Trial Outcomes & Findings for A Double-blind Comparative Study of the Efficacy and Safety of E3810 10mg Once and Twice Daily in Maintenance Therapy for PPI Resistant Gastroesophageal Reflux Disease Patients (NCT NCT02135107)
NCT ID: NCT02135107
Last Updated: 2023-06-22
Results Overview
The non-recurrence rate (at 52 weeks) was determined by the endoscopy central review panel who were blinded to the investigator's assessment, based on the modified Los Angeles Classification using endoscopy photos were submitted by each of the institutions. Participants showing Grade A or above based on the modified Los Angeles Classification were included as a recurrence.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
517 participants
Primary outcome timeframe
Week 52
Results posted on
2023-06-22
Participant Flow
Participant milestones
| Measure |
Rabeprazole: 10 mg Twice Daily
Rabeprazole (10 mg) was administered orally twice daily during the treatment period for 8 weeks (unblinded).
|
Rabeprazole: 20 mg Twice Daily
Rabeprazole (20 mg) was administered orally twice daily during the treatment period for 8 weeks (unblinded).
|
Rabeprazole: 10 or 20 mg Twice Daily, Then 10 mg Once Daily
Rabeprazole 10 mg or 20 mg was administered orally twice daily during the treatment period (unblinded), and 10 mg was administered once daily during the maintenance period (double-blind).
|
Rabeprazole: 10 or 20 mg Twice Daily, Then 10 mg Twice Daily
Rabeprazole 10 mg or 20 mg was administered orally twice daily during the treatment period (unblinded), and 10 mg was administered twice daily during the maintenance period (double-blind).
|
|---|---|---|---|---|
|
Treatment Period
STARTED
|
437
|
80
|
0
|
0
|
|
Treatment Period
COMPLETED
|
305
|
54
|
0
|
0
|
|
Treatment Period
NOT COMPLETED
|
132
|
26
|
0
|
0
|
|
Maintenance Therapy Period
STARTED
|
0
|
0
|
178
|
181
|
|
Maintenance Therapy Period
COMPLETED
|
0
|
0
|
163
|
161
|
|
Maintenance Therapy Period
NOT COMPLETED
|
0
|
0
|
15
|
20
|
Reasons for withdrawal
| Measure |
Rabeprazole: 10 mg Twice Daily
Rabeprazole (10 mg) was administered orally twice daily during the treatment period for 8 weeks (unblinded).
|
Rabeprazole: 20 mg Twice Daily
Rabeprazole (20 mg) was administered orally twice daily during the treatment period for 8 weeks (unblinded).
|
Rabeprazole: 10 or 20 mg Twice Daily, Then 10 mg Once Daily
Rabeprazole 10 mg or 20 mg was administered orally twice daily during the treatment period (unblinded), and 10 mg was administered once daily during the maintenance period (double-blind).
|
Rabeprazole: 10 or 20 mg Twice Daily, Then 10 mg Twice Daily
Rabeprazole 10 mg or 20 mg was administered orally twice daily during the treatment period (unblinded), and 10 mg was administered twice daily during the maintenance period (double-blind).
|
|---|---|---|---|---|
|
Treatment Period
Withdrawal by Subject
|
11
|
0
|
0
|
0
|
|
Treatment Period
Adverse Event
|
5
|
2
|
0
|
0
|
|
Treatment Period
Pregnancy
|
1
|
0
|
0
|
0
|
|
Treatment Period
Other
|
115
|
24
|
0
|
0
|
|
Maintenance Therapy Period
Adverse Event
|
0
|
0
|
3
|
7
|
|
Maintenance Therapy Period
Withdrawal by Subject
|
0
|
0
|
5
|
4
|
|
Maintenance Therapy Period
Pregnancy
|
0
|
0
|
0
|
1
|
|
Maintenance Therapy Period
Other
|
0
|
0
|
7
|
8
|
Baseline Characteristics
A Double-blind Comparative Study of the Efficacy and Safety of E3810 10mg Once and Twice Daily in Maintenance Therapy for PPI Resistant Gastroesophageal Reflux Disease Patients
Baseline characteristics by cohort
| Measure |
Rabeprazole: 10 mg Twice Daily
n=437 Participants
Rabeprazole 10 mg was administered orally twice daily during the treatment period for 8 weeks (unblinded).
|
Rabeprazole: 20 mg Twice Daily
n=80 Participants
Rabeprazole 20 mg was administered orally twice daily during the treatment period for 8 weeks (unblinded).
