Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of Vonoprazan Compared to Placebo in Participants With Symptomatic Non-Erosive Gastroesophageal Reflux Disease (NCT NCT04799158)
NCT ID: NCT04799158
Last Updated: 2023-01-04
Results Overview
An evaluable heartburn episode was an episode for which study drug was taken and for which the participant completed at least one entry in the heartburn episode diary. For a heartburn episode to be considered completely relieved, a participant must not have taken rescue antacid within 3 hours of taking study drug. For sustained relief, complete relief must have been accompanied by 24 hours without another heartburn episode after taking study drug.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
458 participants
Primary outcome timeframe
On-Demand Treatment Period: Day 1 to Day 42
Results posted on
2023-01-04
Participant Flow
This study was performed at 54 sites in the United States between 25 March 2021 and 17 January 2022. Of the 1115 participants screened for the study, 458 participants were enrolled into the Run-In Period. Of these participants, 207 participants were randomized to receive study drug in the On-Demand treatment period.
Eligible participants who had symptomatic NERD were initially dosed during an open-label Run-In Period with vonoprazan 20 mg once per day (QD) for 4 weeks. Participants with stable disease (defined by those who had no heartburn on the last 7 consecutive days of the Run-In Period) and were compliant with the electronic diary and study drug were randomized using a 1:1:1:1 allocation ratio to receive either vonoprazan 10 mg, 20 mg, or 40 mg or placebo during the 6-week On-Demand Treatment Period.
Participant milestones
| Measure |
Run-In Period
Participants received oral vonoprazan 20 mg once daily (QD) for up to 4 weeks.
|
Vonoprazan 10 mg: On-Demand Treatment Period
Participants who had stable disease (no heartburn on the last 7 days of the Run-In Period) received oral vonoprazan 10 mg when heartburn occurred during the 6 week On-Demand Treatment Period. Participants could take no more than one dose in a 24-hour period.
|
Vonoprazan 20 mg: On-Demand Treatment Period
Participants who had stable disease (no heartburn on the last 7 days of the Run-In Period) received oral vonoprazan 20 mg when heartburn occurred during the 6 week On-Demand Treatment Period. Participants could take no more than one dose in a 24-hour period.
|
Vonoprazan 40 mg: On-Demand Treatment Period
Participants who had stable disease (no heartburn on the last 7 days of the Run-In Period) received oral vonoprazan 40 mg when heartburn occurred during the 6 week On-Demand Treatment Period. Participants could take no more than one dose in a 24-hour period.
|
Placebo: On-Demand Treatment Period
Participants who had stable disease (no heartburn on the last 7 days of the Run-In Period) received oral placebo when heartburn occurred during the 6 week On-Demand Treatment Period. Participants could take no more than one dose in a 24-hour period.
|
|---|---|---|---|---|---|
|
Run-In Period
STARTED
|
458
|
0
|
0
|
0
|
0
|
|
Run-In Period
COMPLETED
|
207
|
0
|
0
|
0
|
0
|
|
Run-In Period
NOT COMPLETED
|
251
|
0
|
0
|
0
|
0
|
|
On-Demand Treatment Period
STARTED
|
0
|
52
|
52
|
51
|
52
|
|
On-Demand Treatment Period
COMPLETED
|
0
|
51
|
52
|
49
|
48
|
|
On-Demand Treatment Period
NOT COMPLETED
|
0
|
1
|
0
|
2
|
4
|
Reasons for withdrawal
| Measure |
Run-In Period
Participants received oral vonoprazan 20 mg once daily (QD) for up to 4 weeks.
|
Vonoprazan 10 mg: On-Demand Treatment Period
Participants who had stable disease (no heartburn on the last 7 days of the Run-In Period) received oral vonoprazan 10 mg when heartburn occurred during the 6 week On-Demand Treatment Period. Participants could take no more than one dose in a 24-hour period.
