Vonoprazan Study in Patients With Erosive Esophagitis to... | NCT02679508

Obsolete or Duplicate NCT IDs

Not provided

ID	Type	Description	Link
U1111-1178-8948	Registry Identifier	WHO
JapicCTI-163153	Registry Identifier	JapicCTI

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Vonoprazan group	Experimental	Vonoprazan 20 mg administered orally once daily in the healing phase + vonoprazan 10 mg (as the initial dose and adjusted to vonoprazan 10 mg or 20 mg) administered orally once daily in the maintenance phase	Drug: Vonoprazan
Lansoprazole group	Active Comparator	Lansoprazole 30 mg administered orally once daily in the healing phase + lansoprazole 15 mg (as the initial dose and adjusted to lansoprazole 15 mg or 30 mg) administered orally once daily in the maintenance phase	Drug: Lansoprazole

Name	Type	Description	Arm Group Labels	Other Names
Vonoprazan	Drug	Vonoprazan fumarate 10 mg or 20 mg capsules	Vonoprazan group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Malignant Alteration of Epithelial Cells	Numbers of participants with malignant alteration of epithelial cells for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as the endpoint for gastric mucosa histopathology. The number analyzed is the number of participants with data available for analysis.	Time Frame: Up to Week 268 (Week 260 in Maintenance Phase)
Number of Participants With Parietal Cell Protrusion/Hyperplasia	Numbers of participants with parietal cell protrusion/hyperplasia for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as the endpoint for gastric mucosa histopathology. The number analyzed is the number of participants with data available for analysis.	Up to Week 268 (Week 260 in Maintenance Phase)
Number of Participants With Foveolar Hyperplasia	Numbers of participants with foveolar hyperplasia for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as the endpoint for gastric mucosa histopathology. The number analyzed is the number of participants with data available for analysis.	Up to Week 268 (Week 260 in Maintenance Phase)
Number of Participants With Enterochromaffin-like-cell Hyperplasia	Numbers of participants with enterochromaffin-like-cell hyperplasia for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as the endpoint for gastric mucosa histopathology. The number analyzed is the number of participants with data available for analysis.	Up to Week 268 (Week 260 in Maintenance Phase)
Number of Participants With G-cell Hyperplasia	Numbers of participants with G-cell hyperplasia for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as the endpoint for gastric mucosa histopathology. The number analyzed is the number of participants with data available for analysis.

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Recurrence of Erosive Esophagitis (EE)	Erosive esophagitis recurrence is defined as endoscopically confirmed to have erosive esophagitis (LA classification grades O and A to D) during the Maintenance Phase. The LA classification graded as follows- Grade O: normal mucosa; Grade A: nonconfluent 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.

Eligibility Module

Eligibility Criteria

Inclusion Criteria

Healing Phase:

Participants endoscopically diagnosed with EE of grades A to D by the LA Classification Grading System at the start of treatment (Week 0 of the healing phase)
Participants with H. pylori negative
Participants who, in the opinion of the principal investigator or investigator, are capable of understanding the content of the clinical research and complying with the research protocol requirements.
Participants who can sign and date an informed consent form and information sheet prior to the conduction of the clinical research procedures.
Male or female participants aged 20 years or older at the time of informed consent
Therapeutic category: Ambulatory

Maintenance Phase:
Participants who have endoscopically confirmed EE healing* (mucous membrane disorder is not observed) at completion of the healing phase (Week 4 or 8 of the healing phase)

* Participants who are classified as grade 0 according to severity classification of EE (See Table 9.b)
Participants who have been determined to be appropriate as subjects for maintenance treatment of EE by the principal investigator or investigator

Exclusion Criteria:

Healing Phase:

Participants with concurrent peptic ulcer (except scarred stage) or Zollinger-Ellison syndrome
Participants who received treatment with PPIs (including vonoprazan) within 4 weeks (Week -4 to Week 0) prior to the start of healing phase (Week 0 of the healing phase)
Participants with a history of H. pylori eradication.
Participants who have received surgery or treatment affecting gastroesophageal reflux (fundoplication or dilation for esophageal stenosis [excluding Schatzki's ring], etc.)
Participants with an esophagus-related complication (eosinophilic esophagitis, esophageal varices, scleroderma, viral or fungal infection, esophageal stenosis, etc.), a history of radiotherapy or cryotherapy of the esophagus, a caustic or physiochemical trauma (esophageal sclerotherapy, etc.). However, participants with Schatzki's ring (mucosal tissue ring around inferior esophageal sphincter) or Barrett's esophagus are allowed to be included.
Participants with clinically apparent hepatic impairment (e.g., AST or ALT levels at the time of informed consent: >1.5 times the upper limit of normal (ULN).
Participants with renal impairment or renal failure [creatinine clearance (CCr) ˂30 mL/min, etc.]
Participants with a history of hypersensitivity or allergy for PPIs.
Participants with a history of gastrectomy, gastrointestinal resection, or vagotomy
Participants with a malignant tumor
Participants who are pregnant, breast-feeding, possibly pregnant, or planning to become pregnant
Participants with one of the diseases listed under administration contraindication in the vonoprazan or lansoprazole package insert
Participants planning to take prohibited concomitant medications during the research period
Participants participating in other clinical studies
Participants who have been determined to be inappropriate as subjects in the study by the principal investigator or investigator

Maintenance Phase:
Participants who have taken PPIs other than the study drug or the control drug during the healing phase
Participants who have been determined to be inappropriate as subjects in the study by the principal investigator or investigator

Contacts/Locations Module

Name	Affiliation	Role
Study Director	Takeda	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Tokatsu Tsujinaka Hospital		Abiko	Chiba		Japan
Hohnodai Hospital National Center For Global Health and Medicine

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39209187	Derived	Uemura N, Kinoshita Y, Haruma K, Kushima R, Yao T, Akiyama J, Aoyama N, Baba Y, Suzuki C, Ishiguro K. Vonoprazan as a Long-term Maintenance Treatment for Erosive Esophagitis: VISION, a 5-Year, Randomized, Open-label Study. Clin Gastroenterol Hepatol. 2025 Apr;23(5):748-757.e5. doi: 10.1016/j.cgh.2024.08.004. Epub 2024 Aug 27.