|
Total
n=517 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.0 Years
STANDARD_DEVIATION 13.1 • n=99 Participants
|
70.2 Years
STANDARD_DEVIATION 12.7 • n=107 Participants
|
64.6 Years
STANDARD_DEVIATION 13.6 • n=206 Participants
|
|
Sex/Gender, Customized
Male
|
282 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
313 Participants
n=206 Participants
|
|
Sex/Gender, Customized
Female
|
155 Participants
n=99 Participants
|
49 Participants
n=107 Participants
|
204 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Week 52Population: Central assessment Full Analysis Set (FAS) was defined as all randomized participants who received at least one dose of the study drug, and from whom the results of at least one endoscopic assessment was available. Data analysis excluded participants with missing data.
The non-recurrence rate (at 52 weeks) was determined by the endoscopy central review panel who were blinded to the investigator's assessment, based on the modified Los Angeles Classification using endoscopy photos were submitted by each of the institutions. Participants showing Grade A or above based on the modified Los Angeles Classification were included as a recurrence.
Outcome measures
| Measure |
Rabeprazole: 10 or 20 mg Twice Daily, Then 10 mg Once Daily
n=163 Participants
Rabeprazole 10 mg or 20 mg were administered orally twice daily during the treatment period (unblinded), and 10 mg was administered once daily during the maintenance period (double-blind).
|
Rabeprazole: 10 or 20 mg Twice Daily, Then 10 mg Twice Daily
n=161 Participants
Rabeprazole 10 mg or 20 mg were administered orally twice daily during the treatment period (unblinded), and 10 mg was administered twice daily during the maintenance period (double-blind).
|
Rabeprazole: 10 or 20 mg Twice Daily, Then 10 mg Once daiArm C
Rabeprazole 10 mg or 20 mg were administered orally twice daily during the treatment period (unblinded), and 10 mg was administered once daily during the maintenance period (double-blind).
|
Rabeprazole: 10 or 20 mg Twice Daily, Then 10 mg Twice Daily
Rabeprazole 10 mg or 20 mg were administered orally twice daily during the treatment period (unblinded), and 10 mg was administered twice daily during the maintenance period (double-blind).
|
|---|---|---|---|---|
|
Rate of Non-recurrence at Week 52
Recurrence
|
55.2 Percentage of participants
NA = not calculated
|
26.1 Percentage of participants
NA = not calculated
|
—
|
—
|
|
Rate of Non-recurrence at Week 52
Non-recurrence
|
44.8 Percentage of participants
Interval 37.2 to 52.4
|
73.9 Percentage of participants
Interval 67.1 to 80.7
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 12 and 24Population: Central assessment FAS. Data analysis excluded participants with missing data.
The non-recurrence rate (up to 52 weeks) was determined by the endoscopy central review panel who were blinded to the investigator's assessment, based on the modified Los Angeles Classification using endoscopy photos were submitted by each of the institutions. Participants showing Grade A or above based on the modified Los Angeles Classification were included as a recurrence. The 95% CI was calculated by normal approximation.
Outcome measures
| Measure |
Rabeprazole: 10 or 20 mg Twice Daily, Then 10 mg Once Daily
n=170 Participants
Rabeprazole 10 mg or 20 mg were administered orally twice daily during the treatment period (unblinded), and 10 mg was administered once daily during the maintenance period (double-blind).
|
Rabeprazole: 10 or 20 mg Twice Daily, Then 10 mg Twice Daily
n=173 Participants
Rabeprazole 10 mg or 20 mg were administered orally twice daily during the treatment period (unblinded), and 10 mg was administered twice daily during the maintenance period (double-blind).
|
Rabeprazole: 10 or 20 mg Twice Daily, Then 10 mg Once daiArm C
Rabeprazole 10 mg or 20 mg were administered orally twice daily during the treatment period (unblinded), and 10 mg was administered once daily during the maintenance period (double-blind).
|
Rabeprazole: 10 or 20 mg Twice Daily, Then 10 mg Twice Daily
Rabeprazole 10 mg or 20 mg were administered orally twice daily during the treatment period (unblinded), and 10 mg was administered twice daily during the maintenance period (double-blind).
