|
Number of Participants With Recorded Severity of Subjective Symptoms of Heartburn
Month 6 · Moderate
|
17 Participants
|
|
Number of Participants With Recorded Severity of Subjective Symptoms of Heartburn
Month 6 · Severe
|
2 Participants
|
|
Number of Participants With Recorded Severity of Subjective Symptoms of Heartburn
Month 12 · Mild
|
84 Participants
|
|
Number of Participants With Recorded Severity of Subjective Symptoms of Heartburn
Month 12 · Moderate
|
7 Participants
|
|
Number of Participants With Recorded Severity of Subjective Symptoms of Heartburn
Month 12 · Severe
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, Month 6 and at Month 12Population: 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. Number analyzed is the number of participants who were evaluable at each time point.
Presence or absence and severity of subjective symptoms were collected from participants during medical interviews of each visit as none (asymptomatic), mild (occasionally or slightly symptomatic), moderate (considerably symptomatic), severe (unendurably symptomatic), and unknown. Number of participants who had mild, moderate, or severe acid reflux at each time points were reported.
Outcome measures
| Measure |
Vonoprazan 10 mg or 20 mg
n=1141 Participants
Usually, for adults, 10 mg of vonoprazan administered orally once daily. If that dosing proved insufficient, the dosage may have been increased up to 20 mg once daily. Participants received vonoprazan as part of a routine medical care.
|
|---|---|
|
Number of Participants With Recorded Severity of Subjective Symptoms of Acid Reflux
Baseline · Mild
|
292 Participants
|
|
Number of Participants With Recorded Severity of Subjective Symptoms of Acid Reflux
Baseline · Moderate
|
159 Participants
|
|
Number of Participants With Recorded Severity of Subjective Symptoms of Acid Reflux
Baseline · Severe
|
20 Participants
|
|
Number of Participants With Recorded Severity of Subjective Symptoms of Acid Reflux
Month 6 · Mild
|
94 Participants
|
|
Number of Participants With Recorded Severity of Subjective Symptoms of Acid Reflux
Month 6 · Moderate
|
16 Participants
|
|
Number of Participants With Recorded Severity of Subjective Symptoms of Acid Reflux
Month 6 · Severe
|
2 Participants
|
|
Number of Participants With Recorded Severity of Subjective Symptoms of Acid Reflux
Month 12 · Mild
|
52 Participants
|
|
Number of Participants With Recorded Severity of Subjective Symptoms of Acid Reflux
Month 12 · Moderate
|
11 Participants
|
|
Number of Participants With Recorded Severity of Subjective Symptoms of Acid Reflux
Month 12 · Severe
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, Month 6 and at Month 12Population: 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. Number analyzed is the number of participants who were evaluable at each time point.
Presence or absence and severity of subjective symptoms were collected from participants during medical interviews of each visit as none (asymptomatic), mild (occasionally or slightly symptomatic), moderate (considerably symptomatic), severe (unendurably symptomatic), and unknown. Number of participants who had mild, moderate, or severe postprandial fullness at each time points were reported.
Outcome measures
| Measure |
Vonoprazan 10 mg or 20 mg
n=1141 Participants
Usually, for adults, 10 mg of vonoprazan administered orally once daily. If that dosing proved insufficient, the dosage may have been increased up to 20 mg once daily. Participants received vonoprazan as part of a routine medical care.