Label	URL
To obtain more information on the study, click here/on this link	View source

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Vonoprazan Group	Vonoprazan 20 mg administered orally once daily in the healing phase, after that Vonoprazan 10 mg (as the initial dose and adjusted to Vonoprazan 10 mg or 20 mg) administered orally once daily in the maintenance phase.
FG001	Lansoprazole Group

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jun 10, 2021	Mar 2, 2023

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Randomized Set: All participants who were enrolled in Healing Phase and who received at least one dose of any therapy during the study.

Arm/Group Information

ID	Title	Description
BG000	Vonoprazan Group	Vonoprazan 20 mg administered orally once daily in the healing phase, after that Vonoprazan 10 mg (as the initial dose and adjusted to Vonoprazan 10 mg or 20 mg) administered orally once daily in the maintenance phase.
BG001	Lansoprazole Group	Lansoprazole 30 mg administered orally once daily in the healing phase, after that Lansoprazole 15 mg (as the initial dose and adjusted to Lansoprazole 15 mg or 30 mg) administered orally once daily in the maintenance phase.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	OG0000 OG0010

Primary

Number of Participants With Parietal Cell Protrusion/Hyperplasia

Numbers of participants with parietal cell protrusion/hyperplasia for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as the endpoint for gastric mucosa histopathology. The number analyzed is the number of participants with data available for analysis.

Posted

Count of Participants

Participants

Up to Week 268 (Week 260 in Maintenance Phase)

ID	Title	Description
OG000	Vonoprazan Group	Vonoprazan 20 mg administered orally once daily in the healing phase, after that Vonoprazan 10 mg (as the initial dose and adjusted to Vonoprazan 10 mg or 20 mg) administered orally once daily in the maintenance phase.
OG001	Lansoprazole Group	Lansoprazole 30 mg administered orally once daily in the healing phase, after that Lansoprazole 15 mg (as the initial dose and adjusted to Lansoprazole 15 mg or 30 mg) administered orally once daily in the maintenance phase.

Primary

Number of Participants With Foveolar Hyperplasia

Numbers of participants with foveolar hyperplasia for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as the endpoint for gastric mucosa histopathology. The number analyzed is the number of participants with data available for analysis.

Posted

Count of Participants

Participants

Up to Week 268 (Week 260 in Maintenance Phase)

ID	Title	Description
OG000	Vonoprazan Group	Vonoprazan 20 mg administered orally once daily in the healing phase, after that Vonoprazan 10 mg (as the initial dose and adjusted to Vonoprazan 10 mg or 20 mg) administered orally once daily in the maintenance phase.
OG001	Lansoprazole Group	Lansoprazole 30 mg administered orally once daily in the healing phase, after that Lansoprazole 15 mg (as the initial dose and adjusted to Lansoprazole 15 mg or 30 mg) administered orally once daily in the maintenance phase.

Primary

Number of Participants With Enterochromaffin-like-cell Hyperplasia

Numbers of participants with enterochromaffin-like-cell hyperplasia for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as the endpoint for gastric mucosa histopathology. The number analyzed is the number of participants with data available for analysis.

Posted

Count of Participants

Participants

Up to Week 268 (Week 260 in Maintenance Phase)

ID	Title	Description
OG000	Vonoprazan Group	Vonoprazan 20 mg administered orally once daily in the healing phase, after that Vonoprazan 10 mg (as the initial dose and adjusted to Vonoprazan 10 mg or 20 mg) administered orally once daily in the maintenance phase.
OG001	Lansoprazole Group	Lansoprazole 30 mg administered orally once daily in the healing phase, after that Lansoprazole 15 mg (as the initial dose and adjusted to Lansoprazole 15 mg or 30 mg) administered orally once daily in the maintenance phase.

Primary

Number of Participants With G-cell Hyperplasia

Numbers of participants with G-cell hyperplasia for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as the endpoint for gastric mucosa histopathology. The number analyzed is the number of participants with data available for analysis.

Posted

Count of Participants

Participants

Up to Week 268 (Week 260 in Maintenance Phase)

ID	Title	Description
OG000	Vonoprazan Group	Vonoprazan 20 mg administered orally once daily in the healing phase, after that Vonoprazan 10 mg (as the initial dose and adjusted to Vonoprazan 10 mg or 20 mg) administered orally once daily in the maintenance phase.
OG001	Lansoprazole Group	Lansoprazole 30 mg administered orally once daily in the healing phase, after that Lansoprazole 15 mg (as the initial dose and adjusted to Lansoprazole 15 mg or 30 mg) administered orally once daily in the maintenance phase.

Secondary

Percentage of Participants With Recurrence of Erosive Esophagitis (EE)

Erosive esophagitis recurrence is defined as endoscopically confirmed to have erosive esophagitis (LA classification grades O and A to D) during the Maintenance Phase. The LA classification graded as follows- Grade O: normal mucosa; Grade A: nonconfluent 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.

Full Analysis Set in the Maintenance Phase: All participants who were randomized and who received at least one dose of any therapy in the Maintenance Phase of this study.

