Trial Outcomes & Findings for Study to Evaluate the Efficacy and Safety of Tilpisertib in Adults With Moderately to Severely Active Ulcerative Colitis (NCT NCT04130919)
NCT ID: NCT04130919
Last Updated: 2022-08-24
Results Overview
The modified MCS is a scoring system for assessment of ulcerative colitis (UC) activity and is composed of subscores from endoscopy (range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease \[spontaneous bleeding, ulceration\]), rectal bleeding (range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes), stool frequency (range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 or more stools more than normal), and physician's global assessment (PGA) (range: 0 to 3, where 0 = normal and 3 = severe disease). Total score for MCS ranges from 0 to 12 (sum of all subscores), with higher scores indicating higher disease activity. Clinical remission per modified MCS is defined as stool frequency subscore ≤ 1 and not greater than baseline, rectal bleeding subscore of 0, and endoscopic subscore ≤ 1 at Week 10.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
19 participants
Primary outcome timeframe
Week 10
Results posted on
2022-08-24
Participant Flow
Participants were enrolled at study sites in Australia, Europe and the United States.
32 participants were screened.
Participant milestones
| Measure |
Tilpisertib 300 mg (Blinded Treatment Phase)
Tilpisertib 300 mg tablet orally once daily up to Week 10. Participants who achieved clinical response per Modified Mayo Clinic score (MCS) at Week 10, continued to receive tilpisertib 300 mg tablets orally once daily for a maximum of 50 weeks in the Blinded Treatment phase.
|
Tilpisertib 100 mg (Blinded Treatment Phase)
Tilpisertib 100 mg tablet orally once daily up to Week 10. Participants who achieved clinical response per modified MCS at Week 10, continued to receive tilpisertib 100 mg tablets orally once daily for a maximum of 50 weeks in the Blinded Treatment phase.
|
Placebo (Blinded Treatment Phase)
Placebo tablet orally once daily up to Week 10. Participants who achieved clinical response per modified MCS at Week 10, continued to receive placebo tablets orally once daily for a maximum of 50 weeks in the Blinded Treatment phase.
|
Tilpisertib 300 mg From Tilpisertib 300 mg (Open-label Treatment Phase)
Participants who received tilpisertib 300 mg and did not achieve clinical response per modified MCS at Week 10 in the Blinded Treatment phase, received tilpisertib 300 mg tablets orally once daily for up to 50 weeks in the Open-label Treatment phase.
|
Tilpisertib 300 mg From Tilpisertib 100 mg (Open-label Treatment Phase)
Participants who received tilpisertib 100 mg and did not achieve clinical response per modified MCS at Week 10 in the Blinded Treatment phase, received tilpisertib 300 mg tablets orally once daily for up to 50 weeks in the Open-label Treatment phase.
|
Tilpisertib 300 mg From Placebo (Open-label Treatment Phase)
Participants who received placebo and did not achieve clinical response per modified MCS at Week 10 in the Blinded Treatment phase, received tilpisertib 300 mg tablets orally once daily for up to 50 weeks in the Open-label Treatment phase.
|
|---|---|---|---|---|---|---|
|
Blinded Treatment Phase
STARTED
|
7
|
6
|
6
|
0
|
0
|
0
|
|
Blinded Treatment Phase
COMPLETED
|
5
|
4
|
3
|
0
|
0
|
0
|
|
Blinded Treatment Phase
NOT COMPLETED
|
2
|
2
|
3
|
0
|
0
|
0
|
|
Open-label Treatment Phase
STARTED
|
0
|
0
|
0
|
4
|
3
|
3
|
|
Open-label Treatment Phase
COMPLETED
|
0
|
0
|
0
|
1
|
1
|
0
|
|
Open-label Treatment Phase
NOT COMPLETED
|
0
|
0
|
0
|
3
|
2
|
3
|
Reasons for withdrawal
| Measure |
Tilpisertib 300 mg (Blinded Treatment Phase)
Tilpisertib 300 mg tablet orally once daily up to Week 10. Participants who achieved clinical response per Modified Mayo Clinic score (MCS) at Week 10, continued to receive tilpisertib 300 mg tablets orally once daily for a maximum of 50 weeks in the Blinded Treatment phase.
|
Tilpisertib 100 mg (Blinded Treatment Phase)
Tilpisertib 100 mg tablet orally once daily up to Week 10. Participants who achieved clinical response per modified MCS at Week 10, continued to receive tilpisertib 100 mg tablets orally once daily for a maximum of 50 weeks in the Blinded Treatment phase.
|
Placebo (Blinded Treatment Phase)
Placebo tablet orally once daily up to Week 10. Participants who achieved clinical response per modified MCS at Week 10, continued to receive placebo tablets orally once daily for a maximum of 50 weeks in the Blinded Treatment phase.