|
|---|---|
|
Number of Participants With Recorded Severity of Subjective Symptoms of Postprandial Fullness
Baseline · Moderate
|
77 Participants
|
|
Number of Participants With Recorded Severity of Subjective Symptoms of Postprandial Fullness
Month 6 · Mild
|
61 Participants
|
|
Number of Participants With Recorded Severity of Subjective Symptoms of Postprandial Fullness
Month 6 · Moderate
|
7 Participants
|
|
Number of Participants With Recorded Severity of Subjective Symptoms of Postprandial Fullness
Baseline · Mild
|
196 Participants
|
|
Number of Participants With Recorded Severity of Subjective Symptoms of Postprandial Fullness
Baseline · Severe
|
10 Participants
|
|
Number of Participants With Recorded Severity of Subjective Symptoms of Postprandial Fullness
Month 6 · Severe
|
2 Participants
|
|
Number of Participants With Recorded Severity of Subjective Symptoms of Postprandial Fullness
Month 12 · Mild
|
40 Participants
|
|
Number of Participants With Recorded Severity of Subjective Symptoms of Postprandial Fullness
Month 12 · Moderate
|
5 Participants
|
|
Number of Participants With Recorded Severity of Subjective Symptoms of Postprandial Fullness
Month 12 · Severe
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, Month 6 and at Month 12Population: 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. Number analyzed is the number of participants who were evaluable at each time point.
Presence or absence and severity of subjective symptoms were collected from participants during medical interviews of each visit as none (asymptomatic), mild (occasionally or slightly symptomatic), moderate (considerably symptomatic), severe (unendurably symptomatic), and unknown. Number of participants who had mild, moderate, or severe early satiation at each time points were reported.
Outcome measures
| Measure |
Vonoprazan 10 mg or 20 mg
n=1141 Participants
Usually, for adults, 10 mg of vonoprazan administered orally once daily. If that dosing proved insufficient, the dosage may have been increased up to 20 mg once daily. Participants received vonoprazan as part of a routine medical care.
|
|---|---|
|
Number of Participants With Recorded Severity of Subjective Symptoms of Early Satiation
Month 12 · Severe
|
0 Participants
|
|
Number of Participants With Recorded Severity of Subjective Symptoms of Early Satiation
Baseline · Mild
|
80 Participants
|
|
Number of Participants With Recorded Severity of Subjective Symptoms of Early Satiation
Baseline · Moderate
|
23 Participants
|
|
Number of Participants With Recorded Severity of Subjective Symptoms of Early Satiation
Baseline · Severe
|
5 Participants
|
|
Number of Participants With Recorded Severity of Subjective Symptoms of Early Satiation
Month 6 · Mild
|
29 Participants
|
|
Number of Participants With Recorded Severity of Subjective Symptoms of Early Satiation
Month 6 · Moderate
|
7 Participants
|
|
Number of Participants With Recorded Severity of Subjective Symptoms of Early Satiation
Month 6 · Severe
|
2 Participants
|
|
Number of Participants With Recorded Severity of Subjective Symptoms of Early Satiation
Month 12 · Mild
|
21 Participants
|
|
Number of Participants With Recorded Severity of Subjective Symptoms of Early Satiation
Month 12 · Moderate
|
4 Participants
|
SECONDARY outcome
Timeframe: Baseline, Month 6 and at Month 12Population: 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. Number analyzed is the number of participants who were evaluable at each time point.
Presence or absence and severity of subjective symptoms were collected from participants during medical interviews of each visit as none (asymptomatic), mild (occasionally or slightly symptomatic), moderate (considerably symptomatic), severe (unendurably symptomatic), and unknown. Number of participants who had mild, moderate, or severe epigastric pain at each time points were reported.
Outcome measures
| Measure |
Vonoprazan 10 mg or 20 mg
n=1141 Participants
Usually, for adults, 10 mg of vonoprazan administered orally once daily. If that dosing proved insufficient, the dosage may have been increased up to 20 mg once daily. Participants received vonoprazan as part of a routine medical care.
|
|---|---|
|
Number of Participants With Recorded Severity of Subjective Symptoms of Epigastric Pain
Baseline · Mild
|
167 Participants
|
|
Number of Participants With Recorded Severity of Subjective Symptoms of Epigastric Pain
Baseline · Moderate
|
52 Participants
|
|
Number of Participants With Recorded Severity of Subjective Symptoms of Epigastric Pain
Baseline · Severe
|
13 Participants
|
|
Number of Participants With Recorded Severity of Subjective Symptoms of Epigastric Pain
Month 6 · Mild
|
63 Participants
|
|
Number of Participants With Recorded Severity of Subjective Symptoms of Epigastric Pain
Month 6 · Moderate
|
6 Participants
|
|
Number of Participants With Recorded Severity of Subjective Symptoms of Epigastric Pain
Month 6 · Severe
|
0 Participants
|
|
Number of Participants With Recorded Severity of Subjective Symptoms of Epigastric Pain
Month 12 · Mild
|
40 Participants
|
|
Number of Participants With Recorded Severity of Subjective Symptoms of Epigastric Pain
Month 12 · Moderate
|
4 Participants
|
|
Number of Participants With Recorded Severity of Subjective Symptoms of Epigastric Pain
Month 12 · Severe
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, Month 6 and at Month 12Population: 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. Number analyzed is the number of participants who were evaluable at each time point.