Posted

Number

95% Confidence Interval

Percentage of participants

Up to Week 268 (Week 260 in Maintenance Phase)

ID	Title	Description
OG000	Vonoprazan Group	Vonoprazan 20 mg administered orally once daily in the healing phase, after that Vonoprazan 10 mg (as the initial dose and adjusted to Vonoprazan 10 mg or 20 mg) administered orally once daily in the maintenance phase.
OG001	Lansoprazole Group	Lansoprazole 30 mg administered orally once daily in the healing phase, after that Lansoprazole 15 mg (as the initial dose and adjusted to Lansoprazole 15 mg or 30 mg) administered orally once daily in the maintenance phase.

Secondary

Percentage of Participants Who Healed EE at the End of Healing Phase

Percentage of participants who healed EE at the end of healing phase was reported.

Full Analysis Set in the Healing Phase: All participants who were randomized and who received at least one dose of any therapy in the Healing Phase of this study.

Posted

Number

95% Confidence Interval

Percentage of participants

Up to Week 8

ID	Title	Description
OG000	Vonoprazan Group	Vonoprazan 20 mg administered orally once daily in the healing phase, after that Vonoprazan 10 mg (as the initial dose and adjusted to Vonoprazan 10 mg or 20 mg) administered orally once daily in the maintenance phase.
OG001	Lansoprazole Group	Lansoprazole 30 mg administered orally once daily in the healing phase, after that Lansoprazole 15 mg (as the initial dose and adjusted to Lansoprazole 15 mg or 30 mg) administered orally once daily in the maintenance phase.

Units	Counts
Participants

Secondary

Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) in Maintenance Phase

Number of participants reporting one or more TEAEs in Maintenance Phase was reported. An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.

Safety Data Analysis Set in the Maintenance Phase: All participants who were enrolled in Maintenance Phase and who received at least one dose of any therapy in the Maintenance Phase of this study.

Posted

Count of Participants

Participants

260 weeks (Baseline, up to the end of Maintenance Phase)

ID	Title	Description
OG000	Vonoprazan Group	Vonoprazan 20 mg administered orally once daily in the healing phase, after that Vonoprazan 10 mg (as the initial dose and adjusted to Vonoprazan 10 mg or 20 mg) administered orally once daily in the maintenance phase.
OG001	Lansoprazole Group	Lansoprazole 30 mg administered orally once daily in the healing phase, after that Lansoprazole 15 mg (as the initial dose and adjusted to Lansoprazole 15 mg or 30 mg) administered orally once daily in the maintenance phase.

Secondary

Number of Participants With Fundic Gland Polyp

Numbers of participants with fundic gland polyp for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as the endpoint for endoscopic findings. The number analyzed is the number of participants with data available for analysis.

Posted

Count of Participants

Participants

Up to Week 268 (Week 260 in Maintenance Phase)

ID	Title	Description
OG000	Vonoprazan Group	Vonoprazan 20 mg administered orally once daily in the healing phase, after that Vonoprazan 10 mg (as the initial dose and adjusted to Vonoprazan 10 mg or 20 mg) administered orally once daily in the maintenance phase.
OG001	Lansoprazole Group	Lansoprazole 30 mg administered orally once daily in the healing phase, after that Lansoprazole 15 mg (as the initial dose and adjusted to Lansoprazole 15 mg or 30 mg) administered orally once daily in the maintenance phase.

Secondary

Number of Participants With Hyperplastic Polyp

Numbers of participants with hyperplastic polyp for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as the endpoint for endoscopic findings. The number analyzed is the number of participants with data available for analysis.

Posted

Count of Participants

Participants

Up to Week 268 (Week 260 in Maintenance Phase)

ID	Title	Description
OG000	Vonoprazan Group	Vonoprazan 20 mg administered orally once daily in the healing phase, after that Vonoprazan 10 mg (as the initial dose and adjusted to Vonoprazan 10 mg or 20 mg) administered orally once daily in the maintenance phase.
OG001	Lansoprazole Group	Lansoprazole 30 mg administered orally once daily in the healing phase, after that Lansoprazole 15 mg (as the initial dose and adjusted to Lansoprazole 15 mg or 30 mg) administered orally once daily in the maintenance phase.

Secondary

Number of Participants With Cobblestone Mucosa

Numbers of participants with cobblestone mucosa for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as the endpoint for endoscopic findings. The number analyzed is the number of participants with data available for analysis.

Posted

Count of Participants

Participants

Up to Week 268 (Week 260 in Maintenance Phase)

ID	Title	Description
OG000	Vonoprazan Group	Vonoprazan 20 mg administered orally once daily in the healing phase, after that Vonoprazan 10 mg (as the initial dose and adjusted to Vonoprazan 10 mg or 20 mg) administered orally once daily in the maintenance phase.
OG001	Lansoprazole Group	Lansoprazole 30 mg administered orally once daily in the healing phase, after that Lansoprazole 15 mg (as the initial dose and adjusted to Lansoprazole 15 mg or 30 mg) administered orally once daily in the maintenance phase.

Secondary

Number of Participants With Multiple White and Flat Elevated Lesions

Numbers of participants with multiple white and flat elevated lesions for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as the endpoint for endoscopic findings. The number analyzed is the number of participants with data available for analysis.

Posted

Count of Participants

Participants

Up to Week 268 (Week 260 in Maintenance Phase)

ID	Title	Description
OG000	Vonoprazan Group	Vonoprazan 20 mg administered orally once daily in the healing phase, after that Vonoprazan 10 mg (as the initial dose and adjusted to Vonoprazan 10 mg or 20 mg) administered orally once daily in the maintenance phase.
OG001	Lansoprazole Group	Lansoprazole 30 mg administered orally once daily in the healing phase, after that Lansoprazole 15 mg (as the initial dose and adjusted to Lansoprazole 15 mg or 30 mg) administered orally once daily in the maintenance phase.

