Trial Outcomes & Findings for Study to Assess Efficacy and Safety of Cx601, Adult Allogeneic Expanded Adipose-derived Stem Cells (eASC) for the Treatment of Complex Perianal Fistula(s) in Participants With Crohn's Disease (CD) (NCT NCT03279081)
NCT ID: NCT03279081
Last Updated: 2024-09-19
Results Overview
Combined remission was defined as the closure of all treated external openings that were draining at baseline despite gentle finger compression and absence of collection(s) \>2 cm (in at least 2 dimensions) of the treated perianal fistula(s) confirmed by blinded central magnetic resonance imaging (MRI) assessment. Percentages are rounded off to whole number at the nearest decimal.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
568 participants
Primary outcome timeframe
Week 24
Results posted on
2024-09-19
Participant Flow
Participants took part in the study at 113 investigative sites in Belgium, Czechia, Denmark, France, Germany, Hungary, Israel, Italy, Poland, Spain, United Kingdom, Canada, and United States from 15 September 2017 to 26 July 2023.
A total of 568 participants with a diagnosis of Crohn's disease were enrolled in a 1:1 ratio to receive either Cx601 or matching placebo.
Participant milestones
| Measure |
Placebo
Placebo (saline) 24 milliliters (mL) was administered once by local injection.
|
Cx601
Cx601 expanded adipose-derived stem cells (eASCs) 120 million cells (5 million cells per mL) was administered once by local injection.
|
|---|---|---|
|
Overall Study
STARTED
|
285
|
283
|
|
Overall Study
COMPLETED
|
246
|
249
|
|
Overall Study
NOT COMPLETED
|
39
|
34
|
Reasons for withdrawal
| Measure |
Placebo
Placebo (saline) 24 milliliters (mL) was administered once by local injection.
|
Cx601
Cx601 expanded adipose-derived stem cells (eASCs) 120 million cells (5 million cells per mL) was administered once by local injection.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
12
|
20
|
|
Overall Study
Physician Decision
|
4
|
1
|
|
Overall Study
Lost to Follow-up
|
8
|
8
|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Reason not Specified
|
14
|
4
|
Baseline Characteristics
Number of participants analyzed is the number of participants with data available for height at the Baseline.
Baseline characteristics by cohort
| Measure |
Placebo
n=285 Participants
Placebo (saline) 24 mL was administered once by local injection.
|
Cx601
n=283 Participants
Cx601 eASCs 120 million cells (5 million cells/mL) was administered once by local injection.
|
Total
n=568 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.7 years
STANDARD_DEVIATION 10.78 • n=285 Participants
|
38.4 years
STANDARD_DEVIATION 11.91 • n=283 Participants
|
38.1 years
STANDARD_DEVIATION 11.35 • n=568 Participants
|
|
Sex: Female, Male
Female
|
130 Participants
n=285 Participants
|
121 Participants
n=283 Participants
|
251 Participants
n=568 Participants
|
|
Sex: Female, Male
Male
|
155 Participants
n=285 Participants
|
162 Participants
n=283 Participants
|
317 Participants
n=568 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=285 Participants
|
13 Participants
n=283 Participants
|
26 Participants
n=568 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
250 Participants
n=285 Participants
|
240 Participants
n=283 Participants
|
490 Participants
n=568 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
22 Participants
n=285 Participants
|
30 Participants
n=283 Participants
|
52 Participants
n=568 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=285 Participants
|
0 Participants
n=283 Participants
|
1 Participants
n=568 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=285 Participants
|
8 Participants
n=283 Participants
|
13 Participants
n=568 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=285 Participants
|
0 Participants
n=283 Participants
|
0 Participants
n=568 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=285 Participants
|
8 Participants
n=283 Participants
|
15 Participants
n=568 Participants
|
|
Race (NIH/OMB)
White
|
254 Participants
n=285 Participants
|
243 Participants
n=283 Participants
|
497 Participants
n=568 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=285 Participants
|
0 Participants
n=283 Participants
|
0 Participants
n=568 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
18 Participants
n=285 Participants
|
24 Participants
n=283 Participants
|
42 Participants
n=568 Participants
|
|
Height
|
171.78 centimeters (cm)
STANDARD_DEVIATION 9.088 • n=274 Participants • Number of participants analyzed is the number of participants with data available for height at the Baseline.
|
171.59 centimeters (cm)
STANDARD_DEVIATION 9.429 • n=278 Participants • Number of participants analyzed is the number of participants with data available for height at the Baseline.
|
171.69 centimeters (cm)
STANDARD_DEVIATION 9.253 • n=552 Participants • Number of participants analyzed is the number of participants with data available for height at the Baseline.