Presence or absence and severity of subjective symptoms were collected from participants during medical interviews of each visit as none (asymptomatic), mild (occasionally or slightly symptomatic), moderate (considerably symptomatic), severe (unendurably symptomatic), and unknown. Number of participants who had mild, moderate, or severe epigastric burning at each time points were reported.
Outcome measures
| Measure |
Vonoprazan 10 mg or 20 mg
n=1141 Participants
Usually, for adults, 10 mg of vonoprazan administered orally once daily. If that dosing proved insufficient, the dosage may have been increased up to 20 mg once daily. Participants received vonoprazan as part of a routine medical care.
|
|---|---|
|
Number of Participants With Recorded Severity of Subjective Symptoms of Epigastric Burning
Baseline · Mild
|
97 Participants
|
|
Number of Participants With Recorded Severity of Subjective Symptoms of Epigastric Burning
Baseline · Moderate
|
49 Participants
|
|
Number of Participants With Recorded Severity of Subjective Symptoms of Epigastric Burning
Baseline · Severe
|
12 Participants
|
|
Number of Participants With Recorded Severity of Subjective Symptoms of Epigastric Burning
Month 6 · Mild
|
28 Participants
|
|
Number of Participants With Recorded Severity of Subjective Symptoms of Epigastric Burning
Month 6 · Moderate
|
3 Participants
|
|
Number of Participants With Recorded Severity of Subjective Symptoms of Epigastric Burning
Month 6 · Severe
|
1 Participants
|
|
Number of Participants With Recorded Severity of Subjective Symptoms of Epigastric Burning
Month 12 · Mild
|
9 Participants
|
|
Number of Participants With Recorded Severity of Subjective Symptoms of Epigastric Burning
Month 12 · Moderate
|
1 Participants
|
|
Number of Participants With Recorded Severity of Subjective Symptoms of Epigastric Burning
Month 12 · Severe
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, Month 6 and at Month 12Population: 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. Number analyzed is the number of participants who were evaluable at each time point.
Presence or absence and severity of subjective symptoms were collected from participants during medical interviews of each visit as none (asymptomatic), mild (occasionally or slightly symptomatic), moderate (considerably symptomatic), severe (unendurably symptomatic), and unknown. Number of participants who had mild, moderate, or severe abdominal bloating at each time points were reported.
Outcome measures
| Measure |
Vonoprazan 10 mg or 20 mg
n=1141 Participants
Usually, for adults, 10 mg of vonoprazan administered orally once daily. If that dosing proved insufficient, the dosage may have been increased up to 20 mg once daily. Participants received vonoprazan as part of a routine medical care.
|
|---|---|
|
Number of Participants With Recorded Severity of Subjective Symptoms of Abdominal Bloating
Baseline · Mild
|
91 Participants
|
|
Number of Participants With Recorded Severity of Subjective Symptoms of Abdominal Bloating
Baseline · Moderate
|
31 Participants
|
|
Number of Participants With Recorded Severity of Subjective Symptoms of Abdominal Bloating
Baseline · Severe
|
5 Participants
|
|
Number of Participants With Recorded Severity of Subjective Symptoms of Abdominal Bloating
Month 6 · Mild
|
40 Participants
|
|
Number of Participants With Recorded Severity of Subjective Symptoms of Abdominal Bloating
Month 6 · Moderate
|
5 Participants
|
|
Number of Participants With Recorded Severity of Subjective Symptoms of Abdominal Bloating
Month 6 · Severe
|
3 Participants
|
|
Number of Participants With Recorded Severity of Subjective Symptoms of Abdominal Bloating
Month 12 · Mild
|
28 Participants
|
|
Number of Participants With Recorded Severity of Subjective Symptoms of Abdominal Bloating
Month 12 · Moderate
|
5 Participants
|
|
Number of Participants With Recorded Severity of Subjective Symptoms of Abdominal Bloating
Month 12 · Severe
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, Month 6 and at Month 12Population: 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. Number analyzed is the number of participants who were evaluable at each time point.