Secondary

Number of Participants With Black Spots

Numbers of participants with black spots for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as the endpoint for endoscopic findings. The number analyzed is the number of participants with data available for analysis.

Safety Data Analysis Set in the Maintenance Phase: All participants who were enrolled in Maintenance Phase and who received at least one dose of any therapy in the Maintenance Phase of this study.

Posted

Count of Participants

Participants

Up to Week 268 (Week 260 in Maintenance Phase)

ID	Title	Description
OG000	Vonoprazan Group	Vonoprazan 20 mg administered orally once daily in the healing phase, after that Vonoprazan 10 mg (as the initial dose and adjusted to Vonoprazan 10 mg or 20 mg) administered orally once daily in the maintenance phase.
OG001	Lansoprazole Group	Lansoprazole 30 mg administered orally once daily in the healing phase, after that Lansoprazole 15 mg (as the initial dose and adjusted to Lansoprazole 15 mg or 30 mg) administered orally once daily in the maintenance phase.

Units	Counts

Secondary

Number of Participants With Inflammation (Mononuclear Infiltration) in Greater Curvature of Middle Gastric Body

Numbers of participants with inflammation (mononuclear infiltration) in greater curvature of the middle gastric body for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as histological assessment of gastritis.

Posted

Count of Participants

Participants

Up to Week 268 (Week 260 in Maintenance Phase)

ID	Title	Description
OG000	Vonoprazan Group	Vonoprazan 20 mg administered orally once daily in the healing phase, after that Vonoprazan 10 mg (as the initial dose and adjusted to Vonoprazan 10 mg or 20 mg) administered orally once daily in the maintenance phase.
OG001	Lansoprazole Group	Lansoprazole 30 mg administered orally once daily in the healing phase, after that Lansoprazole 15 mg (as the initial dose and adjusted to Lansoprazole 15 mg or 30 mg) administered orally once daily in the maintenance phase.

Secondary

Number of Participants With Inflammation (Mononuclear Infiltration) in Greater Curvature of Antrum

Numbers of participants with inflammation (mononuclear infiltration) in greater curvature of the antrum for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as histological assessment of gastritis.

Posted

Count of Participants

Participants

Up to Week 268 (Week 260 in Maintenance Phase)

ID	Title	Description
OG000	Vonoprazan Group	Vonoprazan 20 mg administered orally once daily in the healing phase, after that Vonoprazan 10 mg (as the initial dose and adjusted to Vonoprazan 10 mg or 20 mg) administered orally once daily in the maintenance phase.
OG001	Lansoprazole Group	Lansoprazole 30 mg administered orally once daily in the healing phase, after that Lansoprazole 15 mg (as the initial dose and adjusted to Lansoprazole 15 mg or 30 mg) administered orally once daily in the maintenance phase.

Secondary

Number of Participants With Neutrophilic Infiltration in Greater Curvature of Middle Gastric Body

Numbers of participants with neutrophilic infiltration in greater curvature of the middle gastric body for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as histological assessment of gastritis.

Posted

Count of Participants

Participants

Up to Week 268 (Week 260 in Maintenance Phase)

ID	Title	Description
OG000	Vonoprazan Group	Vonoprazan 20 mg administered orally once daily in the healing phase, after that Vonoprazan 10 mg (as the initial dose and adjusted to Vonoprazan 10 mg or 20 mg) administered orally once daily in the maintenance phase.
OG001	Lansoprazole Group	Lansoprazole 30 mg administered orally once daily in the healing phase, after that Lansoprazole 15 mg (as the initial dose and adjusted to Lansoprazole 15 mg or 30 mg) administered orally once daily in the maintenance phase.

Secondary

Number of Participants With Neutrophilic Infiltration in Greater Curvature of Antrum

Numbers of participants with neutrophilic infiltration in greater curvature of the antrum for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as histological assessment of gastritis.

Posted

Count of Participants

Participants

Up to Week 268 (Week 260 in Maintenance Phase)

ID	Title	Description
OG000	Vonoprazan Group	Vonoprazan 20 mg administered orally once daily in the healing phase, after that Vonoprazan 10 mg (as the initial dose and adjusted to Vonoprazan 10 mg or 20 mg) administered orally once daily in the maintenance phase.
OG001	Lansoprazole Group	Lansoprazole 30 mg administered orally once daily in the healing phase, after that Lansoprazole 15 mg (as the initial dose and adjusted to Lansoprazole 15 mg or 30 mg) administered orally once daily in the maintenance phase.

Secondary

Number of Participants With Atrophy in Greater Curvature of Middle Gastric Body

Numbers of participants with atrophy in greater curvature of the middle gastric body for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as histological assessment of gastritis.

Posted

Count of Participants

Participants

Up to Week 268 (Week 260 in Maintenance Phase)

ID	Title	Description
OG000	Vonoprazan Group	Vonoprazan 20 mg administered orally once daily in the healing phase, after that Vonoprazan 10 mg (as the initial dose and adjusted to Vonoprazan 10 mg or 20 mg) administered orally once daily in the maintenance phase.
OG001	Lansoprazole Group	Lansoprazole 30 mg administered orally once daily in the healing phase, after that Lansoprazole 15 mg (as the initial dose and adjusted to Lansoprazole 15 mg or 30 mg) administered orally once daily in the maintenance phase.

Secondary

Number of Participants With Atrophy in Greater Curvature of Antrum

Numbers of participants with atrophy in greater curvature of the antrum for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as histological assessment of gastritis.