|
Tilpisertib 300 mg From Tilpisertib 300 mg (Open-label Treatment Phase)
Participants who received tilpisertib 300 mg and did not achieve clinical response per modified MCS at Week 10 in the Blinded Treatment phase, received tilpisertib 300 mg tablets orally once daily for up to 50 weeks in the Open-label Treatment phase.
|
Tilpisertib 300 mg From Tilpisertib 100 mg (Open-label Treatment Phase)
Participants who received tilpisertib 100 mg and did not achieve clinical response per modified MCS at Week 10 in the Blinded Treatment phase, received tilpisertib 300 mg tablets orally once daily for up to 50 weeks in the Open-label Treatment phase.
|
Tilpisertib 300 mg From Placebo (Open-label Treatment Phase)
Participants who received placebo and did not achieve clinical response per modified MCS at Week 10 in the Blinded Treatment phase, received tilpisertib 300 mg tablets orally once daily for up to 50 weeks in the Open-label Treatment phase.
|
|---|---|---|---|---|---|---|
|
Blinded Treatment Phase
Study terminated by sponsor
|
1
|
1
|
1
|
0
|
0
|
0
|
|
Blinded Treatment Phase
Adverse Event
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Blinded Treatment Phase
Disease worsening
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Blinded Treatment Phase
Investigator's decision
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Blinded Treatment Phase
Withdrew consent
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Open-label Treatment Phase
Withdrew consent
|
0
|
0
|
0
|
1
|
1
|
1
|
|
Open-label Treatment Phase
Disease worsening
|
0
|
0
|
0
|
1
|
0
|
1
|
|
Open-label Treatment Phase
Investigator's decision
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Open-label Treatment Phase
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Open-label Treatment Phase
MCS response not achieved at open-label week 10
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Study to Evaluate the Efficacy and Safety of Tilpisertib in Adults With Moderately to Severely Active Ulcerative Colitis
Baseline characteristics by cohort
| Measure |
Tilpisertib 300 mg (Blinded Treatment Phase)
n=7 Participants
Tilpisertib 300 mg tablet orally once daily up to Week 10. Participants who achieved clinical response per modified MCS at Week 10, continued to receive tilpisertib 300 mg tablets orally once daily for a maximum of 50 weeks in the Blinded Treatment phase.
|
Tilpisertib 100 mg (Blinded Treatment Phase)
n=6 Participants
Tilpisertib 100 mg tablet orally once daily up to Week 10. Participants who achieved clinical response per modified MCS at Week 10, continued to receive tilpisertib 100 mg tablets orally once daily for a maximum of 50 weeks in the Blinded Treatment phase.
|
Placebo (Blinded Treatment Phase)
n=6 Participants
Placebo tablet orally once daily up to Week 10. Participants who achieved clinical response per modified MCS at Week 10, continued to receive placebo tablets orally once daily for a maximum of 50 weeks in the Blinded Treatment phase.
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
51 years
STANDARD_DEVIATION 11.8 • n=5 Participants
|
49 years
STANDARD_DEVIATION 22.6 • n=7 Participants
|
43 years
STANDARD_DEVIATION 18.4 • n=5 Participants
|
48 years
STANDARD_DEVIATION 17.2 • n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Not Permitted
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not Permitted
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
Austria
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Region of Enrollment
Australia
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Region of Enrollment
Switzerland
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Region of Enrollment
Germany
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Week 10Population: Full analysis set included all randomized participants who received at least 1 dose of study drug.
The modified MCS is a scoring system for assessment of ulcerative colitis (UC) activity and is composed of subscores from endoscopy (range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease \[spontaneous bleeding, ulceration\]), rectal bleeding (range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes), stool frequency (range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 or more stools more than normal), and physician's global assessment (PGA) (range: 0 to 3, where 0 = normal and 3 = severe disease). Total score for MCS ranges from 0 to 12 (sum of all subscores), with higher scores indicating higher disease activity. Clinical remission per modified MCS is defined as stool frequency subscore ≤ 1 and not greater than baseline, rectal bleeding subscore of 0, and endoscopic subscore ≤ 1 at Week 10.