Presence or absence and severity of subjective symptoms were collected from participants during medical interviews of each visit as none (asymptomatic), mild (occasionally or slightly symptomatic), moderate (considerably symptomatic), severe (unendurably symptomatic), and unknown. Number of participants who had mild, moderate, or severe nausea/vomiting at each time points were reported.
Outcome measures
| Measure |
Vonoprazan 10 mg or 20 mg
n=1141 Participants
Usually, for adults, 10 mg of vonoprazan administered orally once daily. If that dosing proved insufficient, the dosage may have been increased up to 20 mg once daily. Participants received vonoprazan as part of a routine medical care.
|
|---|---|
|
Number of Participants With Recorded Severity of Subjective Symptoms of Nausea/Vomiting
Baseline · Mild
|
69 Participants
|
|
Number of Participants With Recorded Severity of Subjective Symptoms of Nausea/Vomiting
Baseline · Moderate
|
25 Participants
|
|
Number of Participants With Recorded Severity of Subjective Symptoms of Nausea/Vomiting
Baseline · Severe
|
2 Participants
|
|
Number of Participants With Recorded Severity of Subjective Symptoms of Nausea/Vomiting
Month 6 · Mild
|
28 Participants
|
|
Number of Participants With Recorded Severity of Subjective Symptoms of Nausea/Vomiting
Month 6 · Moderate
|
9 Participants
|
|
Number of Participants With Recorded Severity of Subjective Symptoms of Nausea/Vomiting
Month 6 · Severe
|
1 Participants
|
|
Number of Participants With Recorded Severity of Subjective Symptoms of Nausea/Vomiting
Month 12 · Mild
|
20 Participants
|
|
Number of Participants With Recorded Severity of Subjective Symptoms of Nausea/Vomiting
Month 12 · Moderate
|
1 Participants
|
|
Number of Participants With Recorded Severity of Subjective Symptoms of Nausea/Vomiting
Month 12 · Severe
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, Month 6 and at Month 12Population: 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. Number analyzed is the number of participants who were evaluable at each time point.
Presence or absence and severity of subjective symptoms were collected from participants during medical interviews of each visit as none (asymptomatic), mild (occasionally or slightly symptomatic), moderate (considerably symptomatic), severe (unendurably symptomatic), and unknown. Number of participants who had mild, moderate, or severe belching at each time points were reported.
Outcome measures
| Measure |
Vonoprazan 10 mg or 20 mg
n=1141 Participants
Usually, for adults, 10 mg of vonoprazan administered orally once daily. If that dosing proved insufficient, the dosage may have been increased up to 20 mg once daily. Participants received vonoprazan as part of a routine medical care.
|
|---|---|
|
Number of Participants With Recorded Severity of Subjective Symptoms of Belching
Baseline · Mild
|
138 Participants
|
|
Number of Participants With Recorded Severity of Subjective Symptoms of Belching
Baseline · Moderate
|
60 Participants
|
|
Number of Participants With Recorded Severity of Subjective Symptoms of Belching
Baseline · Severe
|
8 Participants
|
|
Number of Participants With Recorded Severity of Subjective Symptoms of Belching
Month 6 · Mild
|
62 Participants
|
|
Number of Participants With Recorded Severity of Subjective Symptoms of Belching
Month 6 · Moderate
|
7 Participants
|
|
Number of Participants With Recorded Severity of Subjective Symptoms of Belching
Month 6 · Severe
|
2 Participants
|
|
Number of Participants With Recorded Severity of Subjective Symptoms of Belching
Month 12 · Mild
|
51 Participants
|
|
Number of Participants With Recorded Severity of Subjective Symptoms of Belching
Month 12 · Moderate
|
6 Participants
|
|
Number of Participants With Recorded Severity of Subjective Symptoms of Belching
Month 12 · Severe
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, Month 6 and at Month 12Population: 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. Number analyzed is the number of participants who were evaluable at each time point.
