Trial Outcomes & Findings for Vonoprazan Study in Patients With Erosive Esophagitis to Evaluate Long-term Safety (NCT NCT02679508)
NCT ID: NCT02679508
Last Updated: 2023-12-13
Results Overview
Numbers of participants with malignant alteration of epithelial cells for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as the endpoint for gastric mucosa histopathology. The number analyzed is the number of participants with data available for analysis.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
208 participants
Primary outcome timeframe
Time Frame: Up to Week 268 (Week 260 in Maintenance Phase)
Results posted on
2023-12-13
Participant Flow
Participants took part in the survey at 36 investigative sites in Japan, from 20 March 2016 to 5 March 2022.
Participants with a historical diagnosis of erosive esophagitis were enrolled. Participants received Vonoprazan or Lansoprazole as part of a routine medical care.
Participant milestones
| Measure |
Vonoprazan Group
Vonoprazan 20 mg administered orally once daily in the healing phase, after that Vonoprazan 10 mg (as the initial dose and adjusted to Vonoprazan 10 mg or 20 mg) administered orally once daily in the maintenance phase.
|
Lansoprazole Group
Lansoprazole 30 mg administered orally once daily in the healing phase, after that Lansoprazole 15 mg (as the initial dose and adjusted to Lansoprazole 15 mg or 30 mg) administered orally once daily in the maintenance phase.
|
|---|---|---|
|
Healing Phase
STARTED
|
139
|
69
|
|
Healing Phase
COMPLETED
|
137
|
68
|
|
Healing Phase
NOT COMPLETED
|
2
|
1
|
|
Maintenance Phase
STARTED
|
137
|
68
|
|
Maintenance Phase
COMPLETED
|
105
|
53
|
|
Maintenance Phase
NOT COMPLETED
|
32
|
15
|
Reasons for withdrawal
| Measure |
Vonoprazan Group
Vonoprazan 20 mg administered orally once daily in the healing phase, after that Vonoprazan 10 mg (as the initial dose and adjusted to Vonoprazan 10 mg or 20 mg) administered orally once daily in the maintenance phase.
|
Lansoprazole Group
Lansoprazole 30 mg administered orally once daily in the healing phase, after that Lansoprazole 15 mg (as the initial dose and adjusted to Lansoprazole 15 mg or 30 mg) administered orally once daily in the maintenance phase.
|
|---|---|---|
|
Healing Phase
Protocol Violation
|
1
|
1
|
|
Healing Phase
Lost to Follow-up
|
1
|
0
|
|
Maintenance Phase
Adverse Event
|
12
|
2
|
|
Maintenance Phase
Lost to Follow-up
|
0
|
1
|
|
Maintenance Phase
Withdrawal by Subject
|
15
|
8
|
|
Maintenance Phase
Other
|
5
|
4
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Vonoprazan Group
n=139 Participants
Vonoprazan 20 mg administered orally once daily in the healing phase, after that Vonoprazan 10 mg (as the initial dose and adjusted to Vonoprazan 10 mg or 20 mg) administered orally once daily in the maintenance phase.
|
Lansoprazole Group
n=69 Participants
Lansoprazole 30 mg administered orally once daily in the healing phase, after that Lansoprazole 15 mg (as the initial dose and adjusted to Lansoprazole 15 mg or 30 mg) administered orally once daily in the maintenance phase.
|
Total
n=208 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.5 years
STANDARD_DEVIATION 11.90 • n=139 Participants
|
61.8 years
STANDARD_DEVIATION 12.13 • n=69 Participants
|
60.9 years
STANDARD_DEVIATION 11.97 • n=208 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=139 Participants
|
27 Participants
n=69 Participants
|
68 Participants
n=208 Participants
|
|
Sex: Female, Male
Male
|
98 Participants
n=139 Participants
|
42 Participants
n=69 Participants
|
140 Participants
n=208 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Japan
|
139 Participants
n=139 Participants
|
69 Participants
n=69 Participants
|
208 Participants
n=208 Participants
|
|
Height
|
164.4 Centimeters (cm)
STANDARD_DEVIATION 8.96 • n=139 Participants
|
162.7 Centimeters (cm)
STANDARD_DEVIATION 10.12 • n=69 Participants
|
163.8 Centimeters (cm)
STANDARD_DEVIATION 9.37 • n=208 Participants
|
|
Weight
|
68.55 Kilograms (kg)
STANDARD_DEVIATION 13.011 • n=139 Participants
|
65.98 Kilograms (kg)
STANDARD_DEVIATION 11.520 • n=69 Participants
|
67.70 Kilograms (kg)
STANDARD_DEVIATION 12.566 • n=208 Participants
|
|
BMI (Body Mass Index)
|
25.25 Kilogram (kg)/meter (m)^2
STANDARD_DEVIATION 3.737 • n=139 Participants
|
24.85 Kilogram (kg)/meter (m)^2
STANDARD_DEVIATION 3.280 • n=69 Participants
|
25.12 Kilogram (kg)/meter (m)^2
STANDARD_DEVIATION 3.589 • n=208 Participants
|
|
Smoking History
Never Smoked
|
52 Participants
n=139 Participants
|
31 Participants
n=69 Participants
|
83 Participants
n=208 Participants
|
|
Smoking History
Current Smoker
|
25 Participants
n=139 Participants
|
9 Participants
n=69 Participants
|
34 Participants
n=208 Participants
|
|
Smoking History
Ex-Smoker
|
62 Participants
n=139 Participants
|
29 Participants
n=69 Participants
|
91 Participants
n=208 Participants
|
|
Drinking History
Drinks Every Day
|
44 Participants