|
|---|---|---|---|---|
|
Rate of Non-recurrence at Weeks 12 and 24
Week 12, Non-recurrence
|
62.5 Percentage of participants
Interval 55.2 to 69.8
|
92.4 Percentage of participants
Interval 88.4 to 96.4
|
—
|
—
|
|
Rate of Non-recurrence at Weeks 12 and 24
Week 12, Recurrence
|
37.5 Percentage of participants
NA = not calculated
|
7.6 Percentage of participants
NA = not calculated
|
—
|
—
|
|
Rate of Non-recurrence at Weeks 12 and 24
Week 24, Non-recurrence
|
55.8 Percentage of participants
Interval 48.2 to 63.3
|
85.1 Percentage of participants
Interval 79.7 to 90.5
|
—
|
—
|
|
Rate of Non-recurrence at Weeks 12 and 24
Week 24, Recurrence
|
44.2 Percentage of participants
NA = not calculated
|
14.9 Percentage of participants
NA = not calculated
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 52Population: Central assessment FAS
Non-recurrence rate at Week 52 was estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Rabeprazole: 10 or 20 mg Twice Daily, Then 10 mg Once Daily
n=170 Participants
Rabeprazole 10 mg or 20 mg were administered orally twice daily during the treatment period (unblinded), and 10 mg was administered once daily during the maintenance period (double-blind).
|
Rabeprazole: 10 or 20 mg Twice Daily, Then 10 mg Twice Daily
n=173 Participants
Rabeprazole 10 mg or 20 mg were administered orally twice daily during the treatment period (unblinded), and 10 mg was administered twice daily during the maintenance period (double-blind).
|
Rabeprazole: 10 or 20 mg Twice Daily, Then 10 mg Once daiArm C
Rabeprazole 10 mg or 20 mg were administered orally twice daily during the treatment period (unblinded), and 10 mg was administered once daily during the maintenance period (double-blind).
|
Rabeprazole: 10 or 20 mg Twice Daily, Then 10 mg Twice Daily
Rabeprazole 10 mg or 20 mg were administered orally twice daily during the treatment period (unblinded), and 10 mg was administered twice daily during the maintenance period (double-blind).
|
|---|---|---|---|---|
|
Cumulative Non-recurrence Rate at Week 52
|
41.5 Percentage of non-recurrence
Interval 33.0 to 49.8
|
71.4 Percentage of non-recurrence
Interval 62.8 to 78.4
|
—
|
—
|
SECONDARY outcome
Timeframe: From Week 4 up to Week 52Population: Central assessment FAS - LOCF. Analysis was carried out on participants who were determined to be free of symptoms at maintenance therapy entry.
A comparison of the rabeprazole 10 mg once daily group and the rabeprazole 10 mg twice daily group was performed for participants who did not exhibit daytime or nighttime heartburn at Week 0 of the Maintenance Therapy Period. Heartburn is a burning sensation in the stomach or lower chest; it is worsened by bending or pressure on the abdomen. Heartburn frequency was rated from 0-day (no) to 7-day (always) and severity was graded on a 3-point scale (mild, moderate, severe). Heartburn was evaluated in the daytime (from wake-up time to time for bed) and nighttime (from time for bed to wake-up time).
Outcome measures
| Measure |
Rabeprazole: 10 or 20 mg Twice Daily, Then 10 mg Once Daily
n=138 Participants
Rabeprazole 10 mg or 20 mg were administered orally twice daily during the treatment period (unblinded), and 10 mg was administered once daily during the maintenance period (double-blind).
|
Rabeprazole: 10 or 20 mg Twice Daily, Then 10 mg Twice Daily
n=137 Participants
Rabeprazole 10 mg or 20 mg were administered orally twice daily during the treatment period (unblinded), and 10 mg was administered twice daily during the maintenance period (double-blind).
|
Rabeprazole: 10 or 20 mg Twice Daily, Then 10 mg Once daiArm C
Rabeprazole 10 mg or 20 mg were administered orally twice daily during the treatment period (unblinded), and 10 mg was administered once daily during the maintenance period (double-blind).
|
Rabeprazole: 10 or 20 mg Twice Daily, Then 10 mg Twice Daily
Rabeprazole 10 mg or 20 mg were administered orally twice daily during the treatment period (unblinded), and 10 mg was administered twice daily during the maintenance period (double-blind).
|
|---|---|---|---|---|
|
Percentage of Participants With Heartburn (Daytime / Nighttime) During the Maintenance Therapy Period
Heartburn (no)
|
76.8 Percentage of participants
|
92.0 Percentage of participants
|
—
|
—
|
|
Percentage of Participants With Heartburn (Daytime / Nighttime) During the Maintenance Therapy Period
Heartburn (yes)
|
23.2 Percentage of participants
|
8.0 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From Week 4 up to Week 52Population: Central assessment FAS
A comparison of rabeprazole 10 mg once daily group and the rabeprazole 10 mg twice daily group shall be performed for participants who did not exhibit daytime or nighttime heartburn at 0 weeks of the maintenance therapy period. Daytime and nighttime heartburn, and nighttime sleep disorders shall likewise be compared. For the participants who had recurrence, values at the final evaluation were imputed using a last observation carried forward (LOCF) method.