Outcome measures
| Measure |
Tilpisertib 300 mg (Blinded Treatment Phase)
n=7 Participants
Tilpisertib 300 mg tablet orally once daily up to Week 10. Participants who achieved clinical response per modified MCS at Week 10, continued to receive tilpisertib 300 mg tablets orally once daily for a maximum of 50 weeks in the Blinded Treatment phase.
|
Tilpisertib 100 mg (Blinded Treatment Phase)
n=6 Participants
Tilpisertib 100 mg tablet orally once daily up to Week 10. Participants who achieved clinical response per modified MCS at Week 10, continued to receive tilpisertib 100 mg tablets orally once daily for a maximum of 50 weeks in the Blinded Treatment phase.
|
Placebo (Blinded Treatment Phase)
n=6 Participants
Placebo tablet orally once daily up to Week 10. Participants who achieved clinical response per modified MCS at Week 10, continued to receive placebo tablets orally once daily for a maximum of 50 weeks in the Blinded Treatment phase.
|
Tilpisertib 300 mg From Tilpisertib 300 mg (Open-label Treatment Phase)
Participants who received tilpisertib 300 mg and did not achieve clinical response per modified MCS at Week 10 in the Blinded Treatment phase, received tilpisertib 300 mg tablets orally once daily for up to 50 weeks in the Open-label Treatment phase.
|
Tilpisertib 300 mg From Tilpisertib 100 mg (Open-label Treatment Phase)
Participants who received tilpisertib 100 mg and did not achieve clinical response per modified MCS at Week 10 in the Blinded Treatment phase, received tilpisertib 300 mg tablets orally once daily for up to 50 weeks in the Open-label Treatment phase.
|
Tilpisertib 300 mg From Placebo (Open-label Treatment Phase)
Participants who received placebo and did not achieve clinical response per modified MCS at Week 10 in the Blinded Treatment phase, received tilpisertib 300 mg tablets orally once daily for up to 50 weeks in the Open-label Treatment phase.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved Clinical Remission Per Modified Mayo Clinic Score (MCS) at Week 10
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 10Population: Participants in the Full Analysis Set were analyzed.
Endoscopic response was defined as an endoscopic subscore of ≤ 1 at Week 10. Endoscopic subscore is a part of the modified MCS which is a scoring system for assessment of UC activity. Endoscopic subscore range: 0 to 3, where 0 = normal or inactive disease, 1 = mild disease (erythema, decreased vascular pattern), 2 = moderate disease (marked erythema, lack of vascular pattern, friability, erosions), and 3 = severe disease (spontaneous bleeding, ulceration).
Outcome measures
| Measure |
Tilpisertib 300 mg (Blinded Treatment Phase)
n=7 Participants
Tilpisertib 300 mg tablet orally once daily up to Week 10. Participants who achieved clinical response per modified MCS at Week 10, continued to receive tilpisertib 300 mg tablets orally once daily for a maximum of 50 weeks in the Blinded Treatment phase.
|
Tilpisertib 100 mg (Blinded Treatment Phase)
n=6 Participants
Tilpisertib 100 mg tablet orally once daily up to Week 10. Participants who achieved clinical response per modified MCS at Week 10, continued to receive tilpisertib 100 mg tablets orally once daily for a maximum of 50 weeks in the Blinded Treatment phase.
|
Placebo (Blinded Treatment Phase)
n=6 Participants
Placebo tablet orally once daily up to Week 10. Participants who achieved clinical response per modified MCS at Week 10, continued to receive placebo tablets orally once daily for a maximum of 50 weeks in the Blinded Treatment phase.
|
Tilpisertib 300 mg From Tilpisertib 300 mg (Open-label Treatment Phase)
Participants who received tilpisertib 300 mg and did not achieve clinical response per modified MCS at Week 10 in the Blinded Treatment phase, received tilpisertib 300 mg tablets orally once daily for up to 50 weeks in the Open-label Treatment phase.
|
Tilpisertib 300 mg From Tilpisertib 100 mg (Open-label Treatment Phase)
Participants who received tilpisertib 100 mg and did not achieve clinical response per modified MCS at Week 10 in the Blinded Treatment phase, received tilpisertib 300 mg tablets orally once daily for up to 50 weeks in the Open-label Treatment phase.
|
Tilpisertib 300 mg From Placebo (Open-label Treatment Phase)
Participants who received placebo and did not achieve clinical response per modified MCS at Week 10 in the Blinded Treatment phase, received tilpisertib 300 mg tablets orally once daily for up to 50 weeks in the Open-label Treatment phase.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved Endoscopic Response at Week 10
|
14.3 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 10Population: Participants in the Full Analysis Set were analyzed.
The modified MCS is a scoring system for assessment of UC activity and is composed of subscores from endoscopy (range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease \[spontaneous bleeding, ulceration\]), rectal bleeding (range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes), stool frequency (range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 or more stools more than normal), and PGA (range: 0 to 3, where 0 = normal and 3 = severe disease). Total score for MCS ranges from 0 to 12 (sum of all subscores), with higher scores indicating higher disease activity. MCS response is defined as a decrease from baseline of ≥ 3 points and at least 30% in MCS, in addition to a ≥ 1 point decrease from baseline in the rectal bleeding subscore or a rectal bleeding subscore ≤ 1 at Week 10.