n=139 Participants
|
17 Participants
n=69 Participants
|
61 Participants
n=208 Participants
|
|
Drinking History
Drinks a Few Days per Week
|
27 Participants
n=139 Participants
|
16 Participants
n=69 Participants
|
43 Participants
n=208 Participants
|
|
Drinking History
Drinks a Few Days per Month
|
22 Participants
n=139 Participants
|
19 Participants
n=69 Participants
|
41 Participants
n=208 Participants
|
|
Drinking History
Never Drank or Ex Drinker
|
46 Participants
n=139 Participants
|
17 Participants
n=69 Participants
|
63 Participants
n=208 Participants
|
|
Consumption of Caffeine-Containing Beverage
Yes
|
112 Participants
n=139 Participants
|
50 Participants
n=69 Participants
|
162 Participants
n=208 Participants
|
|
Consumption of Caffeine-Containing Beverage
No
|
27 Participants
n=139 Participants
|
19 Participants
n=69 Participants
|
46 Participants
n=208 Participants
|
|
Endoscopic Findings in Esophagus
Grade A
|
64 Participants
n=139 Participants
|
33 Participants
n=69 Participants
|
97 Participants
n=208 Participants
|
|
Endoscopic Findings in Esophagus
Grade B
|
50 Participants
n=139 Participants
|
25 Participants
n=69 Participants
|
75 Participants
n=208 Participants
|
|
Endoscopic Findings in Esophagus
Grade C
|
20 Participants
n=139 Participants
|
10 Participants
n=69 Participants
|
30 Participants
n=208 Participants
|
|
Endoscopic Findings in Esophagus
Grade D
|
5 Participants
n=139 Participants
|
1 Participants
n=69 Participants
|
6 Participants
n=208 Participants
|
|
Serum Gastrin Level
|
130.2 Picogram/milliliter (pg/mL)
STANDARD_DEVIATION 77.97 • n=139 Participants
|
155.1 Picogram/milliliter (pg/mL)
STANDARD_DEVIATION 128.73 • n=69 Participants
|
138.5 Picogram/milliliter (pg/mL)
STANDARD_DEVIATION 98.15 • n=208 Participants
|
|
Serum Pepsinogen I/II Ratio
|
5.45 Ratio
STANDARD_DEVIATION 1.226 • n=139 Participants
|
5.24 Ratio
STANDARD_DEVIATION 1.314 • n=69 Participants
|
5.38 Ratio
STANDARD_DEVIATION 1.257 • n=208 Participants
|
PRIMARY outcome
Timeframe: Time Frame: Up to Week 268 (Week 260 in Maintenance Phase)Population: Safety Data Analysis Set in the Maintenance Phase: All participants who were enrolled in Maintenance Phase and who received at least one dose of any therapy in the Maintenance Phase of this study. The number analyzed is the number of participants with data available for analysis.
Numbers of participants with malignant alteration of epithelial cells for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as the endpoint for gastric mucosa histopathology. The number analyzed is the number of participants with data available for analysis.
Outcome measures
| Measure |
Vonoprazan Group
n=102 Participants
Vonoprazan 20 mg administered orally once daily in the healing phase, after that Vonoprazan 10 mg (as the initial dose and adjusted to Vonoprazan 10 mg or 20 mg) administered orally once daily in the maintenance phase.
|
Lansoprazole Group
n=52 Participants
Lansoprazole 30 mg administered orally once daily in the healing phase, after that Lansoprazole 15 mg (as the initial dose and adjusted to Lansoprazole 15 mg or 30 mg) administered orally once daily in the maintenance phase.
|
|---|---|---|
|
Number of Participants With Malignant Alteration of Epithelial Cells
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to Week 268 (Week 260 in Maintenance Phase)Population: Safety Data Analysis Set in the Maintenance Phase: All participants who were enrolled in Maintenance Phase and who received at least one dose of any therapy in the Maintenance Phase of this study. The number analyzed is the number of participants with data available for analysis.
Numbers of participants with parietal cell protrusion/hyperplasia for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as the endpoint for gastric mucosa histopathology. The number analyzed is the number of participants with data available for analysis.
Outcome measures
| Measure |
Vonoprazan Group
n=102 Participants
Vonoprazan 20 mg administered orally once daily in the healing phase, after that Vonoprazan 10 mg (as the initial dose and adjusted to Vonoprazan 10 mg or 20 mg) administered orally once daily in the maintenance phase.
|
Lansoprazole Group
n=52 Participants
Lansoprazole 30 mg administered orally once daily in the healing phase, after that Lansoprazole 15 mg (as the initial dose and adjusted to Lansoprazole 15 mg or 30 mg) administered orally once daily in the maintenance phase.
|
|---|---|---|
|
Number of Participants With Parietal Cell Protrusion/Hyperplasia
|
99 Participants
|
45 Participants
|
PRIMARY outcome
Timeframe: Up to Week 268 (Week 260 in Maintenance Phase)Population: Safety Data Analysis Set in the Maintenance Phase: All participants who were enrolled in Maintenance Phase and who received at least one dose of any therapy in the Maintenance Phase of this study. The number analyzed is the number of participants with data available for analysis.
