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| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-163202 | Registry Identifier | JapicCTI |
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The purpose of this survey is to evaluate the safety and effectiveness of long-term administration of vonoprazan tablets when used as maintenance therapy for reflux esophagitis in routine clinical settings.
The drug being tested in this survey is called vonoprazan. Vonoprazan is being tested to treat patients who have reflux esophagitis.
This survey will look at the safety and effectiveness of long-term administration of vonoprazan tablets when used as maintenance therapy for reflux esophagitis in routine clinical settings. The survey will enroll approximately 1000 participants.
- Vonoprazan 10 mg or 20 mg
This multi-center observational trial will be conducted in Japan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vonoprazan | Drug | Vonoprazan tablets |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Had One or More Adverse Drug Reactions | 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. | Up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Endoscopic Relapse Rate | 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. |
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Inclusion Criteria:
- Participants who require maintenance therapy for relapsed/recurrent reflux esophagitis
Exclusion Criteria:
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The study population will consist of participants with a diagnosis of reflux esophagitis and received dose of vonoprazan in the routine medical care.
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Takeda Selected Site | Tokyo | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41982134 | Derived | Manabe N, Matsuo M, Suzuki C. Long-term safety and effectiveness of vonoprazan as maintenance therapy for reflux esophagitis in Japan: a 12-month post-marketing surveillance study. Expert Opin Drug Saf. 2026 Apr 15:1-10. doi: 10.1080/14740338.2026.2612982. Online ahead of print. |
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Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Participants with a historical diagnosis of reflux esophagitis were enrolled. Participants received vonoprazan as part of a routine medical care.
Participants took part in the survey at 122 investigative sites in Japan, from 01 March 2016 to 31 August 2018.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Who Had One or More Adverse Drug Reactions | 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. | Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey. | Posted | Number | Percentage of Participants | Up to 12 months |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA Ver. 21.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA Ver. 21.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 2, 2017 | Aug 29, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 20, 2019 | Aug 29, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D004942 | Esophagitis, Peptic |
| ID | Term |
|---|---|
| D004941 | Esophagitis |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C552956 | 1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine |
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| From the initiation of the maintenance therapy to Month 12 (or discontinuation of the therapy), up to 12 months |
| Number of Participants With Recorded Severity of Subjective Symptoms of Heartburn | 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. | Baseline, Month 6 and at Month 12 |
| Number of Participants With Recorded Severity of Subjective Symptoms of Acid Reflux | 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. | Baseline, Month 6 and at Month 12 |
| Number of Participants With Recorded Severity of Subjective Symptoms of Postprandial Fullness | 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. | Baseline, Month 6 and at Month 12 |
| Number of Participants With Recorded Severity of Subjective Symptoms of Early Satiation | 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. | Baseline, Month 6 and at Month 12 |
| Number of Participants With Recorded Severity of Subjective Symptoms of Epigastric Pain | 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. | Baseline, Month 6 and at Month 12 |
| Number of Participants With Recorded Severity of Subjective Symptoms of Epigastric Burning | 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. | Baseline, Month 6 and at Month 12 |
| Number of Participants With Recorded Severity of Subjective Symptoms of Abdominal Bloating | 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. | Baseline, Month 6 and at Month 12 |
| Number of Participants With Recorded Severity of Subjective Symptoms of Nausea/Vomiting | 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. | Baseline, Month 6 and at Month 12 |
| Number of Participants With Recorded Severity of Subjective Symptoms of Belching | 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. | Baseline, Month 6 and at Month 12 |
| Number of Participants With Recorded Severity of Subjective Symptoms of Anorexia | 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. | Baseline, Month 6 and at Month 12 |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Duration of Diagnosis of Reflux esophagitis | Mean duration between start of study and first time of diagnosis of reflux esophagitis was reported. | The number analyzed is the number of participants with data available for analysis. | Mean | Standard Deviation | Days |
|
| Healthcare Category | Participants were categorized as outpatient and inpatient. | Count of Participants | Participants |
|
| Predisposition to Hypersensitivity | Number of participants who had or did not have a liability or tendency to suffer from hypersensitivity was reported. | Count of Participants | Participants |
|
| Medical Complications | Complications defined as a disease or a health condition for each participant at the start of study. Complications were classified as congenital anomalies, endocrine disorders, hematologic disorders, psychiatric and nervous system disorders, cardiovascular disorders, respiratory disorders, gastrointestinal (GI) disorders, renal disease and other complications. Other complications included all complications except for those mentioned above. | Count of Participants | Participants |
|
| Height | The number analyzed is the number of participants with data available for analysis. | Mean | Standard Deviation | Centimeters (cm) |
|
| Weight | The number analyzed is the number of participants with data available for analysis. | Mean | Standard Deviation | Kilograms (kg) |
|
| BMI | Body Mass Index = weight (kg)/[height (m)^2] | The number analyzed is the number of participants with data available for analysis. | Mean | Standard Deviation | Kilogram (kg)/meter (m)^2 |
|
| Helicobacter Pylori Infection | Number of participants with or without history of H. pylori infection was reported. "Negative" indicates the absence of H. pylori infection, "Positive" indicates presence of the infection. | Count of Participants | Participants |
|
| Medical History of Esophageal Hiatal Hernia | Number of participants with or without medical history of esophageal hiatal hernia was reported. | Count of Participants | Participants |
|
| Smoking Classification | Count of Participants | Participants |
|
| Drinking Habits | Participants who answered Yes or No for a question "Drink Alcohol Almost Every Day?" were reported. | Count of Participants | Participants |
|