Outcome measures
| Measure |
Tilpisertib 300 mg (Blinded Treatment Phase)
n=7 Participants
Tilpisertib 300 mg tablet orally once daily up to Week 10. Participants who achieved clinical response per modified MCS at Week 10, continued to receive tilpisertib 300 mg tablets orally once daily for a maximum of 50 weeks in the Blinded Treatment phase.
|
Tilpisertib 100 mg (Blinded Treatment Phase)
n=6 Participants
Tilpisertib 100 mg tablet orally once daily up to Week 10. Participants who achieved clinical response per modified MCS at Week 10, continued to receive tilpisertib 100 mg tablets orally once daily for a maximum of 50 weeks in the Blinded Treatment phase.
|
Placebo (Blinded Treatment Phase)
n=6 Participants
Placebo tablet orally once daily up to Week 10. Participants who achieved clinical response per modified MCS at Week 10, continued to receive placebo tablets orally once daily for a maximum of 50 weeks in the Blinded Treatment phase.
|
Tilpisertib 300 mg From Tilpisertib 300 mg (Open-label Treatment Phase)
Participants who received tilpisertib 300 mg and did not achieve clinical response per modified MCS at Week 10 in the Blinded Treatment phase, received tilpisertib 300 mg tablets orally once daily for up to 50 weeks in the Open-label Treatment phase.
|
Tilpisertib 300 mg From Tilpisertib 100 mg (Open-label Treatment Phase)
Participants who received tilpisertib 100 mg and did not achieve clinical response per modified MCS at Week 10 in the Blinded Treatment phase, received tilpisertib 300 mg tablets orally once daily for up to 50 weeks in the Open-label Treatment phase.
|
Tilpisertib 300 mg From Placebo (Open-label Treatment Phase)
Participants who received placebo and did not achieve clinical response per modified MCS at Week 10 in the Blinded Treatment phase, received tilpisertib 300 mg tablets orally once daily for up to 50 weeks in the Open-label Treatment phase.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved MCS Response at Week 10
|
28.6 percentage of participants
|
16.7 percentage of participants
|
16.7 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 10Population: Participants in the Full Analysis Set were analyzed.
The modified MCS is a scoring system for assessment of UC activity and is composed of subscores from endoscopy (range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease \[spontaneous bleeding, ulceration\]), rectal bleeding (range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes), stool frequency (range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 or more stools more than normal), and PGA (range: 0 to 3, where 0 = normal and 3 = severe disease). Total score for MCS ranges from 0 to 12 (sum of all subscores), with higher scores indicating higher disease activity. MCS remission is defined as a MCS score of ≤ 2 and no individual subscore \> 1 at Week 10.
Outcome measures
| Measure |
Tilpisertib 300 mg (Blinded Treatment Phase)
n=7 Participants
Tilpisertib 300 mg tablet orally once daily up to Week 10. Participants who achieved clinical response per modified MCS at Week 10, continued to receive tilpisertib 300 mg tablets orally once daily for a maximum of 50 weeks in the Blinded Treatment phase.
|
Tilpisertib 100 mg (Blinded Treatment Phase)
n=6 Participants
Tilpisertib 100 mg tablet orally once daily up to Week 10. Participants who achieved clinical response per modified MCS at Week 10, continued to receive tilpisertib 100 mg tablets orally once daily for a maximum of 50 weeks in the Blinded Treatment phase.
|
Placebo (Blinded Treatment Phase)
n=6 Participants
Placebo tablet orally once daily up to Week 10. Participants who achieved clinical response per modified MCS at Week 10, continued to receive placebo tablets orally once daily for a maximum of 50 weeks in the Blinded Treatment phase.
|
Tilpisertib 300 mg From Tilpisertib 300 mg (Open-label Treatment Phase)
Participants who received tilpisertib 300 mg and did not achieve clinical response per modified MCS at Week 10 in the Blinded Treatment phase, received tilpisertib 300 mg tablets orally once daily for up to 50 weeks in the Open-label Treatment phase.
|
Tilpisertib 300 mg From Tilpisertib 100 mg (Open-label Treatment Phase)
Participants who received tilpisertib 100 mg and did not achieve clinical response per modified MCS at Week 10 in the Blinded Treatment phase, received tilpisertib 300 mg tablets orally once daily for up to 50 weeks in the Open-label Treatment phase.
|
Tilpisertib 300 mg From Placebo (Open-label Treatment Phase)
Participants who received placebo and did not achieve clinical response per modified MCS at Week 10 in the Blinded Treatment phase, received tilpisertib 300 mg tablets orally once daily for up to 50 weeks in the Open-label Treatment phase.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved MCS Remission at Week 10
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 10Population: Participants in the Full Analysis Set with at least 1 histological assessment were analyzed.