Posted

Count of Participants

Participants

Up to Week 268 (Week 260 in Maintenance Phase)

ID	Title	Description
OG000	Vonoprazan Group	Vonoprazan 20 mg administered orally once daily in the healing phase, after that Vonoprazan 10 mg (as the initial dose and adjusted to Vonoprazan 10 mg or 20 mg) administered orally once daily in the maintenance phase.
OG001	Lansoprazole Group	Lansoprazole 30 mg administered orally once daily in the healing phase, after that Lansoprazole 15 mg (as the initial dose and adjusted to Lansoprazole 15 mg or 30 mg) administered orally once daily in the maintenance phase.

Units

Secondary

Number of Participants With Intestinal Metaplasia in Greater Curvature of Middle Gastric Body

Numbers of participants with intestinal metaplasia in greater curvature of the middle gastric body for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as histological assessment of gastritis.

Posted

Count of Participants

Participants

Up to Week 268 (Week 260 in Maintenance Phase)

ID	Title	Description
OG000	Vonoprazan Group	Vonoprazan 20 mg administered orally once daily in the healing phase, after that Vonoprazan 10 mg (as the initial dose and adjusted to Vonoprazan 10 mg or 20 mg) administered orally once daily in the maintenance phase.
OG001	Lansoprazole Group	Lansoprazole 30 mg administered orally once daily in the healing phase, after that Lansoprazole 15 mg (as the initial dose and adjusted to Lansoprazole 15 mg or 30 mg) administered orally once daily in the maintenance phase.

Secondary

Number of Participants With Intestinal Metaplasia in Greater Curvature of Antrum

Numbers of participants with intestinal metaplasia in greater curvature of the antrum for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as histological assessment of gastritis.

Posted

Count of Participants

Participants

Up to Week 268 (Week 260 in Maintenance Phase)

ID	Title	Description
OG000	Vonoprazan Group	Vonoprazan 20 mg administered orally once daily in the healing phase, after that Vonoprazan 10 mg (as the initial dose and adjusted to Vonoprazan 10 mg or 20 mg) administered orally once daily in the maintenance phase.
OG001	Lansoprazole Group	Lansoprazole 30 mg administered orally once daily in the healing phase, after that Lansoprazole 15 mg (as the initial dose and adjusted to Lansoprazole 15 mg or 30 mg) administered orally once daily in the maintenance phase.

Secondary

Number of Participants With Presence of H.Pylori in Greater Curvature of Middle Gastric Body

Numbers of participants with presence of H.pylori in greater curvature of the middle gastric body for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as histological assessment of gastritis.

Posted

Count of Participants

Participants

Up to Week 268 (Week 260 in Maintenance Phase)

ID	Title	Description
OG000	Vonoprazan Group	Vonoprazan 20 mg administered orally once daily in the healing phase, after that Vonoprazan 10 mg (as the initial dose and adjusted to Vonoprazan 10 mg or 20 mg) administered orally once daily in the maintenance phase.
OG001	Lansoprazole Group	Lansoprazole 30 mg administered orally once daily in the healing phase, after that Lansoprazole 15 mg (as the initial dose and adjusted to Lansoprazole 15 mg or 30 mg) administered orally once daily in the maintenance phase.

Secondary

Number of Participants With Presence of H.Pylori in Greater Curvature of Antrum

Numbers of participants with presence of H.pylori in greater curvature of the antrum for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as histological assessment of gastritis.

Posted

Count of Participants

Participants

Up to Week 268 (Week 260 in Maintenance Phase)

ID	Title	Description
OG000	Vonoprazan Group	Vonoprazan 20 mg administered orally once daily in the healing phase, after that Vonoprazan 10 mg (as the initial dose and adjusted to Vonoprazan 10 mg or 20 mg) administered orally once daily in the maintenance phase.
OG001	Lansoprazole Group	Lansoprazole 30 mg administered orally once daily in the healing phase, after that Lansoprazole 15 mg (as the initial dose and adjusted to Lansoprazole 15 mg or 30 mg) administered orally once daily in the maintenance phase.

Secondary

Number of Participants With Gastric Polyp

Numbers of participants with gastric polyp for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported. The number analyzed is the number of participants with data available for analysis.

Posted

Count of Participants

Participants

Up to Week 268 (Week 260 in Maintenance Phase)

ID	Title	Description
OG000	Vonoprazan Group	Vonoprazan 20 mg administered orally once daily in the healing phase, after that Vonoprazan 10 mg (as the initial dose and adjusted to Vonoprazan 10 mg or 20 mg) administered orally once daily in the maintenance phase.
OG001	Lansoprazole Group	Lansoprazole 30 mg administered orally once daily in the healing phase, after that Lansoprazole 15 mg (as the initial dose and adjusted to Lansoprazole 15 mg or 30 mg) administered orally once daily in the maintenance phase.