Presence or absence and severity of subjective symptoms were collected from participants during medical interviews of each visit as none (asymptomatic), mild (occasionally or slightly symptomatic), moderate (considerably symptomatic), severe (unendurably symptomatic), and unknown. Number of participants who had mild, moderate, or severe anorexia at each time points were reported.
Outcome measures
| Measure |
Vonoprazan 10 mg or 20 mg
n=1141 Participants
Usually, for adults, 10 mg of vonoprazan administered orally once daily. If that dosing proved insufficient, the dosage may have been increased up to 20 mg once daily. Participants received vonoprazan as part of a routine medical care.
|
|---|---|
|
Number of Participants With Recorded Severity of Subjective Symptoms of Anorexia
Month 6 · Mild
|
35 Participants
|
|
Number of Participants With Recorded Severity of Subjective Symptoms of Anorexia
Month 6 · Moderate
|
9 Participants
|
|
Number of Participants With Recorded Severity of Subjective Symptoms of Anorexia
Baseline · Mild
|
67 Participants
|
|
Number of Participants With Recorded Severity of Subjective Symptoms of Anorexia
Baseline · Moderate
|
33 Participants
|
|
Number of Participants With Recorded Severity of Subjective Symptoms of Anorexia
Baseline · Severe
|
5 Participants
|
|
Number of Participants With Recorded Severity of Subjective Symptoms of Anorexia
Month 6 · Severe
|
2 Participants
|
|
Number of Participants With Recorded Severity of Subjective Symptoms of Anorexia
Month 12 · Mild
|
15 Participants
|
|
Number of Participants With Recorded Severity of Subjective Symptoms of Anorexia
Month 12 · Moderate
|
4 Participants
|
|
Number of Participants With Recorded Severity of Subjective Symptoms of Anorexia
Month 12 · Severe
|
0 Participants
|
Adverse Events
Vonoprazan 10 mg or 20 mg
Serious adverse events
| Measure |
Vonoprazan 10 mg or 20 mg
n=1174 participants at risk
Usually, for adults, 10 mg of vonoprazan administered orally once daily. If that dosing proved insufficient, the dosage may have been increased up to 20 mg once daily. Participants received vonoprazan as part of a routine medical care.
|
|---|---|
|
Infections and infestations
Pneumonia
|
0.17%
2/1174 • 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
Peritonitis bacterial
|
0.09%
1/1174 • 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)
Acute Leukaemia
|
0.09%
1/1174 • 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%
1/1174 • 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)
Myelodysplastic syndrome
|
0.09%
1/1174 • 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)
Hepatic cancer
|
0.09%
1/1174 • 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%
1/1174 • 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
Subarachnoid haemorrhage
|
0.09%
1/1174 • 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
|
0.09%
1/1174 • 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
Respiratory failure
|
0.09%
1/1174 • 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
Mallory-Weiss syndrome
|
0.09%
1/1174 • 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
Oesophageal varices haemorrhage
|
0.09%
1/1174 • 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
Varices oesophageal
|
0.09%
1/1174 • 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
Hepatic failure
|
0.09%
1/1174 • 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%
1/1174 • 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
Death
|
0.09%
1/1174 • 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
Platelet count decreased
|
0.17%
2/1174 • 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 or 20 mg
n=1174 participants at risk
Usually, for adults, 10 mg of vonoprazan administered orally once daily. If that dosing proved insufficient, the dosage may have been increased up to 20 mg once daily. Participants received vonoprazan as part of a routine medical care.
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.94%
11/1174 • 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