Geboes histologic remission was assessed using the Geboes histologic scores to identify histologic changes in ulcerative colitis. Possible scores are Grade 0:Architectural changes(0.0=No abnormality to 0.3=Severe diffuse or multifocal abnormalities); Grade 1:Chronic inflammatory infiltrate(1.0=No increase to 1.3=Marked increase);Grade 2A:Eosinophils in lamina propria(2A.0=No increase to 2A.3-=Marked increase; Grade 2B:Neutrophils in lamina propria(2B.0= No increase to 2B.3=Marked increase);Grade 3:Neutrophils in epithelium (3.0=None to 3.3=\>50% crypts involved);Grade 4:Crypt destruction(4.0=none to 4.3=Unequivocal crypt destruction),and Grade 5:Erosions and ulcerations:(5.0=No erosion, ulceration or granulation to 5.4=Ulcer or granulation tissue). Histologic remission defined as having Grade 0 of ≤ 0.3, Grade 1 of ≤ 1.1, Grade 2a of ≤ 2A.3, Grade 2b of 2B.0, Grade 3 of 3.0, Grade 4 of 4.0, and Grade 5 of 5.0. Geboes score ranges from 0 to 5.4. Lower values indicate better outcome.
Outcome measures
| Measure |
Tilpisertib 300 mg (Blinded Treatment Phase)
n=6 Participants
Tilpisertib 300 mg tablet orally once daily up to Week 10. Participants who achieved clinical response per modified MCS at Week 10, continued to receive tilpisertib 300 mg tablets orally once daily for a maximum of 50 weeks in the Blinded Treatment phase.
|
Tilpisertib 100 mg (Blinded Treatment Phase)
n=6 Participants
Tilpisertib 100 mg tablet orally once daily up to Week 10. Participants who achieved clinical response per modified MCS at Week 10, continued to receive tilpisertib 100 mg tablets orally once daily for a maximum of 50 weeks in the Blinded Treatment phase.
|
Placebo (Blinded Treatment Phase)
n=4 Participants
Placebo tablet orally once daily up to Week 10. Participants who achieved clinical response per modified MCS at Week 10, continued to receive placebo tablets orally once daily for a maximum of 50 weeks in the Blinded Treatment phase.
|
Tilpisertib 300 mg From Tilpisertib 300 mg (Open-label Treatment Phase)
Participants who received tilpisertib 300 mg and did not achieve clinical response per modified MCS at Week 10 in the Blinded Treatment phase, received tilpisertib 300 mg tablets orally once daily for up to 50 weeks in the Open-label Treatment phase.
|
Tilpisertib 300 mg From Tilpisertib 100 mg (Open-label Treatment Phase)
Participants who received tilpisertib 100 mg and did not achieve clinical response per modified MCS at Week 10 in the Blinded Treatment phase, received tilpisertib 300 mg tablets orally once daily for up to 50 weeks in the Open-label Treatment phase.
|
Tilpisertib 300 mg From Placebo (Open-label Treatment Phase)
Participants who received placebo and did not achieve clinical response per modified MCS at Week 10 in the Blinded Treatment phase, received tilpisertib 300 mg tablets orally once daily for up to 50 weeks in the Open-label Treatment phase.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved Histologic Remission Based Upon the Geboes Scale at Week 10
|
16.7 percentage of participants
|
16.7 percentage of participants
|
25.0 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label phase: First dose date up to 50.7 weeks plus 30 daysPopulation: Safety Analysis Set included all participants who received at least one dose of study drug.
Treatment-emergent adverse events (TEAEs) for the Blinded Treatment phase are either defined as AEs with an onset date on or after the Blinded Treatment phase study drug start date and no later than 30 days after permanent discontinuation of the Blinded Treatment phase study drug if no Open-label Treatment phase study drug was taken, or any AEs with an onset date on or after the Blinded Treatment phase study drug start date and before the Open-label Treatment phase study drug start date if Open-label Treatment phase study drug was taken and/or any AEs leading to premature discontinuation of Blinded Treatment phase study drug. TEAEs for the Open-label Treatment phase are either defined as AEs with an onset date on or after the Open-label Treatment phase study drug start date and no later than 30 days after permanent discontinuation of the Open-lab Treatment phase study drug and/or any AEs leading to premature discontinuation of Open-label Treatment phase study drug.