Numbers of participants with foveolar hyperplasia for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as the endpoint for gastric mucosa histopathology. The number analyzed is the number of participants with data available for analysis.
Outcome measures
| Measure |
Vonoprazan Group
n=102 Participants
Vonoprazan 20 mg administered orally once daily in the healing phase, after that Vonoprazan 10 mg (as the initial dose and adjusted to Vonoprazan 10 mg or 20 mg) administered orally once daily in the maintenance phase.
|
Lansoprazole Group
n=52 Participants
Lansoprazole 30 mg administered orally once daily in the healing phase, after that Lansoprazole 15 mg (as the initial dose and adjusted to Lansoprazole 15 mg or 30 mg) administered orally once daily in the maintenance phase.
|
|---|---|---|
|
Number of Participants With Foveolar Hyperplasia
|
15 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to Week 268 (Week 260 in Maintenance Phase)Population: Safety Data Analysis Set in the Maintenance Phase: All participants who were enrolled in Maintenance Phase and who received at least one dose of any therapy in the Maintenance Phase of this study. The number analyzed is the number of participants with data available for analysis.
Numbers of participants with enterochromaffin-like-cell hyperplasia for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as the endpoint for gastric mucosa histopathology. The number analyzed is the number of participants with data available for analysis.
Outcome measures
| Measure |
Vonoprazan Group
n=102 Participants
Vonoprazan 20 mg administered orally once daily in the healing phase, after that Vonoprazan 10 mg (as the initial dose and adjusted to Vonoprazan 10 mg or 20 mg) administered orally once daily in the maintenance phase.
|
Lansoprazole Group
n=52 Participants
Lansoprazole 30 mg administered orally once daily in the healing phase, after that Lansoprazole 15 mg (as the initial dose and adjusted to Lansoprazole 15 mg or 30 mg) administered orally once daily in the maintenance phase.
|
|---|---|---|
|
Number of Participants With Enterochromaffin-like-cell Hyperplasia
|
5 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Up to Week 268 (Week 260 in Maintenance Phase)Population: Safety Data Analysis Set in the Maintenance Phase: All participants who were enrolled in Maintenance Phase and who received at least one dose of any therapy in the Maintenance Phase of this study. The number analyzed is the number of participants with data available for analysis.
Numbers of participants with G-cell hyperplasia for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as the endpoint for gastric mucosa histopathology. The number analyzed is the number of participants with data available for analysis.
Outcome measures
| Measure |
Vonoprazan Group
n=102 Participants
Vonoprazan 20 mg administered orally once daily in the healing phase, after that Vonoprazan 10 mg (as the initial dose and adjusted to Vonoprazan 10 mg or 20 mg) administered orally once daily in the maintenance phase.
|
Lansoprazole Group
n=52 Participants
Lansoprazole 30 mg administered orally once daily in the healing phase, after that Lansoprazole 15 mg (as the initial dose and adjusted to Lansoprazole 15 mg or 30 mg) administered orally once daily in the maintenance phase.
|
|---|---|---|
|
Number of Participants With G-cell Hyperplasia
|
87 Participants
|
40 Participants
|
SECONDARY outcome
Timeframe: Up to Week 268 (Week 260 in Maintenance Phase)Population: Full Analysis Set in the Maintenance Phase: All participants who were randomized and who received at least one dose of any therapy in the Maintenance Phase of this study.
Erosive esophagitis recurrence is defined as endoscopically confirmed to have erosive esophagitis (LA classification grades O and A to D) during the Maintenance Phase. The LA classification graded as follows- Grade O: normal mucosa; Grade A: nonconfluent mucosal breaks \<5 mm in length; Grade B: nonconfluent mucosal breaks ≥ 5mm in length; Grade C: confluent mucosal breaks \<75% circumferential; Grade D: confluent mucosal breaks \>75% circumferential.
Outcome measures
| Measure |
Vonoprazan Group
n=135 Participants
Vonoprazan 20 mg administered orally once daily in the healing phase, after that Vonoprazan 10 mg (as the initial dose and adjusted to Vonoprazan 10 mg or 20 mg) administered orally once daily in the maintenance phase.
|
Lansoprazole Group
n=67 Participants
Lansoprazole 30 mg administered orally once daily in the healing phase, after that Lansoprazole 15 mg (as the initial dose and adjusted to Lansoprazole 15 mg or 30 mg) administered orally once daily in the maintenance phase.
|
|---|---|---|
|
Percentage of Participants With Recurrence of Erosive Esophagitis (EE)
|
3.8 Percentage of participants
Interval 1.1 to 9.6
|
11.3 Percentage of participants
Interval 4.3 to 23.0
|
SECONDARY outcome
Timeframe: Up to Week 8Population: Full Analysis Set in the Healing Phase: All participants who were randomized and who received at least one dose of any therapy in the Healing Phase of this study.
Percentage of participants who healed EE at the end of healing phase was reported.
Outcome measures
| Measure |
Vonoprazan Group
n=139 Participants
Vonoprazan 20 mg administered orally once daily in the healing phase, after that Vonoprazan 10 mg (as the initial dose and adjusted to Vonoprazan 10 mg or 20 mg) administered orally once daily in the maintenance phase.
|
Lansoprazole Group
n=69 Participants
Lansoprazole 30 mg administered orally once daily in the healing phase, after that Lansoprazole 15 mg (as the initial dose and adjusted to Lansoprazole 15 mg or 30 mg) administered orally once daily in the maintenance phase.
|
|---|---|---|
|
Percentage of Participants Who Healed EE at the End of Healing Phase
|
1.4 Percentage of participants
Interval 0.2 to 5.1
|
0.0 Percentage of participants
Interval 0.0 to 5.2
|
SECONDARY outcome
Timeframe: 260 weeks (Baseline, up to the end of Maintenance Phase)Population: Safety Data Analysis Set in the Maintenance Phase: All participants who were enrolled in Maintenance Phase and who received at least one dose of any therapy in the Maintenance Phase of this study.
Number of participants reporting one or more TEAEs in Maintenance Phase was reported. An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.
Outcome measures
| Measure |
Vonoprazan Group
n=135 Participants
Vonoprazan 20 mg administered orally once daily in the healing phase, after that Vonoprazan 10 mg (as the initial dose and adjusted to Vonoprazan 10 mg or 20 mg) administered orally once daily in the maintenance phase.
|
Lansoprazole Group
n=67 Participants
Lansoprazole 30 mg administered orally once daily in the healing phase, after that Lansoprazole 15 mg (as the initial dose and adjusted to Lansoprazole 15 mg or 30 mg) administered orally once daily in the maintenance phase.
|
|---|---|---|
|
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) in Maintenance Phase
|
126 Participants
|
64 Participants
|
SECONDARY outcome
Timeframe: Up to Week 268 (Week 260 in Maintenance Phase)Population: Safety Data Analysis Set in the Maintenance Phase: All participants who were enrolled in Maintenance Phase and who received at least one dose of any therapy in the Maintenance Phase of this study. The number analyzed is the number of participants with data available for analysis.
Numbers of participants with fundic gland polyp for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as the endpoint for endoscopic findings. The number analyzed is the number of participants with data available for analysis.
Outcome measures
| Measure |
Vonoprazan Group
n=104 Participants
Vonoprazan 20 mg administered orally once daily in the healing phase, after that Vonoprazan 10 mg (as the initial dose and adjusted to Vonoprazan 10 mg or 20 mg) administered orally once daily in the maintenance phase.
|
Lansoprazole Group
n=53 Participants
Lansoprazole 30 mg administered orally once daily in the healing phase, after that Lansoprazole 15 mg (as the initial dose and adjusted to Lansoprazole 15 mg or 30 mg) administered orally once daily in the maintenance phase.
|
|---|---|---|
|
Number of Participants With Fundic Gland Polyp
|
75 Participants
|
45 Participants
|
SECONDARY outcome
Timeframe: Up to Week 268 (Week 260 in Maintenance Phase)Population: Safety Data Analysis Set in the Maintenance Phase: All participants who were enrolled in Maintenance Phase and who received at least one dose of any therapy in the Maintenance Phase of this study. The number analyzed is the number of participants with data available for analysis.
Numbers of participants with hyperplastic polyp for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as the endpoint for endoscopic findings. The number analyzed is the number of participants with data available for analysis.
Outcome measures
| Measure |
Vonoprazan Group
n=104 Participants
Vonoprazan 20 mg administered orally once daily in the healing phase, after that Vonoprazan 10 mg (as the initial dose and adjusted to Vonoprazan 10 mg or 20 mg) administered orally once daily in the maintenance phase.
|
Lansoprazole Group
n=53 Participants
Lansoprazole 30 mg administered orally once daily in the healing phase, after that Lansoprazole 15 mg (as the initial dose and adjusted to Lansoprazole 15 mg or 30 mg) administered orally once daily in the maintenance phase.
|
|---|---|---|
|
Number of Participants With Hyperplastic Polyp
|
24 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Up to Week 268 (Week 260 in Maintenance Phase)Population: Safety Data Analysis Set in the Maintenance Phase: All participants who were enrolled in Maintenance Phase and who received at least one dose of any therapy in the Maintenance Phase of this study. The number analyzed is the number of participants with data available for analysis.
Numbers of participants with cobblestone mucosa for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as the endpoint for endoscopic findings. The number analyzed is the number of participants with data available for analysis.
Outcome measures
| Measure |
Vonoprazan Group
n=104 Participants
Vonoprazan 20 mg administered orally once daily in the healing phase, after that Vonoprazan 10 mg (as the initial dose and adjusted to Vonoprazan 10 mg or 20 mg) administered orally once daily in the maintenance phase.
|
Lansoprazole Group
n=53 Participants
Lansoprazole 30 mg administered orally once daily in the healing phase, after that Lansoprazole 15 mg (as the initial dose and adjusted to Lansoprazole 15 mg or 30 mg) administered orally once daily in the maintenance phase.
|
|---|---|---|
|
Number of Participants With Cobblestone Mucosa
|
23 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Up to Week 268 (Week 260 in Maintenance Phase)Population: Safety Data Analysis Set in the Maintenance Phase: All participants who were enrolled in Maintenance Phase and who received at least one dose of any therapy in the Maintenance Phase of this study. The number analyzed is the number of participants with data available for analysis.
Numbers of participants with multiple white and flat elevated lesions for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as the endpoint for endoscopic findings. The number analyzed is the number of participants with data available for analysis.
Outcome measures
| Measure |
Vonoprazan Group
n=104 Participants
Vonoprazan 20 mg administered orally once daily in the healing phase, after that Vonoprazan 10 mg (as the initial dose and adjusted to Vonoprazan 10 mg or 20 mg) administered orally once daily in the maintenance phase.
|
Lansoprazole Group
n=53 Participants
Lansoprazole 30 mg administered orally once daily in the healing phase, after that Lansoprazole 15 mg (as the initial dose and adjusted to Lansoprazole 15 mg or 30 mg) administered orally once daily in the maintenance phase.
|
|---|---|---|
|
Number of Participants With Multiple White and Flat Elevated Lesions
|
8 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Up to Week 268 (Week 260 in Maintenance Phase)Population: Safety Data Analysis Set in the Maintenance Phase: All participants who were enrolled in Maintenance Phase and who received at least one dose of any therapy in the Maintenance Phase of this study.
Numbers of participants with black spots for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as the endpoint for endoscopic findings. The number analyzed is the number of participants with data available for analysis.
Outcome measures
| Measure |
Vonoprazan Group
n=104 Participants
Vonoprazan 20 mg administered orally once daily in the healing phase, after that Vonoprazan 10 mg (as the initial dose and adjusted to Vonoprazan 10 mg or 20 mg) administered orally once daily in the maintenance phase.
|
Lansoprazole Group
n=53 Participants
Lansoprazole 30 mg administered orally once daily in the healing phase, after that Lansoprazole 15 mg (as the initial dose and adjusted to Lansoprazole 15 mg or 30 mg) administered orally once daily in the maintenance phase.
|
|---|---|---|
|
Number of Participants With Black Spots
|
8 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Up to Week 268 (Week 260 in Maintenance Phase)Population: Safety Data Analysis Set in the Maintenance Phase: All participants who were enrolled in Maintenance Phase and who received at least one dose of any therapy in the Maintenance Phase of this study. The number analyzed is the number of participants with data available for analysis.
Numbers of participants with inflammation (mononuclear infiltration) in greater curvature of the middle gastric body for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as histological assessment of gastritis.
Outcome measures
| Measure |
Vonoprazan Group
n=102 Participants
Vonoprazan 20 mg administered orally once daily in the healing phase, after that Vonoprazan 10 mg (as the initial dose and adjusted to Vonoprazan 10 mg or 20 mg) administered orally once daily in the maintenance phase.
|
Lansoprazole Group
n=52 Participants
Lansoprazole 30 mg administered orally once daily in the healing phase, after that Lansoprazole 15 mg (as the initial dose and adjusted to Lansoprazole 15 mg or 30 mg) administered orally once daily in the maintenance phase.
|
|---|---|---|
|
Number of Participants With Inflammation (Mononuclear Infiltration) in Greater Curvature of Middle Gastric Body
|
15 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Up to Week 268 (Week 260 in Maintenance Phase)Population: Safety Data Analysis Set in the Maintenance Phase: All participants who were enrolled in Maintenance Phase and who received at least one dose of any therapy in the Maintenance Phase of this study. The number analyzed is the number of participants with data available for analysis.
Numbers of participants with inflammation (mononuclear infiltration) in greater curvature of the antrum for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as histological assessment of gastritis.
Outcome measures
| Measure |
Vonoprazan Group
n=102 Participants
Vonoprazan 20 mg administered orally once daily in the healing phase, after that Vonoprazan 10 mg (as the initial dose and adjusted to Vonoprazan 10 mg or 20 mg) administered orally once daily in the maintenance phase.
|
Lansoprazole Group
n=52 Participants
Lansoprazole 30 mg administered orally once daily in the healing phase, after that Lansoprazole 15 mg (as the initial dose and adjusted to Lansoprazole 15 mg or 30 mg) administered orally once daily in the maintenance phase.
|
|---|---|---|
|
Number of Participants With Inflammation (Mononuclear Infiltration) in Greater Curvature of Antrum
|
11 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Up to Week 268 (Week 260 in Maintenance Phase)Population: Safety Data Analysis Set in the Maintenance Phase: All participants who were enrolled in Maintenance Phase and who received at least one dose of any therapy in the Maintenance Phase of this study. The number analyzed is the number of participants with data available for analysis.
Numbers of participants with neutrophilic infiltration in greater curvature of the middle gastric body for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as histological assessment of gastritis.
Outcome measures
| Measure |
Vonoprazan Group
n=102 Participants
Vonoprazan 20 mg administered orally once daily in the healing phase, after that Vonoprazan 10 mg (as the initial dose and adjusted to Vonoprazan 10 mg or 20 mg) administered orally once daily in the maintenance phase.
|
Lansoprazole Group
n=52 Participants
Lansoprazole 30 mg administered orally once daily in the healing phase, after that Lansoprazole 15 mg (as the initial dose and adjusted to Lansoprazole 15 mg or 30 mg) administered orally once daily in the maintenance phase.
|
|---|---|---|
|
Number of Participants With Neutrophilic Infiltration in Greater Curvature of Middle Gastric Body
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Week 268 (Week 260 in Maintenance Phase)Population: Safety Data Analysis Set in the Maintenance Phase: All participants who were enrolled in Maintenance Phase and who received at least one dose of any therapy in the Maintenance Phase of this study. The number analyzed is the number of participants with data available for analysis.
Numbers of participants with neutrophilic infiltration in greater curvature of the antrum for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as histological assessment of gastritis.