Outcome measures
| Measure |
Rabeprazole: 10 or 20 mg Twice Daily, Then 10 mg Once Daily
n=170 Participants
Rabeprazole 10 mg or 20 mg were administered orally twice daily during the treatment period (unblinded), and 10 mg was administered once daily during the maintenance period (double-blind).
|
Rabeprazole: 10 or 20 mg Twice Daily, Then 10 mg Twice Daily
n=173 Participants
Rabeprazole 10 mg or 20 mg were administered orally twice daily during the treatment period (unblinded), and 10 mg was administered twice daily during the maintenance period (double-blind).
|
Rabeprazole: 10 or 20 mg Twice Daily, Then 10 mg Once daiArm C
Rabeprazole 10 mg or 20 mg were administered orally twice daily during the treatment period (unblinded), and 10 mg was administered once daily during the maintenance period (double-blind).
|
Rabeprazole: 10 or 20 mg Twice Daily, Then 10 mg Twice Daily
Rabeprazole 10 mg or 20 mg were administered orally twice daily during the treatment period (unblinded), and 10 mg was administered twice daily during the maintenance period (double-blind).
|
|---|---|---|---|---|
|
Frequency of Heartburn (Daytime / Nighttime) During the Maintenance Therapy Period
5 to 6 Days (often had symptoms)
|
0.0 Percentage of participants
|
1.9 Percentage of participants
|
—
|
—
|
|
Frequency of Heartburn (Daytime / Nighttime) During the Maintenance Therapy Period
7 Days (always had symptoms)
|
0.6 Percentage of participants
|
1.2 Percentage of participants
|
—
|
—
|
|
Frequency of Heartburn (Daytime / Nighttime) During the Maintenance Therapy Period
0 Days (no symptoms)
|
85.2 Percentage of participants
|
85.1 Percentage of participants
|
—
|
—
|
|
Frequency of Heartburn (Daytime / Nighttime) During the Maintenance Therapy Period
1 to 2 Days (occasional symptoms)
|
12.3 Percentage of participants
|
11.2 Percentage of participants
|
—
|
—
|
|
Frequency of Heartburn (Daytime / Nighttime) During the Maintenance Therapy Period
3 to 4 Days (sometimes had symptoms)
|
1.9 Percentage of participants
|
0.6 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From Week 4 up to Week 52Population: Central assessment FAS - LOCF
A comparison of the rabeprazole (10 mg once daily group) and the rabeprazole (10 mg twice daily group) was performed for participants who did not exhibit daytime or nighttime heartburn at Week 0 of the Maintenance Therapy Period. The presence or absence of heartburn was assessed by the investigators during medical interviews. The heartburn incidence during each of the 7-day periods immediately before visiting the hospital was assessed on a scale of five stages based on the number of days with symptoms: 0 (no symptoms), 1 to 2 (occasional symptoms), 3 to 4 (sometimes had symptoms), 5 to 6 (often had symptoms), and 7 (always had symptoms). The incidence was tabulated by an analysis classifying the states into two groups: "no symptom group" (0 days with symptoms) and "with symptoms group" (1 day or more with symptoms). The severity of heartburn was as below: Mild (feel heartburn but tolerable), Moderate (feel heartburn and hard), and Severe (feel heartburn and terrible).
Outcome measures
| Measure |
Rabeprazole: 10 or 20 mg Twice Daily, Then 10 mg Once Daily
n=170 Participants
Rabeprazole 10 mg or 20 mg were administered orally twice daily during the treatment period (unblinded), and 10 mg was administered once daily during the maintenance period (double-blind).
|
Rabeprazole: 10 or 20 mg Twice Daily, Then 10 mg Twice Daily
n=173 Participants
Rabeprazole 10 mg or 20 mg were administered orally twice daily during the treatment period (unblinded), and 10 mg was administered twice daily during the maintenance period (double-blind).
|
Rabeprazole: 10 or 20 mg Twice Daily, Then 10 mg Once daiArm C
Rabeprazole 10 mg or 20 mg were administered orally twice daily during the treatment period (unblinded), and 10 mg was administered once daily during the maintenance period (double-blind).
|
Rabeprazole: 10 or 20 mg Twice Daily, Then 10 mg Twice Daily
Rabeprazole 10 mg or 20 mg were administered orally twice daily during the treatment period (unblinded), and 10 mg was administered twice daily during the maintenance period (double-blind).
|
|---|---|---|---|---|
|
Severity of Heartburn (Daytime / Nighttime) During the Maintenance Therapy Period
None
|
85.2 Percentage of participants
|
85.1 Percentage of participants
|
—
|
—
|
|
Severity of Heartburn (Daytime / Nighttime) During the Maintenance Therapy Period
Mild
|
14.8 Percentage of participants
|
14.3 Percentage of participants
|
—
|
—
|
|
Severity of Heartburn (Daytime / Nighttime) During the Maintenance Therapy Period
Moderate
|
0.0 Percentage of participants
|
0.6 Percentage of participants
|
—
|
—
|
|
Severity of Heartburn (Daytime / Nighttime) During the Maintenance Therapy Period
Severe
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From Week 4 up to Week 52Population: Central assessment FAS. Participants who did not have sleep disorder due to nighttime heartburn or swallowing at the time of maintenance of the Maintenance Therapy Period, participants whose visit data was not missing.
Sleep disorders were defined as the condition of lack of dead sleep and arousal during sleep arising from heartburn or acid reflux. Sleep disorders during each of the 7-day periods immediately before visiting the hospital were assessed. Evaluation of sleep disorders arising from heartburn or acid reflux included recording if sleep-inducing drugs were being taken before enrollment; their type, method of use, and dosage. It was requested that no changes in sleep-inducing drug be made after enrollment. Sleep disorders were rated from 0-day (no) to 7-day (always). The incidence of sleep disorder was tabulated by an analysis classifying the stages into two groups: "No" (0 days with sleep disorder) and "Yes" (1 or more days with sleep disorder). Heartburn was evaluated prior to 7 days of each visit.
Outcome measures
| Measure |
Rabeprazole: 10 or 20 mg Twice Daily, Then 10 mg Once Daily
n=157 Participants
Rabeprazole 10 mg or 20 mg were administered orally twice daily during the treatment period (unblinded), and 10 mg was administered once daily during the maintenance period (double-blind).
|
Rabeprazole: 10 or 20 mg Twice Daily, Then 10 mg Twice Daily
n=158 Participants
Rabeprazole 10 mg or 20 mg were administered orally twice daily during the treatment period (unblinded), and 10 mg was administered twice daily during the maintenance period (double-blind).
|
Rabeprazole: 10 or 20 mg Twice Daily, Then 10 mg Once daiArm C
Rabeprazole 10 mg or 20 mg were administered orally twice daily during the treatment period (unblinded), and 10 mg was administered once daily during the maintenance period (double-blind).
|
Rabeprazole: 10 or 20 mg Twice Daily, Then 10 mg Twice Daily
Rabeprazole 10 mg or 20 mg were administered orally twice daily during the treatment period (unblinded), and 10 mg was administered twice daily during the maintenance period (double-blind).
|
|---|---|---|---|---|
|
Percentage of Participants With Sleep Disorders During the Maintenance Therapy Period
Sleep disorders from heartburn/acid reflux (yes)
|
2.5 Percentage of participants
|
2.5 Percentage of participants
|
—
|
—
|
|
Percentage of Participants With Sleep Disorders During the Maintenance Therapy Period
Sleep disorders from heartburn/acid reflux (no)
|
97.5 Percentage of participants
|
97.5 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From Week 4 up to Week 52Population: Central assessment FAS
Sleep disorders were defined as the condition of lack of dead sleep and arousal during sleep arising from heartburn or acid reflux. Evaluation of sleep disorders arising from heartburn or acid reflux included recording if sleep-inducing drugs were being taken before enrollment; their type, method of use, and dosage. It was requested that no changes in sleep-inducing drug be made after enrollment. Sleep disorders were rated from 0-day (no) to 7-day (always). Heartburn was evaluated prior to 7 days of each visit.