Units	Counts

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Vonoprazan Group	Vonoprazan 20 mg administered orally once daily in the healing phase, after that Vonoprazan 10 mg (as the initial dose and adjusted to Vonoprazan 10 mg or 20 mg) administered orally once daily in the maintenance phase.	0	139	50	139	128	139
EG001	Lansoprazole Group	Lansoprazole 30 mg administered orally once daily in the healing phase, after that Lansoprazole 15 mg (as the initial dose and adjusted to Lansoprazole 15 mg or 30 mg) administered orally once daily in the maintenance phase.	1	69	27	69	65	69

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Leukopenia	Blood and lymphatic system disorders	MedDRA Ver.24.0	Systematic Assessment	EG0001 affected139 at risk EG0010 affected69 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA Ver.24.0	Systematic Assessment	EG0001 affected139 at risk EG0011 affected69 at risk
Angina pectoris	Cardiac disorders	MedDRA Ver.24.0	Systematic Assessment	EG0001 affected139 at risk EG0010 affected69 at risk
Angina unstable	Cardiac disorders	MedDRA Ver.24.0	Systematic Assessment	EG0000 affected139 at risk EG0011 affected69 at risk
Atrioventricular block second degree	Cardiac disorders	MedDRA Ver.24.0	Systematic Assessment	EG0001 affected139 at risk EG0010 affected69 at risk
Prinzmetal angina	Cardiac disorders	MedDRA Ver.24.0	Systematic Assessment	EG0000 affected139 at risk EG0011 affected69 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA Ver.24.0	Systematic Assessment	EG0001 affected139 at risk EG0010 affected69 at risk
Vertigo	Ear and labyrinth disorders	MedDRA Ver.24.0	Systematic Assessment	EG0001 affected139 at risk EG0010 affected69 at risk
Hypopituitarism	Endocrine disorders	MedDRA Ver.24.0	Systematic Assessment	EG0001 affected139 at risk EG0010 affected69 at risk
Cataract	Eye disorders	MedDRA Ver.24.0	Systematic Assessment	EG0003 affected139 at risk EG0016 affected69 at risk
Cataract nuclear	Eye disorders	MedDRA Ver.24.0	Systematic Assessment	EG0001 affected139 at risk EG0010 affected69 at risk
Eyelid ptosis	Eye disorders	MedDRA Ver.24.0	Systematic Assessment	EG0000 affected139 at risk EG0011 affected69 at risk
Macular fibrosis	Eye disorders	MedDRA Ver.24.0	Systematic Assessment	EG0000 affected139 at risk EG0011 affected69 at risk
Large intestine polyp	Gastrointestinal disorders	MedDRA Ver.24.0	Systematic Assessment	EG0005 affected139 at risk EG0014 affected69 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA Ver.24.0	Systematic Assessment	EG0002 affected139 at risk EG0012 affected69 at risk
Diverticulum intestinal haemorrhagic	Gastrointestinal disorders	MedDRA Ver.24.0	Systematic Assessment	EG0003 affected139 at risk EG0010 affected69 at risk
Colitis ischaemic	Gastrointestinal disorders	MedDRA Ver.24.0	Systematic Assessment	EG0001 affected139 at risk EG0010 affected69 at risk
Diverticulum intestinal	Gastrointestinal disorders	MedDRA Ver.24.0	Systematic Assessment	EG0000 affected139 at risk EG0011 affected69 at risk
Duodenal obstruction	Gastrointestinal disorders	MedDRA Ver.24.0	Systematic Assessment	EG0001 affected139 at risk EG0010 affected69 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA Ver.24.0	Systematic Assessment	EG0001 affected139 at risk EG0010 affected69 at risk
Enterovesical fistula	Gastrointestinal disorders	MedDRA Ver.24.0	Systematic Assessment	EG0000 affected139 at risk EG0011 affected69 at risk
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA Ver.24.0	Systematic Assessment	EG0000 affected139 at risk EG0011 affected69 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA Ver.24.0	Systematic Assessment	EG0000 affected139 at risk EG0011 affected69 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA Ver.24.0	Systematic Assessment	EG0001 affected139 at risk EG0010 affected69 at risk
Pancreatic steatosis	Gastrointestinal disorders	MedDRA Ver.24.0	Systematic Assessment	EG0001 affected139 at risk EG0010 affected69 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA Ver.24.0	Systematic Assessment	EG0000 affected139 at risk EG0011 affected69 at risk
Cholangitis	Hepatobiliary disorders	MedDRA Ver.24.0	Systematic Assessment	EG0001 affected139 at risk EG0011 affected69 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA Ver.24.0	Systematic Assessment	EG0001 affected139 at risk EG0010 affected69 at risk
Cholangitis acute	Hepatobiliary disorders	MedDRA Ver.24.0	Systematic Assessment	EG0001 affected139 at risk EG0010 affected69 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA Ver.24.0	Systematic Assessment	EG0001 affected139 at risk EG0010 affected69 at risk
Hepatic function abnormal	Hepatobiliary disorders	MedDRA Ver.24.0	Systematic Assessment	EG0001 affected139 at risk EG0010 affected69 at risk
Anaphylactic shock	Immune system disorders	MedDRA Ver.24.0	Systematic Assessment	EG0001 affected139 at risk EG0010 affected69 at risk
Diverticulitis	Infections and infestations	MedDRA Ver.24.0	Systematic Assessment	EG0002 affected139 at risk EG0010 affected69 at risk
Abscess limb	Infections and infestations	MedDRA Ver.24.0	Systematic Assessment	EG0001 affected139 at risk EG0010 affected69 at risk
Cellulitis	Infections and infestations	MedDRA Ver.24.0	Systematic Assessment	EG0001 affected139 at risk EG0010 affected69 at risk
Cholangitis infective	Infections and infestations	MedDRA Ver.24.0	Systematic Assessment	EG0000 affected139 at risk EG0011 affected69 at risk
Chronic sinusitis	Infections and infestations	MedDRA Ver.24.0	Systematic Assessment	EG0001 affected139 at risk EG0010 affected69 at risk
Herpes zoster	Infections and infestations	MedDRA Ver.24.0	Systematic Assessment	EG0000 affected139 at risk EG0011 affected69 at risk
Pneumonia	Infections and infestations	MedDRA Ver.24.0	Systematic Assessment	EG0001 affected139 at risk EG0010 affected69 at risk
Pneumonia bacterial	Infections and infestations	MedDRA Ver.24.0	Systematic Assessment	EG0001 affected139 at risk EG0010 affected69 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA Ver.24.0	Systematic Assessment	EG0001 affected139 at risk EG0011 affected69 at risk
Acetabulum fracture	Injury, poisoning and procedural complications	MedDRA Ver.24.0	Systematic Assessment	EG0001 affected139 at risk EG0010 affected69 at risk
Facial bones fracture	Injury, poisoning and procedural complications	MedDRA Ver.24.0	Systematic Assessment	EG0001 affected139 at risk EG0010 affected69 at risk
Fall	Injury, poisoning and procedural complications	MedDRA Ver.24.0	Systematic Assessment	EG0001 affected139 at risk EG0010 affected69 at risk
Heat illness	Injury, poisoning and procedural complications	MedDRA Ver.24.0	Systematic Assessment	EG0001 affected139 at risk EG0010 affected69 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA Ver.24.0	Systematic Assessment	EG0001 affected139 at risk EG0010 affected69 at risk
Patella fracture	Injury, poisoning and procedural complications	MedDRA Ver.24.0	Systematic Assessment	EG0001 affected139 at risk EG0010 affected69 at risk
Subdural haemorrhage	Injury, poisoning and procedural complications	MedDRA Ver.24.0	Systematic Assessment	EG0000 affected139 at risk EG0011 affected69 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA Ver.24.0	Systematic Assessment	EG0001 affected139 at risk EG0010 affected69 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA Ver.24.0	Systematic Assessment	EG0001 affected139 at risk EG0010 affected69 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA Ver.24.0	Systematic Assessment	EG0002 affected139 at risk EG0010 affected69 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA Ver.24.0	Systematic Assessment	EG0000 affected139 at risk EG0012 affected69 at risk
Spondylolisthesis	Musculoskeletal and connective tissue disorders	MedDRA Ver.24.0	Systematic Assessment	EG0002 affected139 at risk EG0010 affected69 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA Ver.24.0	Systematic Assessment	EG0001 affected139 at risk EG0010 affected69 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA Ver.24.0	Systematic Assessment	EG0001 affected139 at risk EG0010 affected69 at risk
Spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA Ver.24.0	Systematic Assessment	EG0001 affected139 at risk EG0010 affected69 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Ver.24.0	Systematic Assessment	EG0001 affected139 at risk EG0012 affected69 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Ver.24.0	Systematic Assessment	EG0002 affected139 at risk EG0010 affected69 at risk
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Ver.24.0	Systematic Assessment	EG0001 affected139 at risk EG0011 affected69 at risk
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Ver.24.0	Systematic Assessment	EG0002 affected139 at risk EG0010 affected69 at risk
Adenocarcinoma gastric	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Ver.24.0	Systematic Assessment	EG0000 affected139 at risk EG0011 affected69 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Ver.24.0	Systematic Assessment	EG0000 affected139 at risk EG0011 affected69 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Ver.24.0	Systematic Assessment	EG0001 affected139 at risk EG0010 affected69 at risk
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Ver.24.0	Systematic Assessment	EG0001 affected139 at risk EG0010 affected69 at risk
Lung neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Ver.24.0	Systematic Assessment	EG0001 affected139 at risk EG0010 affected69 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Ver.24.0	Systematic Assessment	EG0001 affected139 at risk EG0010 affected69 at risk
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Ver.24.0	Systematic Assessment	EG0001 affected139 at risk EG0010 affected69 at risk
Metastases to retroperitoneum	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Ver.24.0	Systematic Assessment	EG0001 affected139 at risk EG0010 affected69 at risk
Mucinous adenocarcinoma of appendix	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Ver.24.0	Systematic Assessment	EG0001 affected139 at risk EG0010 affected69 at risk
Myelodysplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Ver.24.0	Systematic Assessment	EG0001 affected139 at risk EG0010 affected69 at risk
Renal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Ver.24.0	Systematic Assessment	EG0001 affected139 at risk EG0010 affected69 at risk
Tongue neoplasm malignant stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Ver.24.0	Systematic Assessment	EG0001 affected139 at risk EG0010 affected69 at risk
Ureteric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Ver.24.0	Systematic Assessment	EG0001 affected139 at risk EG0010 affected69 at risk
Ureteric cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Ver.24.0	Systematic Assessment	EG0001 affected139 at risk EG0010 affected69 at risk
Carpal tunnel syndrome	Nervous system disorders	MedDRA Ver.24.0	Systematic Assessment	EG0003 affected139 at risk EG0011 affected69 at risk
Thrombotic cerebral infarction	Nervous system disorders	MedDRA Ver.24.0	Systematic Assessment	EG0000 affected139 at risk EG0012 affected69 at risk
Loss of consciousness	Nervous system disorders	MedDRA Ver.24.0	Systematic Assessment	EG0001 affected139 at risk EG0010 affected69 at risk
Peripheral nerve palsy	Nervous system disorders	MedDRA Ver.24.0	Systematic Assessment	EG0001 affected139 at risk EG0010 affected69 at risk
Sciatic nerve palsy	Nervous system disorders	MedDRA Ver.24.0	Systematic Assessment	EG0001 affected139 at risk EG0010 affected69 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA Ver.24.0	Systematic Assessment	EG0000 affected139 at risk EG0011 affected69 at risk