|
Vonoprazan 20 mg: On-Demand Treatment Period
Participants who had stable disease (no heartburn on the last 7 days of the Run-In Period) received oral vonoprazan 20 mg when heartburn occurred during the 6 week On-Demand Treatment Period. Participants could take no more than one dose in a 24-hour period.
|
Vonoprazan 40 mg: On-Demand Treatment Period
Participants who had stable disease (no heartburn on the last 7 days of the Run-In Period) received oral vonoprazan 40 mg when heartburn occurred during the 6 week On-Demand Treatment Period. Participants could take no more than one dose in a 24-hour period.
|
Placebo: On-Demand Treatment Period
Participants who had stable disease (no heartburn on the last 7 days of the Run-In Period) received oral placebo when heartburn occurred during the 6 week On-Demand Treatment Period. Participants could take no more than one dose in a 24-hour period.
|
|---|---|---|---|---|---|
|
Run-In Period
Adverse Event
|
6
|
0
|
0
|
0
|
0
|
|
Run-In Period
Lost to Follow-up
|
4
|
0
|
0
|
0
|
0
|
|
Run-In Period
Significant Protocol Deviation
|
1
|
0
|
0
|
0
|
0
|
|
Run-In Period
Withdrawal by Subject
|
11
|
0
|
0
|
0
|
0
|
|
Run-In Period
Miscellaneous
|
3
|
0
|
0
|
0
|
0
|
|
Run-In Period
Did not meet On-Demand Eligibility Criteria
|
226
|
0
|
0
|
0
|
0
|
|
On-Demand Treatment Period
Adverse Event
|
0
|
1
|
0
|
0
|
1
|
|
On-Demand Treatment Period
Lost to Follow-up
|
0
|
0
|
0
|
0
|
1
|
|
On-Demand Treatment Period
Significant Protocol Deviation
|
0
|
0
|
0
|
1
|
0
|
|
On-Demand Treatment Period
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
0
|
|
On-Demand Treatment Period
Lack of Efficacy
|
0
|
0
|
0
|
0
|
1
|
|
On-Demand Treatment Period
Miscellaneous
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Study to Evaluate the Efficacy and Safety of Vonoprazan Compared to Placebo in Participants With Symptomatic Non-Erosive Gastroesophageal Reflux Disease
Baseline characteristics by cohort
| Measure |
Vonoprazan 10 mg: On-Demand Treatment Period
n=49 Participants
Participants who had stable disease (no heartburn on the last 7 days of the Run-In Period) received oral vonoprazan 10 mg when heartburn occurred during the 6 week On-Demand Treatment Period. Participants could take no more than one dose in a 24-hour period.
|
Vonoprazan 20 mg: On-Demand Treatment Period
n=49 Participants
Participants who had stable disease (no heartburn on the last 7 days of the Run-In Period) received oral vonoprazan 20 mg when heartburn occurred during the 6 week On-Demand Treatment Period. Participants could take no more than one dose in a 24-hour period.
|
Vonoprazan 40 mg: On-Demand Treatment Period
n=48 Participants
Participants who had stable disease (no heartburn on the last 7 days of the Run-In Period) received oral vonoprazan 40 mg when heartburn occurred during the 6 week On-Demand Treatment Period. Participants could take no more than one dose in a 24-hour period.
|
Placebo: On-Demand Treatment Period
n=47 Participants
Participants who had stable disease (no heartburn on the last 7 days of the Run-In Period) received oral placebo when heartburn occured during the 6 week On-Demand Treatment Period. Participants could take no more than one dose in a 24-hour period.
|
Total
n=193 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
54.1 years
STANDARD_DEVIATION 11.89 • n=5 Participants
|
55.7 years
STANDARD_DEVIATION 12.87 • n=7 Participants
|
52.0 years
STANDARD_DEVIATION 14.60 • n=5 Participants
|
52.7 years
STANDARD_DEVIATION 15.20 • n=4 Participants
|
53.7 years
STANDARD_DEVIATION 13.65 • n=21 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
118 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
75 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
16 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
60 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
33 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
133 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
32 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
136 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black or African-American
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Not reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: On-Demand Treatment Period: Day 1 to Day 42Population: Intent-to-Treat (ITT) On-Demand Set: includes all participants in the Safety Run-In set who were randomized and completed at least one heartburn episode diary during the On-Demand Treatment Period.