Outcome measures
| Measure |
Rabeprazole: 10 or 20 mg Twice Daily, Then 10 mg Once Daily
n=170 Participants
Rabeprazole 10 mg or 20 mg were administered orally twice daily during the treatment period (unblinded), and 10 mg was administered once daily during the maintenance period (double-blind).
|
Rabeprazole: 10 or 20 mg Twice Daily, Then 10 mg Twice Daily
n=173 Participants
Rabeprazole 10 mg or 20 mg were administered orally twice daily during the treatment period (unblinded), and 10 mg was administered twice daily during the maintenance period (double-blind).
|
Rabeprazole: 10 or 20 mg Twice Daily, Then 10 mg Once daiArm C
Rabeprazole 10 mg or 20 mg were administered orally twice daily during the treatment period (unblinded), and 10 mg was administered once daily during the maintenance period (double-blind).
|
Rabeprazole: 10 or 20 mg Twice Daily, Then 10 mg Twice Daily
Rabeprazole 10 mg or 20 mg were administered orally twice daily during the treatment period (unblinded), and 10 mg was administered twice daily during the maintenance period (double-blind).
|
|---|---|---|---|---|
|
Frequency of Sleep Disorders During the Maintenance Therapy Period
3 to 4 Days (sometimes had symptoms)
|
0.6 Percentage of participants
|
0.0 Percentage of participants
|
—
|
—
|
|
Frequency of Sleep Disorders During the Maintenance Therapy Period
7 Days (always had symptoms)
|
0.0 Percentage of participants
|
0.6 Percentage of participants
|
—
|
—
|
|
Frequency of Sleep Disorders During the Maintenance Therapy Period
0 Day (none)
|
96.9 Percentage of participants
|
98.1 Percentage of participants
|
—
|
—
|
|
Frequency of Sleep Disorders During the Maintenance Therapy Period
1 to 2 Days (occasional symptoms)
|
2.5 Percentage of participants
|
0.6 Percentage of participants
|
—
|
—
|
|
Frequency of Sleep Disorders During the Maintenance Therapy Period
5 to 6 Days (often had symptoms)
|
0.0 Percentage of participants
|
0.6 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)Population: Safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Period and had at least one post-dose safety assessment.
Safety was assessed by monitoring and recording all adverse events (AEs) and SAEs, regular monitoring of hematology, clinical chemistry, urine values, and regular measurement of vital signs. All AEs were graded on a 3-point scale; 1) mild was defined as discomfort that did not interfere with normal daily activities, 2) moderate was defined as discomfort that interfered with normal activities, and 3) severe was defined as discomfort that interfered with the ability to work or normal daily activities were impossible. SAEs were medical events that led to death, were life-threatening, required hospitalization or prolongation of hospitalization, caused persistent disability, or resulted in a congenital abnormality. TEAEs were AEs with an onset date on or after the first dose of study drug and up to 30 days after receiving the last dose of study drug. Treatment-related AEs were medical events that were considered by the investigator to be possibly or probably related to rabeprazole.
Outcome measures
| Measure |
Rabeprazole: 10 or 20 mg Twice Daily, Then 10 mg Once Daily
n=437 Participants
Rabeprazole 10 mg or 20 mg were administered orally twice daily during the treatment period (unblinded), and 10 mg was administered once daily during the maintenance period (double-blind).
|
Rabeprazole: 10 or 20 mg Twice Daily, Then 10 mg Twice Daily
n=80 Participants
Rabeprazole 10 mg or 20 mg were administered orally twice daily during the treatment period (unblinded), and 10 mg was administered twice daily during the maintenance period (double-blind).
|
Rabeprazole: 10 or 20 mg Twice Daily, Then 10 mg Once daiArm C
n=178 Participants
Rabeprazole 10 mg or 20 mg were administered orally twice daily during the treatment period (unblinded), and 10 mg was administered once daily during the maintenance period (double-blind).
|
Rabeprazole: 10 or 20 mg Twice Daily, Then 10 mg Twice Daily
n=181 Participants
Rabeprazole 10 mg or 20 mg were administered orally twice daily during the treatment period (unblinded), and 10 mg was administered twice daily during the maintenance period (double-blind).
|
|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Treatment-related TEAEs
|
20 Participants
|
1 Participants
|
7 Participants
|
11 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Severe TEAEs
|
2 Participants
|
1 Participants
|
4 Participants
|
3 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Serious TEAEs
|
6 Participants
|
4 Participants
|
11 Participants
|
17 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
TEAEs
|
111 Participants
|
21 Participants
|
111 Participants
|
125 Participants
|
Adverse Events
Rabeprazole: 10 mg Twice Daily
Serious events: 6 serious events
Other events: 63 other events
Deaths: 0 deaths
Rabeprazole: 20 mg Twice Daily
Serious events: 4 serious events
Other events: 12 other events
Deaths: 0 deaths
Rabeprazole: 10 or 20 mg Twice Daily, Then 10 mg Once Daily
Serious events: 11 serious events
Other events: 75 other events
Deaths: 1 deaths
Rabeprazole: 10 or 20 mg Twice Daily, Then 10 mg Twice Daily
Serious events: 17 serious events
Other events: 87 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rabeprazole: 10 mg Twice Daily
n=437 participants at risk
Rabeprazole 10 mg was administered orally twice daily during the treatment period for 8 weeks (unblinded).
|
Rabeprazole: 20 mg Twice Daily
n=80 participants at risk
Rabeprazole 20 mg was administered orally twice daily during the treatment period for 8 weeks (unblinded).
|
Rabeprazole: 10 or 20 mg Twice Daily, Then 10 mg Once Daily
n=178 participants at risk
Rabeprazole 10 mg or 20 mg were administered orally twice daily during the treatment period (unblinded), and 10 mg was administered once daily during the maintenance period (double-blind).
|
Rabeprazole: 10 or 20 mg Twice Daily, Then 10 mg Twice Daily
n=181 participants at risk
Rabeprazole 10 mg or 20 mg were administered orally twice daily during the treatment period (unblinded), and 10 mg was administered twice daily during the maintenance period (double-blind).
|
|---|---|---|---|---|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/437 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/80 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/178 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.55%
1/181 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.00%
0/437 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/80 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/178 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.55%
1/181 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/437 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/80 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.56%
1/178 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.55%
1/181 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma gastric
|
0.00%
0/437 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/80 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/178 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.55%
1/181 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/437 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/80 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/178 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.55%
1/181 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.00%
0/437 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/80 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/178 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.55%
1/181 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/437 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/80 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.56%
1/178 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/181 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/437 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/80 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.56%
1/178 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/181 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
|
Product Issues
Device dislocation
|
0.00%
0/437 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/80 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/178 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.55%
1/181 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/437 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/80 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/178 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.55%
1/181 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
|
Cardiac disorders
Coronary artery stenosis
|
0.23%
1/437 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/80 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/178 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/181 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
|
Ear and labyrinth disorders
Meniere's disease
|
0.23%
1/437 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/80 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/178 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/181 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.00%
0/437 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
1.2%
1/80 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/178 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/181 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.23%
1/437 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/80 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/178 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/181 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/437 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
1.2%
1/80 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/178 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/181 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.23%
1/437 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/80 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/178 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/181 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
|
Musculoskeletal and connective tissue disorders
Sacroiliitis
|
0.23%
1/437 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/80 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/178 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/181 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small intestine carcinoma
|
0.00%
0/437 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
1.2%
1/80 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/178 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/181 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/437 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
1.2%
1/80 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/178 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/181 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
|
Surgical and medical procedures
Abortion induced
|
0.23%
1/437 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/80 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/178 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/181 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/437 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/80 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/178 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.55%
1/181 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
|
Cardiac disorders
Prinzmetal angina
|
0.00%
0/437 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/80 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/178 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.55%
1/181 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
|
Congenital, familial and genetic disorders
Heart disease congenital
|
0.00%
0/437 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/80 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/178 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.55%
1/181 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/437 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/80 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.56%
1/178 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.55%
1/181 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/437 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/80 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/178 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.55%
1/181 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.00%
0/437 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/80 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.56%
1/178 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/181 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/437 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/80 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.56%
1/178 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/181 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
|
Gastrointestinal disorders
Alcoholic pancreatitis
|
0.00%
0/437 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/80 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/178 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.55%
1/181 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
|
General disorders
Drowning
|
0.00%
0/437 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/80 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.56%
1/178 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/181 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
|
General disorders
Pyrexia
|
0.00%
0/437 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/80 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/178 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.55%
1/181 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
|
Infections and infestations
Cellulitis
|
0.00%
0/437 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/80 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/178 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.55%
1/181 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/437 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/80 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/178 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.55%
1/181 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
|
Infections and infestations
Sepsis
|
0.00%
0/437 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/80 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.56%
1/178 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/181 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
|
Infections and infestations
Infectious pleural effusion
|
0.00%
0/437 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/80 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.56%
1/178 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/181 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
|
Injury, poisoning and procedural complications
Skull fractured base
|
0.00%
0/437 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/80 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.56%
1/178 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/181 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/437 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/80 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.56%
1/178 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/181 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/437 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/80 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/178 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.55%
1/181 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/437 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/80 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.56%
1/178 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/181 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
Other adverse events
| Measure |
Rabeprazole: 10 mg Twice Daily
n=437 participants at risk
Rabeprazole 10 mg was administered orally twice daily during the treatment period for 8 weeks (unblinded).