Outcome measures
| Measure |
Tilpisertib 300 mg (Blinded Treatment Phase)
n=7 Participants
Tilpisertib 300 mg tablet orally once daily up to Week 10. Participants who achieved clinical response per modified MCS at Week 10, continued to receive tilpisertib 300 mg tablets orally once daily for a maximum of 50 weeks in the Blinded Treatment phase.
|
Tilpisertib 100 mg (Blinded Treatment Phase)
n=6 Participants
Tilpisertib 100 mg tablet orally once daily up to Week 10. Participants who achieved clinical response per modified MCS at Week 10, continued to receive tilpisertib 100 mg tablets orally once daily for a maximum of 50 weeks in the Blinded Treatment phase.
|
Placebo (Blinded Treatment Phase)
n=6 Participants
Placebo tablet orally once daily up to Week 10. Participants who achieved clinical response per modified MCS at Week 10, continued to receive placebo tablets orally once daily for a maximum of 50 weeks in the Blinded Treatment phase.
|
Tilpisertib 300 mg From Tilpisertib 300 mg (Open-label Treatment Phase)
n=4 Participants
Participants who received tilpisertib 300 mg and did not achieve clinical response per modified MCS at Week 10 in the Blinded Treatment phase, received tilpisertib 300 mg tablets orally once daily for up to 50 weeks in the Open-label Treatment phase.
|
Tilpisertib 300 mg From Tilpisertib 100 mg (Open-label Treatment Phase)
n=3 Participants
Participants who received tilpisertib 100 mg and did not achieve clinical response per modified MCS at Week 10 in the Blinded Treatment phase, received tilpisertib 300 mg tablets orally once daily for up to 50 weeks in the Open-label Treatment phase.
|
Tilpisertib 300 mg From Placebo (Open-label Treatment Phase)
n=3 Participants
Participants who received placebo and did not achieve clinical response per modified MCS at Week 10 in the Blinded Treatment phase, received tilpisertib 300 mg tablets orally once daily for up to 50 weeks in the Open-label Treatment phase.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)
|
57.1 percentage of participants
|
50.0 percentage of participants
|
50.0 percentage of participants
|
50.0 percentage of participants
|
66.7 percentage of participants
|
66.7 percentage of participants
|
SECONDARY outcome
Timeframe: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label phase: First dose date up to 50.7 weeks plus 30 daysPopulation: Participants in the Safety Analysis Set were analyzed.
Treatment-emergent laboratory abnormalities for Blinded Treatment phase are defined as values that increase at least 1 toxicity grade from baseline at any postbaseline time point, up to and including the date of last dose of Blinded Treatment phase study drug plus 30 days for participants who permanently discontinued Blinded Treatment phase study drug or before the first dose of Open-label Treatment phase study drug. For the Open-label Treatment phase, treatment-emergent laboratory abnormalities are defined as values that increase at least 1 toxicity grade from Open-label baseline at any postbaseline time point, up to and including the date of last dose of Open-label Treatment phase study drug plus 30 days for participants who permanently discontinued Open-label phase study drug. For maximum postbaseline toxicity grade, the most severe graded abnormality from all tests was counted for each patient. Grade 1: mild; Grade 2: moderate; Grade 3: severe; Grade 4: life-threatening.
Outcome measures
| Measure |
Tilpisertib 300 mg (Blinded Treatment Phase)
n=7 Participants
Tilpisertib 300 mg tablet orally once daily up to Week 10. Participants who achieved clinical response per modified MCS at Week 10, continued to receive tilpisertib 300 mg tablets orally once daily for a maximum of 50 weeks in the Blinded Treatment phase.
|
Tilpisertib 100 mg (Blinded Treatment Phase)
n=6 Participants
Tilpisertib 100 mg tablet orally once daily up to Week 10. Participants who achieved clinical response per modified MCS at Week 10, continued to receive tilpisertib 100 mg tablets orally once daily for a maximum of 50 weeks in the Blinded Treatment phase.
|
Placebo (Blinded Treatment Phase)
n=6 Participants
Placebo tablet orally once daily up to Week 10. Participants who achieved clinical response per modified MCS at Week 10, continued to receive placebo tablets orally once daily for a maximum of 50 weeks in the Blinded Treatment phase.
|
Tilpisertib 300 mg From Tilpisertib 300 mg (Open-label Treatment Phase)
n=4 Participants
Participants who received tilpisertib 300 mg and did not achieve clinical response per modified MCS at Week 10 in the Blinded Treatment phase, received tilpisertib 300 mg tablets orally once daily for up to 50 weeks in the Open-label Treatment phase.
|
Tilpisertib 300 mg From Tilpisertib 100 mg (Open-label Treatment Phase)
n=3 Participants
Participants who received tilpisertib 100 mg and did not achieve clinical response per modified MCS at Week 10 in the Blinded Treatment phase, received tilpisertib 300 mg tablets orally once daily for up to 50 weeks in the Open-label Treatment phase.
|
Tilpisertib 300 mg From Placebo (Open-label Treatment Phase)
n=3 Participants
Participants who received placebo and did not achieve clinical response per modified MCS at Week 10 in the Blinded Treatment phase, received tilpisertib 300 mg tablets orally once daily for up to 50 weeks in the Open-label Treatment phase.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Who Experienced Laboratory Abnormalities
Grade 1
|
42.9 percentage of participants
|
66.7 percentage of participants
|
16.7 percentage of participants
|
25.0 percentage of participants
|
33.3 percentage of participants
|
66.7 percentage of participants
|
|
Percentage of Participants Who Experienced Laboratory Abnormalities
Grade 2
|
28.6 percentage of participants
|
33.3 percentage of participants
|
50.0 percentage of participants
|
25.0 percentage of participants
|
0 percentage of participants
|
33.3 percentage of participants
|
|
Percentage of Participants Who Experienced Laboratory Abnormalities
Grade 3
|
14.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
25.0 percentage of participants
|
66.7 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Who Experienced Laboratory Abnormalities
Grade 4
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
Adverse Events
Tilpisertib 300 mg (Blinded Treatment Phase)
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Tilpisertib 100 mg (Blinded Treatment Phase)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo (Blinded Treatment Phase)
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Tilpisertib 300 mg From Tilpisertib 300 mg (Open-label Treatment Phase)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Tilpisertib 300 mg From Tilpisertib 100 mg (Open-label Treatment Phase)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Tilpisertib 300 mg From Placebo (Open-label Treatment Phase)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tilpisertib 300 mg (Blinded Treatment Phase)
n=7 participants at risk
Tilpisertib 300 mg tablet orally once daily up to Week 10. Participants who achieved clinical response per modified MCS at Week 10, continued to receive tilpisertib 300 mg tablets orally once daily for a maximum of 50 weeks in the Blinded Treatment phase.
|
Tilpisertib 100 mg (Blinded Treatment Phase)
n=6 participants at risk
Tilpisertib 100 mg tablet orally once daily up to Week 10. Participants who achieved clinical response per modified MCS at Week 10, continued to receive tilpisertib 100 mg tablets orally once daily for a maximum of 50 weeks in the Blinded Treatment phase.
|
Placebo (Blinded Treatment Phase)
n=6 participants at risk
Placebo tablet orally once daily up to Week 10. Participants who achieved clinical response per modified MCS at Week 10, continued to receive placebo tablets orally once daily for a maximum of 50 weeks in the Blinded Treatment phase.
|
Tilpisertib 300 mg From Tilpisertib 300 mg (Open-label Treatment Phase)
n=4 participants at risk
Participants who received tilpisertib 300 mg and did not achieve clinical response per modified MCS at Week 10 in the Blinded Treatment phase, received tilpisertib 300 mg tablets orally once daily for up to 50 weeks in the Open-label Treatment phase.
|
Tilpisertib 300 mg From Tilpisertib 100 mg (Open-label Treatment Phase)
n=3 participants at risk
Participants who received tilpisertib 100 mg and did not achieve clinical response per modified MCS at Week 10 in the Blinded Treatment phase, received tilpisertib 300 mg tablets orally once daily for up to 50 weeks in the Open-label Treatment phase.
|
Tilpisertib 300 mg From Placebo (Open-label Treatment Phase)
n=3 participants at risk
Participants who received placebo and did not achieve clinical response per modified MCS at Week 10 in the Blinded Treatment phase, received tilpisertib 300 mg tablets orally once daily for up to 50 weeks in the Open-label Treatment phase.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Proctalgia
|
14.3%
1/7 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/6 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/6 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/4 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/3 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/3 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
|
Infections and infestations
Campylobacter infection
|
0.00%
0/7 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/6 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
16.7%
1/6 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/4 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/3 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/3 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
Other adverse events
| Measure |
Tilpisertib 300 mg (Blinded Treatment Phase)
n=7 participants at risk
Tilpisertib 300 mg tablet orally once daily up to Week 10. Participants who achieved clinical response per modified MCS at Week 10, continued to receive tilpisertib 300 mg tablets orally once daily for a maximum of 50 weeks in the Blinded Treatment phase.
|
Tilpisertib 100 mg (Blinded Treatment Phase)
n=6 participants at risk
Tilpisertib 100 mg tablet orally once daily up to Week 10. Participants who achieved clinical response per modified MCS at Week 10, continued to receive tilpisertib 100 mg tablets orally once daily for a maximum of 50 weeks in the Blinded Treatment phase.