|
|
Weight
|
77.69 kilograms (kg)
STANDARD_DEVIATION 16.675 • n=274 Participants • Number of participants analyzed is the number of participants with data available for weight at the Baseline.
|
78.73 kilograms (kg)
STANDARD_DEVIATION 19.620 • n=278 Participants • Number of participants analyzed is the number of participants with data available for weight at the Baseline.
|
78.21 kilograms (kg)
STANDARD_DEVIATION 18.209 • n=552 Participants • Number of participants analyzed is the number of participants with data available for weight at the Baseline.
|
|
Body Mass Index (BMI)
Less than 18.5 kilograms per square meter(kg/m^2)
|
4 Participants
n=274 Participants • Number of participants analyzed is the number of participants with data available for BMI at the Baseline.
|
9 Participants
n=278 Participants • Number of participants analyzed is the number of participants with data available for BMI at the Baseline.
|
13 Participants
n=552 Participants • Number of participants analyzed is the number of participants with data available for BMI at the Baseline.
|
|
Body Mass Index (BMI)
18.5 to <25.0 kg/m^2
|
132 Participants
n=274 Participants • Number of participants analyzed is the number of participants with data available for BMI at the Baseline.
|
110 Participants
n=278 Participants • Number of participants analyzed is the number of participants with data available for BMI at the Baseline.
|
242 Participants
n=552 Participants • Number of participants analyzed is the number of participants with data available for BMI at the Baseline.
|
|
Body Mass Index (BMI)
25.0 to <30.0 kg/m^2
|
81 Participants
n=274 Participants • Number of participants analyzed is the number of participants with data available for BMI at the Baseline.
|
92 Participants
n=278 Participants • Number of participants analyzed is the number of participants with data available for BMI at the Baseline.
|
173 Participants
n=552 Participants • Number of participants analyzed is the number of participants with data available for BMI at the Baseline.
|
|
Body Mass Index (BMI)
30.0 kg/m^2 or Higher
|
57 Participants
n=274 Participants • Number of participants analyzed is the number of participants with data available for BMI at the Baseline.
|
67 Participants
n=278 Participants • Number of participants analyzed is the number of participants with data available for BMI at the Baseline.
|
124 Participants
n=552 Participants • Number of participants analyzed is the number of participants with data available for BMI at the Baseline.
|
PRIMARY outcome
Timeframe: Week 24Population: The ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not.
Combined remission was defined as the closure of all treated external openings that were draining at baseline despite gentle finger compression and absence of collection(s) \>2 cm (in at least 2 dimensions) of the treated perianal fistula(s) confirmed by blinded central magnetic resonance imaging (MRI) assessment. Percentages are rounded off to whole number at the nearest decimal.
Outcome measures
| Measure |
Placebo
n=285 Participants
Placebo (saline) 24 mL was administered once by local injection.
|
Cx601
n=283 Participants
Cx601 eASCs 120 million cells (5 million cells/mL) was administered once by local injection.
|
|---|---|---|
|
Percentage of Participants With Combined Remission at Week 24
|
46.32 percentage of participants
Interval 40.53 to 52.1
|
48.76 percentage of participants
Interval 42.94 to 54.59
|
SECONDARY outcome
Timeframe: Week 24Population: The ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not.
Clinical remission was defined as closure of all treated external openings that were draining at baseline despite gentle finger compression. Percentages are rounded off to whole number at the nearest decimal.
Outcome measures
| Measure |
Placebo
n=285 Participants
Placebo (saline) 24 mL was administered once by local injection.
|
Cx601
n=283 Participants
Cx601 eASCs 120 million cells (5 million cells/mL) was administered once by local injection.
|
|---|---|---|
|
Percentage of Participants With Clinical Remission at Week 24
|
47.02 percentage of participants
Interval 41.22 to 52.81
|
49.82 percentage of participants
Interval 44.0 to 55.65
|
SECONDARY outcome
Timeframe: Week 24Population: The ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Overall number analyzed is the number of participants who had clinical remission at Week 24.
Time to clinical remission was defined as the time from treatment start to first visit with closure of all treated external openings that were draining at baseline despite gentle finger compression, as clinically assessed.
Outcome measures
| Measure |
Placebo
n=134 Participants
Placebo (saline) 24 mL was administered once by local injection.
|
Cx601
n=141 Participants
Cx601 eASCs 120 million cells (5 million cells/mL) was administered once by local injection.
|
|---|---|---|
|
Time to Clinical Remission at Week 24
|
7.14 weeks
Interval 7.0 to 11.29
|
7.00 weeks
Interval 6.71 to 7.29
|
SECONDARY outcome
Timeframe: Week 52Population: The ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not.