|
Rabeprazole: 20 mg Twice Daily
n=80 participants at risk
Rabeprazole 20 mg was administered orally twice daily during the treatment period for 8 weeks (unblinded).
|
Rabeprazole: 10 or 20 mg Twice Daily, Then 10 mg Once Daily
n=178 participants at risk
Rabeprazole 10 mg or 20 mg were administered orally twice daily during the treatment period (unblinded), and 10 mg was administered once daily during the maintenance period (double-blind).
|
Rabeprazole: 10 or 20 mg Twice Daily, Then 10 mg Twice Daily
n=181 participants at risk
Rabeprazole 10 mg or 20 mg were administered orally twice daily during the treatment period (unblinded), and 10 mg was administered twice daily during the maintenance period (double-blind).
|
|---|---|---|---|---|
|
Investigations
Blood pressure increased
|
0.46%
2/437 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/80 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
1.1%
2/178 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
2.2%
4/181 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.92%
4/437 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/80 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
1.7%
3/178 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
5.5%
10/181 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/437 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
1.2%
1/80 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
3.9%
7/178 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
1.7%
3/181 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.23%
1/437 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/80 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
1.7%
3/178 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
3.3%
6/181 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
|
Gastrointestinal disorders
Constipation
|
0.69%
3/437 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
1.2%
1/80 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
2.2%
4/178 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
1.7%
3/181 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
|
Gastrointestinal disorders
Vomiting
|
0.23%
1/437 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/80 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
1.7%
3/178 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
2.8%
5/181 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
|
Gastrointestinal disorders
Stomatitis
|
0.69%
3/437 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/80 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
2.2%
4/178 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.55%
1/181 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
|
General disorders
Pyrexia
|
0.46%
2/437 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
1.2%
1/80 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.56%
1/178 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
2.2%
4/181 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
|
Infections and infestations
Nasopharyngitis
|
5.7%
25/437 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
6.2%
5/80 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
18.0%
32/178 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
18.2%
33/181 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.69%
3/437 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
2.5%
2/80 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
5.1%
9/178 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
5.5%
10/181 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
|
Infections and infestations
Pharyngitis
|
0.92%
4/437 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/80 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
2.8%
5/178 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
4.4%
8/181 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
|
Infections and infestations
Influenza
|
0.46%
2/437 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/80 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
2.8%
5/178 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
2.2%
4/181 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
|
Infections and infestations
Gastroenteritis
|
0.46%
2/437 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/80 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
1.1%
2/178 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
2.8%
5/181 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
|
Injury, poisoning and procedural complications
Contusion
|
0.69%
3/437 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/80 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
2.2%
4/178 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
3.3%
6/181 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/437 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/80 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.56%
1/178 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
2.2%
4/181 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.23%
1/437 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
2.5%
2/80 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/178 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/181 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/437 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/80 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.56%
1/178 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
2.2%
4/181 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.4%
6/437 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/80 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
2.2%
4/178 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
5.0%
9/181 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/437 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/80 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
2.2%
4/178 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
2.2%
4/181 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/437 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/80 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/178 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
2.8%
5/181 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
|
Nervous system disorders
Headache
|
0.69%
3/437 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
1.2%
1/80 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
2.8%
5/178 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
1.1%
2/181 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.23%
1/437 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/80 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
3.4%
6/178 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
4.4%
8/181 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
|
Vascular disorders
Hypertension
|
0.92%
4/437 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
1.2%
1/80 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
0.00%
0/178 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
2.2%
4/181 • From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
|
Additional Information
Public Relations Group (EA Pharma Co., Ltd.)
Eisai Co., Ltd. and EA Pharma Co., Ltd.
Phone: +81-(0)3-6280-9600
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER