Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-163177 | Registry Identifier | JapicCTI |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this survey is to evaluate the safety and effectiveness of vonoprazan tablets in patients with gastric ulcer, duodenal ulcer, and reflux esophagitis in the routine clinical setting.
The drug being tested in this survey is called vonoprazan. Vonoprazan is being tested to treat patients who have gastric ulcer, duodenal ulcer, and reflux esophagitis.
This survey will look at the safety and effectiveness of vonoprazan in patients with gastric ulcer, duodenal ulcer, and reflux esophagitis in the routine clinical setting. The survey will enroll approximately 3000 participants.
- Vonoprazan 20 mg
This multi-center survey will be conducted in Japan.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vonoprazan 20 mg | The usual adult dosage for oral use is 20 mg of vonoprazan administered orally once daily. An 8-week treatment for gastric ulcer and a 6-week treatment for duodenal ulcer. For reflux esophagitis, the usual adult dosage for oral use was administered for a total of 4 weeks of treatment, and if that dosing proved insufficient, the administration may have been extended, but for no longer than 8 weeks of treatment. Participants received vonoprazan as part of a routine medical care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vonoprazan | Drug | Vonoprazan tablets |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Gastric Ulcer 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 the administered drug. | Up to 8 weeks |
| Percentage of Participants With Duodenal Ulcer Who Had One or More Adverse Drug Reactions | An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction refers to AE related to the administered drug. | Up to 6 weeks |
| Percentage of Participants With Reflux Esophagitis Who Had One or More Adverse Drug Reactions | An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction refers to AE related to the administered drug. | Up to 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Endoscopic Cure Rate in Participants With Gastric Ulcer | Endoscopic cure rate was defined as a percentage of participants treated for gastric ulcer who classified as Scarring stage at the end of survey per Sakita-Miwa Classification. Endoscopic findings of ulcer were classified per Sakita-Miwa Classification as follows; Active stage: A1 and A2, Healing stage: H1 and H2, Scarring stage: S1 and S2. |
Not provided
Inclusion Criteria:
- Participants with gastric ulcer, duodenal ulcer, and reflux esophagitis
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
The study population will consist of participants with a diagnosis of gastric ulcer, duodenal ulcer, and reflux esophagitis and receive Vonoprazan in the routine clinical setting.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Takeda Selected Site | Tokyo | Japan |
Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.
Not provided
Not provided
Not provided
Not provided
Participants with a historical diagnosis of gastric ulcer, duodenal ulcer, and reflux esophagitis were enrolled. Participants received vonoprazan as part of a routine medical care.
Participants took part in the survey at 291 investigative sites in Japan, from 01 March 2016 to 31 October 2018.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Vonoprazan 20 mg | The usual adult dosage for oral use is 20 mg of vonoprazan administered orally once daily. An 8-week treatment for gastric ulcer and a 6-week treatment for duodenal ulcer. For reflux esophagitis, the usual adult dosage for oral use was administered for a total of 4 weeks of treatment, and if that dosing proved insufficient, the administration may have been extended, but for no longer than 8 weeks of treatment. Participants received vonoprazan as part of a routine medical care. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Vonoprazan 20 mg | The usual adult dosage for oral use is 20 mg of vonoprazan administered orally once daily. An 8-week treatment for gastric ulcer and a 6-week treatment for duodenal ulcer. For reflux esophagitis, the usual adult dosage for oral use was administered for a total of 4 weeks of treatment, and if that dosing proved insufficient, the administration may have been extended, but for no longer than 8 weeks of treatment. Participants received vonoprazan as part of a routine medical care. |
| 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 With Gastric Ulcer 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 the administered drug. | Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey. Participants who treated for gastric ulcer within the Safety Analysis Set were analyzed for this outcome measure. | Posted | Number | Percentage of Participants | Up to 8 weeks |
|
Up to 8 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vonoprazan 20 mg | The usual adult dosage for oral use is 20 mg of vonoprazan administered orally once daily. An 8-week treatment for gastric ulcer and a 6-week treatment for duodenal ulcer. For reflux esophagitis, the usual adult dosage for oral use was administered for a total of 4 weeks of treatment, and if that dosing proved insufficient, the administration may have been extended, but for no longer than 8 weeks of treatment. Participants received vonoprazan as part of a routine medical care. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Ver. 21.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA Ver. 21.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 3, 2018 | Oct 29, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 18, 2019 | Oct 29, 2019 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D013276 | Stomach Ulcer |
| D004381 | Duodenal Ulcer |
| D004942 | Esophagitis, Peptic |
| ID | Term |
|---|---|
| D010437 | Peptic Ulcer |
| D004378 | Duodenal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C552956 | 1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Up to 8 weeks |
| Endoscopic Cure Rate in Participants With Duodenal Ulcer | Endoscopic cure rate was defined as a percentage of participants treated for duodenal ulcer who classified as Scarring stage at the end of survey per Sakita-Miwa Classification. Endoscopic findings of ulcer were classified per Sakita-Miwa Classification as follows; Active stage: A1 and A2, Healing stage: H1 and H2, Scarring stage: S1 and S2. | Up to 6 weeks |
| Endoscopic Cure Rate in Participants With Reflux Esophagitis | Endoscopic cure rate was defined as a percentage of participants who treated for reflux esophagitis and met the criteria of Grade N or M in the modified Los Angeles (LA) classification at the end of survey. Grade N: normal mucosa; Grade M: minimal changes to the mucosa, such as erythema and/or whitish turbidity. | Up to 8 weeks |
| Percentage of Participants With Gastric Ulcer Whose Subjective Symptoms Improved | Percentage of participants who treated for gastric ulcer and whose subjective symptoms, including heartburn, acid reflux, postprandial fullness, early satiation, epigastric pain, epigastric burning, abdominal bloating, nausea/vomiting, belching and anorexia, were improved was reported. Presence or absence and severity of subjective symptoms were graded as asymptomatic, mild (occasionally or slightly symptomatic), moderate (considerably symptomatic), and severe (unendurably symptomatic). Participants with whose subjective symptom was improved by one grade or better were defined as "Improved". | Baseline and at the end of the survey (up to 8 weeks) |
| Percentage of Participants With Duodenal Ulcer Whose Subjective Symptoms Improved | Percentage of participants who treated for duodenal ulcer and whose subjective symptoms, including heartburn, acid reflux, postprandial fullness, early satiation, epigastric pain, epigastric burning, abdominal bloating, nausea/vomiting, belching and anorexia, were improved was reported. Presence or absence and severity of subjective symptoms were graded as asymptomatic, mild (occasionally or slightly symptomatic), moderate (considerably symptomatic), and severe (unendurably symptomatic). Participants with whose subjective symptom was improved by one grade or better were defined as "Improved". | Baseline and at the end of the survey (up to 6 weeks) |
| Percentage of Participants With Reflux Esophagitis Whose Subjective Symptoms Improved | Percentage of participants who treated for reflux esophagitis and whose subjective symptoms, including heartburn, acid reflux, postprandial fullness, early satiation, epigastric pain, epigastric burning, abdominal bloating, nausea/vomiting, belching and anorexia, were improved was reported. Presence or absence and severity of subjective symptoms were graded as asymptomatic, mild (occasionally or slightly symptomatic), moderate (considerably symptomatic), and severe (unendurably symptomatic). Participants with whose subjective symptom was improved by one grade or better were defined as "Improved". | Baseline and at the end of the survey (up to 8 weeks) |
| 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 |
|
| Target Conditions of Study Treatment | Participants could be counted in more than one category, including duplicates. | Count of Participants | Participants |
|
| Duration of Diagnosis of Gastric Ulcer, Duodenal Ulcer, and Reflux Esophagitis | Mean duration between first time of diagnosis of gastric ulcer, duodenal ulcer, and reflux esophagitis and start of survey 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 |
|
| Medical History of Gastric Ulcer, Duodenal Ulcer, and Reflux Esophagitis | Number of participants with or without medical history of gastric ulcer, duodenal ulcer, and reflux esophagitis was reported. | 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; Gastric Ulcer | Endoscopic findings of ulcer were classified per Sakita-Miwa Classification as follows; Active stage: A1 and A2, Healing stage: H1 and H2, Scarring stage: S1 and S2. | The number analyzed is the number of participants with data available for analysis. | Count of Participants | Participants |