Combined remission was defined as the closure of all treated external openings that were draining at baseline despite gentle finger compression, and absence of collections \>2 cm (in at least 2 dimensions) confirmed by blinded central MRI assessment. Percentages are rounded off to whole number at the nearest decimal.
Outcome measures
| Measure |
Placebo
n=285 Participants
Placebo (saline) 24 mL was administered once by local injection.
|
Cx601
n=283 Participants
Cx601 eASCs 120 million cells (5 million cells/mL) was administered once by local injection.
|
|---|---|---|
|
Percentage of Participants With Combined Remission at Week 52
|
39.65 percentage of participants
Interval 33.97 to 45.33
|
40.99 percentage of participants
Interval 35.26 to 46.72
|
SECONDARY outcome
Timeframe: Week 52Population: The ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not.
Clinical remission was defined as closure of all treated external openings that were draining at baseline despite gentle finger compression. Percentages are rounded off to whole number at the nearest decimal.
Outcome measures
| Measure |
Placebo
n=285 Participants
Placebo (saline) 24 mL was administered once by local injection.
|
Cx601
n=283 Participants
Cx601 eASCs 120 million cells (5 million cells/mL) was administered once by local injection.
|
|---|---|---|
|
Percentage of Participants With Clinical Remission at Week 52
|
41.40 percentage of participants
Interval 35.69 to 47.12
|
43.11 percentage of participants
Interval 37.34 to 48.88
|
SECONDARY outcome
Timeframe: Week 24Population: The ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not.
Clinical response was defined as closure of at least 50 percent (%) of all treated external openings that were draining at baseline despite gentle finger compression. Percentages are rounded off to whole number at the nearest decimal.
Outcome measures
| Measure |
Placebo
n=285 Participants
Placebo (saline) 24 mL was administered once by local injection.
|
Cx601
n=283 Participants
Cx601 eASCs 120 million cells (5 million cells/mL) was administered once by local injection.
|
|---|---|---|
|
Percentage of Participants With Clinical Response at Week 24
|
58.60 percentage of participants
Interval 52.88 to 64.31
|
61.84 percentage of participants
Interval 56.18 to 67.5
|
SECONDARY outcome
Timeframe: Week 52Population: The ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not.
Clinical response was defined as closure of at least 50% of all treated external openings that were draining at baseline, despite gentle finger compression. Percentages are rounded off to whole number at the nearest decimal.
Outcome measures
| Measure |
Placebo
n=285 Participants
Placebo (saline) 24 mL was administered once by local injection.
|
Cx601
n=283 Participants
Cx601 eASCs 120 million cells (5 million cells/mL) was administered once by local injection.
|
|---|---|---|
|
Percentage of Participants With Clinical Response at Week 52
|
50.88 percentage of participants
Interval 45.07 to 56.68
|
53.71 percentage of participants
Interval 47.9 to 59.52
|
SECONDARY outcome
Timeframe: Week 52Population: The ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Overall number analyzed is the number of participants with clinical remission at Week 52.
Time to clinical remission was defined as the time from treatment start to first visit with closure of all treated external openings that were draining at baseline despite gentle finger compression, as clinically assessed.
Outcome measures
| Measure |
Placebo
n=118 Participants
Placebo (saline) 24 mL was administered once by local injection.
|
Cx601
n=122 Participants
Cx601 eASCs 120 million cells (5 million cells/mL) was administered once by local injection.
|
|---|---|---|
|
Time to Clinical Remission at Week 52
|
7.14 weeks
Interval 7.0 to 11.29
|
7.00 weeks
Interval 6.71 to 7.29
|
SECONDARY outcome
Timeframe: Week 24Population: The ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Overall number analyzed is the number of participants with clinical response at Week 24.
Time to clinical response was defined as the time from treatment start to first visit with closure of at least 50% of all treated external openings that were draining at baseline, despite gentle finger compression, as clinically assessed.
Outcome measures
| Measure |
Placebo
n=167 Participants
Placebo (saline) 24 mL was administered once by local injection.
|
Cx601
n=175 Participants
Cx601 eASCs 120 million cells (5 million cells/mL) was administered once by local injection.
|
|---|---|---|
|
Time to Clinical Response at Week 24
|
6.71 weeks
Interval 6.29 to 6.86
|
6.71 weeks
Interval 6.43 to 7.0
|
SECONDARY outcome
Timeframe: Week 52Population: The ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Overall number analyzed is the number of participants with clinical response at Week 52.