An evaluable heartburn episode was an episode for which study drug was taken and for which the participant completed at least one entry in the heartburn episode diary. For a heartburn episode to be considered completely relieved, a participant must not have taken rescue antacid within 3 hours of taking study drug. For sustained relief, complete relief must have been accompanied by 24 hours without another heartburn episode after taking study drug.
Outcome measures
| Measure |
Vonoprazan 10 mg: On-Demand Treatment Period
n=359 evaluable heartburn episodes
Participants who had stable disease (no heartburn on the last 7 days of the Run-In Period) received oral vonoprazan 10 mg when heartburn occurred during the 6 week On-Demand Treatment Period. Participants could take no more than one dose in a 24 hour period.
|
Vonoprazan 20 mg: On-Demand Treatment Period
n=327 evaluable heartburn episodes
Participants who had stable disease (no heartburn on the last 7 days of the Run-In Period) received oral vonoprazan 20 mg when heartburn occurred during the 6 week On-Demand Treatment Period. Participants could take no more than one dose in a 24 hour period.
|
Vonoprazan 40 mg: On-Demand Treatment Period
n=323 evaluable heartburn episodes
Participants who had stable disease (no heartburn on the last 7 days of the Run-In Period) received oral vonoprazan 40 mg when heartburn occurred during the 6 week On-Demand Treatment Period. Participants could take no more than one dose in a 24 hour period.
|
Placebo: On-Demand Treatment Period
n=370 evaluable heartburn episodes
Participants who had stable disease (no heartburn on the last 7 days of the Run-In Period) received oral placebo when heartburn occured during the 6 week On-Demand Treatment Period. Participants could take no more than one dose in a 24 hour period.
|
|---|---|---|---|---|
|
Percentage of Evaluable Heartburn Episodes Completely Relieved Within 3 Hours and With No Further Heartburn Reported for 24 Hours After Taking Study Drug
|
56.0 percentage of heartburn episodes
|
60.6 percentage of heartburn episodes
|
70.0 percentage of heartburn episodes
|
27.3 percentage of heartburn episodes
|
SECONDARY outcome
Timeframe: On-Demand Treatment Period: Day 1 to Day 42Population: ITT On-Demand Set: includes all participants in the Safety Run-In set who were randomized and completed at least one heartburn episode diary during the On-Demand Treatment Period.
An evaluable heartburn episode was an episode for which study drug was taken and for which the participant completed at least one entry in the heartburn episode diary. For a heartburn episode to be considered completely relieved, a participant must not have taken rescue antacid within 3 hours of taking study drug.
Outcome measures
| Measure |
Vonoprazan 10 mg: On-Demand Treatment Period
n=359 evaluable heartburn episodes
Participants who had stable disease (no heartburn on the last 7 days of the Run-In Period) received oral vonoprazan 10 mg when heartburn occurred during the 6 week On-Demand Treatment Period. Participants could take no more than one dose in a 24 hour period.
|
Vonoprazan 20 mg: On-Demand Treatment Period
n=327 evaluable heartburn episodes
Participants who had stable disease (no heartburn on the last 7 days of the Run-In Period) received oral vonoprazan 20 mg when heartburn occurred during the 6 week On-Demand Treatment Period. Participants could take no more than one dose in a 24 hour period.
|
Vonoprazan 40 mg: On-Demand Treatment Period
n=323 evaluable heartburn episodes
Participants who had stable disease (no heartburn on the last 7 days of the Run-In Period) received oral vonoprazan 40 mg when heartburn occurred during the 6 week On-Demand Treatment Period. Participants could take no more than one dose in a 24 hour period.