|
Placebo (Blinded Treatment Phase)
n=6 participants at risk
Placebo tablet orally once daily up to Week 10. Participants who achieved clinical response per modified MCS at Week 10, continued to receive placebo tablets orally once daily for a maximum of 50 weeks in the Blinded Treatment phase.
|
Tilpisertib 300 mg From Tilpisertib 300 mg (Open-label Treatment Phase)
n=4 participants at risk
Participants who received tilpisertib 300 mg and did not achieve clinical response per modified MCS at Week 10 in the Blinded Treatment phase, received tilpisertib 300 mg tablets orally once daily for up to 50 weeks in the Open-label Treatment phase.
|
Tilpisertib 300 mg From Tilpisertib 100 mg (Open-label Treatment Phase)
n=3 participants at risk
Participants who received tilpisertib 100 mg and did not achieve clinical response per modified MCS at Week 10 in the Blinded Treatment phase, received tilpisertib 300 mg tablets orally once daily for up to 50 weeks in the Open-label Treatment phase.
|
Tilpisertib 300 mg From Placebo (Open-label Treatment Phase)
n=3 participants at risk
Participants who received placebo and did not achieve clinical response per modified MCS at Week 10 in the Blinded Treatment phase, received tilpisertib 300 mg tablets orally once daily for up to 50 weeks in the Open-label Treatment phase.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
14.3%
1/7 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/6 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/6 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/4 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/3 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/3 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
|
Ear and labyrinth disorders
External ear inflammation
|
14.3%
1/7 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/6 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/6 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/4 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/3 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/3 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
14.3%
1/7 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/6 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/6 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
25.0%
1/4 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/3 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
33.3%
1/3 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/7 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
16.7%
1/6 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/6 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/4 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/3 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/3 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
|
Gastrointestinal disorders
Haemorrhoids thrombosed
|
14.3%
1/7 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/6 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/6 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/4 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/3 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/3 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
|
General disorders
Pyrexia
|
14.3%
1/7 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/6 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/6 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/4 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/3 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/3 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/7 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
16.7%
1/6 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/6 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/4 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/3 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/3 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
|
Infections and infestations
Asymptomatic COVID-19
|
0.00%
0/7 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/6 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/6 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
25.0%
1/4 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/3 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/3 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
|
Infections and infestations
Cystitis
|
0.00%
0/7 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/6 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
16.7%
1/6 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/4 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/3 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/3 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/7 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/6 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
16.7%
1/6 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/4 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/3 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/3 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
|
Infections and infestations
Mastitis
|
0.00%
0/7 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/6 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/6 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/4 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/3 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
33.3%
1/3 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/7 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
16.7%
1/6 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/6 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/4 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/3 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/3 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
|
Infections and infestations
Viral infection
|
0.00%
0/7 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
16.7%
1/6 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/6 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/4 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/3 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/3 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
14.3%
1/7 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/6 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/6 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/4 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/3 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/3 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/7 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
16.7%
1/6 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/6 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/4 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/3 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/3 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
14.3%
1/7 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/6 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/6 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/4 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/3 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/3 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
0.00%
0/7 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
16.7%
1/6 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/6 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/4 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/3 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/3 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/7 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
16.7%
1/6 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/6 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/4 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/3 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/3 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/7 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/6 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
16.7%
1/6 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/4 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/3 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/3 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.3%
1/7 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/6 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/6 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/4 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/3 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/3 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
14.3%
1/7 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/6 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/6 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/4 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/3 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/3 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/7 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/6 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
16.7%
1/6 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/4 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/3 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/3 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/7 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/6 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/6 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/4 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
33.3%
1/3 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/3 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
|
Nervous system disorders
Headache
|
0.00%
0/7 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
16.7%
1/6 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
16.7%
1/6 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/4 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/3 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
33.3%
1/3 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/7 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/6 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
16.7%
1/6 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/4 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/3 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/3 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/7 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/6 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/6 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/4 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
33.3%
1/3 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/3 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/7 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/6 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
16.7%
1/6 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/4 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/3 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/3 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
14.3%
1/7 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/6 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
16.7%
1/6 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/4 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/3 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/3 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
14.3%
1/7 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/6 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/6 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
25.0%
1/4 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/3 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/3 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/7 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/6 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
16.7%
1/6 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/4 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/3 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/3 • Adverse Events: Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label Treatment phase: First dose date up to 50.7 weeks plus 30 days; All-Cause Mortality: Enrollment up to Week 70.3
Adverse Events: Safety Analysis Set included all participants who received at least one dose of study drug; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
Additional Information
Gilead Clinical Study Information Center
Gilead Sciences
Phone: 1-833-445-3230 (GILEAD-0)
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
- Publication restrictions are in place
Restriction type: OTHER