Time to clinical response was defined as time from treatment start to first visit with closure of at least 50% of all treated external openings that were draining at baseline despite gentle finger compression, as clinically assessed.
Outcome measures
| Measure |
Placebo
n=145 Participants
Placebo (saline) 24 mL was administered once by local injection.
|
Cx601
n=152 Participants
Cx601 eASCs 120 million cells (5 million cells/mL) was administered once by local injection.
|
|---|---|---|
|
Time to Clinical Response at Week 52
|
6.71 weeks
Interval 6.29 to 6.86
|
6.71 weeks
Interval 6.43 to 7.0
|
SECONDARY outcome
Timeframe: From Week 24 to Week 52Population: The ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Overall number analyzed is the number of participants who were responders (achieved combined remission) at Week 24.
Relapse was defined as reopening of any of the treated fistulas external openings with active drainage as clinically assessed, or the development of a perianal fluid collection \>2 cm of the treated perianal fistula confirmed by centrally read MRI assessment in participants who were in combined remission at week 24. Percentages are rounded off to whole number at the nearest decimal.
Outcome measures
| Measure |
Placebo
n=132 Participants
Placebo (saline) 24 mL was administered once by local injection.
|
Cx601
n=138 Participants
Cx601 eASCs 120 million cells (5 million cells/mL) was administered once by local injection.
|
|---|---|---|
|
Percentage of Participants With Relapse by Week 52 After Achieving Combined Remission at Week 24
|
31.06 percentage of participants
Interval 23.17 to 38.95
|
34.06 percentage of participants
Interval 26.15 to 41.96
|
SECONDARY outcome
Timeframe: From first dose of study drug to end of follow up period (up to Week 52)Population: The Safety (SAF) Analysis Set included all randomized participants who received the actual study treatment.
An adverse event(AE)=any untoward medical occurrence in a clinical investigation participant receiving a medicinal product; it did not necessarily have to have a causal relationship with this treatment. Serious adverse event(SAE)=any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization/prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital abnormality/birth defect, or was a medically significant event or required intervention to prevent at least one of the outcomes listed above, or was a suspected transmission of an infectious agent. AESIs included tumorigenicity, ectopic tissue formation, hypersensitivity reactions, transmission of infectious agents, immunogenicity/alloimmune reactions, and medication errors, as reported by the investigator. TEAE=AE whose onset occurred, severity worsened, or intensity increased after receiving the study treatment.
Outcome measures
| Measure |
Placebo
n=274 Participants
Placebo (saline) 24 mL was administered once by local injection.
|
Cx601
n=278 Participants
Cx601 eASCs 120 million cells (5 million cells/mL) was administered once by local injection.
|
|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs), and Treatment-emergent Adverse Events of Special Interest (TEAESIs)
TEAEs
|
201 Participants
|
203 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs), and Treatment-emergent Adverse Events of Special Interest (TEAESIs)
TESAEs
|
35 Participants
|
41 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs), and Treatment-emergent Adverse Events of Special Interest (TEAESIs)
TEAESIs
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From first dose of study drug to end of follow up period (up to Week 52)Population: SAF Analysis Set included all randomized participants who received the actual study treatment.
Vital signs included measurement of pulse rate, systolic and diastolic blood pressure, respiratory rate, and body temperature. Clinically significant vital signs assessment was based on investigator interpretation. Number of participants with clinically significant changes in vital signs were reported.
Outcome measures
| Measure |
Placebo
n=274 Participants
Placebo (saline) 24 mL was administered once by local injection.
|
Cx601
n=278 Participants
Cx601 eASCs 120 million cells (5 million cells/mL) was administered once by local injection.
|
|---|---|---|
|
Number of Participants With Clinically Significant Changes in Vital Sign Parameters
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From first dose of study drug to end of follow up period (up to Week 52)Population: SAF Analysis Set included all randomized participants who received the actual study treatment.
Laboratory parameters included blood chemistry and hematology. Clinically significant laboratory parameters assessment was based on investigator interpretation. Number of participants with clinically significant changes in laboratory parameters (hematology and blood chemistry) were reported.
Outcome measures
| Measure |
Placebo
n=274 Participants
Placebo (saline) 24 mL was administered once by local injection.
|
Cx601
n=278 Participants
Cx601 eASCs 120 million cells (5 million cells/mL) was administered once by local injection.
|
|---|---|---|
|
Number of Participants With Clinically Significant Changes in Laboratory Parameters
|
0 Participants
|
0 Participants
|
Adverse Events
Placebo
Serious events: 35 serious events
Other events: 67 other events
Deaths: 0 deaths
Cx601
Serious events: 41 serious events
Other events: 66 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Placebo
n=274 participants at risk
Placebo (saline) 24 mL was administered once by local injection.
|
Cx601
n=278 participants at risk
Cx601 eASCs 120 million cells (5 million cells/mL) was administered once by local injection.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.73%
2/274 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
0.00%
0/278 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/274 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
0.36%
1/278 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
|
Infections and infestations
Anal abscess
|
4.4%
12/274 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
4.3%
12/278 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
|
Gastrointestinal disorders
Anal fistula
|
1.5%
4/274 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
1.4%
4/278 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
|
Gastrointestinal disorders
Anal inflammation
|
0.36%
1/274 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
0.00%
0/278 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
|
Immune system disorders
Anaphylactic shock
|
0.00%
0/274 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
0.36%
1/278 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
|
Gastrointestinal disorders
Anorectal discomfort
|
0.36%
1/274 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
0.00%
0/278 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
|
Gastrointestinal disorders
Anorectal disorder
|
0.00%
0/274 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
0.36%
1/278 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/274 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
0.36%
1/278 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/274 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
0.36%
1/278 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.36%
1/274 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
0.00%
0/278 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.36%
1/274 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
0.00%
0/278 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
|
Infections and infestations
COVID-19
|
0.73%
2/274 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
1.1%
3/278 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.36%
1/274 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
0.00%
0/278 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
|
Cardiac disorders
Cardiomyopathy
|
0.36%
1/274 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
0.36%
1/278 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/274 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
0.36%
1/278 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/274 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
0.36%
1/278 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
|
Gastrointestinal disorders
Crohn's disease
|
0.73%
2/274 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
0.72%
2/278 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/274 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
0.36%
1/278 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
|
Nervous system disorders
Dizziness
|
0.36%
1/274 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
0.00%
0/278 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fallopian tube cancer
|
0.77%
1/130 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
0.00%
0/121 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
|
Reproductive system and breast disorders
Female genital tract fistula
|
0.77%
1/130 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
0.83%
1/121 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/274 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
0.36%
1/278 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.00%
0/274 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
0.36%
1/278 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
|
Infections and infestations
Histoplasmosis disseminated
|
0.36%
1/274 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
0.00%
0/278 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/274 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
0.36%
1/278 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.73%
2/274 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
0.00%
0/278 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/274 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
0.36%
1/278 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.36%
1/274 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
0.00%
0/278 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/274 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
0.36%
1/278 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/274 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
0.36%
1/278 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.36%
1/274 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
0.00%
0/278 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.36%
1/274 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
0.00%
0/278 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.00%
0/274 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
0.36%
1/278 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.77%
1/130 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
0.00%
0/121 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
|
Infections and infestations
Perirectal abscess
|
0.36%
1/274 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
0.36%
1/278 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
|
Infections and infestations
Peritonitis
|
0.36%
1/274 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
0.00%
0/278 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/274 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
0.36%
1/278 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
|
Injury, poisoning and procedural complications
Procedural hypotension
|
0.36%
1/274 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
0.00%
0/278 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/274 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
0.36%
1/278 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
|
Gastrointestinal disorders
Proctalgia
|
0.36%
1/274 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
1.8%
5/278 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/274 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
0.36%
1/278 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
|
Infections and infestations
Pyelonephritis
|
0.36%
1/274 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
0.00%
0/278 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/274 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
0.36%
1/278 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.73%
2/274 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
0.72%
2/278 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/274 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
0.36%
1/278 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
|
Nervous system disorders
Syncope
|
0.00%
0/274 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
0.36%
1/278 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/274 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
0.36%
1/278 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/274 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
0.36%
1/278 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/274 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
0.36%
1/278 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
|
Infections and infestations
Viral infection
|
0.36%
1/274 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
0.00%
0/278 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.73%
2/274 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
0.00%
0/278 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
Other adverse events
| Measure |
Placebo
n=274 participants at risk
Placebo (saline) 24 mL was administered once by local injection.
|
Cx601
n=278 participants at risk
Cx601 eASCs 120 million cells (5 million cells/mL) was administered once by local injection.
|
|---|---|---|
|
Infections and infestations
COVID-19
|
8.0%
22/274 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
7.6%
21/278 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
|
Gastrointestinal disorders
Crohn's disease
|
5.8%
16/274 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
4.7%
13/278 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
|
Gastrointestinal disorders
Proctalgia
|
14.6%
40/274 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
14.4%
40/278 • From first dose of study drug to end of follow up period (up to Week 52)
All-cause Mortality: ITT Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not. Serious and Other Adverse Events: SAF Analysis Set included all randomized participants who received the actual study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi-site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER