Trial Outcomes & Findings for Efficacy and Safety of Vonoprazan Compared to Lansoprazole in Participants With Erosive Esophagitis (NCT NCT04124926)
NCT ID: NCT04124926
Last Updated: 2022-07-29
Results Overview
A participant was considered to have complete healing of EE if healing was demonstrated during endoscopy.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1027 participants
Primary outcome timeframe
Week 8
Results posted on
2022-07-29
Participant Flow
This study was performed at 111 sites in 6 countries (Bulgaria, Czechia, Hungary, Poland, the United Kingdom and the United States) between 28 October 2019 and 24 August 2021. Of the 4,167 participants screened for the study, 1,027 participants with erosive esophagitis (EE) were randomized in the Healing Phase.
Participants were randomized to receive vonoprazan 20 mg once per day (QD) or lansoprazole 30 mg QD using a 1:1 ratio in the Healing Phase. Participants with endoscopic healing of EE at 2 or 8 weeks were re-randomized to receive vonoprazan 10 mg QD, vonoprazan 20 mg QD, or lansoprazole 15 mg QD using a 1:1:1 ratio in the Maintenance Phase.
Participant milestones
| Measure |
Healing Phase: Vonoprazan 20 mg
Participants received oral vonoprazan 20 mg QD for a maximum of 8 weeks in the Healing Phase.
|
Healing Phase: Lansoprazole 30 mg
Participants received oral lansoprazole 30 mg QD for a maximum of 8 weeks in the Healing Phase.
|
Maintenance Phase: Vonoprazan 10 mg
Participants received oral vonoprazan 10 mg QD for 24 weeks.
|
Maintenance Phase: Vonoprazan 20 mg
Participants received oral vonoprazan 20 mg QD for 24 weeks.
|
Maintenance Phase: Lansoprazole 15 mg
Participants received oral lansoprazole 15 mg QD for 24 weeks.
|
|---|---|---|---|---|---|
|
Healing Phase
STARTED
|
514
|
513
|
0
|
0
|
0
|
|
Healing Phase
Treated With Study Drug
|
514
|
510
|
0
|
0
|
0
|
|
Healing Phase
COMPLETED
|
483
|
481
|
0
|
0
|
0
|
|
Healing Phase
NOT COMPLETED
|
31
|
32
|
0
|
0
|
0
|
|
Maintenance Phase
STARTED
|
0
|
0
|
298
|
298
|
297
|
|
Maintenance Phase
Treated With Study Drug
|
0
|
0
|
296
|
296
|
297
|
|
Maintenance Phase
COMPLETED
|
0
|
0
|
274
|
269
|
269
|
|
Maintenance Phase
NOT COMPLETED
|
0
|
0
|
24
|
29
|
28
|
Reasons for withdrawal
| Measure |
Healing Phase: Vonoprazan 20 mg
Participants received oral vonoprazan 20 mg QD for a maximum of 8 weeks in the Healing Phase.
|
Healing Phase: Lansoprazole 30 mg
Participants received oral lansoprazole 30 mg QD for a maximum of 8 weeks in the Healing Phase.
|
Maintenance Phase: Vonoprazan 10 mg
Participants received oral vonoprazan 10 mg QD for 24 weeks.
|
Maintenance Phase: Vonoprazan 20 mg
Participants received oral vonoprazan 20 mg QD for 24 weeks.
|
Maintenance Phase: Lansoprazole 15 mg
Participants received oral lansoprazole 15 mg QD for 24 weeks.
|
|---|---|---|---|---|---|
|
Healing Phase
Pretreatment Event, Adverse Event (AE), or Serious AE (SAE)
|
3
|
7
|
0
|
0
|
0
|
|
Healing Phase
Protocol Violation
|
0
|
1
|
0
|
0
|
0
|
|
Healing Phase
Lost to Follow-up
|
5
|
4
|
0
|
0
|
0
|
|
Healing Phase
Voluntary Withdrawal
|
10
|
7
|
0
|
0
|
0
|
|
Healing Phase
Withdrawal of Consent
|
5
|
3
|
0
|
0
|
0
|
|
Healing Phase
Miscellaneous
|
8
|
7
|
0
|
0
|
0
|
|
Healing Phase
Randomized but not Treated
|
0
|
3
|
0
|
0
|
0
|
|
Maintenance Phase
Pretreatment Event, AE, or SAE
|
0
|
0
|
3
|
5
|
4
|
|
Maintenance Phase
Protocol Violation
|
0
|
0
|
3
|
0
|
0
|
|
Maintenance Phase
Lost to Follow-up
|
0
|
0
|
7
|
8
|
9
|
|
Maintenance Phase
Voluntary Withdrawal
|
0
|
0
|
3
|
6
|
5
|
|
Maintenance Phase
Pregnancy
|
0
|
0
|
0
|
1
|
0
|
|
Maintenance Phase
Lack of Efficacy
|
0
|
0
|
0
|
0
|
1
|
|
Maintenance Phase
Withdrawal of Consent
|
0
|
0
|
5
|
5
|
5
|
|
Maintenance Phase
Miscellaneous
|
0
|
0
|
1
|
2
|
4
|
|
Maintenance Phase
Randomized but not Treated
|
0
|
0
|
2
|
2
|
0
|
Baseline Characteristics
Efficacy and Safety of Vonoprazan Compared to Lansoprazole in Participants With Erosive Esophagitis
Baseline characteristics by cohort
| Measure |
Healing Phase: Vonoprazan 20 mg
n=514 Participants
Participants received oral vonoprazan 20 mg QD for a maximum of 8 weeks in the Healing Phase. Participants were re-randomized to receive vonoprazan 10 mg QD, vonoprazan 20 mg QD, or lansoprazole 15 mg QD using a 1:1:1 allocation ratio in the Maintenance Phase.
|
Healing Phase: Lansoprazole 30 mg
n=513 Participants
Participants received oral lansoprazole 30 mg QD for a maximum of 8 weeks in the Healing Phase. Participants were re-randomized to receive vonoprazan 10 mg QD, vonoprazan 20 mg QD, or lansoprazole 15 mg QD using a 1:1:1 allocation ratio in the Maintenance Phase.
|
Total
n=1027 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
421 Participants
n=5 Participants
|
406 Participants
n=7 Participants
|
827 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
93 Participants
n=5 Participants
|
107 Participants
n=7 Participants
|
200 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
256 Participants
n=5 Participants
|
289 Participants
n=7 Participants
|
545 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
258 Participants
n=5 Participants
|
224 Participants
n=7 Participants
|
482 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
62 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
121 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
450 Participants
n=5 Participants
|
451 Participants
n=7 Participants
|
901 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
474 Participants
n=5 Participants
|
458 Participants
n=7 Participants
|
932 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African-American
|
23 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Adjudicated Los Angeles (LA) Classification of Esophagitis Grading Scale
Grade A or B
|
337 Participants
n=5 Participants
|
336 Participants
n=7 Participants
|
673 Participants
n=5 Participants
|
|
Adjudicated Los Angeles (LA) Classification of Esophagitis Grading Scale
Grade C or D
|
177 Participants
n=5 Participants
|
174 Participants
n=7 Participants
|
351 Participants
n=5 Participants
|
|
Adjudicated Los Angeles (LA) Classification of Esophagitis Grading Scale
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 8Population: The Modified Intent-to-Treat (MITT) Set (Healing Phase) included all participants randomized into the Healing Phase who had documented EE at baseline and received at least 1 dose of study drug during the Healing Phase. All analyses using the MITT Set grouped subjects according to the randomized treatment.
A participant was considered to have complete healing of EE if healing was demonstrated during endoscopy.
Outcome measures
| Measure |
Healing Phase: Vonoprazan 20 mg
n=514 Participants
Participants received oral vonoprazan 20 mg QD for a maximum of 8 weeks in the Healing Phase.
|
Healing Phase: Lansoprazole 30 mg
n=510 Participants
Participants received oral lansoprazole 30 mg QD for a maximum of 8 weeks in the Healing Phase.
|
Maintenance Phase: Lansoprazole 15 mg
Participants received oral lansoprazole 15 mg QD for 24 weeks.
|
|---|---|---|---|
|
Healing Phase: Percentage of Participants Who Had Complete Healing of EE by Week 8
|
92.9 percentage of participants
|
84.6 percentage of participants
|
—
|
PRIMARY outcome
Timeframe: Week 24Population: The MITT Set (Maintenance Phase) included all participants randomized into the Maintenance Phase who had healed EE at the end of the Healing Phase and received at least 1 dose of study drug during the Maintenance Phase. All analyses using the MITT Set grouped participants according to the randomized treatment.
A participant was considered to have complete healing of EE if healing was demonstrated during endoscopy.
Outcome measures
| Measure |
Healing Phase: Vonoprazan 20 mg
n=293 Participants
Participants received oral vonoprazan 20 mg QD for a maximum of 8 weeks in the Healing Phase.
|
Healing Phase: Lansoprazole 30 mg
n=291 Participants
Participants received oral lansoprazole 30 mg QD for a maximum of 8 weeks in the Healing Phase.
|
Maintenance Phase: Lansoprazole 15 mg
n=294 Participants
Participants received oral lansoprazole 15 mg QD for 24 weeks.
|
|---|---|---|---|
|
Maintenance Phase: Percentage of Participants Who Maintained Complete Healing of EE at Week 24
|
79.2 percentage of participants
|
80.7 percentage of participants
|
72.0 percentage of participants
|
SECONDARY outcome
Timeframe: Day 1 to Week 8Population: The MITT Set (Healing Phase) including only participants with at least one heartburn diary entry.
A 24-hour heartburn-free day was defined as a day having no heartburn among all diary entries for that day. The percentage of 24-hour heartburn-free days was calculated using all days with at least 1 evening or morning diary entry during the treatment period of this phase.
Outcome measures
| Measure |
Healing Phase: Vonoprazan 20 mg
n=509 Participants
Participants received oral vonoprazan 20 mg QD for a maximum of 8 weeks in the Healing Phase.
|
Healing Phase: Lansoprazole 30 mg
n=507 Participants
Participants received oral lansoprazole 30 mg QD for a maximum of 8 weeks in the Healing Phase.
|
Maintenance Phase: Lansoprazole 15 mg
Participants received oral lansoprazole 15 mg QD for 24 weeks.
|
|---|---|---|---|
|
Healing Phase: Percentage of 24-hour Heartburn-free Days
|
66.8 percentage of days
Standard Deviation 34.60
|
64.1 percentage of days
Standard Deviation 35.46
|
—
|
SECONDARY outcome
Timeframe: Week 2Population: The MITT Set (Healing Phase) including only participants with baseline LA Classification Grades C or D.
A participant was considered to have complete healing of EE if healing was demonstrated during endoscopy. LA Classification of Esophagitis Grading Scale: Grade C: One or more mucosal breaks that are continuous between the tops of 2 or more mucosal folds, which involves less than 75% of the circumference. Grade D: One or more mucosal breaks, which involves at least 75% of the circumference.
Outcome measures
| Measure |
Healing Phase: Vonoprazan 20 mg
n=177 Participants
Participants received oral vonoprazan 20 mg QD for a maximum of 8 weeks in the Healing Phase.
|
Healing Phase: Lansoprazole 30 mg
n=174 Participants
Participants received oral lansoprazole 30 mg QD for a maximum of 8 weeks in the Healing Phase.
|
Maintenance Phase: Lansoprazole 15 mg
Participants received oral lansoprazole 15 mg QD for 24 weeks.
|
|---|---|---|---|
|
Healing Phase: Percentage of Participants With Baseline LA Classification Grades C or D Who Had Complete Healing of EE at Week 2
|
70.2 percentage of participants
|
52.6 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Day 1 to maximum of Day 10 (inclusive of 7 day heartburn assessment)Population: The MITT Set (Healing Phase) included all participants randomized into the Healing Phase who had documented EE at baseline and received at least 1 dose of study drug during the Healing Phase. All analyses using the MITT Set grouped subjects according to the randomized treatment.
Sustained resolution was defined as at least 7 consecutive days with no daytime or night time heartburn as assessed by the daily diary. A participant was considered to have sustained resolution of heartburn by Day 3 if the first day of the 7 consecutive days without symptoms was on Days 1, 2, or 3.
Outcome measures
| Measure |
Healing Phase: Vonoprazan 20 mg
n=514 Participants
Participants received oral vonoprazan 20 mg QD for a maximum of 8 weeks in the Healing Phase.
|
Healing Phase: Lansoprazole 30 mg
n=510 Participants
Participants received oral lansoprazole 30 mg QD for a maximum of 8 weeks in the Healing Phase.
|
Maintenance Phase: Lansoprazole 15 mg
Participants received oral lansoprazole 15 mg QD for 24 weeks.
|
|---|---|---|---|
|
Healing Phase: Percentage of Participants With Onset of Sustained Resolution of Heartburn by Day 3
|
34.4 percentage of participants
|
32.2 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Week 8Population: The MITT Set (Healing Phase) including only participants with baseline LA Classification Grades C or D.
A participant was considered to have complete healing of EE if healing was demonstrated during endoscopy. LA Classification of Esophagitis Grading Scale: Grade C: One or more mucosal breaks that are continuous between the tops of 2 or more mucosal folds, which involves less than 75% of the circumference. Grade D: One or more mucosal breaks, which involves at least 75% of the circumference.
Outcome measures
| Measure |
Healing Phase: Vonoprazan 20 mg
n=177 Participants
Participants received oral vonoprazan 20 mg QD for a maximum of 8 weeks in the Healing Phase.
|
Healing Phase: Lansoprazole 30 mg
n=174 Participants
Participants received oral lansoprazole 30 mg QD for a maximum of 8 weeks in the Healing Phase.
|
Maintenance Phase: Lansoprazole 15 mg
Participants received oral lansoprazole 15 mg QD for 24 weeks.
|
|---|---|---|---|
|
Healing Phase: Percentage of Participants With Baseline LA Classification Grades C or D Who Had Complete Healing of EE by Week 8
|
91.7 percentage of participants
|
72.0 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Week 2Population: The MITT Set (Healing Phase) included all participants randomized into the Healing Phase who had documented EE at baseline and received at least 1 dose of study drug during the Healing Phase. All analyses using the MITT Set grouped subjects according to the randomized treatment.
A participant was considered to have complete healing of EE if healing was demonstrated during endoscopy.
Outcome measures
| Measure |
Healing Phase: Vonoprazan 20 mg
n=514 Participants
Participants received oral vonoprazan 20 mg QD for a maximum of 8 weeks in the Healing Phase.
|
Healing Phase: Lansoprazole 30 mg
n=510 Participants
Participants received oral lansoprazole 30 mg QD for a maximum of 8 weeks in the Healing Phase.
|
Maintenance Phase: Lansoprazole 15 mg
Participants received oral lansoprazole 15 mg QD for 24 weeks.
|
|---|---|---|---|
|
Healing Phase: Percentage of Participants Who Had Complete Healing of EE at Week 2
|
74.3 percentage of participants
|
68.2 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Week 24Population: The MITT Set (Maintenance Phase) including only participants with baseline LA Classification Grades C or D with nonmissing data.
A participant was considered to have complete healing of EE if healing was demonstrated during endoscopy. LA Classification of Esophagitis Grading Scale: Grade C: One or more mucosal breaks that are continuous between the tops of 2 or more mucosal folds, which involves less than 75% of the circumference. Grade D: One or more mucosal breaks, which involves at least 75% of the circumference.
Outcome measures
| Measure |
Healing Phase: Vonoprazan 20 mg
n=95 Participants
Participants received oral vonoprazan 20 mg QD for a maximum of 8 weeks in the Healing Phase.
|
Healing Phase: Lansoprazole 30 mg
n=92 Participants
Participants received oral lansoprazole 30 mg QD for a maximum of 8 weeks in the Healing Phase.
|
Maintenance Phase: Lansoprazole 15 mg
n=96 Participants
Participants received oral lansoprazole 15 mg QD for 24 weeks.
|
|---|---|---|---|
|
Maintenance Phase: Percentage of Participants With Baseline LA Classification Grades C or D Who Maintained Complete Healing of EE at Week 24
|
74.7 percentage of participants
|
77.2 percentage of participants
|
61.5 percentage of participants
|
SECONDARY outcome
Timeframe: Day 1 to Week 24Population: The MITT Set (Maintenance Phase) including only participants with at least one heartburn diary entry.
A 24-hour heartburn-free day was defined as a day having no heartburn among all diary entries for that day. The percentage of 24-hour heartburn-free days was calculated using all days with at least 1 evening or morning diary entry during the treatment period of this phase.
Outcome measures
| Measure |
Healing Phase: Vonoprazan 20 mg
n=291 Participants
Participants received oral vonoprazan 20 mg QD for a maximum of 8 weeks in the Healing Phase.
|
Healing Phase: Lansoprazole 30 mg
n=290 Participants
Participants received oral lansoprazole 30 mg QD for a maximum of 8 weeks in the Healing Phase.
|
Maintenance Phase: Lansoprazole 15 mg
n=294 Participants
Participants received oral lansoprazole 15 mg QD for 24 weeks.
|
|---|---|---|---|
|
Maintenance Phase: Percentage of 24-hour Heartburn-free Days
|
80.9 percentage of days
Standard Deviation 28.59
|
80.6 percentage of days
Standard Deviation 29.96
|
78.6 percentage of days
Standard Deviation 27.49
|
Adverse Events
Healing Phase: Vonoprazan 20 mg
Serious events: 3 serious events
Other events: 50 other events
Deaths: 0 deaths
Healing Phase: Lansoprazole 30 mg
Serious events: 3 serious events
Other events: 46 other events
Deaths: 0 deaths
Maintenance Phase: Vonoprazan 10 mg
Serious events: 10 serious events
Other events: 72 other events
Deaths: 0 deaths
Maintenance Phase: Vonoprazan 20 mg
Serious events: 14 serious events
Other events: 81 other events
Deaths: 2 deaths
Maintenance Phase: Lansoprazole 15 mg
Serious events: 7 serious events
Other events: 74 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Healing Phase: Vonoprazan 20 mg
n=514 participants at risk
Participants received oral vonoprazan 20 mg QD for a maximum of 8 weeks in the Healing Phase.
|
Healing Phase: Lansoprazole 30 mg
n=510 participants at risk
Participants received oral lansoprazole 30 mg QD for a maximum of 8 weeks in the Healing Phase.
|
Maintenance Phase: Vonoprazan 10 mg
n=296 participants at risk
Participants received oral vonoprazan 10 mg QD for 24 weeks.
|
Maintenance Phase: Vonoprazan 20 mg
n=296 participants at risk
Participants received oral vonoprazan 20 mg QD for 24 weeks.
|
Maintenance Phase: Lansoprazole 15 mg
n=297 participants at risk
Participants received oral lansoprazole 15 mg QD for 24 weeks.
|
|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Ligament injury
|
0.00%
0/514 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/510 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/296 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/296 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.34%
1/297 • Number of events 1 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/514 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/510 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/296 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/296 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.34%
1/297 • Number of events 1 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
|
Infections and infestations
COVID-19
|
0.19%
1/514 • Number of events 1 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/510 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.34%
1/296 • Number of events 1 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.68%
2/296 • Number of events 2 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/297 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
|
Infections and infestations
Influenza
|
0.00%
0/514 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.20%
1/510 • Number of events 1 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/296 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/296 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/297 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
|
General disorders
Chest pain
|
0.19%
1/514 • Number of events 1 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/510 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/296 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/296 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/297 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
|
General disorders
Oedema peripheral
|
0.19%
1/514 • Number of events 1 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/510 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/296 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.34%
1/296 • Number of events 1 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/297 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/514 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.20%
1/510 • Number of events 1 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/296 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/296 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/297 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer stage I
|
0.00%
0/514 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.20%
1/510 • Number of events 1 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/296 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/296 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/297 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
|
Nervous system disorders
Cerebrospinal fluid leakage
|
0.19%
1/514 • Number of events 1 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/510 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/296 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/296 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/297 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/514 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/510 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.34%
1/296 • Number of events 1 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.68%
2/296 • Number of events 2 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/297 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/514 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/510 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.34%
1/296 • Number of events 1 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/296 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/297 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
|
Infections and infestations
Peritonsillar abscess
|
0.00%
0/514 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/510 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/296 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.34%
1/296 • Number of events 1 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/297 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/514 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/510 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.34%
1/296 • Number of events 1 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/296 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/297 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/514 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/510 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/296 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/296 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.34%
1/297 • Number of events 1 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/514 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/510 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.34%
1/296 • Number of events 1 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/296 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/297 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/514 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/510 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.34%
1/296 • Number of events 1 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/296 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/297 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/514 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/510 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/296 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.34%
1/296 • Number of events 1 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/297 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
|
Gastrointestinal disorders
Pancreatolithiasis
|
0.00%
0/514 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/510 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/296 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.34%
1/296 • Number of events 1 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/297 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/514 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/510 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.34%
1/296 • Number of events 1 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/296 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/297 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
|
Injury, poisoning and procedural complications
Traumatic haemothorax
|
0.00%
0/514 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/510 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/296 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/296 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.34%
1/297 • Number of events 1 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.00%
0/514 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/510 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/296 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/296 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.34%
1/297 • Number of events 1 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Follicular thyroid cancer
|
0.00%
0/514 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/510 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/296 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.34%
1/296 • Number of events 1 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/297 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small intestine adenocarcinoma
|
0.00%
0/514 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/510 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/296 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.34%
1/296 • Number of events 1 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/297 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
|
General disorders
Chest discomfort
|
0.00%
0/514 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/510 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/296 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.34%
1/296 • Number of events 1 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/297 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/514 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/510 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.34%
1/296 • Number of events 1 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/296 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/297 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/514 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/510 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.34%
1/296 • Number of events 1 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/296 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/297 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
|
Renal and urinary disorders
Stress urinary incontinence
|
0.00%
0/514 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/510 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/296 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/296 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.34%
1/297 • Number of events 1 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.00%
0/514 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/510 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/296 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.34%
1/296 • Number of events 1 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/297 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/514 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/510 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/296 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.34%
1/296 • Number of events 1 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/297 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/514 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/510 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/296 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.34%
1/296 • Number of events 1 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/297 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/514 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/510 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/296 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/296 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.34%
1/297 • Number of events 1 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
|
Nervous system disorders
Syncope
|
0.00%
0/514 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/510 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/296 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.34%
1/296 • Number of events 1 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/297 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/514 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/510 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/296 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/296 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.34%
1/297 • Number of events 1 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
|
Surgical and medical procedures
Gastric bypass
|
0.00%
0/514 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/510 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.34%
1/296 • Number of events 1 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/296 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/297 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/514 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/510 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.34%
1/296 • Number of events 1 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/296 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/297 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
Other adverse events
| Measure |
Healing Phase: Vonoprazan 20 mg
n=514 participants at risk
Participants received oral vonoprazan 20 mg QD for a maximum of 8 weeks in the Healing Phase.
|
Healing Phase: Lansoprazole 30 mg
n=510 participants at risk
Participants received oral lansoprazole 30 mg QD for a maximum of 8 weeks in the Healing Phase.
|
Maintenance Phase: Vonoprazan 10 mg
n=296 participants at risk
Participants received oral vonoprazan 10 mg QD for 24 weeks.
|
Maintenance Phase: Vonoprazan 20 mg
n=296 participants at risk
Participants received oral vonoprazan 20 mg QD for 24 weeks.
|
Maintenance Phase: Lansoprazole 15 mg
n=297 participants at risk
Participants received oral lansoprazole 15 mg QD for 24 weeks.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
2.1%
11/514 • Number of events 11 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
2.5%
13/510 • Number of events 13 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
1.0%
3/296 • Number of events 3 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
2.4%
7/296 • Number of events 7 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
4.4%
13/297 • Number of events 14 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.6%
8/514 • Number of events 9 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.39%
2/510 • Number of events 2 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
1.4%
4/296 • Number of events 4 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
3.4%
10/296 • Number of events 12 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
1.0%
3/297 • Number of events 3 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.39%
2/514 • Number of events 2 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.20%
1/510 • Number of events 1 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
3.0%
9/296 • Number of events 9 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
1.4%
4/296 • Number of events 4 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
1.7%
5/297 • Number of events 5 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.19%
1/514 • Number of events 1 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.59%
3/510 • Number of events 3 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
3.7%
11/296 • Number of events 12 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
4.1%
12/296 • Number of events 12 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
2.7%
8/297 • Number of events 8 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.2%
6/514 • Number of events 6 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.39%
2/510 • Number of events 2 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
2.4%
7/296 • Number of events 7 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
3.7%
11/296 • Number of events 12 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
2.0%
6/297 • Number of events 6 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
|
Infections and infestations
Bronchitis
|
0.39%
2/514 • Number of events 2 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.39%
2/510 • Number of events 2 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.68%
2/296 • Number of events 2 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.34%
1/296 • Number of events 1 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
2.4%
7/297 • Number of events 8 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
|
Infections and infestations
COVID-19
|
1.6%
8/514 • Number of events 8 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
1.2%
6/510 • Number of events 6 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
4.1%
12/296 • Number of events 12 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
8.8%
26/296 • Number of events 26 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
6.1%
18/297 • Number of events 18 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
|
Infections and infestations
Sinusitis
|
0.19%
1/514 • Number of events 1 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.59%
3/510 • Number of events 3 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
2.4%
7/296 • Number of events 7 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
1.4%
4/296 • Number of events 4 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.34%
1/297 • Number of events 1 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
|
Infections and infestations
Urinary tract infection
|
1.2%
6/514 • Number of events 6 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.78%
4/510 • Number of events 4 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
2.7%
8/296 • Number of events 8 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.34%
1/296 • Number of events 1 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
1.7%
5/297 • Number of events 6 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.39%
2/514 • Number of events 2 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.00%
0/510 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.68%
2/296 • Number of events 2 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
1.7%
5/296 • Number of events 5 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
2.4%
7/297 • Number of events 9 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.39%
2/514 • Number of events 2 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.78%
4/510 • Number of events 4 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
2.0%
6/296 • Number of events 6 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
2.7%
8/296 • Number of events 8 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
1.3%
4/297 • Number of events 4 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
|
Vascular disorders
Hypertension
|
0.58%
3/514 • Number of events 3 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.78%
4/510 • Number of events 4 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
3.0%
9/296 • Number of events 9 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
2.7%
8/296 • Number of events 9 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
2.0%
6/297 • Number of events 6 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
|
Nervous system disorders
Headache
|
1.2%
6/514 • Number of events 6 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
1.2%
6/510 • Number of events 6 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
1.0%
3/296 • Number of events 3 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
0.68%
2/296 • Number of events 2 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
2.7%
8/297 • Number of events 8 • Healing Phase: Day 1 to Week 8; Maintenance Phase: Day 1 to Week 28
The Safety Set included all randomized participants who received at least 1 dose of study drug. All analyses using the Safety Set grouped subjects according to the treatment actually received.
|
Additional Information
Phathom Medical Information
Phathom Pharmaceuticals, Inc.
Phone: 1-888-775-PHAT (7428)
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place