|
Placebo: On-Demand Treatment Period
n=370 evaluable heartburn episodes
Participants who had stable disease (no heartburn on the last 7 days of the Run-In Period) received oral placebo when heartburn occured during the 6 week On-Demand Treatment Period. Participants could take no more than one dose in a 24 hour period.
|
|---|---|---|---|---|
|
Percentage of Evaluable Heartburn Episodes Completely Relieved Within 3 Hours After Taking Study Drug
|
72.1 percentage of heartburn episodes
|
65.7 percentage of heartburn episodes
|
79.6 percentage of heartburn episodes
|
41.9 percentage of heartburn episodes
|
SECONDARY outcome
Timeframe: On-Demand Treatment Period: Day 1 to Day 42Population: ITT On-Demand Set: includes all participants in the Safety Run-In set who were randomized and completed at least one heartburn episode diary during the On-Demand Treatment Period. Only participants with at least one evaluable heartburn episode during the On-Demand Treatment Period are included.
An evaluable heartburn episode was an episode for which study drug was taken and for which the participant completed at least one entry in the heartburn episode diary. For a heartburn episode to be considered completely relieved, a participant must not have taken rescue antacid within 3 hours of taking study drug. For sustained relief, complete relief must have been accompanied by 24 hours without another heartburn episode after taking study drug.
Outcome measures
| Measure |
Vonoprazan 10 mg: On-Demand Treatment Period
n=46 Participants
Participants who had stable disease (no heartburn on the last 7 days of the Run-In Period) received oral vonoprazan 10 mg when heartburn occurred during the 6 week On-Demand Treatment Period. Participants could take no more than one dose in a 24 hour period.
|
Vonoprazan 20 mg: On-Demand Treatment Period
n=42 Participants
Participants who had stable disease (no heartburn on the last 7 days of the Run-In Period) received oral vonoprazan 20 mg when heartburn occurred during the 6 week On-Demand Treatment Period. Participants could take no more than one dose in a 24 hour period.
|
Vonoprazan 40 mg: On-Demand Treatment Period
n=43 Participants
Participants who had stable disease (no heartburn on the last 7 days of the Run-In Period) received oral vonoprazan 40 mg when heartburn occurred during the 6 week On-Demand Treatment Period. Participants could take no more than one dose in a 24 hour period.
|
Placebo: On-Demand Treatment Period
n=43 Participants
Participants who had stable disease (no heartburn on the last 7 days of the Run-In Period) received oral placebo when heartburn occured during the 6 week On-Demand Treatment Period. Participants could take no more than one dose in a 24 hour period.
|
|---|---|---|---|---|
|
Percentage of Evaluable Heartburn Episodes for Each Participant That Are Completely Relieved Within 3 Hours and With No Further Heartburn Reported for 24 Hours After Taking Study Drug
|
60.08 % of heartburn episodes per participant
Standard Deviation 38.452
|
60.78 % of heartburn episodes per participant
Standard Deviation 37.458
|
71.99 % of heartburn episodes per participant
Standard Deviation 28.894
|
47.77 % of heartburn episodes per participant
Standard Deviation 40.998
|
SECONDARY outcome
Timeframe: On-Demand Treatment Period: Day 1 to Day 42Population: ITT On-Demand Set: includes all participants in the Safety Run-In set who were randomized and completed at least one heartburn episode diary during the On-Demand Treatment Period.