Calculus bladder	Renal and urinary disorders	MedDRA Ver.24.0	Systematic Assessment	EG0000 affected139 at risk EG0011 affected69 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA Ver.24.0	Systematic Assessment	EG0001 affected139 at risk EG0010 affected69 at risk
Renal cyst	Renal and urinary disorders	MedDRA Ver.24.0	Systematic Assessment	EG0001 affected139 at risk EG0010 affected69 at risk
Ureterolithiasis	Renal and urinary disorders	MedDRA Ver.24.0	Systematic Assessment	EG0000 affected139 at risk EG0011 affected69 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA Ver.24.0	Systematic Assessment	EG0001 affected139 at risk EG0010 affected69 at risk
Varicose vein	Vascular disorders	MedDRA Ver.24.0	Systematic Assessment	EG0001 affected139 at risk EG0011 affected69 at risk
Subclavian artery stenosis	Vascular disorders	MedDRA Ver.24.0	Systematic Assessment	EG0001 affected139 at risk EG0010 affected69 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Vertigo	Ear and labyrinth disorders	MedDRA Ver.24.0	Systematic Assessment	EG0007 affected139 at risk EG0011 affected69 at risk
Gastric polyps	Gastrointestinal disorders	MedDRA Ver.24.0	Systematic Assessment	EG00062 affected139 at risk EG00131 affected69 at risk
Gastric mucosal lesion	Gastrointestinal disorders	MedDRA Ver.24.0	Systematic Assessment	EG00030 affected139 at risk EG00117 affected69 at risk
Gastritis erosive	Gastrointestinal disorders	MedDRA Ver.24.0	Systematic Assessment	EG00012 affected139 at risk EG0019 affected69 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA Ver.24.0	Systematic Assessment	EG00013 affected139 at risk EG0016 affected69 at risk
Large intestine polyp	Gastrointestinal disorders	MedDRA Ver.24.0	Systematic Assessment	EG00011 affected139 at risk EG0016 affected69 at risk
Gastrointestinal mucosal disorder	Gastrointestinal disorders	MedDRA Ver.24.0	Systematic Assessment	EG00010 affected139 at risk EG0016 affected69 at risk
Constipation	Gastrointestinal disorders	MedDRA Ver.24.0	Systematic Assessment	EG0008 affected139 at risk EG0014 affected69 at risk
Dental caries	Gastrointestinal disorders	MedDRA Ver.24.0	Systematic Assessment	EG0007 affected139 at risk EG0012 affected69 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA Ver.24.0	Systematic Assessment	EG0002 affected139 at risk EG0014 affected69 at risk
Nasopharyngitis	Infections and infestations	MedDRA Ver.24.0	Systematic Assessment	EG00049 affected139 at risk EG00129 affected69 at risk
Bronchitis	Infections and infestations	MedDRA Ver.24.0	Systematic Assessment	EG00013 affected139 at risk EG0017 affected69 at risk
Influenza	Infections and infestations	MedDRA Ver.24.0	Systematic Assessment	EG00013 affected139 at risk EG0011 affected69 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA Ver.24.0	Systematic Assessment	EG0007 affected139 at risk EG0016 affected69 at risk
Gastroenteritis	Infections and infestations	MedDRA Ver.24.0	Systematic Assessment	EG0008 affected139 at risk EG0014 affected69 at risk
Cystitis	Infections and infestations	MedDRA Ver.24.0	Systematic Assessment	EG0008 affected139 at risk EG0012 affected69 at risk
Pharyngitis	Infections and infestations	MedDRA Ver.24.0	Systematic Assessment	EG0005 affected139 at risk EG0015 affected69 at risk
Herpes zoster	Infections and infestations	MedDRA Ver.24.0	Systematic Assessment	EG0003 affected139 at risk EG0014 affected69 at risk
Tonsillitis bacterial	Infections and infestations	MedDRA Ver.24.0	Systematic Assessment	EG0002 affected139 at risk EG0014 affected69 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA Ver.24.0	Systematic Assessment	EG0008 affected139 at risk EG0013 affected69 at risk
Ligament sprain	Injury, poisoning and procedural complications	MedDRA Ver.24.0	Systematic Assessment	EG0007 affected139 at risk EG0012 affected69 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA Ver.24.0	Systematic Assessment	EG00013 affected139 at risk EG0013 affected69 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA Ver.24.0	Systematic Assessment	EG0005 affected139 at risk EG0015 affected69 at risk
Headache	Nervous system disorders	MedDRA Ver.24.0	Systematic Assessment	EG0006 affected139 at risk EG0014 affected69 at risk
Dizziness	Nervous system disorders	MedDRA Ver.24.0	Systematic Assessment	EG0002 affected139 at risk EG0015 affected69 at risk
Insomnia	Psychiatric disorders	MedDRA Ver.24.0	Systematic Assessment	EG0007 affected139 at risk EG0010 affected69 at risk
Upper respiratory tract inflammation	Respiratory, thoracic and mediastinal disorders	MedDRA Ver.24.0	Systematic Assessment	EG0005 affected139 at risk EG0014 affected69 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA Ver.24.0	Systematic Assessment	EG0004 affected139 at risk EG0014 affected69 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA Ver.24.0	Systematic Assessment	EG00010 affected139 at risk EG00110 affected69 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA Ver.24.0	Systematic Assessment	EG0004 affected139 at risk EG0014 affected69 at risk
Hypertension	Vascular disorders	MedDRA Ver.24.0	Systematic Assessment	EG00015 affected139 at risk EG0016 affected69 at risk

ID	Term
D004941	Esophagitis

ID	Term
C552956	1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine
D064747	Lansoprazole

Ancestor Terms

ID	Term
D053799	2-Pyridinylmethylsulfinylbenzimidazoles
D013454	Sulfoxides
D013457	Sulfur Compounds
D009930	Organic Chemicals
D011725	Pyridines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D001562	Benzimidazoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

Units	Counts
Participants	OG000135 OG00167

ID	Term
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D005759	Gastroenteritis