| Endoscopic Findings | Endoscopic findings were assessed using the modified Los Angeles (LA) classification. The modified LA classification graded 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 ≥ 5mm in length; Grade C: confluent mucosal breaks <75% circumferential; Grade D: confluent mucosal breaks >75% circumferential. | The number analyzed is the number of participants with data available for analysis. | Count of Participants | Participants |
|
| Prior Treatment with Acid Suppressants | Number of participants who had or had not been treated with acid suppressants for reflux esophagitis was reported. | Count of Participants | Participants |
|
| Purpose of Acid Suppressants Treatment | The purpose of treatment for those who received prior treatment with acid suppressants was reported. | Population Analysis Description: The number analyzed is the number of participants with data available for analysis. | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Endoscopic Relapse Rate | 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of Participants | From the initiation of the maintenance therapy to Month 12 (or discontinuation of the therapy), up to 12 months |
|
|
|
| Secondary | Number of Participants With Recorded Severity of Subjective Symptoms of Heartburn | 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. | 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. | Posted | Count of Participants | Participants | Baseline, Month 6 and at Month 12 |
|
|
|
| Secondary | Number of Participants With Recorded Severity of Subjective Symptoms of Acid Reflux | 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. | 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. | Posted | Count of Participants | Participants | Baseline, Month 6 and at Month 12 |
|
|
|
| Secondary | Number of Participants With Recorded Severity of Subjective Symptoms of Postprandial Fullness | 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. | 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. | Posted | Count of Participants | Participants | Baseline, Month 6 and at Month 12 |
|
|
|
| Secondary | Number of Participants With Recorded Severity of Subjective Symptoms of Early Satiation | 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. | 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. | Posted | Count of Participants | Participants | Baseline, Month 6 and at Month 12 |
|
|
|
| Secondary | Number of Participants With Recorded Severity of Subjective Symptoms of Epigastric Pain | 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. | 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. | Posted | Count of Participants | Participants | Baseline, Month 6 and at Month 12 |
|
|
|
| Secondary | Number of Participants With Recorded Severity of Subjective Symptoms of Epigastric Burning | 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. | 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. | Posted | Count of Participants | Participants | Baseline, Month 6 and at Month 12 |
|
|
|
| Secondary | Number of Participants With Recorded Severity of Subjective Symptoms of Abdominal Bloating | 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. | 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. | Posted | Count of Participants | Participants | Baseline, Month 6 and at Month 12 |
|
|
|
| Secondary | Number of Participants With Recorded Severity of Subjective Symptoms of Nausea/Vomiting | 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. | 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. | Posted | Count of Participants | Participants | Baseline, Month 6 and at Month 12 |
|
|
|
| Secondary | Number of Participants With Recorded Severity of Subjective Symptoms of Belching | 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. | 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. | Posted | Count of Participants | Participants | Baseline, Month 6 and at Month 12 |
|
|
|
| Secondary | Number of Participants With Recorded Severity of Subjective Symptoms of Anorexia | 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. | 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. | Posted | Count of Participants | Participants | Baseline, Month 6 and at Month 12 |
|
|
|
| 7 |
| 1,174 |
| 15 |
| 1,174 |
| 11 |
| 1,174 |
| Peritonitis bacterial | Infections and infestations | MedDRA Ver. 21.1 | Systematic Assessment |
|
| Acute Leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Ver. 21.1 | Systematic Assessment |
|
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Ver. 21.1 | Systematic Assessment |
|
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Ver. 21.1 | Systematic Assessment |
|
| Hepatic cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Ver. 21.1 | Systematic Assessment |
|
| Myelopathy | Nervous system disorders | MedDRA Ver. 21.1 | Systematic Assessment |
|
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA Ver. 21.1 | Systematic Assessment |
|
| Angina unstable | Cardiac disorders | MedDRA Ver. 21.1 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA Ver. 21.1 | Systematic Assessment |
|
| Mallory-Weiss syndrome | Gastrointestinal disorders | MedDRA Ver. 21.1 | Systematic Assessment |
|
| Oesophageal varices haemorrhage | Gastrointestinal disorders | MedDRA Ver. 21.1 | Systematic Assessment |
|
| Varices oesophageal | Gastrointestinal disorders | MedDRA Ver. 21.1 | Systematic Assessment |
|
| Hepatic failure | Hepatobiliary disorders | MedDRA Ver. 21.1 | Systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA Ver. 21.1 | Systematic Assessment |
|
| Death | General disorders | MedDRA Ver. 21.1 | Systematic Assessment | The event had a causal relationship with a complication of ureteral cancer, and the causality of the event was "not related" to vonoprazan. |
|
| Platelet count decreased | Investigations | MedDRA Ver. 21.1 | Systematic Assessment |
|
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.
| D005759 |
| Gastroenteritis |
| D010437 | Peptic Ulcer |
| D004378 | Duodenal Diseases |
| D007410 | Intestinal Diseases |
| D013272 | Stomach Diseases |
| Severe |
|
| Month 6 |
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| Month 12 |
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| Severe |
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| Month 6 |
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| Month 12 |
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| Severe |
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| Month 6 |
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| Month 12 |
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| Severe |
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| Month 6 |
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| Month 12 |
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| Severe |
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| Month 6 |
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| Month 12 |
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| Severe |
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| Month 6 |
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| Month 12 |
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| Severe |
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| Month 6 |
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| Month 12 |
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| Severe |
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| Month 6 |
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| Month 12 |
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| Severe |
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| Month 6 |
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| Month 12 |
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| Severe |
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| Month 6 |
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| Month 12 |
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