Outcome measures
| Measure |
Vonoprazan Group
n=102 Participants
Vonoprazan 20 mg administered orally once daily in the healing phase, after that Vonoprazan 10 mg (as the initial dose and adjusted to Vonoprazan 10 mg or 20 mg) administered orally once daily in the maintenance phase.
|
Lansoprazole Group
n=52 Participants
Lansoprazole 30 mg administered orally once daily in the healing phase, after that Lansoprazole 15 mg (as the initial dose and adjusted to Lansoprazole 15 mg or 30 mg) administered orally once daily in the maintenance phase.
|
|---|---|---|
|
Number of Participants With Neutrophilic Infiltration in Greater Curvature of Antrum
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Week 268 (Week 260 in Maintenance Phase)Population: Safety Data Analysis Set in the Maintenance Phase: All participants who were enrolled in Maintenance Phase and who received at least one dose of any therapy in the Maintenance Phase of this study. The number analyzed is the number of participants with data available for analysis.
Numbers of participants with atrophy in greater curvature of the middle gastric body for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as histological assessment of gastritis.
Outcome measures
| Measure |
Vonoprazan Group
n=102 Participants
Vonoprazan 20 mg administered orally once daily in the healing phase, after that Vonoprazan 10 mg (as the initial dose and adjusted to Vonoprazan 10 mg or 20 mg) administered orally once daily in the maintenance phase.
|
Lansoprazole Group
n=52 Participants
Lansoprazole 30 mg administered orally once daily in the healing phase, after that Lansoprazole 15 mg (as the initial dose and adjusted to Lansoprazole 15 mg or 30 mg) administered orally once daily in the maintenance phase.
|
|---|---|---|
|
Number of Participants With Atrophy in Greater Curvature of Middle Gastric Body
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Week 268 (Week 260 in Maintenance Phase)Population: Safety Data Analysis Set in the Maintenance Phase: All participants who were enrolled in Maintenance Phase and who received at least one dose of any therapy in the Maintenance Phase of this study. The number analyzed is the number of participants with data available for analysis.
Numbers of participants with atrophy in greater curvature of the antrum for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as histological assessment of gastritis.
Outcome measures
| Measure |
Vonoprazan Group
n=102 Participants
Vonoprazan 20 mg administered orally once daily in the healing phase, after that Vonoprazan 10 mg (as the initial dose and adjusted to Vonoprazan 10 mg or 20 mg) administered orally once daily in the maintenance phase.
|
Lansoprazole Group
n=52 Participants
Lansoprazole 30 mg administered orally once daily in the healing phase, after that Lansoprazole 15 mg (as the initial dose and adjusted to Lansoprazole 15 mg or 30 mg) administered orally once daily in the maintenance phase.
|
|---|---|---|
|
Number of Participants With Atrophy in Greater Curvature of Antrum
|
7 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Up to Week 268 (Week 260 in Maintenance Phase)Population: Safety Data Analysis Set in the Maintenance Phase: All participants who were enrolled in Maintenance Phase and who received at least one dose of any therapy in the Maintenance Phase of this study. The number analyzed is the number of participants with data available for analysis.
Numbers of participants with intestinal metaplasia in greater curvature of the middle gastric body for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as histological assessment of gastritis.
Outcome measures
| Measure |
Vonoprazan Group
n=102 Participants
Vonoprazan 20 mg administered orally once daily in the healing phase, after that Vonoprazan 10 mg (as the initial dose and adjusted to Vonoprazan 10 mg or 20 mg) administered orally once daily in the maintenance phase.
|
Lansoprazole Group
n=52 Participants
Lansoprazole 30 mg administered orally once daily in the healing phase, after that Lansoprazole 15 mg (as the initial dose and adjusted to Lansoprazole 15 mg or 30 mg) administered orally once daily in the maintenance phase.
|
|---|---|---|
|
Number of Participants With Intestinal Metaplasia in Greater Curvature of Middle Gastric Body
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Week 268 (Week 260 in Maintenance Phase)Population: Safety Data Analysis Set in the Maintenance Phase: All participants who were enrolled in Maintenance Phase and who received at least one dose of any therapy in the Maintenance Phase of this study. The number analyzed is the number of participants with data available for analysis.
Numbers of participants with intestinal metaplasia in greater curvature of the antrum for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as histological assessment of gastritis.
Outcome measures
| Measure |
Vonoprazan Group
n=102 Participants
Vonoprazan 20 mg administered orally once daily in the healing phase, after that Vonoprazan 10 mg (as the initial dose and adjusted to Vonoprazan 10 mg or 20 mg) administered orally once daily in the maintenance phase.
|
Lansoprazole Group
n=52 Participants
Lansoprazole 30 mg administered orally once daily in the healing phase, after that Lansoprazole 15 mg (as the initial dose and adjusted to Lansoprazole 15 mg or 30 mg) administered orally once daily in the maintenance phase.
|
|---|---|---|
|
Number of Participants With Intestinal Metaplasia in Greater Curvature of Antrum
|
6 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Up to Week 268 (Week 260 in Maintenance Phase)Population: Safety Data Analysis Set in the Maintenance Phase: All participants who were enrolled in Maintenance Phase and who received at least one dose of any therapy in the Maintenance Phase of this study. The number analyzed is the number of participants with data available for analysis.
Numbers of participants with presence of H.pylori in greater curvature of the middle gastric body for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as histological assessment of gastritis.
Outcome measures
| Measure |
Vonoprazan Group
n=102 Participants
Vonoprazan 20 mg administered orally once daily in the healing phase, after that Vonoprazan 10 mg (as the initial dose and adjusted to Vonoprazan 10 mg or 20 mg) administered orally once daily in the maintenance phase.
|
Lansoprazole Group
n=52 Participants
Lansoprazole 30 mg administered orally once daily in the healing phase, after that Lansoprazole 15 mg (as the initial dose and adjusted to Lansoprazole 15 mg or 30 mg) administered orally once daily in the maintenance phase.
|
|---|---|---|
|
Number of Participants With Presence of H.Pylori in Greater Curvature of Middle Gastric Body
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Week 268 (Week 260 in Maintenance Phase)Population: Safety Data Analysis Set in the Maintenance Phase: All participants who were enrolled in Maintenance Phase and who received at least one dose of any therapy in the Maintenance Phase of this study. The number analyzed is the number of participants with data available for analysis.
Numbers of participants with presence of H.pylori in greater curvature of the antrum for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as histological assessment of gastritis.
Outcome measures
| Measure |
Vonoprazan Group
n=102 Participants
Vonoprazan 20 mg administered orally once daily in the healing phase, after that Vonoprazan 10 mg (as the initial dose and adjusted to Vonoprazan 10 mg or 20 mg) administered orally once daily in the maintenance phase.
|
Lansoprazole Group
n=52 Participants
Lansoprazole 30 mg administered orally once daily in the healing phase, after that Lansoprazole 15 mg (as the initial dose and adjusted to Lansoprazole 15 mg or 30 mg) administered orally once daily in the maintenance phase.
|
|---|---|---|
|
Number of Participants With Presence of H.Pylori in Greater Curvature of Antrum
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Week 268 (Week 260 in Maintenance Phase)Population: Safety Data Analysis Set in the Maintenance Phase: All participants who were enrolled in Maintenance Phase and who received at least one dose of any therapy in the Maintenance Phase of this study. The number analyzed is the number of participants with data available for analysis.
Numbers of participants with gastric polyp for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported. The number analyzed is the number of participants with data available for analysis.
Outcome measures
| Measure |
Vonoprazan Group
n=104 Participants
Vonoprazan 20 mg administered orally once daily in the healing phase, after that Vonoprazan 10 mg (as the initial dose and adjusted to Vonoprazan 10 mg or 20 mg) administered orally once daily in the maintenance phase.
|
Lansoprazole Group
n=53 Participants
Lansoprazole 30 mg administered orally once daily in the healing phase, after that Lansoprazole 15 mg (as the initial dose and adjusted to Lansoprazole 15 mg or 30 mg) administered orally once daily in the maintenance phase.
|
|---|---|---|
|
Number of Participants With Gastric Polyp
|
82 Participants
|
46 Participants
|
Adverse Events
Vonoprazan Group
Serious events: 50 serious events
Other events: 128 other events
Deaths: 0 deaths
Lansoprazole Group
Serious events: 27 serious events
Other events: 65 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Vonoprazan Group
n=139 participants at risk
Vonoprazan 20 mg administered orally once daily in the healing phase, after that Vonoprazan 10 mg (as the initial dose and adjusted to Vonoprazan 10 mg or 20 mg) administered orally once daily in the maintenance phase.
|
Lansoprazole Group
n=69 participants at risk
Lansoprazole 30 mg administered orally once daily in the healing phase, after that Lansoprazole 15 mg (as the initial dose and adjusted to Lansoprazole 15 mg or 30 mg) administered orally once daily in the maintenance phase.
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.72%
1/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.72%
1/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.72%
1/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
1.4%
1/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Cardiac disorders
Angina pectoris
|
0.72%
1/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
1.4%
1/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.72%
1/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Cardiac disorders
Prinzmetal angina
|
0.00%
0/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
1.4%
1/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.72%
1/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Ear and labyrinth disorders
Vertigo
|
0.72%
1/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Endocrine disorders
Hypopituitarism
|
0.72%
1/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Eye disorders
Cataract
|
2.2%
3/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
8.7%
6/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Eye disorders
Cataract nuclear
|
0.72%
1/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Eye disorders
Eyelid ptosis
|
0.00%
0/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
1.4%
1/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Eye disorders
Macular fibrosis
|
0.00%
0/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
1.4%
1/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Gastrointestinal disorders
Large intestine polyp
|
3.6%
5/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
5.8%
4/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Gastrointestinal disorders
Inguinal hernia
|
1.4%
2/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
2.9%
2/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
2.2%
3/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.72%
1/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.00%
0/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
1.4%
1/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Gastrointestinal disorders
Duodenal obstruction
|
0.72%
1/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.72%
1/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Gastrointestinal disorders
Enterovesical fistula
|
0.00%
0/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
1.4%
1/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
1.4%
1/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
1.4%
1/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.72%
1/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Gastrointestinal disorders
Pancreatic steatosis
|
0.72%
1/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
1.4%
1/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Hepatobiliary disorders
Cholangitis
|
0.72%
1/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
1.4%
1/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.72%
1/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.72%
1/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.72%
1/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.72%
1/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Immune system disorders
Anaphylactic shock
|
0.72%
1/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Infections and infestations
Diverticulitis
|
1.4%
2/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Infections and infestations
Abscess limb
|
0.72%
1/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Infections and infestations
Cellulitis
|
0.72%
1/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Infections and infestations
Cholangitis infective
|
0.00%
0/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
1.4%
1/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Infections and infestations
Chronic sinusitis
|
0.72%
1/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
1.4%
1/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Infections and infestations
Pneumonia
|
0.72%
1/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Infections and infestations
Pneumonia bacterial
|
0.72%
1/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.72%
1/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
1.4%
1/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Injury, poisoning and procedural complications
Acetabulum fracture
|
0.72%
1/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.72%
1/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
0.72%
1/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Injury, poisoning and procedural complications
Heat illness
|
0.72%
1/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.72%
1/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.72%