|
| Endoscopic Findings; Duodenal Ulcer | Endoscopic findings of ulcer were classified per Sakita-Miwa Classification as follows; Active stage: A1 and A2, Healing stage: H1 and H2, Scarring stage: S1 and S2. | The number analyzed is the number of participants with data available for analysis. | Count of Participants | Participants |
|
| Endoscopic Findings; Reflux Esophagitis | 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 less than (<) 5 mm in length; Grade B: nonconfluent mucosal breaks greater than or equal to (>=) 5mm in length; Grade C: confluent mucosal breaks <75% circumferential; Grade D: confluent mucosal breaks greater than (>) 75% circumferential. | The number analyzed is the number of participants with data available for analysis. | Count of Participants | Participants |
|
| Prior Treatment for Gastric Ulcer, Duodenal Ulcer, and Reflux Esophagitis | Number of participants who had or had not been treated for gastric ulcer, duodenal ulcer, and reflux esophagitis was reported. | Count of Participants | Participants |
|
| Duration of Prior Treatment | Duration of prior treatment for gastric ulcer, duodenal ulcer, and reflux esophagitis was categorized as < 1 month, >= 1 month and < 2 months, and >= 2 months by number of participants. | The number analyzed is the number of participants with data available for analysis. | Count of Participants | Participants |
|
|
|
| Primary | Percentage of Participants With Duodenal Ulcer Who Had One or More Adverse Drug Reactions | An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction refers to AE related to the administered drug. | Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey. Participants who treated for duodenal ulcer within the Safety Analysis Set were analyzed for this outcome measure. | Posted | Number | Percentage of Participants | Up to 6 weeks |
|
|
|
| Primary | Percentage of Participants With Reflux Esophagitis Who Had One or More Adverse Drug Reactions | An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction refers to AE related to the administered drug. | Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey. Participants who treated for reflux esophagitis within the Safety Analysis Set were analyzed for this outcome measure. | Posted | Number | Percentage of Participants | Up to 8 weeks |
|
|
|
| Secondary | Endoscopic Cure Rate in Participants With Gastric Ulcer | Endoscopic cure rate was defined as a percentage of participants treated for gastric ulcer who classified as Scarring stage at the end of survey per Sakita-Miwa Classification. Endoscopic findings of ulcer were classified per Sakita-Miwa Classification as follows; Active stage: A1 and A2, Healing stage: H1 and H2, Scarring stage: S1 and S2. | Efficacy assessment population, participants who completed the survey and evaluable for efficacy; Participants who treated for gastric ulcer within Efficacy assessment population and evaluable for endoscopic cure rate were analyzed for this outcome measure. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to 8 weeks |
|
|
|
| Secondary | Endoscopic Cure Rate in Participants With Duodenal Ulcer | Endoscopic cure rate was defined as a percentage of participants treated for duodenal ulcer who classified as Scarring stage at the end of survey per Sakita-Miwa Classification. Endoscopic findings of ulcer were classified per Sakita-Miwa Classification as follows; Active stage: A1 and A2, Healing stage: H1 and H2, Scarring stage: S1 and S2. | Efficacy assessment population, participants who completed the survey and evaluable for efficacy; Participants who treated for duodenal ulcer within Efficacy assessment population and evaluable for endoscopic cure rate were analyzed for this outcome measure. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to 6 weeks |
|
|
|
| Secondary | Endoscopic Cure Rate in Participants With Reflux Esophagitis | Endoscopic cure rate was defined as a percentage of participants who treated for reflux esophagitis and met the criteria of Grade N or M in the modified Los Angeles (LA) classification at the end of survey. Grade N: normal mucosa; Grade M: minimal changes to the mucosa, such as erythema and/or whitish turbidity. | Efficacy assessment population, participants who completed the survey and evaluable for efficacy; Participants who treated for reflux esophagitis within Efficacy assessment population and evaluable for endoscopic cure rate were analyzed for this outcome measure. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to 8 weeks |
|
|
|
| Secondary | Percentage of Participants With Gastric Ulcer Whose Subjective Symptoms Improved | Percentage of participants who treated for gastric ulcer and whose subjective symptoms, including heartburn, acid reflux, postprandial fullness, early satiation, epigastric pain, epigastric burning, abdominal bloating, nausea/vomiting, belching and anorexia, were improved was reported. Presence or absence and severity of subjective symptoms were graded as asymptomatic, mild (occasionally or slightly symptomatic), moderate (considerably symptomatic), and severe (unendurably symptomatic). Participants with whose subjective symptom was improved by one grade or better were defined as "Improved". | Efficacy assessment population, participants who completed the survey and evaluable for efficacy; Participants who treated for gastric ulcer within Efficacy assessment population and evaluable for subjective symptoms were analyzed for this outcome measure. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Baseline and at the end of the survey (up to 8 weeks) |
|
|
|
| Secondary | Percentage of Participants With Duodenal Ulcer Whose Subjective Symptoms Improved | Percentage of participants who treated for duodenal ulcer and whose subjective symptoms, including heartburn, acid reflux, postprandial fullness, early satiation, epigastric pain, epigastric burning, abdominal bloating, nausea/vomiting, belching and anorexia, were improved was reported. Presence or absence and severity of subjective symptoms were graded as asymptomatic, mild (occasionally or slightly symptomatic), moderate (considerably symptomatic), and severe (unendurably symptomatic). Participants with whose subjective symptom was improved by one grade or better were defined as "Improved". | Efficacy assessment population, participants who completed the survey and evaluable for efficacy; Participants who treated for duodenal ulcer within Efficacy assessment population and evaluable for subjective symptoms were analyzed for this outcome measure. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Baseline and at the end of the survey (up to 6 weeks) |
|
|
|
| Secondary | Percentage of Participants With Reflux Esophagitis Whose Subjective Symptoms Improved | Percentage of participants who treated for reflux esophagitis and whose subjective symptoms, including heartburn, acid reflux, postprandial fullness, early satiation, epigastric pain, epigastric burning, abdominal bloating, nausea/vomiting, belching and anorexia, were improved was reported. Presence or absence and severity of subjective symptoms were graded as asymptomatic, mild (occasionally or slightly symptomatic), moderate (considerably symptomatic), and severe (unendurably symptomatic). Participants with whose subjective symptom was improved by one grade or better were defined as "Improved". | Efficacy assessment population, participants who completed the survey and evaluable for efficacy; Participants who treated for reflux esophagitis within Efficacy assessment population and evaluable for subjective symptoms were analyzed for this outcome measure. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Baseline and at the end of the survey (up to 8 weeks) |
|
|
|
| 6 |
| 3,125 |
| 20 |
| 3,125 |
| 10 |
| 3,125 |
| Gastric cancer | 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 |
|
| Oesophageal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Ver. 21.1 | Systematic Assessment |
|
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Ver. 21.1 | Systematic Assessment |
|
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Ver. 21.1 | Systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Ver. 21.1 | Systematic Assessment |
|
| Alcoholic psychosis | Psychiatric disorders | MedDRA Ver. 21.1 | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA Ver. 21.1 | Systematic Assessment |
|
| Aortic aneurysm rupture | Vascular disorders | MedDRA Ver. 21.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA Ver. 21.1 | Systematic Assessment |
|
| Duodenal ulcer haemorrhage | Gastrointestinal disorders | MedDRA Ver. 21.1 | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA Ver. 21.1 | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA Ver. 21.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA Ver. 21.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA Ver. 21.1 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | 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.
| D004066 |
| Digestive System Diseases |
| D013272 | Stomach Diseases |
| D004941 | Esophagitis |
| D004935 | Esophageal Diseases |
| D005759 | Gastroenteritis |
|
| Postprandial Fullness |
|
|
| Early Satiation |
|
|
| Epigastric Pain |
|
|
| Epigastric Burning |
|
|
| Abdominal Bloating |
|
|
| Nausea/Vomiting |
|
|
| Belching |
|
|
| Anorexia |
|
|
|
| Postprandial Fullness |
|
|
| Early Satiation |
|
|
| Epigastric Pain |
|
|
| Epigastric Burning |
|
|
| Abdominal Bloating |
|
|
| Nausea/Vomiting |
|
|
| Belching |
|
|
| Anorexia |
|
|
|
| Postprandial Fullness |
|
|
| Early Satiation |
|
|
| Epigastric Pain |
|
|
| Epigastric Burning |
|
|
| Abdominal Bloating |
|
|
| Nausea/Vomiting |
|
|
| Belching |
|
|
| Anorexia |
|
|