Outcome measures
| Measure |
Vonoprazan 10 mg: On-Demand Treatment Period
n=52 Participants
Participants who had stable disease (no heartburn on the last 7 days of the Run-In Period) received oral vonoprazan 10 mg when heartburn occurred during the 6 week On-Demand Treatment Period. Participants could take no more than one dose in a 24 hour period.
|
Vonoprazan 20 mg: On-Demand Treatment Period
n=52 Participants
Participants who had stable disease (no heartburn on the last 7 days of the Run-In Period) received oral vonoprazan 20 mg when heartburn occurred during the 6 week On-Demand Treatment Period. Participants could take no more than one dose in a 24 hour period.
|
Vonoprazan 40 mg: On-Demand Treatment Period
n=51 Participants
Participants who had stable disease (no heartburn on the last 7 days of the Run-In Period) received oral vonoprazan 40 mg when heartburn occurred during the 6 week On-Demand Treatment Period. Participants could take no more than one dose in a 24 hour period.
|
Placebo: On-Demand Treatment Period
n=52 Participants
Participants who had stable disease (no heartburn on the last 7 days of the Run-In Period) received oral placebo when heartburn occured during the 6 week On-Demand Treatment Period. Participants could take no more than one dose in a 24 hour period.
|
|---|---|---|---|---|
|
Mean Number of Tablets of Rescue Antacid Taken Per Day Over the On-Demand Treatment Period
|
0.1 tablets of rescue antacid per day
Standard Deviation 0.21
|
0.2 tablets of rescue antacid per day
Standard Deviation 0.29
|
0.1 tablets of rescue antacid per day
Standard Deviation 0.26
|
0.5 tablets of rescue antacid per day
Standard Deviation 0.87
|
SECONDARY outcome
Timeframe: On-Demand Treatment Period: Day 1 to Day 42Population: ITT On-Demand Set: includes all participants in the Safety Run-In set who were randomized and completed at least one heartburn episode diary during the On-Demand Treatment Period. Only participants with at least one evaluable heartburn episode during the On-Demand Treatment Period are included.
An evaluable heartburn episode was an episode for which study drug was taken and for which the participant completed at least one entry in the heartburn episode diary. For a heartburn episode to be considered completely relieved, a participant must not have taken rescue antacid within 3 hours of taking study drug. For sustained relief, complete relief must have been accompanied by 24 hours without another heartburn episode after taking study drug.
Outcome measures
| Measure |
Vonoprazan 10 mg: On-Demand Treatment Period
n=46 Participants
Participants who had stable disease (no heartburn on the last 7 days of the Run-In Period) received oral vonoprazan 10 mg when heartburn occurred during the 6 week On-Demand Treatment Period. Participants could take no more than one dose in a 24 hour period.
|
Vonoprazan 20 mg: On-Demand Treatment Period
n=42 Participants
Participants who had stable disease (no heartburn on the last 7 days of the Run-In Period) received oral vonoprazan 20 mg when heartburn occurred during the 6 week On-Demand Treatment Period. Participants could take no more than one dose in a 24 hour period.
|
Vonoprazan 40 mg: On-Demand Treatment Period
n=43 Participants
Participants who had stable disease (no heartburn on the last 7 days of the Run-In Period) received oral vonoprazan 40 mg when heartburn occurred during the 6 week On-Demand Treatment Period. Participants could take no more than one dose in a 24 hour period.
|
Placebo: On-Demand Treatment Period
n=43 Participants
Participants who had stable disease (no heartburn on the last 7 days of the Run-In Period) received oral placebo when heartburn occured during the 6 week On-Demand Treatment Period. Participants could take no more than one dose in a 24 hour period.
|
|---|---|---|---|---|
|
Percentage of Participants With Complete Relief of Heartburn Within 3 Hours After the First Episode and With No Further Heartburn Reported for 24 Hours After Taking Study Drug
|
56.5 percentage of participants
|
61.9 percentage of participants
|
62.8 percentage of participants
|
60.5 percentage of participants
|
SECONDARY outcome
Timeframe: On-Demand Treatment Period: Day 1 to Day 42Population: ITT On-Demand Set: includes all participants in the Safety Run-In set who were randomized and completed at least one heartburn episode diary during the On-Demand Treatment Period.
Outcome measures
| Measure |
Vonoprazan 10 mg: On-Demand Treatment Period
n=52 Participants
Participants who had stable disease (no heartburn on the last 7 days of the Run-In Period) received oral vonoprazan 10 mg when heartburn occurred during the 6 week On-Demand Treatment Period. Participants could take no more than one dose in a 24 hour period.
|
Vonoprazan 20 mg: On-Demand Treatment Period
n=52 Participants
Participants who had stable disease (no heartburn on the last 7 days of the Run-In Period) received oral vonoprazan 20 mg when heartburn occurred during the 6 week On-Demand Treatment Period. Participants could take no more than one dose in a 24 hour period.
|
Vonoprazan 40 mg: On-Demand Treatment Period
n=51 Participants
Participants who had stable disease (no heartburn on the last 7 days of the Run-In Period) received oral vonoprazan 40 mg when heartburn occurred during the 6 week On-Demand Treatment Period. Participants could take no more than one dose in a 24 hour period.
|
Placebo: On-Demand Treatment Period
n=52 Participants
Participants who had stable disease (no heartburn on the last 7 days of the Run-In Period) received oral placebo when heartburn occured during the 6 week On-Demand Treatment Period. Participants could take no more than one dose in a 24 hour period.
|
|---|---|---|---|---|
|
Percentage of Days Study Drug Was Taken Over the On-Demand Treatment Period
|
21.93 percentage of days
Standard Deviation 19.241
|
20.75 percentage of days
Standard Deviation 16.950
|
21.01 percentage of days
Standard Deviation 17.302
|
22.15 percentage of days
Standard Deviation 23.266
|
SECONDARY outcome
Timeframe: On-Demand Treatment Period: Day 1 to Day 42Population: ITT On-Demand Set: includes all participants in the Safety Run-In set who were randomized and completed at least one heartburn episode diary during the On-Demand Treatment Period.
A 24-hour heartburn-free day was defined as a day having no heartburn among all diary entries for that day. The percentage of 24-hour heartburn-free days was calculated using all days with at least 1 evening or morning diary entry during the treatment period of this phase.
Outcome measures
| Measure |
Vonoprazan 10 mg: On-Demand Treatment Period
n=52 Participants
Participants who had stable disease (no heartburn on the last 7 days of the Run-In Period) received oral vonoprazan 10 mg when heartburn occurred during the 6 week On-Demand Treatment Period. Participants could take no more than one dose in a 24 hour period.
|
Vonoprazan 20 mg: On-Demand Treatment Period
n=52 Participants
Participants who had stable disease (no heartburn on the last 7 days of the Run-In Period) received oral vonoprazan 20 mg when heartburn occurred during the 6 week On-Demand Treatment Period. Participants could take no more than one dose in a 24 hour period.
|
Vonoprazan 40 mg: On-Demand Treatment Period
n=51 Participants
Participants who had stable disease (no heartburn on the last 7 days of the Run-In Period) received oral vonoprazan 40 mg when heartburn occurred during the 6 week On-Demand Treatment Period. Participants could take no more than one dose in a 24 hour period.
|
Placebo: On-Demand Treatment Period
n=52 Participants
Participants who had stable disease (no heartburn on the last 7 days of the Run-In Period) received oral placebo when heartburn occured during the 6 week On-Demand Treatment Period. Participants could take no more than one dose in a 24 hour period.
|
|---|---|---|---|---|
|
Percentage of 24-Hour Heartburn-Free Days Over the On-Demand Treatment Period
|
74.95 percentage of days
Standard Deviation 21.410
|
73.57 percentage of days
Standard Deviation 21.465
|
74.01 percentage of days
Standard Deviation 22.277
|
71.22 percentage of days
Standard Deviation 28.867
|
Adverse Events
Run-In Period
Serious events: 4 serious events
Other events: 29 other events
Deaths: 0 deaths
Vonoprazan 10 mg: On-Demand Treatment Period
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Vonoprazan 20 mg: On-Demand Treatment Period
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Vonoprazan 40 mg: On-Demand Treatment Period
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Placebo: On-Demand Treatment Period
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Run-In Period
n=457 participants at risk
Participants received oral vonoprazan 20 mg QD for up to 4 weeks.
|
Vonoprazan 10 mg: On-Demand Treatment Period
n=49 participants at risk
Participants who had stable disease (no heartburn on the last 7 days of the Run-In Period) received oral vonoprazan 10 mg when heartburn occurred during the 6 week On-Demand Treatment Period. Participants could take no more than one dose in a 24-hour period.
|
Vonoprazan 20 mg: On-Demand Treatment Period
n=49 participants at risk
Participants who had stable disease (no heartburn on the last 7 days of the Run-In Period) received oral vonoprazan 20 mg when heartburn occurred during the 6 week On-Demand Treatment Period. Participants could take no more than one dose in a 24-hour period.
|
Vonoprazan 40 mg: On-Demand Treatment Period
n=48 participants at risk
Participants who had stable disease (no heartburn on the last 7 days of the Run-In Period) received oral vonoprazan 40 mg when heartburn occurred during the 6 week On-Demand Treatment Period. Participants could take no more than one dose in a 24-hour period.
|
Placebo: On-Demand Treatment Period
n=47 participants at risk
Participants who had stable disease (no heartburn on the last 7 days of the Run-In Period) received oral placebo when heartburn occured during the 6 week On-Demand Treatment Period. Participants could take no more than one dose in a 24-hour period.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.22%
1/457 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/49 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/49 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/48 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/47 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
|
Cardiac disorders
Myocardial infarction
|
0.22%
1/457 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/49 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/49 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/48 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/47 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
|
Immune system disorders
Anaphylactic reaction
|
0.22%
1/457 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/49 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/49 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/48 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/47 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
|
Psychiatric disorders
Suicidal ideation
|
0.22%
1/457 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/49 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/49 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/48 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/47 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
Other adverse events
| Measure |
Run-In Period
n=457 participants at risk
Participants received oral vonoprazan 20 mg QD for up to 4 weeks.
|
Vonoprazan 10 mg: On-Demand Treatment Period
n=49 participants at risk
Participants who had stable disease (no heartburn on the last 7 days of the Run-In Period) received oral vonoprazan 10 mg when heartburn occurred during the 6 week On-Demand Treatment Period. Participants could take no more than one dose in a 24-hour period.
|
Vonoprazan 20 mg: On-Demand Treatment Period
n=49 participants at risk
Participants who had stable disease (no heartburn on the last 7 days of the Run-In Period) received oral vonoprazan 20 mg when heartburn occurred during the 6 week On-Demand Treatment Period. Participants could take no more than one dose in a 24-hour period.
|
Vonoprazan 40 mg: On-Demand Treatment Period
n=48 participants at risk
Participants who had stable disease (no heartburn on the last 7 days of the Run-In Period) received oral vonoprazan 40 mg when heartburn occurred during the 6 week On-Demand Treatment Period. Participants could take no more than one dose in a 24-hour period.
|
Placebo: On-Demand Treatment Period
n=47 participants at risk
Participants who had stable disease (no heartburn on the last 7 days of the Run-In Period) received oral placebo when heartburn occured during the 6 week On-Demand Treatment Period. Participants could take no more than one dose in a 24-hour period.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/457 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/49 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/49 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
2.1%
1/48 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/47 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/457 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/49 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/49 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/48 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
2.1%
1/47 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
|
Gastrointestinal disorders
Abdominal distension
|
1.3%
6/457 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/49 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
2.0%
1/49 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/48 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/47 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.22%
1/457 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
2.0%
1/49 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/49 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/48 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/47 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.5%
7/457 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
2.0%
1/49 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/49 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/48 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/47 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
|
Gastrointestinal disorders
Flatulence
|
0.88%
4/457 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/49 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
2.0%
1/49 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/48 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/47 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/457 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/49 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/49 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/48 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
2.1%
1/47 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
|
Gastrointestinal disorders
Nausea
|
1.3%
6/457 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
2.0%
1/49 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/49 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/48 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/47 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
|
General disorders
Chest discomfort
|
0.00%
0/457 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/49 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/49 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/48 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
2.1%
1/47 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
|
Infections and infestations
Breast abscess
|
0.00%
0/457 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/49 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/49 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/48 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
2.1%
1/47 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
|
Infections and infestations
COVID-19
|
0.44%
2/457 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
2.0%
1/49 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
2.0%
1/49 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
2.1%
1/48 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
2.1%
1/47 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
|
Infections and infestations
Cystitis
|
0.00%
0/457 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/49 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/49 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/48 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
2.1%
1/47 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
|
Infections and infestations
Gastroenteritis
|
0.22%
1/457 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/49 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
2.0%
1/49 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/48 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/47 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
|
Infections and infestations
Nasopharyngitis
|
0.44%
2/457 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
2.0%
1/49 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/49 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/48 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/47 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
|
Infections and infestations
Otitis media
|
0.00%
0/457 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/49 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
2.0%
1/49 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/48 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/47 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/457 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/49 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/49 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
2.1%
1/48 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/47 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/457 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/49 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/49 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
2.1%
1/48 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
2.1%
1/47 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
|
Infections and infestations
Urinary tract infection
|
0.66%
3/457 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/49 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
2.0%
1/49 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/48 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/47 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/457 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/49 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/49 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
2.1%
1/48 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/47 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/457 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/49 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/49 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
2.1%
1/48 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/47 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
|
Injury, poisoning and procedural complications
Nail avulsion
|
0.00%
0/457 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/49 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
2.0%
1/49 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/48 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/47 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
0.00%
0/457 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/49 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/49 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/48 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
2.1%
1/47 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/457 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
2.0%
1/49 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/49 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/48 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/47 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/457 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/49 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/49 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
2.1%
1/48 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/47 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
|
Investigations
Blood glucose increased
|
0.00%
0/457 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/49 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
2.0%
1/49 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/48 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/47 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.22%
1/457 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/49 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/49 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/48 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
2.1%
1/47 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
|
Investigations
Liver function test increased
|
0.00%
0/457 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
2.0%
1/49 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/49 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/48 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/47 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
|
Investigations
Urine analysis abnormal
|
0.00%
0/457 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
2.0%
1/49 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/49 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/48 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/47 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/457 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/49 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/49 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
2.1%
1/48 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/47 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.22%
1/457 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
2.0%
1/49 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/49 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/48 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/47 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.44%
2/457 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/49 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/49 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/48 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
2.1%
1/47 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.22%
1/457 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/49 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/49 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
2.1%
1/48 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/47 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/457 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
2.0%
1/49 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/49 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/48 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/47 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.22%
1/457 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/49 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
2.0%
1/49 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/48 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/47 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/457 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/49 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/49 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/48 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
2.1%
1/47 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
|
Nervous system disorders
Migraine
|
0.22%
1/457 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/49 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
2.0%
1/49 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/48 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
2.1%
1/47 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/457 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/49 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/49 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
2.1%
1/48 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/47 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/457 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/49 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/49 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
2.1%
1/48 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/47 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/457 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/49 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/49 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/48 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
2.1%
1/47 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/457 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/49 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/49 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
2.1%
1/48 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/47 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/457 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/49 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
2.0%
1/49 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/48 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
0.00%
0/47 • Run-In Period: Day 1 to Day 28; On-Demand Treatment: Day 1 to Day 49
Run-In Period: The Safety Run-In Set includes participants who received at least one dose of vonoprazan during the Run-In Period. On-Demand Treatment Period: The Safety On Demand Set includes all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
|
Additional Information
Phathom Medical Information
Phathom Pharmaceuticals, Inc.
Phone: 1-888-775-PHAT
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place