1/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.00%
0/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
1.4%
1/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.72%
1/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.72%
1/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
1.4%
2/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
2.9%
2/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
1.4%
2/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.72%
1/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.72%
1/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
0.72%
1/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.72%
1/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
2.9%
2/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
1.4%
2/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.72%
1/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
1.4%
1/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
1.4%
2/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma gastric
|
0.00%
0/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
1.4%
1/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
1.4%
1/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.72%
1/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.72%
1/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.72%
1/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.72%
1/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to retroperitoneum
|
0.72%
1/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mucinous adenocarcinoma of appendix
|
0.72%
1/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.72%
1/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.72%
1/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue neoplasm malignant stage unspecified
|
0.72%
1/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ureteric cancer
|
0.72%
1/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ureteric cancer metastatic
|
0.72%
1/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
2.2%
3/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
1.4%
1/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Nervous system disorders
Thrombotic cerebral infarction
|
0.00%
0/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
2.9%
2/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Nervous system disorders
Loss of consciousness
|
0.72%
1/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Nervous system disorders
Peripheral nerve palsy
|
0.72%
1/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Nervous system disorders
Sciatic nerve palsy
|
0.72%
1/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
1.4%
1/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Renal and urinary disorders
Calculus bladder
|
0.00%
0/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
1.4%
1/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.72%
1/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Renal and urinary disorders
Renal cyst
|
0.72%
1/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
1.4%
1/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.72%
1/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Vascular disorders
Varicose vein
|
0.72%
1/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
1.4%
1/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Vascular disorders
Subclavian artery stenosis
|
0.72%
1/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
Other adverse events
| Measure |
Vonoprazan Group
n=139 participants at risk
Vonoprazan 20 mg administered orally once daily in the healing phase, after that Vonoprazan 10 mg (as the initial dose and adjusted to Vonoprazan 10 mg or 20 mg) administered orally once daily in the maintenance phase.
|
Lansoprazole Group
n=69 participants at risk
Lansoprazole 30 mg administered orally once daily in the healing phase, after that Lansoprazole 15 mg (as the initial dose and adjusted to Lansoprazole 15 mg or 30 mg) administered orally once daily in the maintenance phase.
|
|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
5.0%
7/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
1.4%
1/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Gastrointestinal disorders
Gastric polyps
|
44.6%
62/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
44.9%
31/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Gastrointestinal disorders
Gastric mucosal lesion
|
21.6%
30/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
24.6%
17/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Gastrointestinal disorders
Gastritis erosive
|
8.6%
12/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
13.0%
9/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
9.4%
13/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
8.7%
6/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Gastrointestinal disorders
Large intestine polyp
|
7.9%
11/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
8.7%
6/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Gastrointestinal disorders
Gastrointestinal mucosal disorder
|
7.2%
10/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
8.7%
6/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Gastrointestinal disorders
Constipation
|
5.8%
8/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
5.8%
4/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Gastrointestinal disorders
Dental caries
|
5.0%
7/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
2.9%
2/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
1.4%
2/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
5.8%
4/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Infections and infestations
Nasopharyngitis
|
35.3%
49/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
42.0%
29/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Infections and infestations
Bronchitis
|
9.4%
13/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
10.1%
7/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Infections and infestations
Influenza
|
9.4%
13/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
1.4%
1/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.0%
7/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
8.7%
6/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Infections and infestations
Gastroenteritis
|
5.8%
8/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
5.8%
4/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Infections and infestations
Cystitis
|
5.8%
8/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
2.9%
2/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Infections and infestations
Pharyngitis
|
3.6%
5/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
7.2%
5/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Infections and infestations
Herpes zoster
|
2.2%
3/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
5.8%
4/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Infections and infestations
Tonsillitis bacterial
|
1.4%
2/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
5.8%
4/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Injury, poisoning and procedural complications
Contusion
|
5.8%
8/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
4.3%
3/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
5.0%
7/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
2.9%
2/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.4%
13/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
4.3%
3/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.6%
5/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
7.2%
5/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Nervous system disorders
Headache
|
4.3%
6/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
5.8%
4/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Nervous system disorders
Dizziness
|
1.4%
2/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
7.2%
5/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Psychiatric disorders
Insomnia
|
5.0%
7/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
3.6%
5/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
5.8%
4/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
2.9%
4/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
5.8%
4/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
7.2%
10/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
14.5%
10/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
2.9%
4/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
5.8%
4/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Vascular disorders
Hypertension
|
10.8%
15/139 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
8.7%
6/69 • Up to Week 268 (Week 260 in Maintenance Phase)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER